Cdisc Clinical Research Glossary

SPECIAL RESOURCE ISSUE
CDISC Clinical Research Glossary

Version 7.0
Glossary Terms
CDISC Glossary Project
510(k). Premarket Notification (PMN) Stephen A. Raymond, Project Leader Helle-Mai Gawrylewski, Johnson and
required for certain medical devices. See Johnson PRD; Arthur Gertel, Beardsworth
Glossary Project Core Team*:
http://www.fda.gov/cdrh/510k Patricia Beers Block, Liaison from the Consulting; Stephen A. Raymond, PHT
home.html Office of Science and Health, FDA; Corporation
abbreviation. A set of letters that Orientation: The following Glossary is Glossary follows the practice of
the seventh produced by the Glossary preceding certain terms with the letter
are drawn from a word or from a
Project of CDISC, which seeks to “e” to denote that they pertain to
sequence of words and that are used
harmonize definitions (including electronic or Web implementation.
for brevity in place of the full word or acronyms, abbreviations, and initials) Each term in the Glossary has the
phrase. NOTE: An abbreviation is used in the various standards initiatives following conventions concerning
NOT pronounced as a word, but each undertaken by CDISC in clinical content and order of presentation:
letter is read in sequence (e.g., NIH). research. The purpose of the CDISC
Compare to acronym. Glossary is also to serve the community Term. The word or phrase being
of clinical researchers by selecting and defined is followed by a period. Only
absorption. The process by which defining terms pertaining to clinical proper nouns are capitalized.
research, particularly eClinical
medications reach the blood stream
investigations, sponsored by the Definition. Multiple meanings of the
when administered other than
pharmaceutical industry or a federal same term are numbered 1., 2., 3., etc.
intravenously, for example, through agency. The Glossary is publicly
nasal membranes. See also ADME accessible on the CDISC Web site NOTE: Comments including usage or
(pharmacokinetics). (CDISC.org), where comments on the domain knowledge related to a term
Glossary are welcomed. may follow the definition.
acronym. 1. A word formed from
the beginning letters (e.g., ANSI) or Note that this CDISC Glossary is NOT Source(s). The sources for definitions
a combination of syllables and comprehensive for all words bearing are cited (see “Reference Citations”) in
on human health, medicine, or square brackets. Where the definition
letters (e.g., MedDRA) of a name or
laboratory methods. The Glossary has been altered by CDISC, the citation
phrase. 2. The short set of letters
includes references and links to other states “modified from.” Where the
that identify a clinical study protocol. glossaries such as regulatory definition has been drawn by CDISC
NOTE: An acronym is usually dictionaries and to health-related from text that is not itself a definition,
pronounced as a word, not by controlled terminologies that are the citation states “after” or “from.”
speaking each letter individually. known to be useful in conducting Where no source is listed, the
Compare to abbreviation. clinical research, including the CDISC definition is from CDISC.
Terminology Project.
action letter. An official Related terms. Some definitions offer
Glossary terms are organized synonyms (See), comments, or related
communication from FDA to an
alphabetically by first word according terms (See also or Compare to) to
NDA sponsor announcing an
to the opinion of the Glossary Project sharpen or expand upon the definition.
agency decision. See also approval Team concerning most common usage
letter, approvable letter, not- in clinical research. Thus “source
approvable letter. document verification” would appear *See Reference Citations, p. 52, for
under “source,” not “verification.” The Glossary Project Team Members
activation. Enabling an eClinical
trial system to capture data; usually
used for EDC systems. clinical trial. Subjects must be screened match any single one of the exclusion
to ensure that their characteristics criteria set up for the study.
admission criteria. Basis for match a list of admission criteria See also inclusion criteria, exclusion
selecting target population for a and that none of their characteristics criteria.
12 APPLIED CLINICAL TRIALS appliedclinicaltrialsonline.com December 2008

adverse drug experience. choices among alternative decisions to the set based upon the intent-to-treat
See adverse drug reaction. reach a calculated result or decision. principle. [ICH E9]
adverse drug reaction (ADR). Any alpha error. The likelihood that a analysis variables. Variables used
noxious and unintended response relationship observed between 2 to test the statistical hypotheses
associated with the use of a drug in variables is due to chance. The identified in the protocol and analysis
humans. 1. Post-approval: an adverse probability of a Type 1 error. [Modified plan; variables to be analyzed. [PR
event that occurs at doses normally used from AMA Manual of Style] Project] See also variable.
in man for prophylaxis, diagnosis, or
therapy of diseases or for modification of anchor. Designation for a planned
amendment. A written description
physiological function. 2. Pre-approval: activity, often marking the transition
of a change(s) to, or formal clarification
an adverse event that occurs at any dose between epochs or elements of a
of, a protocol.
and where a causal relationship is at clinical study plan (e.g., “FPFV—first
least a reasonable possibility. NOTE: FDA patient first visit”).
American National Standards
21 CFR 310.305 defines an adverse drug
Institute (ANSI). Founded in 1918,
experience to include any adverse event, applet. A small application, typically
ANSI itself does not develop standards.
“whether or not considered to be drug- downloaded from a server.
ANSI’s roles include serving as the
related.” CDISC recognizes that current
coordinator for U.S. voluntary standards
usage incorporates the concept of application software. See
efforts, acting as the approval body to
causality. [WHO Technical Report application.
recognize documents developed by
498(1972); ICH E2A]
other national organizations as
American National Standards, acting as application. 1. Computer
adverse event (AE). Any untoward
the U.S. representative in international application: software designed to fill
medical occurrence in a patient or clinical
and regional standards efforts, and specific needs of a user; for example,
investigation subject administered a
serving as a clearinghouse for national software for navigation, project
pharmaceutical product and which does
and international standards management, or process control. 2.
not necessarily have a causal relationship
development information. [HL7] Regulatory application: application
with this treatment. An adverse event
made to a health authority to invest-
(AE) can therefore be any unintended sign
analysis dataset. An organized igate, market, or license a new product
(including an abnormal laboratory
collection of data or information with a or indication. Synonyms: 1. computer
finding), symptom, or disease temporally
common theme arranged in rows and application, application software.
associated with the use of a medicinal
(investigational) product, whether or not columns and represented as a single file;
comparable to a database table. NOTE: approvable letter. An official
related to the medicinal (investigational)
Standardizing analysis datasets is communication from FDA to an
product. NOTE: For further information,
intended to make review and assessment NDA/BLA sponsor that lists issues to be
see the ICH Guideline for Clinical Safety
of analysis more consistent [ADaM]. resolved before an approval can be
Data Management: Definitions and
issued. [Modified from 21 CFR 314.3;
Standards for Expedited Reporting.
Guidance to Industry and FDA Staff
“[Modified from ICH E2A]” Synonyms: analysis set. A set of subjects whose
(10/08/2003)]
side effect, adverse experience. See also data are to be included in the main
serious adverse event, serious adverse analyses. This should be defined in the
approval (in relation to
experience. statistical section of the protocol.
institutional review boards). The
NOTE: There are a number of potential
affirmative decision of the IRB that the
adverse experience. See adverse analysis sets, including, for example, clinical trial has been reviewed and may
event.
adverse reaction. See adverse drug

reaction.
algorithm. Step-by-step procedure

for solving a mathematical problem;
also used to describe step-by-step
procedures for making a series of
December 2008 appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS 13

SPECIAL RESOURCE ISSUE CDISC CLINICAL RESEARCH GLOSSARY
be conducted at the institution site audit report. A written evaluation by compare groups of participants that
within the constraints set forth by the the auditor of the results of the audit. differ only with respect to the
IRB, the institution, good clinical [Modified from ICH E6 Glossary] intervention (treatment). Although
practice (GCP), and the applicable proper random assignment prevents
regulatory requirements. [ICH E6] audit trail. A process that captures selection bias, it does not guarantee
details such as additions, deletions, or that the groups are equivalent at
approval letter. An official alterations of information in an baseline. Any differences in baseline
communication from FDA to inform an electronic record without obliterating characteristics are, however, the result
applicant of a decision to allow the original record. An audit trail of chance rather than bias. The study
commercial marketing consistent with facilitates the reconstruction of the groups should be compared at baseline
conditions of approval. [Modified from history of such actions relating to the for important demographic and clinical
21 CFR 314.3; Guidance to Industry electronic record. [after ICH E6, CSUICI] characteristics. Baseline data may be
and FDA Staff (10/08/2003)] especially valuable when the outcome
back translation (natural measure can also be measured at the
language). The process of translating start of the trial. [CONSORT Statement]
arm. A planned sequence of elements, a document that was translated from
typically equivalent to a treatment one language to another back to the baseline imbalance. Systematic error
group. [SDTM] See element. original language. Used to ensure that in creating intervention groups, such
consent forms, surveys, and other that they differ with respect to
clinical trial documents will be clear prognosis. That is, the groups differ in
assessment. A measurement,
and accurate in the translated form. measured or unmeasured baseline
evaluation, or judgment for a study
characteristics because of the way
variable pertaining to the status of a
background material. Information participants were selected or assigned.
subject. NOTE: Assessments are usually
pertinent to the understanding of a NOTE: Also used to mean that the
measured at a certain time, and usually
protocol. NOTE: Examples include participants are not representative of the
are not compounded significantly by
investigator brochure, literature review, population of all possible participants.
combining several simultaneous
history, rationale, or other [ICH E9]
measurements to form a derived
documentation that places a study in
assessment (e.g., BMI) or a result of
context or presents critical features. Bayesian approaches. Approaches
statistical analysis. See variable;
[PR Project] to data analysis that provide a posterior
outcome, endpoint; the term
probability distribution for some
assessment is intended to invoke some balanced study. Trial in which a parameter (e.g., treatment effect),
degree of evaluation or judgment particular type of subject is equally derived from the observed data and a
concerning subject status. represented in each study group. prior probability distribution for the
parameter. The posterior distribution is
audit. A systematic and independent bandwidth. An indicator of the then used as the basis for statistical
examination of trial-related activities and throughput (speed) of data flow on a inference. [ICH E9 Glossary]
documents to determine whether the transmission path; the width of the
evaluated trial-related activities were range of frequencies on which a Bayesian statistics. Statistical
conducted and the data were recorded, transmission medium carries electronic approach named for Thomas Bayes
analyzed, and accurately reported signals. All digital and analog signal (1701–1761) that has among its
according to the protocol, sponsor’s channels have a bandwidth. features giving a subjective
standard operating procedures (SOPs), interpretation to probability, accepting
good clinical practice (GCP), and the baseline assessment. Assessment the idea that it is possible to talk about
applicable regulatory requirement(s). of subjects as they enter a trial and the probability of hypotheses being
[ICH E6 Glossary] before they receive any treatment. true and of parameters having
particular values.
baseline characteristics.
audit certificate. Document that beta error. Probability of showing no
Demographic, clinical, and other data
certifies that an audit has taken place significant difference when a true
collected for each participant at the
(at an investigative site, CRO, or clinical difference exists; a false acceptance of
beginning of the trial before the
research department of a pharm- the null hypothesis. See also Type 2
intervention is administered. NOTE:
aceutical company). [ICH E6 Glossary] error. [AMA Manual of Style]
Randomized, controlled trials aim to

bias. Situation or condition that outcome) to determine which has been stopped, sometimes beyond
causes a result to depart from the true medication is being administered. the time of a medication’s known
value in a consistent direction. Bias biological activity.
refers to defects in study design or blinded study. A study in which the
measurement. [AMA Manual of Style. subject, the investigator, or anyone case history. An adequate and
See also ICH E9, CONSORT Statement] assessing the outcome is unaware of accurate record prepared and maintained
the treatment assignment(s). NOTE: by an investigator that records all
bioanalytical assays. Methods for Blinding is used to reduce the potential observations and other data pertinent to
quantitative measurement of a drug, for bias. [Modified ICH E6 Glossary] See the investigation on each individual
drug metabolites, or chemicals in also blinding/masking, double-blind administered the investigational drug
biological fluids. study, single-blind study, triple-blind (device or other therapy) or employed as
study; contrast with open-label or a control in the investigation. NOTE: Case
bioavailability. Rate and extent to unblinded study. histories include the case report forms
which a drug is absorbed or is
and supporting data including, for
otherwise available to the treatment blinding. A procedure to limit bias example, signed and dated consent
site in the body. by preventing subjects and/or study forms and medical records including, for
personnel from identifying which example, progress notes of the physician,
bioequivalence. Scientific basis on treatments or procedures are
which drugs with the same active the individual’s hospital chart(s), and the
administered, or from learning the nurses’ notes. The case history for each
ingredient(s) are compared. NOTE: To results of tests and measures
be considered bioequivalent, the individual shall document that informed
undertaken as part of a clinical consent was obtained prior to
bioavailability of two products must investigation. NOTE: Masking, while
not differ significantly when the two participation in the study. [21 CFR
often used synonymously with 312.62b]
products are given in studies at the blinding, usually denotes concealing
same dosage under similar conditions. the specific study intervention used. case record form. See case report
[from ICH E9] The term masking is form.
biological marker. See biomarker.
often preferred to blinding in the field
Biologics Licensing Application of ophthalmology. [from AMA Manual case report form (CRF). 1. A
(BLA). An application to FDA for a of Style]. See also blinding, double- printed, optical, or electronic document
license to market a new biologic blind study, masking, single-blind designed to record all of the protocol-
product in the United States. study, triple-blind study. Contrast with required information to be reported to
open-label and/or unblinded study. the sponsor for each trial subject. 2. A
biomarker. A characteristic that is
record of clinical study observations
objectively measured and evaluated as branch. Point within a study design
and other information that a study
an indicator of normal biological where there is an allocation of subject
protocol designates must be completed
processes, pathogenic processes, or subsets to particular procedures or
for each subject. NOTE: In common
pharmacologic responses to a treatment groups.
usage, CRF can refer to either a CRF
therapeutic intervention. [Biomarker
brand name. See proprietary name. page, which denotes a group of one or
definitions working group]
Synonyms: trade name; proprietary more data items linked together for
biostatistics. Branch of statistics name. [SPL] collection and display, or a casebook,
applied to the analysis of biological which includes the entire group of CRF
phenomena. browser. Computer program that pages on which a set of clinical study
runs on the user’s desktop computer observations and other information can
blind review. Checking and and is used to navigate the World Wide be or have been collected, or the
assessing data prior to breaking the Web. See also Web browser. information actually collected by
blind, for the purpose of finalizing the completion of such CRF pages for a
planned analysis. [Modified ICH E9] cache. Storage area on a computer’s subject in a clinical study [ICH E6
hard drive where the browser stores Glossary]. See also CRF (paper).
blinded (masked) medications. (for a limited time) Web pages and/or
Products that appear identical in size, graphic elements. case report tabulations (CRT). In
shape, color, flavor, and other attributes a paper submission, listings of data
to make it very difficult for subjects and carry-over effect. Effects of that may be organized by domain (type
investigators (or anyone assessing the treatment that persist after treatment of data) or by subject. See also eCRT.

categorical data. Data evaluated by clean file. When all data cleaning is persistence, stewardship, potential for
sorting values (for example, severe, completed and database is ready for authentication, wholeness, and human
moderate, and mild) into various quality review and unblinding. readability. [SPL]
categories.
client. A program that makes a clinical efficacy. Power or capacity to
service request of another program, produce a desired effect (i.e.,
causality assessment. An
usually running on a server, that fulfills appropriate pharmacological activity in a
evaluation performed by a medical
the request. Web browsers (such as specified indication) in humans. [SQA]
professional concerning the likelihood
that a therapy or product under study Netscape Navigator and Microsoft
clinical investigation. See clinical
caused or contributed to an adverse Explorer) are clients that request HTML
files from Web servers. trial, clinical study. NOTE: Increased
event.
usage of investigation or study in the
clinical benefit. A therapeutic U.S. rather than “trial,” may reflect the
CDISC Standard (The). CDISC term appearance of the term in FDA
intervention may be said to confer
for a proposed uniform CDISC standard regulations concerning clinical research
clinical benefit if it prolongs life,
intended to address the full life-cycle of a activities.
improves function, and/or improves the
clinical trial including protocol
way a subject feels.
representation, capture of source data, clinical pharmacology. Science
submission, and archiving using a set of that deals with the characteristics,
fully integrated and consistent models, clinical clarification. A query
effects, properties, reactions, and uses
terms, and controlled vocabularies derived resolution received from the sponsor
of drugs, particularly their therapeutic
from the current set of CDISC standards. staff (medical monitors, DSMB
value in humans, including their
monitoring board, etc.). See also self-
toxicology, safety, pharmacodynamics,
evident change.
certified copy. A copy of original and pharmacokinetics (ADME).
information that has been verified as
clinical data. Data pertaining to the clinical protocol. See protocol.
indicated by a dated signature, as an
exact copy having all of the same medical well-being or status of a
attributes and information as the patient or subject. clinical research and
original. NOTE: The copy may be development. The testing of a drug
verified by dated signature or by a clinical development plan. A compound in humans primarily done to
validated electronic process. A certified document that describes the collection determine its safety and
copy of a source document may serve of clinical studies that are to be pharmacological effectiveness. Clinical
as a source for a clinical investigation. performed in sequence, or in parallel, development is done in phases, which
See also source data, source. [After with a particular active substance, progress from very tightly controlled
CSUICI] device, procedure, or treatment dosing of a small number of subjects to
strategy, typically with the intention of less tightly controlled studies involving
submitting them as part of an large numbers of patients. [SQA]
Certified IRB Professional (CIP).
application for a marketing
Certification awarded to persons who
authorization. NOTE: The plan should clinical research associate (CRA).
satisfy the educational and
have appropriate decision points and Person employed by a sponsor or by a
employment requirements and pass an
allow modification as knowledge contract research organization acting on
examination conducted by the Applied
accumulates. [from ICH E9] See also a sponsor’s behalf, who monitors the
Research Ethics National Association
development plan. progress of investigator sites participating
(ARENA), the membership division of
in a clinical study. At some sites (primarily
Public Responsibility in Medicine and
clinical document architecture. in academic settings), clinical research
Research (PRIM&R).
Specification for the structure and coordinators are called CRAs.
semantics of “clinical documents” for
clean database. A set of reviewed clinical research coordinator
the purpose of exchange. [HL7; SPL]
data in which errors have been resolved (CRC). Person who handles most of the
to meet QA requirements for error rate administrative responsibilities of a
and in which measurements and other clinical document. A documentation
clinical trial on behalf of a site
values are provided in acceptable units; of clinical observations and services.
investigator, acts as liaison between
database that is ready to be locked. NOTE: An electronic document should
investigative site and sponsor, and
See also database lock, clean file. incorporate the following characteristics:
reviews all data and records before a

monitor’s visit. Synonyms: trial working days). NOTE: Approval means studies can be prospective or
coordinator, study coordinator, research that the company is exempt from the retrospective. [AMA Manual of Style] See
coordinator, clinical coordinator, requirement to hold a clinical trial also prospective study.
research nurse, protocol nurse. certificate (CTC). [UK]
combination product. 1. A product
clinical significance. Change in a clinical trial information. Data comprising two or more individual
subject’s clinical condition regarded as collected in the course of a clinical trial products. 2. Two or more separate
important whether or not due to the or documentation related to the products packaged together in a single
test intervention. NOTE: Some integrity or administration of that data. package or as a unit. 3. A product that
statistically significant changes (in A superset of clinical trial data. is packaged separately but is used only
blood tests, for example) have no with another product. [Modified from
clinical trial materials. Complete
clinical significance. The criterion or SPL Glossary]
set of supplies provided to an
criteria for clinical significance should investigator by the trial sponsor. common data element. A
be stated in the protocol. The term
structured item characterized by a stem
“clinical significance” is not advisable clinician reported outcome.
and response options together with a
unless operationally defined. Clinician assessment of patient
history of usage that can be
outcomes, based on objective or
standardized for research purposes
clinical study (trial) report. A subjective data evaluated by the clinician.
across studies conducted by and for
written description of a study of any
codelist. Finite list of codes and their NIH. NOTE: The mark up or tagging
therapeutic, prophylactic, or diagnostic
meanings that represent the only facilitates document indexing, search
agent conducted in human subjects, in
allowed values for a data item. See also and retrieval, and provides standard
which the clinical and statistical
controlled vocabulary. A codelist is one conventions for insertion of codes.
description, presentations, and analysis
type of controlled vocabulary. [NCI, CaBIG]. See also item.
are fully integrated into a single report.
NOTE: For further information, see the coding. In clinical trials, the process of Common Technical Document. A
the ICH Guideline for Structure and assigning data to categories for analysis format agreed upon by ICH to organize
Content of Clinical Study Reports. [ICH NOTE: Adverse events, for example, applications to regulatory authorities
E6 Glossary] may be coded using MedDRA. for registration of pharmaceuticals for
human use. [ICH] See also eCTD.
clinical study. See clinical trial. cognitive debriefing. A qualitative
research tool used to determine comparative study. One in which
clinical trial. A research investigation whether concepts and items are the investigative drug is compared
involving human subjects that is understood by patients in the same against another product, either active
designed to answer specific questions way that PRO instrument developers drug or placebo.
about the safety and efficacy of a intend. NOTE: Cognitive debriefing
biomedical intervention (drug, interviews involve incorporating follow- comparator (product). An
treatment, device) or new ways of using up questions in a field test interview to investigational or marketed product
a known drug, treatment, or device). gain better understanding of how (i.e., active control), or placebo, used
[modified from ICH E6 Glossary, patients interpret questions asked of as a reference in a clinical trial. [ICH E6
Directive 2001/20/EC] Synonym: clinical them and to collect and consider all Glossary] See also control.
investigation or study. concepts elicited by an item. [from PRO
Draft Guidance Glossary] Competent Authority (CA). The
clinical trial data. Data collected in regulatory body charged with
the course of a clinical trial. See also cohort. 1. A group of individuals who monitoring compliance with the
clinical trial information. share a common exposure, experience or national statutes and regulations of
characteristic. 2. A group of individuals European Member States.
clinical trial exemption (CTX). A followed-up or traced over time in a
cohort study. [AMA Manual of Style] complete file. File for which all data
scheme that allows sponsors to apply
cleaning is complete and database is
for approval for each clinical study in
cohort study. Study of a group of ready for quality review and unblinding.
turn, submitting supporting data to the
individuals, some of whom are exposed
Medicines Control Agency (MCA),
to a variable of interest, in which completion. 1. Subject completion:
which approves or rejects the
subjects are followed over time. Cohort the case where a subject ceases active
application (generally within 35

participation in a trial because the EMEA’s Essential Requirements is control (of electronic records). To
subject has, or is presumed to have, assessed. See also Notified Body. prepare and maintain case histories and
followed all appropriate conditions of a other records for regulated clinical
protocol. 2. Study completion: consent form. Document used investigations. NOTE: Control is often
according to the study protocol, the during the informed consent process used as a casual synonym for the terms in
point at which all protocol-required that is the basis for explaining to 21 CFR 312.62 requiring investigative
activities have been executed. potential subjects the risks and sites to prepare, maintain, and retain
[Modified EU CTD] potential benefits of a study and the adequate and accurate case histories.
rights and responsibilities of the parties
involved. NOTE: The informed consent control group. The group of
compliance (in relation to
document provides a summary of a subjects in a controlled study that
trials). Adherence to trial-related
clinical trial (including its purpose, the receives no treatment, a standard
requirements, good clinical practice
treatment procedures and schedule, treatment, or a placebo. [21 CFR
(GCP) requirements, and the applicable
potential risks and benefits, alternatives 314.126] See also controls.
regulatory requirements. [Modified ICH
E6 Glossary] to participation, etc.) and explains an
individual’s rights as a subject. It is control(s). 1. Comparator against
designed to begin the informed consent which the study treatment is evaluated
computer application. See [e.g., concurrent (placebo, no
process, which consists of conversations
application. treatment, dose-response, active), and
between the subject and the research
team. If the individual then decides to external (historical, published
concept. Discrete notion having a single enter the trial, s/he gives her/his official literature)] 2. Computer: processes or
meaning. In a controlled vocabulary a operations intended to ensure
consent by signing the document.
concept is mapped to one or more of the authenticity, integrity, and
Synonym: informed consent form; see
words that convey its meaning. confidentiality of electronic records.
also informed consent.
NOTE: The protocol incorporates
scientific rationale for selection of
confidence interval. A measure of consumer safety officer (CSO).
comparator and describes how the
the precision of an estimated value. FDA official who coordinates the
comparator serves as a reference point
The interval represents the range of review process of various applications.
for the evaluation. [1. After ICH E10. 2.
values, consistent with the data, that is After 21 CFR Part 11; CSUCT]
believed to encompass the “true” content validity. The extent to
value with high probability (usually which a variable (for example, a rating
controlled study. A study in which
95%). The confidence interval is scale) measures what it is supposed to
a test article is compared with a
expressed in the same units as the measure. [ICH E9 Glossary]
treatment that has known effects. The
estimate. Wider intervals indicate lower control group may receive no
precision; narrow intervals, greater contingent subject trial contact.
treatment, active treatment, placebo,
precision. [CONSORT Statement] Planned response to an anticipated but
or dose comparison concurrent control.
conditional event in a clinical trial.
NOTE: For further information on
[CDISC Trial Design Project]
confidentiality. Prevention of “adequate and well-controlled study”
disclosure to other than authorized see 21 CFR 314.126.
contract research organization
individuals of a sponsor’s proprietary (CRO). A person or an organization
information or of a subject’s identity. controlled terminology. Synonym
(commercial, academic, or other)
[ICH E6 Glossary] for controlled vocabulary.
contracted by the sponsor to perform
one or more of a sponsor’s trial-related
controlled vocabulary. A finite set
confirmatory trial. Phase 3 trial duties and functions. [ICH E6 Glossary]
of values that represent the only
during which the previously revealed
allowed values for a data item. These
actions of a therapeutic intervention are contract. A written, dated, and
values may be codes, text, or numeric.
confirmed. NOTE: Procedures in signed agreement between two or
See also codelist.
confirmatory trials should be set firmly in more involved parties that sets out any
advance. Compare to exploratory trial. arrangements on delegation and
coordinating committee. A
distribution of tasks and obligations
committee that a sponsor may
and, if appropriate, on financial
conformity assessment. The organize to coordinate the conduct of
matters. The protocol may serve as the
process by which compliance with the a multicenter trial. [ICH E6]
basis of a contract. [ICH E6 Glossary]

coordinating investigator. An physical properties of paper to suitable for communication,
investigator assigned the responsibility particular pages. NOTE: Data are interpretation, or processing by
for the coordination of investigators at captured manually and any comments, humans or by automated means. [FDA]
different centers participating in a notes, and signatures are also linked to
multicenter trial. [ICH E6] those data items by writing or data acquisition. Capture of data
typescript on the paper pages. See also into a structured, computerized format
correlation. The degree to which eCRF, case report form. without a human-to-computer
two or more variables are related. interface (i.e., from another measuring
Typically the linear relationship is crossover trial. A trial design for instrument or computerized source).
measured with either Pearson’s which subjects function as their own Contrast with data entry, electronic
correlation or Spearman’s rho. NOTE: control and are assigned to receive data capture.
Correlation does not necessarily mean investigational product and controls in
causation. [After HyperStat Online an order determined by data and safety monitoring
Glossary; ADaM] randomizations, typically with a board (DSMB). See data monitoring
washout period between the two committee.
covariate (prognostic). Factor or products. [Center for the Advancement
condition that influences outcome of a of Clinical Research; ADaM] data capture. See data entry.
trial. [ADaM]
curriculum vitae (cv). Document data clarification. Answer supplied
CRF data. Subset of clinical trial data that outlines a person’s educational by the investigator in response to a
that are entered into fields on a CRF. and professional history. query. NOTE: The investigator may
supply a new data point value to
CRF (paper). Case report form in data. Representations of facts, replace the initial value or a
which the data items are linked by the concepts, or instructions in a manner confirmation of the queried data point.

data clarification form. A form Federal Information Processing component [ANSI]. See also data
used to query an investigator and Standards (FIPS) Publication 46-2] model, data element.
collect feedback to resolve questions
regarding data. data entry. Human input of data into data management conventions.
a structured, computerized format Procedures and policies for data
using an interface such as a keyboard, management (e.g., documented
data collection instrument. A
pen-based tablet, or voice recognition. procedure(s) for resolving self-evident
substrate or tool (either electronic or
NOTE: Although data capture is often changes). [ICH E6] See self-evident
paper) used to record, transcribe, or
used synonymously, capture implies change.
collect clinical data. [PR Project]
direct entry of original source data into
an electronic record rather than data management. Tasks
data element. 1. For XML, an item transcription (entry) from paper source. associated with the entry, transfer,
of data provided in a mark up mode Contrast with data acquisition, and/or preparation of source data and
to allow machine processing. 2. electronic data capture; direct entry. derived items for entry into a clinical
Smallest unit of information in a trial database. NOTE: Data
transaction. 3. A structured item data integrity. A dimension of data management could include database
characterized by a stem and response contributing to trustworthiness and creation, data entry, review, coding,
options together with a history of pertaining to the systems and data editing, data QC, locking, or
usage that can be standardized for processes for data capture, correction, archiving; it typically does not include
research purposes across studies maintenance, transmission, and source data capture.
conducted by and for NIH. NOTE: The retention. Key elements of data
mark up or tagging facilitates integrity include security, privacy, access data model. Unambiguous, formally
document indexing, search and controls, a continuous pedigree from stated, expression of items, the
retrieval, and provides standard capture to archive, stability (of values, relationship among items, and the
conventions for insertion of codes. [1. of attribution), protection against loss structure of the data in a certain
FDA - GL/IEEE. 2. Center for or destruction, ease of review by users problem area or context of use. A
Advancement of Clinical Research. 3. responsible for data quality, proper data model uses symbolic conventions
NCI, caBIG] operation and validation of systems, agreed to represent content so that
training of users. NOTE: In clinical content does not lose its intended
research the FDA requires that data meaning when communicated.
data encryption standard (DES).
relied on to determine safety and
A FIPS approved cryptographic data monitoring. Process by which
efficacy of therapeutic interventions be
algorithm for encrypting (enciphering) clinical data are examined for
trustworthy and establishes guidance
and decrypting (deciphering) binary completeness, consistency, and accuracy.
and regulations concerning practices
coded information. Encrypting data
and system requirements needed to data monitoring committee
converts it to an unintelligible form
promote an acceptable level of data (DMC). Group of individuals with
called cipher. Decrypting cipher
integrity. [FDA, CSUICI, IEEE]. Compare pertinent expertise that reviews on a
converts the data back to its original
with data quality. regular basis accumulating data from
form called plaintext. The standard
specifies both enciphering and an ongoing clinical trial. The DMC
data integrity verification. Process advises the sponsor regarding the
deciphering operations, which are
of manually supervised verification of continuing safety of current
based on a 64 bit binary number called
data for internal consistency. participants and those yet to be
a key. Unauthorized recipients of the
cipher who know the algorithm but do recruited, as well as the continuing
data interchange. Transfer of validity and scientific merit of the trial.
not have the correct key cannot derive
information between two or more NOTE: A DMC can stop a trial if it finds
the original data algorithmically. NOTE:
parties, which maintains the integrity toxicities or if treatment is proved
Data that is considered sensitive by the
of the contents of the data for the beneficial. [After FDA guidance on
responsible authority or data that
purpose intended. See also establishment and operation of clinical
represents a high value should be
interoperability. trial data monitoring committees]
cryptographically protected if it is
vulnerable to unauthorized disclosure
data item. A named component of a data quality. A dimension of data
or undetected modification during
data element. Usually the smallest contributing its trustworthiness and
transmission or while in storage. [from
pertaining to accuracy, sensitivity,

validity, and suitability to purpose. Key database. A collection of data or deployment. Readying an electronic
elements of data quality include information, typically organized for clinical trial system for field use by
attributability, legibility (decipherable, ease and speed of search and retrieval. providing or disseminating capture
unambiguous), contemporaneousness, devices, tokens, or passwords for users
originality (i.e., not duplicated), database lock. Action taken to of an activated system. See activation.
accuracy, precision, completeness, prevent further changes to a clinical
consistency (logical, not out of range). trial database. NOTE: Locking of a derived variable. New variable
NOTE: Scientists may reasonably trust database is done after review, query created as a function of existing
data that are accurate (high quality) that resolution, and a determination has variables and/or application of
have also been reviewed by investigators been made that the database is ready mathematical functions. See also
and protected from unauthorized for analysis. variable, raw data.
alteration (high integrity). See also
ALCOA, data integrity. dataset. A collection of structured
data in a single file. [CDISC, ODM, and design. 1. In the context of clinical
SDS] Compare with analysis dataset, trials, see design configuration. 2. In
data security. Degree to which data the context of eClinical trials systems, a
are protected from the risk of tabulation dataset.
design for an application to support
accidental or malicious alteration or actions on electronic records.
decision rule. Succinct statement of
destruction and from unauthorized
how a decision will be reached based
access or disclosure. [FDA]
upon the expected foreseen clinical design configuration. Clinical trial
benefits in terms of outcomes of the design developed to compare
data selection criteria. The rules
primary endpoint. [FDA documentation] treatment groups in a clinical trial.
by which particular data are selected
NOTE: The configuration usually
and/or transferred between the point
Declaration of Helsinki. A set of requires randomization to one or more
of care and the patient record;
recommendations or basic principles treatment arms, each arm being
subsequently, from the patient record
that guide medical doctors in the allocated a different (or no) treatment.
to the database; and from database to
conduct of biomedical research Examples include: Parallel Group
inclusion in sub-population analyses.
involving human subjects. It was Design, Crossover Design, Factorial
originally adopted by the 18th World Designs. [from ICH E9]
data transformations. Algorithmic
Medical Assembly (Helsinki, Finland,
operations on data or data sets to
1964) and recently revised (52nd WMA development plan. An ordered
achieve a meaningful set of derived
General Assembly, Edinburgh, program of clinical trials, each with
data for analysis. [ADaM] See also
Scotland, October 2000). specific objectives. [Adapted from ICH
derived variable.
E9, see ICH E8]. See also clinical
define.XML. Table used by XML development plan.
data type. Data types define the
review tools to configure a review
structural format of the data carried in
engine to deal with CDISC standard development process. See drug
the attribute and influence the set of
data for a trial. development process.
allowable values an attribute may
assume. [HL7]
demographic data. Characteristics direct access. Permission to examine,
data validation. 1. Checking data of subjects or study populations, which analyze, verify, and reproduce any
for correctness and/or compliance with include such information as age, sex, records and reports that are important
applicable standards, rules, and family history of the disease or condition to evaluation of a clinical trial. NOTE:
conventions. 2. Process used to for which they are being treated, and The party (e.g., domestic and foreign
determine if data are inaccurate, other characteristics relevant to the regulatory authorities, sponsor’s
incomplete, or unreasonable. The study in which they are participating. monitors and auditors) with direct
process may include format checks, access should take all reasonable
completeness checks, check key tests, dependent variable. Outcomes precautions within the constraints of
reasonableness checks, and limit that are measured in an experiment the applicable regulatory
checks. [1. FDA. 2. ISO] and that are expected to change as a requirement(s) to maintain the
result of an experimental manipulation confidentiality of subjects’ identities
data listing. Set of observations of the independent variable(s). [Center and sponsor’s proprietary information.
organized by domain. for Advancement of Clinical Research] [ICH E6 Glossary]

direct entry. Recording of data by
human or automated action where an Ethics Committees
electronic record is the original means Bodies convened to protect human clinical research subjects
of capturing the data into an electronic work under a variety of other names. For convenience and
records system without a paper source consistency, Applied Clinical Trials generally uses the terms
document. Examples are an individual institutional review board and ethics committee. Other names
keying original observations into a and abbreviations for such bodies are shown below.
system or the automatic recording into
the system of the output from CCI committee on clinical investigations
measuring devices such as a balance CCPPRB Comité Consultative pour la Protection des Personnes dans les
that measures subject’s body weight or Recherches Biomédicales (France)
an ECG machine. Compare with data CHR committee on human research
entry, data acquisition. CPPHS committee for the protection of human subjects
CRB central review board
discontinuation. The act of EAB ethical advisory board
concluding participation, prior to EC ethics committee
completion of all protocol-required
HEX human experimentation committee
elements, in a clinical study by an
enrolled subject. NOTE: Four categories HSRC human subjects review committee
of discontinuation are distinguished: 1) IEC independent ethics committee
dropout: active discontinuation by a IRB independent review board; institutional review board
subject [also a noun referring to such a LREC local research ethics committees (UK)
discontinued subject]; 2) investigator- MREC multicentre research ethics committees (UK)
initiated discontinuation [e.g., subject
NIRB noninstitutional review board
experiences an unexpected adverse
event]; 3) loss to follow-up: cessation of NRB noninstitutional review board, also known as an independent
review board
participation without notice by the
subject and without ability to REB research ethics board (Canada)
subsequently contact the subject to
obtain further data; 4) sponsor-initiated function of a part, organ, or system of document (HL7). An ordered
discontinuation [e.g., change in the body as manifested by presentation of XML elements, possibly
protocol]. Note that subject characteristic symptoms and signs. including text and tabular analyses,
discontinuation does not necessarily [Dorland’s Medical Dictionary] description, and figures. Descriptors for
imply exclusion of subject data from
HL7 documents include type, class, and
analysis. “Termination” has a history of
element. NOTE: In HL7, a document can
synonymous use, but is now considered distribution. 1. In statistics, a group
be either physical (referring to the paper)
non-standard. See also withdrawal and of ordered values; the frequencies or
or logical (referring to the content) with
ICH E3, Section 10.1 and FDA Guidance relative frequencies of all possible val-
the following characteristics: 1) Steward-
for Industry: Submission of Abbreviated ues of a characteristic. 2. In pharma-
ship; 2) Potential for authentication; 3)
Reports & Synopses in Support of cokinetics, the processes that control
Wholeness; 4) Human readability; 5)
Marketing Applications, IV A. transfer of a drug from the site of
Persistence; 6) Global vs. local context.
measurement to its target and other
tissues. [1. AMA Manual of Style]. See
discrepancy. The failure of a data document root. The element in an
point to pass a validation check. NOTE: also ADME.
XML document that contains all other
Discrepancies may be detected by
computerized edit checks or
observed/identified by the data
reviewer as a result of manual data
review. See also query.
disease. Any deviation from or

interruption of the normal structure or

elements; the first element in the domain name. The way a particular double-dummy. A technique for
document. [SPL Glossary] Web server is identified on the retaining the blind when administering
Internet. For example, www.fda.gov supplies in a clinical trial, when the two
document type definition (DTD). names the World Wide Web (www) treatments cannot be made identical.
XML specification for content and server for the Food and Drug Supplies are prepared for Treatment A
presentation of data and text in a Administration, which is a government (active and indistinguishable placebo)
document including definitions for the (.gov) entity. [Center for Advancement and for Treatment B (active and
elements considered to be legal in the of Clinical Research] indistinguishable placebo). Subjects
document. NOTE: Agreeing on a then take two sets of treatment; either
common DTD facilitates interoperability dosage. The amount of drug A (active) and B (placebo), or A
among systems incorporating the administered to a patient or test subject (placebo) and B (active). [ICH E9]
agreed standards. [from XML files.com] over the course of the clinical study; a
regulated administration of individual dropout. A subject in a clinical trial
doses. [AMA Manual of Style] who for any reason fails to continue in
documentation. All records, in any
the trial until the last visit or
form (including but not limited to dosage form. Physical characteristics observation required of him/her by the
written, electronic, magnetic, and of a drug product, (e.g., tablet, study protocol. [from ICH E9]
optical records, and scans, x-rays, and capsule, or solution) that contains a
electrocardiograms) that describe or drug substance, generally—but not drug. 1. Article other than food
record the methods, conduct, necessarily—in association with one or intended for use in the diagnosis, cure,
and/or results of a trial, the factors more other ingredients. [21 CFR mitigation, treatment, or prevention of
affecting a trial, and the actions taken. §314.3]. See also drug product. disease; or intended to affect the
[ICH E6 Glossary]
structure or any function of the body.
dosage regimen. The number of
Not a device or a component, part, or
domain. A collection of observations doses per given time period; the
accessory of a device. 2. Substance
with a topic-specific commonality elapsed time between doses (for
recognized by an official pharmacopia
about each subject in a clinical example, every six hours) or the time
or formulary. [from FDA Glossary of
investigation. NOTE: CDISC classifies that the doses are to be given (for
Terms, CDER]
domains. For example, the example, at 8 a.m. and 4 p.m. daily);
Interventions class is a domain that and/or the amount of a medicine (the
drug development process. The
captures investigational treatments, number of capsules, for example) to be
program for advancing an
therapeutic treatments, and surgical given at each specific dosing time.
investigational product from preclinical
procedures that are intentionally [from Center for Advancement of
studies through approval for marketing
administered to the subject (usually for Clinical Research]
following review by regulatory agencies.
therapeutic purposes) either as
specified by the study protocol (e.g., dosage strength. 1. Proportion of
drug product. 1. A dosage form that
exposure), coincident with the study active substance to excipient, measured
contains an active drug ingredient or
assessment period (e.g., concomitant in units of volume or concentration. 2.
placebo. 2. A finished dosage form as
medications), or other substances self- The strength of a drug product tells
described in regulations. [SPL Glossary]
administered by the subject (such as how much of the active ingredient is
alcohol, tobacco, or caffeine). The present in each dosage. [2. FDA
dynamic HTML. Collective term for a
Events class captures occurrences or Glossary of Terms]
combination of tags and options, style
incidents independent of planned study sheets, and programming that allows
dose. The amount of drug
evaluations occurring during the trial users to create Web pages in Hypertext
administered to a patient or test subject
(e.g., “adverse events” or Mark-up Language (HTML) that are
at one time or the total quantity
“disposition”) or prior to the trial (e.g., more responsive to user interaction
administered. [AMA Manual of Style]
“medical history”). The Findings class than previous versions of HTML.
captures the observations resulting
double-blind study. A study in
from planned evaluations such as eClinical trial. Clinical trial in which
which neither the subject nor the
observations made during a physical primarily electronic processes are used
investigator nor the research team
examination, laboratory tests, ECG to plan, collect (acquire), access,
interacting with the subject or data
testing, and sets of individual questions exchange, and archive data required
during the trial knows what treatment
listed on questionnaires. for conduct, management, analysis,
a subject is receiving.

and reporting of the trial. Synonyms: two or more treatments. [ICH E9] See serve also as source data for clinical
eClinical study, eClinical investigation. also treatment effect. trials provided that the controls on the
EMR system and the transfer of such
eCRF. 1. Auditable electronic record effectiveness. The desired measure data to the eClinical trial system were
designed to capture information of a drug’s influence on a disease or to fulfill regulatory requirements (e.g.,
required by the clinical trial protocol to condition as demonstrated by 21 CFR Part 11).
be reported to the sponsor on each substantial evidence from adequate
trial subject. 2. A CRF in which related and well-controlled investigations. electronic personal health
data items and their associated record (ePHR). An electronic record
comments, notes, and signatures are efficacy. The capacity of a drug or for individuals to create, import, store,
linked electronically. NOTE: eCRFs may treatment to produce beneficial effects and use clinical information to support
on the course or duration of a disease their own health.
include special display elements,
at the dose tested and against the
electronic edit checks, and other
illness (and patient population) for
special properties or functions and are electronic record. Any combination
which it is designed.
used for both capture and display of of text, graphics, data, audio, pictorial,
the linked data. [FDA CSUCT] or any other information representation
electronic data capture (EDC).
in digital form that is created, modified,
The process of collecting clinical trial
eCRT. CRTs provided in electronic maintained, archived, retrieved, or
data into a permanent electronic form.
format for eSubmissions (electronic distributed by a computer system. [FDA
NOTE: Permanent in the context of
regulatory submissions). NOTE: CSUCT; 21 CFR Part 11.3 (7)]
these definitions implies that any
According to FDA guidance, eCRTs are changes made to the electronic data
datasets provided as SAS Transport files are recorded with an audit trail. EDC electronic signature. A computer
with accompanying documentation in usually denotes manual entry of CRF data compilation of any symbol or
electronic submissions. They enable data by transcription from source series of symbols, executed, adopted,
reviewers to analyze each dataset for documents. The transcription is or authorized by an individual to be the
each study. Each CRF domain should be typically done by personnel at legally binding equivalent of the
provided as a single dataset; however, investigative sites. See also data entry, individual’s handwritten signature.
additional datasets suitable for direct data entry, data acquisition. [CSUCT Glossary; 21 CFR Part 11.3(7)]
reproducing and confirming analyses
may also be needed. Becoming electronic health record (EHR). element. 1. In trial design, a basic
obsolete, being replaced by SDTM. An electronic record for health care building block for time within a clinical
providers to create, import, store, and trial comprising the following
edit check. An auditable process, use clinical information for patient characteristics: a description of what
usually automated, of assessing the care, according to nationally happens to the subject during the
content of a data field against its recognized interoperability standards. element; a definition of the start of the
expected logical, format, range, or NOTE: The EHR has the following element; a rule for ending the element.
other properties that is intended to distinguishing features: able to be 2. A section of text in an XML
reduce error. NOTE: Time-of-entry edit obtained from multiple sources; document delimited by start and end
checks are a type of edit check that is shareable; interoperable; accessible to tags; or, in the case of empty elements
run (executed) at the time data are authorized parties. [After National (elements with no content, only
first captured or transcribed to an Office of Health Information attributes) indicated by an empty tag.
electronic device at the time entry is Technology—HIT, USHHS] [1. PR Project. 2. HL7]
completed of each field or group of
fields on a form. Back-end edit checks electronic medical record (EMR).
An electronic record for health care endpoint. Variable that pertains to
are a type that is run against data that
providers within one healthcare the efficacy or safety evaluations of a
has been entered or captured
organization to create, store, and use trial. NOTE: Not all endpoints are
electronically and has also been
clinical information for patient care. An themselves assessments since certain
received by a centralized data store.
electronic record derived from a endpoints might apply to populations
computerized system used primarily for or emerge from analysis of results. That
effect. An effect attributed to a
delivering patient care in a clinical is, endpoints might be facts about
treatment in a clinical trial. In most
setting. NOTE: EMRs may serve as assessments (e.g., prolongation of
clinical trials, the treatment effect of
source documents, and such data could survival). See also variable.
interest is a comparison (or contrast) of

enroll. To register or enter a subject NOTE: An investigator who has a paper (binding items together).
into a clinical trial. NOTE: Once a treatment preference or finds out that eSource documents are subject to
subject has been enrolled, the clinical one arm of a comparative trial offers a regulations and guidance that apply to
trial protocol applies to that subject. clinically therapeutic advantage should source documents. See also source
disclose this information to subjects documents. [after eSDI, CDISC]
enrollment. 1. The act of enrolling participating in the trial.
one or more subjects. 2. The class of essential documents. Documents
enrolled subjects in a clinical trial. equivalence trial. A trial with the that individually and collectively permit
primary objective of showing that the evaluation of the conduct of a study
enrollment (cumulative). Current response to two or more treatments and the quality of the data produced.
enrollment as well as any ever-enrolled differs by an amount that is clinically [ICH E6 Glossary]
subjects who have ended participation. unimportant. NOTE: This is usually
demonstrated by showing that the true established name. The official
enrollment (current). Subjects treatment difference is likely to lie name of a drug substance. [Food,
actively continuing to participate in a between a lower and an upper Drug, and Cosmetic Act]
clinical trial as of the current date. equivalence margin of clinically
acceptable differences. ethics committee. See institutional
enrollment (target). The number review board, independent ethics
of subjects in a class or group eSource. Source record that is committee.
(including the total for the entire trial) electronic. See also source, electronic
intended to be enrolled in a trial. record. ethnicity. Denotes social groups with
NOTE: Target enrollments are set so a shared history, sense of identity,
that statistical and scientific objectives geography, and cultural roots.
eSource data (electronic source
of a trial will have a likelihood of being data). Source data captured initially
European Medicines Agency
met as determined by agreement, into a permanent electronic record
(EMEA). The regulatory agency for
algorithm, or other specified process. used for the reconstruction and
the EU.
evaluation of a clinical study. NOTE:
Enterprise Vocabulary Services “Permanent” in the context of these evaluable (for efficacy and
(EVS). A U.S. national resource to house definitions implies that any changes safety). Pertains to data or subjects
and maintain a number of health-related made to the electronic data are that meet Statistical Analysis Plan criteria
glossaries and controlled vocabularies recorded via an audit trail. [ICH, for inclusion in Efficacy/Safety datasets.
under strict versioning. NOTE: Includes CDISC]. See also source data,
the CDISC Glossary. [NCI] permanent data. exclusion criteria. List of
characteristics in a protocol, any one of
epoch. Interval of time in the planned eSource document. The electronic which may exclude a potential subject
conduct of a study. An epoch is record used to aggregate a particular from participation in a study.
associated with a purpose (e.g., instance of eSource data items for
screening, randomization, treatment, capture, transmission, storage, and/or excretion. The act or process of
follow-up), which applies across all arms display, and serving as a source eliminating waste products from the
of a study. NOTE: Epoch is intended as a document for a clinical investigation. body. See also ADME.
standardized term to replace: period, NOTE: Electronic source documents are
cycle, phase, stage. See also arm, visit. recorded in electronic systems exploratory IND study. A clinical
according to conventions (such as study that is conducted early in Phase
ePRO. PRO data initially captured those for PDF documents) that ensure 1; involves very limited human
electronically. NOTE: Usually ePRO data that all the fields of eSource data and exposure and has no therapeutic or
is captured as eSource. [DIA ePRO associated contextual information diagnostic intent (e.g., screening
Working Group]. See also patient (e.g., time of capture, time zone, studies, microdose studies) [FDA
reported outcome, PRO, eSource. authorship, signatures, revisions) are Guidance for Industry, Investigators,
linked to each other in a particular and Reviewers: Exploratory IND Studies,
equipoise. A state in which an structure for presentation. The January 2006] See also Phase 0.
investigator is uncertain about which encoded specifications in the
arm of a clinical trial would be electronic record thus serve the same exploratory study. Phase 1 or 2
therapeutically superior for a patient. role as have the physical properties of study during which the actions of a

therapeutic intervention are assessed final report. A written description of and is screened for potential
and measured. NOTE: Procedures in a trial/study of any therapeutic, enrollment and randomization into a
exploratory studies may appropriately prophylactic, or diagnostic agent study but has not yet been determined
be altered to expand the scope or conducted in human subjects, in which to meet the inclusion/exclusion criteria
method of investigation. Compare to the clinical and statistical description, for the trial.
confirmatory study. presentations, and analyses are fully
integrated into a single report. [ICH E3]
first subject treated. First subject
extraction transformation load who receives the test article or placebo
(ETL). A class of software applications finding. A meaningful interpretation
in a clinical investigation.
for data extraction, transformation, of data or observations resulting from
and loading that are used to planned evaluations. Compare to
implement data interfaces between conclusion, hypothesis. first-in-humans study. The first
disparate database systems, often to Phase 1 study in which the test product
populate data warehouses. first subject in (FSI, FPI). The date is administered to human beings.
and time the first subject is enrolled
and randomized into a study. The
field. Locus on a data collection instru- first-in-man study. See first-in-
subject will have met the
ment (usually a CRF) for recording or humans study.
inclusion/exclusion criteria to
displaying a data element. See data item. participate in the trial and will have
signed an informed consent form. Food and Drug Administration
File Transfer Protocol (FTP). A Synonym: first patient in. (FDA). The United States regulatory
standard protocol for exchanging files authority charged with, among other
between computers on the Internet. first subject screened. First subject responsibilities, granting IND and
See also TCP/IP. who signs the informed consent form NDA approvals.

Form. A collection of items and item clinical trials that provides assurance Organization (SDO) operating in the
groups for capturing and displaying that the data and reported results are healthcare arena. NOTE: Level 7 refers
clinical trial data. credible and accurate and that the to the highest level of the International
rights, integrity, and confidentiality of Standards Organization’s (ISO)
frequentist methods. Statistical trial subjects are protected. NOTE: For communications model for Open
methods, such as significance tests and Guidance on Good Clinical Practice see Systems Interconnection (OSI), the
confidence intervals, which can be COMP/ICH/135/95; Declaration of application level. The application level
interpreted in terms of the frequency of Helsinki; 21 CFR 50, 21 CFR 54, 21 CFR addresses definition of the data to be
certain outcomes occurring in 56, and 21 CFR 312. [ICH] exchanged, the timing of the
hypothetical repeated realizations of the interchange, and the communication of
same experimental situation. [ICH E9] good clinical research practice certain errors to the application. Level 7
(GCRP). Term sometimes used to supports such functions as security
frozen. Status of a database, file, or describe GCP. See good clinical practice. checks, participant identification,
element that has been presumed to be availability checks, exchange
in its final state pending “lock” and granularity. Refers to the size of an mechanism negotiations, and, most
where further editing is prevented information unit in relation to a whole. importantly, data exchange structuring.
without “unfreezing.” NOTE: Freezing NOTE: Structuring “privileges” in
and unfreezing are usually formalized electronic systems is said to be highly healthcare provider. 1. One who
in audit trails and differ from “locking” granular when each of many roles can directly or indirectly administers
and “unlocking” only in the degree of differ in their capacity to act on interventions that are designed to
approval required. See database lock. electronic records. improve the physical or emotional status
of patients. 2. A person licensed,
functional roles (in a study). group sequential design. A trial certified, or otherwise authorized or
See role. design that allows a look at the data at permitted by law to administer
particular time points or after a defined healthcare in the ordinary course of
gender. Subject self-identification re: number of patients have been entered business or practice of a profession,
masculine/feminine. [IOM] See also sex. and followed up based on formulating including a healthcare facility. [1. PR
a stopping rule derived from repeated Project. 2. HL7]
generalizability. The extent to which significance tests. [Center for
the findings of a clinical trial can be Advancement of Clinical Research] healthy volunteer. Subject (not a
reliably extrapolated from the subjects patient) in a clinical trial. NOTE: Usually
who participated in the trial to a broader handwritten signature. The healthy volunteers serve as subjects in
patient population and a broader range scripted name or legal mark of an Phase 1 trials.
of clinical settings. [ICH E9] individual handwritten by that
individual and executed or adopted human subject. Individual who is or
with the present intention to becomes a participant in research,
generic name. The drug identifying
authenticate a writing in a permanent either as a recipient of the test article
name to which all branded (proprietary)
form. NOTE: The act of signing with a or as a control. A subject may be either
names for that indication are associated.
writing or marking instrument such as a healthy human or a patient. [21 CFR
a pen or stylus is preserved. [21CFR 11] 50.3]. Synonym: subject/trial subject.
global assessment variable. A
single variable, usually a scale of ordered
Huriet Law. France’s regulations
categorical ratings, which integrates harmonized standard. A European
covering the initiation and conduct of
objective variables and the investigator’s Norm (EN) that has been accepted by
clinical trials.
overall impression about the state or all Member States and has been
change in state of a subject. [ICH E9] published in the Official Journal of the HyperText Markup Language
European Communities (OJEC). (HTML). A specification of the W3C
glossary. A collection of specialized that provides markup of documents for
words or terms with their meanings. health authority. Synonym for display in a Web browser. [HL7]
regulatory authority. NOTE: Used in the Contrast to XML.
good clinical practice (GCP). A European Union.
standard for the design, conduct, hypertext. Links in a document that
performance, monitoring, auditing, Health Level 7 (HL7). An ANSI- permit browsers to jump immediately
recording, analyses, and reporting of accredited Standards Developing to another document. NOTE: In most

browsers links are displayed as colored, favorable opinion on the trial protocol, other establishments deemed
underlined text. the suitability of the investigator(s), appropriate by the regulatory
facilities, and the methods and material authority(ies). [ICH] See also audit.
hypothesis to test. In a trial, a to be used in obtaining and
statement relating to the possible documenting informed consent of the institution (medical). Any public or
different effect of the interventions on trial subjects. NOTE: The legal status, private entity or agency or medical or
an outcome. The null hypothesis of no composition, function, operations, and dental facility where clinical trials are
such effect is amenable to explicit regulatory requirements pertaining to conducted. [ICH]
statistical evaluation by a hypothesis independent ethics committees may
test, which generates a P value. differ among countries but should allow institutional review board (IRB).
[CONSORT Statement] the independent ethics committee to An independent body constituted of
act in agreement with GCP as described medical, scientific, and non-scientific
impartial witness. A person who is in the ICH guideline. [ICH] See also members, whose responsibility it is to
independent of the trial, who cannot institutional review board. ensure the protection of the rights,
be unfairly influenced by people safety, and well-being of human
involved with the trial, who attends the subjects involved in a trial by, among
indication. A health problem or
informed consent process if the subject other things, reviewing, approving, and
disease that is identified as likely to be
or the subject’s legally acceptable providing continuing review of trial
benefited by a therapy being studied in
representative cannot read, and who protocol and of the methods and
clinical trials. NOTE: Where such a
reads the informed consent form and material to be used in obtaining and
benefit has been established and
any other written information supplied documenting informed consent of the
approved by regulatory authorities, the
to the subject. [ICH] trial subjects. [ICH E6 1.31] Synonyms:
therapy is said to be approved for such
an indication. independent review board, independent
inclusion criteria. The criteria in a
ethics committee, committee for the
protocol that prospective subjects must
protection of human subjects.
meet to be eligible for participation in informed consent. An ongoing
a study. NOTE: Exclusion and inclusion process that provides the subject with instrument. A means to capture
criteria define the study population. explanations that will help in making data (e.g., questionnaire, diary) plus
See also exclusion criteria. educated decisions about whether to all the information and
begin or continue participating in a documentation that supports its use.
independent data monitoring trial. Informed consent is an ongoing, NOTE: Generally, instruments include
committee (IDMC). A committee interactive process rather than a one- clearly defined methods and
established by the sponsor to assess at time information session. NOTE: Under instructions for administration or
intervals the progress of a clinical trial, 21 CFR 50.20, no informed consent responding, a standard format for
safety data, and critical efficacy form may include any “language data collection, and well-documented
variables and recommend to the through which the subject or the methods for scoring, analysis, and
sponsor whether to continue, modify, representative is made to waive or interpretation of results. [from PRO
or terminate the trial. [ICH E9] See also appear to waive any of the subject’s Draft Guidance] Compare to
data monitoring committee. legal rights, or releases or appears to questionnaire, survey (see Comments
release the investigator, the sponsor, on Draft PRO Guidance, April 4, 2006,
independent ethics committee the institution, or its agents from by ISOQoL, p. 8).
(IEC). An independent body (a review liability for negligence.” [ICH] See also
board or a committee, institutional, consent form. intention-to-treat. The principle
regional, national, or supranational) that asserts that the effect of a
constituted of medical/scientific inspection. The act by a regulatory treatment policy can be best assessed
professionals and non-scientific authority(ies) of conducting an official by evaluating the basis of the intention
members, whose responsibility it is to review of documents, facilities, records, to treat a subject (i.e., the planned
ensure the protection of the rights, and any other resources that are treatment regimen) rather than the
safety, and well-being of human deemed by the authority(ies) to be actual treatment given. NOTE: This has
subjects involved in a trial and to related to the clinical trial and that may the consequence that subjects
provide public assurance of that be located at the site of the trial, at the allocated to a treatment group should
protection by, among other things, sponsor’s and/or contract research be followed up, assessed, and analyzed
reviewing and approving/providing organization’s (CRO’s) facilities, or at as members of that group irrespective

of their compliance with the planned [IEEE Standard Computer Dictionary]. investigator’s brochure. A
course of treatment. The principle is See also syntactic, semantic. compilation of the clinical and non-
intended to prevent bias caused by loss clinical data on the investigational
of participants that may reflect non- inter-rater reliability. The property product(s) that is relevant to the study
adherence to the protocol and disrupt of scales yielding equivalent results of the investigational product(s) in
baseline equivalence established by when used by different raters on human subjects.
random assignment. [ICH E9; after different occasions. [ICH E9]
CONSORT Statement] item. 1. A representation of a clinical
intervention. The drug, device, variable, fact, concept, or instruction in a
therapy, or process under investigation manner suitable for communication,
interaction (qualitative and
in a clinical study that is believed to have interpretation, or processing by humans
quantitative). The situation in which
an effect on outcomes of interest in a or by automated means. NOTE: Items are
a treatment contrast (e.g., difference
study (e.g., health-related quality of life, collected together to form item groups.
between investigational product and
efficacy, safety, pharmacoeconomics). 2. An individual question, statement, or
control) is dependent on another factor
Synonyms: therapeutic intervention, task that is evaluated by the patient to
(for example, the center). A
medical product. See also: test articles; address a particular concept to be
quantitative interaction refers to the
devices; drug product; medicinal measured by a PRO instrument. [1.
case where the magnitude of the
product; combination product. CDISC. 2. from PRO Draft Guidance] See
contrast differs at the different levels of
the factor; for a qualitative interaction, also response option.
investigational product. A
the direction of the contrast differs for
pharmaceutical form of an active item definition. 1. In a
at least one level of the factor.
ingredient or placebo being tested or questionnaire or form to be completed
interim analysis(es). Analysis used as a reference in a clinical trial, in a clinical trial, the specification of a
comparing intervention groups at any including a product with a marketing question and the specification of the
time before the formal completion of authorization when used or assembled format and semantics of the response.
the trial, usually before recruitment is (formulated or packaged) in a way 2. Formal specification of the
complete. [CONSORT Statement] different from the approved form, or properties of an item or field of data in
when used for an unapproved an eClinical trial. [2. ODM]
interim analysis schedule. The indication, or when used to gain
time/information points at which further information about an approved item generation. Establishing the
interim analyses are planned. use. NOTE: CDISC includes test articles content to be covered by the items in
in its definition of investigational a PRO instrument, including
interim clinical trial/study products. [ICH] generating item wording, evaluating
report. A report of intermediate the completeness of item coverage of
results and their evaluation based on investigational treatment. An the concepts of interest, and
planned analyses performed during the intervention under investigation in a performing initial assessment of clarity
course of a trial. [ICH] clinical study. and readability. NOTE: PRO instrument
item generation is potentially
internal consistency. Pertaining to investigator. An individual who incomplete without patient
data that do not include contradictions. actually conducts a clinical involvement. [from ISOQOL comments
investigation (i.e., under whose on PRO Draft Guidance]
Internet. A global system of immediate direction the test article is
computer networks that provides the administered or dispensed to, or used item group definition. The
common TCP IP infrastructure for involving a subject, or, in the event of specification in an eClinical trial of a
email, the World Wide Web, and other an investigation conducted by a team collection of items often clinically related
online activities. of individuals, is the responsible leader to each other and useful to consider as
of that team). [21 CFR 50.3] See also an ensemble. NOTE: Item groups are
Internet service provider (ISP). A
sponsor-investigator, site investigator. likely to have greater granularity in
company that provides access to the
analysis datasets using SDTM which can,
Internet for individuals and organizations. investigator/institution. An for example, distinguish between
expression meaning “the investigator different therapy types: study therapy,
interoperability. Ability of two or
and/or institution, where required by prior therapy, concomitant therapy,
more systems or components to
the applicable regulatory protocol forbidden therapies, rescue
exchange information and to use the
requirements.” [ICH E6 1.35] therapies. [ODM]
information that has been exchanged.

Janus. 1. A logical design conceived last subject/patient in (LSI/LPI). markup. Computer-processable
by the FDA for a data warehouse Date and time when the last subject to annotations within a multimedia
intended to integrate submission data, participate in a clinical trial is enrolled. document. NOTE: In the context of the
protocol descriptions, and analysis See also enroll, study initiation. HL7 specification, markup syntax is
plans from clinical and animal studies according to the XML Specification. [HL7]
into as an FDA review environment legal authentication. A completion
that uses a set of validated, standards- status in which a document has been masking. See blinding.
based tools to allow reproducible signed manually or electronically by the
cross-study, data mining, and individual who is legally responsible for matched-pair design. A type of
retrospective comparative analysis. 2. that document. [HL7] parallel trial design in which
The name assigned to a component of investigators identify pairs of subjects
the NCI’s caBIG Clinical Research who are “identical” with respect to
legally acceptable
Information Exchange (CRIX) initiative, relevant factors, then randomize them
representative. An individual or
representing a joint NCI/FDA project to so that one receives Treatment A and
juridical or other body authorized
develop a physical implementation of the other Treatment B. See also pairing.
under applicable law to consent, on
the Janus model. NOTE: Sometimes behalf of a prospective subject, to the
written as JANUS, the term is not an matching. See pairing.
subject’s participation in the clinical
acronym, but harkens to the Roman trial. [ICH, E6 Glossary]
god of gates and doors, beginnings mean. The sum of the values of all
and endings. observations or data points divided by
Leiter der klinischen Prüfung.
the number of observations; an
Under the German Drug Law, the
label. Description of a drug arithmetical average.
physician who is head of the clinical
product/device that includes: the investigation. median. The middle value in a data
indication, who should use it, adverse
set; that is, just as many values are
events, instructions for use, and safety life-threatening adverse greater than the median and lower
information. NOTE: Labels must be event/experience. Any adverse drug than the median value. (With an even
approved by regulatory authorities. experience that places the patient or number of values, the conventional
[FDA; SPL] Synonyms: package insert, subject, in the view of the investigator, median is halfway between the two
patient package leaflet. at immediate risk of death from the middle values.)
reaction as it occurred (i.e., it does not
labeling (content of). All text, include a reaction that, had it occurred medical monitor. A sponsor
tables, and figures in labeling as in a more severe form, might have representative who has medical
described in regulations for a specific caused death). [FDA 21 CFR §312.32; authority for the evaluation of the safety
product (e.g., 21 CFR 201.56 and ICH-E2A] aspects of a clinical trial.
201.57 for human prescription drugs;
201.66 for human over-the-counter longitudinal study. Investigation in medical product. See intervention.
drugs; 21 CFR 801 for medical devices; which data are collected from a
and 21 CFR 606.122 for blood number of subjects over a long period medicinal product. Synonym for
products). See also structured product of time (a well-known example is the therapeutic intervention, but usually a
label. Framingham Study). drug.
laboratory (clinical). A laboratory mapping. In the context of Medicines and Healthcare

providing analyses of samples collected representing or exchanging data, products Regulatory Agency
in clinical care or research. connecting an item or symbol to a (MHRA). The UK government agency
code or concept. Compare with responsible for ensuring that
last subject out/complete translation. medicines and medical devices work,
(LSC/LPC or LSO/LPO). 1. The date and are acceptably safe. [MHRA]
and time when the last subject has marketing support trials. Clinical
reached a planned or achieved studies that are designed to clarify mega-trials. Massive clinical trials
milestone representing the completion therapeutic benefits of a marketed that test the advantages of
of the trial. 2. The last subject to product or to show potential decision- therapeutic interventions by enrolling
complete a trial. See also subject, makers the rationale for preferring one 10,000 or more subjects. Synonym:
patient, completion. therapy over another. large sample trials.

Memorandum of Understand- software quality system. [ISO/IEC/IEEE and reported in accordance with the
ing (MOU). A formal agreement 12207:1995 §5.5.5] protocol, standard operating procedures
between the Food and Drug (SOPs), good clinical practice (GCP), and
Administration (FDA) and federal, missing data. 1. Data not completed the applicable regulatory requirement(s).
state, or local government agencies; or corrupted in reports and case report [ICH E6 Glossary]
academic institutions; and other forms. 2. Particularly the data not
entities. NOTE: The MOU constitutes captured when a subject withdraws monitoring committee. See
an understanding between the parties from a trial. NOTE: Reviewers are independent data-monitoring committee.
but is a non-binding agreement. It is concerned about missing data (meaning
FDA’s policy to enter into MOUs with 2) since patients who are not improved monitoring report. A written report
other entities whenever there is a or who believe they have experienced from the monitor to the sponsor after
need to define lines of authority or side effects may be particularly prone to each site visit and/or other trial-related
responsibility, or to clarify cooperative leave a trial, thus skewing the analysis communication according to the
procedures. of results if such analysis were to be sponsor’s SOPs. [ICH]
done only on the subjects who had
message (HL7). The atomic unit of continued with the trial. Trial designs monitoring visit. A visit to a study
data transferred between systems. It therefore specify plans for how such site to review the progress of a clinical
comprises a group of segments in a missing data will be treated in analysis. study and to ensure protocol adherence,
defined sequence. Each message has a See also intention to treat. accuracy of data, safety of subjects, and
message type that defines its purpose. compliance with regulatory
mode. The most frequently occurring requirements and good clinical practice
NOTE: For example, the Admission,
value in a data set. guidelines. [from ICH E6, 5.18]
Discharge and Transfer (ADT) Message
type is used to transmit portions of a
model. A formal structure for
patient’s ADT data from one system to multicenter study. See multicenter
representing and analyzing a process
another. In HL7, a three-character trial.
such as a clinical trial or the information
code contained within each message
pertaining to a restricted context (e.g.,
identifies its type. [HL7] multicenter trial. Clinical trial
clinical trial data). [CDISC]
conducted according to a single
meta-analysis. The formal protocol but at more than one site and,
modem. From modulator/
evaluation of the quantitative therefore, carried out by more than
demodulator; a device that converts
evidence from two or more trials one investigator. [ICH E9 Glossary]
digital data into analog data that can
bearing on the same question. NOTE: Synonym: multicenter study. See
be transmitted via telephone or cable
This most commonly involves the investigator/institution.
lines used for communications.
statistical combination of summary
statistics from the various trials, but monitor. Person employed by the natural language. Language as
the term is sometimes also used to sponsor or CRO who is responsible for used in ordinary communications
refer to the combination of the raw determining that a trial is being among humans and distinguished from
data. [from ICH E9 Glossary] conducted in accordance with the controlled terminologies and structured
protocol and GCP guidance. NOTE: A languages used exclusively for
monitor’s duties may include but are communication and interoperability
metabolism. The biochemical
not limited to helping to plan and among machines.
alteration of substances introduced
into the body. initiate a trial, assessing the conduct of
trials, and assisting in data analysis, New Drug Application (NDA). An
interpretation, and extrapolation. application to FDA for a license to
metadata. Data that describe other market a new drug in the United States.
Monitors work with the clinical
data, particularly XML tags
research coordinator to check all data
characterizing attributes of values in n-of-1 study. A trial in which an
and documentation from the trial.
clinical data fields. individual subject is administered a
[from ICH E6, 5.18] See also clinical
research associate. treatment repeatedly over a number of
migration. The act of moving a episodes to establish the treatment’s
system or software product (including monitoring. The act of overseeing the effect in that person, often with the
data) from an old to new operational progress of a clinical trial and of order of experimental and control
environment in accordance with a ensuring that it is conducted, recorded, treatments randomized.

nomenclature. Application of objective. The reason for performing ontology. An explicit formal
naming conventions. Compare with a trial in terms of the scientific questions specification of how to represent
vocabulary, terminology. to be answered by the analysis of data relationships among objects, concepts,
collected during the trial. NOTE: The and other entities that belong to a
nonclinical study. Biomedical primary objective is the main question to particular domain of experience or
studies not performed on human be answered and drives any statistical knowledge. See also terminology.
subjects. [ICH E6 Glossary] planning for the trial (e.g., calculation of
the sample size to provide the open-label study. A trial in which
not approvable letter. An official appropriate power for statistical testing). subjects and investigators know which
communication from FDA to inform a Secondary objectives are goals of a trial product each subject is receiving;
sponsor of a marketing application that will provide further information on opposite of a blinded or double-blind
that the important deficiencies the use of the treatment. study. See blinding.
described in the letter preclude
approval unless corrected. objective measurement. A open to enrollment. The status of
measurement of a physiological or a study such that a subject can be
Notified Body (NB). A private medical variable such as blood glucose enrolled into that study. NOTE: Registry
institution charged by the Competent level that is obtained by a measuring terminology in common use is “open
Authority with verifying compliance of device rather than a human judgment to recruitment”; however, recruitment
medical devices (not drugs) with the or assessment. See also outcome, can begin upon IRB approval of the
applicable Essential Requirements patient-reported outcome; objective site; whereas enrollment requires
stated in the Medical Device Directive. measures are observations (SDTM) and availability of study supplies, subject
This process, called Conformity could be endpoints. Patient-reported informed consent, etc., to allow
Assessment, has EU-wide validity once outcomes are subjective participation of eligible subjects.
completed by the NB. measurements.
operational model. The set of
null hypothesis. The assertion that observation. 1. An assessment of
CDISC data standards (including ODM
no true association or difference in the patient condition or analysis of data
and LAB) used to capture and archive
study outcome or comparison of collected on an individual patient or
data from clinical trials.
interest between comparison groups group of patients. 2. (SDTM) A discrete
exists in the larger population from piece of information collected during a
which the study samples are obtained. study. NOTE: Observations (meaning 1) opinion (in relation to
NOTE: A null hypothesis (for are required by protocol (e.g., require independent ethics committee).
example,“subjects will experience no evaluation of patient or data by The judgment and/or the advice
change in blood pressure as a result of investigator/staff). Such planned provided by an independent ethics
administration of the test product”) is observations are typically distinguished committee. [ICH E6 Glossary]
used to rule out every possibility from anecdotal comments noted during
except the one the researcher is trying a clinical trial (which qualify as origin. 1. Source of information
to prove, and is used because most observations under meaning 2). See also collected in the course of a clinical trial.
statistical methods are less able to variable. Referring to an ad hoc Specifically used to differentiate between
prove something true than to provide comment as an observation is colloquial. data collected at point of patient contact
strong evidence that it is false. The [1. CONSORT Statement. 2. SDTM] and data that are derived or calculated.
assertion that no true association or 2. (SDTM) A metadata attribute defined
difference in the study outcome or observer assessment. An for each dataset variable in the “Define”
comparison of interest between assessment of patient condition made document of an SDTM submission that
comparison groups exists in the larger by an observer (investigator, nurse, refers to the source of a variable (e.g.,
population from which the study clinician, family member, etc.). NOTE: CRF, derived, sponsor defined, PRO, etc.).
samples are obtained. See also Distinguished from self-assessment. [1. CONSORT Statement. 2. from SDTM
research hypothesis. [from AMA The observer relies on his or her for descriptions of the Define document]
Manual of Style] judgment to assess the subject. An
interviewer simply capturing subject
original data. The first recorded
Nuremberg Code. Code of ethics, self assessments is not making an
study data values. NOTE: FDA is
set forth in 1947, for conducting observer assessment. Compare to PRO,
allowing original documents and the
human medical research. proxy assessment.
original data recorded on those

documents to be replaced by copies contains or accompanies a marketed or period. NOTE: FDA requires that
provided that the copies have been investigational therapeutic agent once passwords that are part of electronic
verified as identical in content and it is fully prepared for release to signatures be “periodically checked,
meaning. (See FDA Compliance Policy patients and/or subjects in clinical trials. recalled or revised,” but does not
Guide 7150.13). [Modified from mandate password aging. [After NIST,
CSUICI] See also certified copy, source. pairing. A method by which subjects 21 CFR Part 11]
are selected so that two subjects with
outcome (of adverse event). similar characteristics (for example, patient. Person under a physician’s care
Refers to the resolution of an adverse weight, smoking habits) are assigned for a particular disease or condition.
event. NOTE: Often denoted using a to a set, but one receives Treatment A NOTE: A subject in a clinical trial is not
pick list from a controlled terminology and the other receives Treatment B. See necessarily a patient, but a patient in a
such as: Recovered/resolved, also matched-pair design. clinical trial is a subject. See also subject,
recovering/resolving, not recovered/not trial subject, healthy volunteer. Although
resolved, recovered/resolved with parallel trial. Subjects are often used interchangeably as a
sequelae, fatal, or unknown. [SDTM randomized to one of two or more synonym for subject, a healthy volunteer
Events class of observation] differing treatment groups (usually is not a patient.
investigational product and placebo)
outcome. 1. Events or experiences that and usually receive the assigned patient file. One that contains
clinicians or investigators examining the treatment during the entire trial. demographic, medical, and treatment
impact of an intervention or exposure Synonyms: parallel group trial, parallel information about a patient or subject.
measure because they believe such design trial. It may be paper- or computer-based or a
events or experiences may be influenced mixture of computer and paper records.
by the intervention or exposure. 2. parameter. A variable in a model, or
(SDTM) The result of carrying out a a variable that wholly or partially patient-reported outcome (PRO).
mathematical or statistical procedure. characterizes a probability distribution Information coming directly from
NOTE: 1. Such events and experiences (mathematics and statistics). NOTE: In patients or subjects through interviews
are called clinical outcomes clinical trials the term is often used or self-completed questionnaires or
independently of whether they are part synonymously with “variable” for other data capture tools such as diaries
of the original question/protocol of the factual information (age, date of about their life, health condition(s), and
investigation. [1. Guyatt, G., recovery), measurements, and clinical treatment. NOTE: PROs are used to
Schunemann H., Dept. Epidemiology & assessments. It is most appropriately assess outcomes involving the
Statistics, McMaster University—personal linked to statistical conventions and as patients’/subjects’ perceptions,
communication] See also variable; a numeric characteristic of a symptoms, satisfaction with treatment,
outcome can be a result of analysis; population. Parameters are rarely adherence to prescribed regimens. PROs
outcome is more general than endpoint known and are usually estimated by include outcomes recorded by
in that it does not necessarily relate to a statistical computation from samples. interviewers transcribing the views
planned objective of the study. Thus the term is narrower than variable. expressed by the patient, but the term
[Parexel Barnett; ADaM; HyperStat does not apply to outcomes recorded
outcomes research. Research Online] See also variable, outcome. by observers who rely on their own
concerned with benefits, financial
judgment. A PRO is usually a subjective
costs, healthcare system usage, risks, participant. A person or entity with assessment of feeling or function
and quality of life as well as their a role in healthcare or a clinical study. distinguished from a self-reported
relation to therapeutic interventions. NOTE: Participants in a clinical trial may objective measurement such as body
NOTE: Usually distinguished from include subjects and study personnel. A weight. [from PRO Draft Guidance,
research conducted solely to determine subject participates as part of the Gordon Guyatt and Holger Schuneman-
efficacy and safety. [Guyatt et al., group of people who are administered personal communication; Patrick, D.L.,
1993] See also pharmacoeconomics, the therapeutic intervention or control. 2003. After Acquardo C., Berzon C., et
quality of life. See also subject, patient. al., 2001] Synonym: subject-reported
outliers. Values outside of an outcome (SRO). See also outcome,
password aging. A practice subject, patient, instrument.
expected range.
applying to multi-user computer
systems where the validity of a
packaging. The material, both performed activity. Clinical trial
password expires after a certain pre-set
physical and informational, that events as they actually occurred

(as compared with events planned in makeup or the study of genetic are intended to assess new candidate
the protocol). response to a drug. therapeutic and imaging agents. The
study agent is administered at a low
permissible values. Limited pharmacogenomic test. An assay dose for a limited time, and there is
universe of options for data items. intended to study interindividual no therapeutic or diagnostic intent.
(e.g., drop-down menus, codelists, variations in wholegenome or NOTE: FDA Guidance for Industry,
pick lists). candidate gene maps, biomarkers, and Investigators, and Reviewers:
alterations in gene expression or Exploratory IND Studies, January 2006
inactivation that may be correlated classifies such studies as Phase 1.
per-protocol analysis set. The set
with pharmacological function and [Improving the Quality of Cancer
of data generated by the subset of
therapeutic response. Compare to Clinical Trials: Workshop Summary—
subjects who complied with the
pharmacogenetic test. Proceedings of the National Cancer
protocol sufficiently to ensure that
these data would be likely to exhibit the Policy Forum Workshop, Improving the
pharmacogenomics. Science that Quality of Cancer Clinical Trials
effects of treatment according to the
examines inherited variations in genes (Washington, DC, Oct 2007)]
underlying scientific model. [ICH E9]
that dictate drug response and explores
the ways such variations can be used to Phase 1. The initial introduction of
period effect. An effect occurring
predict whether a person will respond an investigational new drug into
during a period of a trial in which
favorably, adversely, or not at all to an humans. Phase 1 studies are typically
subjects are observed and no treatment
investigational product. closely monitored and may be
is administered.
conducted in patients or normal
permanent data. Data that become pharmacokinetics. Study of the volunteer subjects. NOTE: These
or are intended to become part of an processes of bodily absorption, studies are designed to determine the
electronic record in relation to a distribution, metabolism, and excretion metabolism and pharmacologic
regulatory submission. NOTE: Any (ADME) of medicinal products. actions of the drug in humans, the
changes made to such permanent data side effects associated with increasing
are recorded via an audit trail so that pharmacology. Science that deals doses, and, if possible, to gain early
prior values are not obscured. with the characteristics, effects, and evidence on effectiveness. During
uses of drugs and their interactions Phase 1, sufficient information about
pharmacodynamics. Branch of with living organisms. the drug’s pharmacokinetics and
pharmacology that studies reactions pharmacological effects should be
between drugs and living structures, obtained to permit the design of well-
pharmacovigilance. Term used for
including the physiological responses to controlled, scientifically valid Phase 2
adverse event monitoring and reporting.
pharmacological, biochemical, studies. The total number of subjects
physiological, and therapeutic agents. and patients included in Phase 1
phase. One in a set of successive studies varies with the drug, but is
pharmacoeconomics. Branch of stages in a progression or sequence generally in the range of 20 to 80.
economics that applies cost-benefit, such as 1. a step in the progression of Phase 1 studies also include studies of
cost-utility, cost-minimization, and a therapy from initial experimental use drug metabolism, structure–activity
cost-effectiveness analyses to assess in humans to postmarket evaluation. 2. relationships, and mechanism of
the utility of different pharmaceutical a stage in the conduct of a clinical trial. action in humans, as well as studies in
products or to compare drug therapy NOTE: Clinical trials are generally which investigational drugs are used
to other treatments. categorized into four (sometimes five) as research tools to explore biological
phases. A therapeutic intervention may phenomena or disease processes.
pharmacogenetic test. An assay be evaluated in two or more phases [After FDA CDER Handbook, ICH E8]
intended to study interindividual simultaneously in different trials, and
variations in DNA sequence related to some trials may overlap two different Phase 2. Controlled clinical studies
drug absorption and disposition or phases. For meaning 1, see Phase 0–5. conducted to evaluate the effectiveness
drug action. Compare to For meaning 2, see epoch. of the drug for a particular indication
pharmacogenomic test. or indications in patients with the
Phase 0. First-in-human trials, in a disease or condition under study and to
pharmacogenetics. Study of the small number of subjects, that are determine the common short-term side
way drugs interact with genetic conducted before Phase 1 trials and effects and risks associated with the

drug. NOTE: Phase 2 studies are Phase 2 studies, use of the drug in and effects in animals help establish
typically well controlled, closely other patient populations or other boundaries for safe use of the drug in
monitored, and conducted in a stages of the disease, or use of the subsequent human testing (clinical
relatively small number of patients, drug over a longer period of time. studies or trials).
usually involving no more than several [After FDA CDER Handbook, ICH E8]
hundred subjects. [After FDA CDER
Pre-Market Approval
Handbook, ICH E8]
Phase 5. Postmarketing surveillance is Application (PMA). An application
sometimes referred to as Phase 5. See to FDA for a license to market a new
Phase 2A. Controlled clinical studies also outcomes research. device in the United States.
that occur after the completion of
Phase 1 studies and the first set of
placebo. A pharmaceutical primary objective. The primary
exposure-response studies in patients,
preparation that does not contain the objective(s) is the main question to be
and before beginning Phase 2B (i.e.,
investigational agent. In blinded answered and drives any statistical
patient dose-ranging trial) and Phase 3
studies, it is generally prepared to be planning for the trial (e.g., calculation
clinical efficacy-safety studies. [FDA
physically indistinguishable from the of the sample size to provide the appro-
draft Guidance for Industry End of
preparation containing the priate power for statistical testing). [ICH
Phase 2A meetings, 9/08].
investigational product. E6 6.3] See also objective.
Phase 3. Studies are expanded

population. Any finite or infinite primary variable. An outcome
controlled and uncontrolled trials. They
collection of subjects from which a variable specified in the protocol to be
are performed after preliminary
sample is drawn for a study to obtain of greatest importance to the primary
evidence suggesting effectiveness of
estimates for values that would be objective of the trial, usually the one
the drug has been obtained and are
obtained if the entire population were used in the sample size calculation.
intended to gather the additional
sampled. [AMA Style Manual] NOTE: Differences between groups in
information about effectiveness and
safety that is needed to confirm the primary and secondary variable(s)
efficacy and evaluate the overall postmarketing surveillance. are believed to be the result of the
benefit–risk relationship of the drug Ongoing safety monitoring of group-specific interventions. [PR
and to provide an adequate basis for marketed drugs. See also Phase 4 Project; CONSORT Statement]
physician labeling. NOTE: Phase 3 studies, Phase 5 studies. Synonyms: primary endpoint, outcome.
studies usually include from several See also primary objective.
hundred to several thousand subjects.
pragmatic trial. Term used to
[After FDA CDER Handbook, ICH E8] product. 1. Drug product: A finished
describe a clinical study designed to
dosage form that contains a drug
examine the benefits of a product
Phase 3B. A subcategory of Phase 3 substance. 2. A physical entity that is
under real world conditions.
trials done near the time of approval to intended to diagnose, treat, or prevent
elicit additional findings. NOTE: Dossier a disease or other abnormal condition
preamble. A section preceding the and subject to regulatory authority.
review may continue while associated
text of a final FDA regulation published [Modified from FDA Glossary of Terms]
Phase 3B trials are conducted. These
in the Federal Register. NOTE: “The
trials may be required as a condition of
regulatory authority approval. preamble is to contain a thorough and
PROMIS. NIH-sponsored project for
comprehensible explanation of the
the development and evaluation of
reasons for the Commissioner’s decision
Phase 4. Postmarketing (Phase 4) PRO item banks and computer adaptive
on each issue” raised in comments
studies to delineate additional testing for pain, fatigue, physical
submitted in response to the proposed
information about the drug’s risks, function, social function, and
regulation. [from 21CFR10.40]
benefits, and optimal use that may be emotional well-being. [NIH]
requested by regulatory authorities in
conjunction with marketing approval. preclinical studies. Animal studies proprietary name. A commercial
NOTE: These studies could include, but that support Phase 1 safety and name granted by a naming authority
would not be limited to, studying tolerance studies and must comply for use in marketing a drug/device
different doses or schedules of with good laboratory practice (GLP). product. [SPL] Synonyms: trade name,
administration than were used in NOTE: Data about a drug’s activities brand name.

prospective study. Investigation in deviations to the findings of the study furnished by someone other than the
which a group of subjects is recruited can be assessed. Compare to protocol patient and distinguishes the origin of
and monitored in accordance with violation. [See ICH E3] the outcome from a self-report (PRO)
criteria described in a protocol. directly from the patient. NOTE: The
Protocol Identifying Number. term proxy helps qualify outcomes
protocol. A document that describes Any of one or more unique codes that measures that record feelings and
the objective(s), design, methodology, refers to a specific protocol. NOTE: symptoms reported by the patient but
statistical considerations, and There may be multiple numbers (Nat’l not recorded directly. [CDISC (extension
organization of a trial. The protocol number, coop group number). [PR of SDTM based on Table 2 Patrick, D.L.,
usually also gives the background and Project; eudraCT] 2003)] See also observer assessment.
rationale for the trial, but these could
be provided in other protocol protocol referenced documents. proxy respondent. Someone other
referenced documents. Throughout the Protocol referenced documents that than the patient who is responding
ICH GCP Guideline the term protocol optionally supplement the ICH GCP about the patient on behalf of the
refers to protocol and protocol recommended sections of a protocol patient, not as an observer. [Patrick,
amendments. NOTE: Present usage can giving background information and D.L., 2003; DIA ePRO Workgroup]
refer to any of three distinct entities: 1) rationale for the trial. [from ICH E6 Compare to observer assessment.
the plan (i.e., content) of a protocol, 2) 1.44] See also protocol.
the protocol document, and 3) a series
psychometric reliability. See
of tests or treatments (as in oncology). protocol title. Three categories of reliability, psychometric.
[ICH E6 Glossary] protocol title have evolved to address
distinct standardized use cases. 1) psychometric validation. The
protocol amendment(s). A written Scientific Title: A comprehensive specialized process of validating
description of a change(s) to or formal summary of study design and objectives, questionnaires used in outcomes
clarification of a protocol. [ICH E3] aimed at scientific audience. 2) Public research to show that they measure
Title: A brief description intended for what they purport to measure. NOTE:
protocol approval (Sponsor). the lay public in easily understood Several types of validity are
Sponsor action at the completion of language. 3) Trial Acronym: Brief distinguished. For example, face validity
protocol development that is marked popular identifier. NOTE: The scientific means that an assessment instrument
when the signature of the last reviewer title should include the trial acronym, if appears by inspection and
on the protocol approval form has applicable [WHO http://www.who.int/ consideration of the semantic content
been obtained, signifying that all ictrp/data_set/en/index1.html]. Scientific of items in it to be measuring what it is
reviewer changes to the protocol have title may also be referred to as ”official supposed to measure. Construct
been incorporated. NOTE: Approval by title.” Public title may also be referred to validity means that a scale based on
the sponsor usually initiates secondary as “brief title.” one or more items measures an
approvals by IRBs, regulatory
unobservable psychological construct
authorities, and sites. Protocol
protocol violation. A significant (e.g., “distress”) that it is proposed to
amendments usually also require a
departure from processes or procedures measure. Construct validity is usually
cycle of approval by sponsor and study
that were required by the protocol. tested by measuring the correlation in
staff prior to taking effect.
Violations often result in data that are assessments obtained from several
not deemed evaluable for a per- scales purported to measure the same
protocol deviation. A variation
protocol analysis, and may require that construct. [Guyatt et al., 1993; DIA
from processes or procedures defined
the subject(s) who violate the protocol ePRO Workgroup] See also validation;
in a protocol. Deviations usually do not
be discontinued from the study. compare to psychometric reliability.
preclude the overall evaluability of
Compare to protocol deviation.
subject data for either efficacy or
safety, and are often acknowledged psychometrics. The science of
and accepted in advance by the proxy (as an origin of outcome assessing the measurement
sponsor. NOTE: Good clinical practice measures). A proposed standardized characteristics of scales that assess
recommends that deviations be qualifier variable to describe the origin human psychological characteristics.
summarized by site and by category as of observations of the Findings class
part of the report of study results so resulting from outcomes measures. p-value. Study findings can also be
that the possible importance of the Proxy describes outcome data assessed in terms of their statistical

significance. The p-value represents the sponsor’s representative to an investigator records of original observations,
probability that the observed data (or a to resolve an error or inconsistency measurements, and activities (such as
more extreme result) could have arisen discovered during data review. laboratory notes, evaluations, data
by chance when the interventions did recorded by automated instruments)
not differ. [CONSORT Statement] query management. Ongoing without conclusions or interpretations.
process of data review, discrepancy Researcher’s records of subjects/patients,
qualitative variable. One that generation, and resolving errors and such as patient medical charts, hospital
cannot be measured on a continuum inconsistencies that arise in the entry records, X-rays, and attending physician’s
and represented in quantitative relation and transcription of clinical trial data. notes. NOTE: These records may or may
to a scale (race or sex, for example). not accompany an application to a
Data that fit into discrete categories query resolution. The closure of a Regulatory Authority, but must be kept
according to their attributes. query usually based on information in the researcher’s file. See also eSource,
contained in a data clarification. source data, source documents.
quality assurance (QA). All those
planned and systematic actions that are questionnaire. A set of questions or RCRIM. Regulated Clinical Research
established to ensure that the trial is items shown to a respondent in order and Information Management, which is
performed and the data are generated, to get answers for research purposes. a Technical Committee within HL7 (an
documented (recorded), and reported [PRO Draft Guidance] See also acronym pronounced “arcrim”).
in compliance with good clinical instrument, survey.
practice (GCP) and the applicable reconstruction (of a study). For
regulatory requirement(s). [ICH] random allocation. Assignment of eClinical trials FDA expects archival trial
subjects to treatment (or control) records to support review of the data as
quality control (QC). The groups in an unpredictable way. NOTE: well as the processes used for obtaining
operational techniques and activities In a blinded study, assignment and managing the data so that the
undertaken within the quality assurance sequences are concealed, but available trustworthiness of results obtained can
system to verify that the requirements for disclosure in the event a subject has be evaluated. NOTE: Reconstruction
for quality of the trial related activities an adverse experience. from records should support evaluation
have been fulfilled. [ICH] of the operation and validity of
random number table. Table of computerized systems and the
quality of life. A broad ranging numbers with no apparent pattern conformance of the systems to
concept that incorporates an used in the selection of random applicable regulations during design and
individual’s physical health, samples for clinical trials. execution of the trial as well as during
psychological state, level of the period of record retention. [from
independence, social relationships, random sample. Members of a CSUCT VI D, 21 CFR Parts 11, 312]
personal beliefs, and their relationships population selected by a method
to salient features of the environment. designed to ensure that each person in
recruitment (investigators).
NOTE: Quality of Life is one way to the target group has an equal chance
Process used by sponsors to identify,
measure the benefits or negative of selection.
select, and arrange for investigators to
impacts of an “improvement”
serve in a clinical study.
measured in terms of a physiological or randomization. The process of
psychological symptom. QOL research assigning trial subjects to treatment or
seeks to quantify what an intervention control groups using an element of recruitment (subjects). Process
means to a patient’s sense that their chance to determine the assignments in used by investigators to find and enroll
life has changed. [WHO Group, 1994] order to reduce bias. NOTE: Unequal appropriate subjects (those selected on
randomization is used to allocate the basis of the protocol’s inclusion and
quantitative variable. One that subjects into groups at a differential exclusion criteria) into a clinical study.
can be measured and reported rate; for example, three subjects may be
numerically to reflect a quantity or assigned to a treatment group for every recruitment period. Time period
amount, ideally on a continuum. one assigned to the control group. [ICH during which subjects are or are
E6 1.48] See also balanced study. planned to be enrolled in a clinical trial.
query. A request for clarification on a
data item collected for a clinical trial; raw data. Data as originally collected. recruitment target. Number of
specifically a request from a sponsor or Distinct from derived. Raw data includes subjects that must be recruited as

candidates for enrollment into a study particular purpose could then be the condition for which a product is
to meet the requirements of the established by comparing the measured being tested. A product for sore throat,
protocol. In multicenter studies, each reliability to the reliability required for for example, will be expected to have a
investigator has a recruitment target. that purpose. [After Patrick, D.L., 2003] low incidence of troubling side effects.
Compare to psychometric validation; However, the possibility of unpleasant
Reference Information Model see also validation; instrument. side effects may be an acceptable risk
(RIM). An information model used as when testing a promising treatment for
the ultimate defining reference for all repeat rule. Guide for repeating a life-threatening illness.
HL7 standards. [HL7] activities specified in protocol,
including such features as the number role. 1. The function or responsibility
registry. A data bank of information of cycles and the criteria for stopping. assumed by a person in the context of
on clinical trials for drugs for serious or a clinical study. Examples include data
life-threatening diseases and replacement. The act of enrolling a manager, investigator. 2. Classifier for
conditions. NOTE: The registry should clinical trial subject to compensate for variables that describe “observations”
contain basic information about each the withdrawal of another. in the SDTM. Role is a metadata
trial sufficient to inform interested attribute that determines the type of
subjects (and their healthcare representative. See legally information conveyed by an
practitioners) how to enroll in the trial. acceptable representative. observation-describing variable and
[FDAMA 113] standardizes rules for using the
describing variable. [1. HL7. 2. SDTM]
research hypothesis. The proposition
regulatory authorities. Bodies See also functional role.
that a study sets out to support (or
having the power to regulate. NOTE: In disprove); for example, “blood pressure
the ICH GCP guideline the term includes will be lowered by [specific endpoint] in safety. Relative freedom from harm. In
the authorities that review submitted subjects who receive the test product.” clinical trials, this refers to an absence of
clinical data and those that conduct See also null hypothesis. harmful side effects resulting from use
inspections. These bodies are sometimes of the product and may be assessed by
referred to as competent authorities. laboratory testing of biological samples,
response option. One of several
[ICH] Synonym: regulatory agencies. special tests and procedures, psychiatric
choices to be available for selection in
evaluation, and/or physical examination
response to a prompt, question or
reliability, psychometric. The of subjects.
instruction (i.e., a stem) in a PRO item.
degree to which a psychometric See also common data element, stem.
“instrument” is free from random error safety and tolerability. The safety
either by testing the homogeneity of result synopsis. The brief report of a medical product concerns the
content on multi-item tests with prepared by biostatisticians summarizing medical risk to the subject, usually
internal consistency evaluation or primary (and secondary) efficacy results assessed in a clinical trial by laboratory
testing the degree to which the and key demographic information. tests (including clinical chemistry and
instrument yields stable scores over hematology), vital signs, clinical
time. NOTE: Reliability pertains to adverse events (diseases, signs, and
retrospective. Capture of clinical
questions concerning whether an symptoms), and other special safety
trial data is retrospective when it is
instrument is accurate, repeatable, tests (e.g., ECGs, ophthalmology). The
recalled from memory rather than
sensitive. Reliability is distinguished tolerability of the medical product
captured contemporaneously in real-
from validation, which answers represents the degree to which overt
time. NOTE: Retrospective capture is
whether the instrument (e.g., adverse effects can be tolerated by the
important in PROs because of “recall
questionnaire) actually measure the subject. [ICH E9]
bias” and other errors documented in
selected “construct” (latent variable).
psychological research comparing
For example a balance (scale) is easily sample size. 1. A subset of a larger
contemporaneous self-reported
understood as a possibly valid population, selected for investigation
assessments and those that rely on
instrument to measure body weight. Its to draw conclusions or make estimates
recall from memory.
reliability would be assessed by about the larger population. 2. The
measuring the sensitivity, repeatability number of subjects in a clinical trial. 3.
risk. In clinical trials, the probability of
and accuracy of the balance. The Number of subjects required for
harm or discomfort for subjects. NOTE:
validity of using the balance for a primary analysis.
Acceptable risk differs depending on

sample size adjustment. An interim screening trials. Trials conducted to serious adverse experience.
check conducted on blinded data to detect persons with early, mild, and Any experience that suggests a
validate the sample size calculations or asymptomatic disease. significant hazard, contra-indication,
reevaluate the sample size. side effect or precaution. See also
script. A program or a sequence of serious adverse event.
schedule of activities. A instructions that are interpreted or carried
standardized representation of planned out by another program or by a person. server. A computer that controls a
clinical trial activities including central repository of data, files, and/or
interventions (e.g., administering drug, secondary objective. See objective. applications that can be accessed and/or
surgery) and study administrative manipulated in some manner by client
activities (e.g., obtaining informed computers. A file server hosts files for
secondary sponsor. Additional
consent, distributing clinical trial use by client machines. An application
individuals, organizations or other legal
material and diaries, randomization) as server runs programs that may process
persons, if any, that have agreed with
well as assessments. See also schedule and display data exchanged with client
the primary sponsor to take on
of assessments. machines. After the arrival of the Web,
responsibilities of sponsorship. [WHO,
server often refers to software and
CTR Item 6]
schedule of assessments. A computers that perform database
tabular representation of planned queries and collect and present timely
protocol events and activities, in secondary variable. The primary data to users running browsers or other
sequence. [after E3 Annexes IIIa and outcome is the outcome of greatest client applications.
IIIb] Synonym: flow chart. Compare to importance. Data on secondary
study design schematic. outcomes are used to evaluate sex. Phenotypic expression of
additional effects of the intervention. chromosomal makeup that defines a
[CONSORT Statement] See also study subject as male, female, or other.
screen failure. Potential subject who
outcome, endpoint. Compare to gender.
did not meet one or more criteria
required for participation in a trial. See
also screening of subjects. self-evident change. A data side effects. Any actions or effects
discrepancy that can be easily and of a drug or treatment other than the
obviously resolved on the basis of intended effect. Negative or adverse
screen/screening (of
existing information on the CRF (e.g., effects may include headache, nausea,
substances). Screening is the process
obvious spelling errors or the patient is hair loss, skin irritation, or other
by which substances are evaluated in a
known to be a male and a date of last physical problems. Experimental drugs
battery of tests or assays (screens)
pregnancy is provided). See also must be evaluated for both immediate
designed to detect a specific biological
discrepancy. and long-term side effects. See also
property or activity. It can be conducted
on a random basis in which substances adverse reaction.
are tested without any preselection semantic. In the context of a technical
criteria or on a targeted basis in which specification, semantic refers to the single-blind study. A study in
information on a substance with meaning of an element as distinct from which one party, either the investigator
known activity and structure is used as its syntax. Syntax can change without or the subject, does not know which
a basis for selecting other similar affecting semantics. [HL7] medication or placebo is administered
substances on which to run the battery to the subject; also called single-
of tests. [SQA] serious adverse event (SAE) or masked study. See also blind study,
serious adverse drug reaction double-blind study, triple-blind study.
screening (of sites). Determining (serious ADR). Any untoward
the suitability of an investigative site medical occurrence that at any dose: single-masked study. See single-
and personnel to participate in a results in death, is life threatening, blind study.
clinical trial. requires inpatient hospitalization or
prolongation of existing hospitalization, site. See trial site.
screening (of subjects). A process results in persistent or significant
of active consideration of potential disability/incapacity, or is a congenital site investigator. A person
subjects for enrollment in a trial. See anomaly/birth defect. [ICH] See also responsible for the conduct of the
also screen failure. adverse experience. clinical trial at a trial site. If a trial is

conducted by a team of individuals at a (designated by the protocol) or included in clinical trials to ensure that
trial site, the investigator is the referenced as the ones that provide the their specific characteristics are
responsible leader of the team and may information underlying the analyses and considered in interpretation of data
be called the principal investigator. [ICH findings of a clinical investigation. (e.g., geriatric). [FDA]
E6 1.35. 2.] See also investigator. [After ICH E6, CSUICI] See also original
data, certified copy sponsor. 1. An individual, company,
software. Computer programs,
institution, or organization that takes
procedures, rules, and any associated source data. All information in
responsibility for the initiation and
documentation pertaining to the original records and certified copies of
management of a clinical trial,
operation of a system. original records of clinical findings,
although may or may not be the main
observations, or other activities in a
funding organization. If there is also a
software validation. Confirmation clinical trial necessary for the
secondary sponsor, this entity would be
by examination and provision of reconstruction and evaluation of the trial.
considered the primary sponsor. 2. A
objective evidence that software Source data are contained in source
corporation or agency whose
specifications conform to user needs documents (original records or certified
employees conduct the investigation is
and intended uses, and that the copies). [ICH E6; CSUCT]
considered a sponsor and the
particular requirements implemented
employees are considered investigators.
through software can be consistently source data verification. The
[1. After ICH E6 and WHO. 2. 21 CFR
fulfilled. NOTE: Validating software process of ensuring that data that have
50.3 (e)] See also secondary sponsor.
thus should include evaluation of the been derived from source data
suitability of the specifications to accurately represent the source data.
“ensure user needs and intended uses sponsor-investigator. An individual
can be fulfilled on a consistent basis” source document verification. who both initiates and conducts, alone
(21 CFR 820.20). General Principles of The process by which the information or with others, a clinical trial and under
Software Validation; Final Guidance for reported by an investigator is whose immediate direction the
Industry and FDA Staff, Jan 11, 2002. compared with the source records or investigational product is administered
ISO/IEC/IEEE 12207:1995 §3.35; 21 original records to ensure that it is to, dispensed to, or used by a subject.
CFR 820.20; 21 CFR 11.10(a); ISO complete, accurate, and valid. [Schuyl NOTE: The term does not include any
9000-3; Huber, L. (1999) See also and Engel, 1999; Khosla et al., Indian person other than an individual (i.e., it
validation, verification. Verification J. Pharm 32:180-186, 2000] Synonym: does not include a corporation or an
usually concerns confirmation that SDV. See also validation of data. agency). The obligations of a sponsor-
specified requirements have been met, investigator include both those of a
but typically refers to the tracing of source documents. Original sponsor and those of an investigator.
requirements and evidence of documents, data, and records (e.g., [21 CFR 50.3f] [ICH]
conformance in the individual phases hospital records, clinical and office
or modules rather than suitability of charts, laboratory notes, memoranda, standard. Criterion or specification
the complete product. Validation is, subjects’ diaries or evaluation established by authority or consensus
“the evaluation of software at the end checklists, pharmacy dispensing for 1. measuring performance or
of the software development process records, recorded data from automated quality; 2. specifying conventions that
to ensure compliance with the user instruments, copies or transcriptions support interchange of common
requirements” (ANSI/ASQC A3-1978) certified after verification as being materials and information. NOTE:
and should not be thought of as an accurate copies, microfiches, CDISC standards exist to support the
“end-to-end” verification. photographic negatives, microfilm or exchange of clinical data, for example,
magnetic media, x-rays, subject files, at both the syntactic and semantic
source. 1. The specific permanent and records kept at the pharmacy, at levels. See interoperability.
record(s) upon which a user will rely for the laboratories, and at
the reconstruction and evaluation of a medicotechnical departments involved
standard deviation. Indicator of the
clinical investigation. 2. Sometimes used in the clinical trial). See also eSource
relative variability of a variable around its
as shorthand for source documents document, source, original data,
mean; the square root of the variance.
and/or source data. NOTE: Accuracy, certified copy. [ICH; CSUICI]
suitability, and trustworthiness are not
defining attributes of “source.” The special populations. Subsets of standard of care. A guideline for
term identifies records planned study populations of particular interest medical management and treatment.

standard operating procedures stratification. Grouping defined by regulatory criteria. [modified from ICH
(SOPs). Detailed, written instructions to important prognostic factors measured E3] Compare with study start.
achieve uniformity of the performance at baseline. [ICH E9] Synonym: date of first enrollment.
of a specific function. [ICH]
structured product label (SPL). study population. Defined by
standard treatment. A treatment The Structured Product Labeling (SPL) protocol inclusion/exclusion criteria.
currently in wide use and approved by specification is an HL7 ANSI-approved
FDA or other health authority, considered document markup standard that study protocol. See protocol.
to be effective in the treatment of a specifies the structure and semantics
specific disease or condition. for the exchange of product study start. The formal recognition of
information. [HL7] the beginning of a clinical trial that is
statistical analysis plan. A referred to in the clinical study report.
document that contains a more
study. See clinical trial. NOTE:
technical and detailed elaboration of study treatment. See investigational
Occasionally refers to a project of
the principal features of the analysis intervention.
several related clinical trials.
described in the protocol, and includes
detailed procedures for executing the study variable. A term used in trial
statistical analysis of the primary and study coordinator. See clinical
research coordinator. design to denote a variable to be
secondary variables and other data. captured on the CRF. See also variable.
[ICH E9]
study description. Representation
sub-investigator. Any member of
statistical method. The particular of key elements of study (e.g., control,
the clinical trial team designated and
mathematical tests and techniques that blinding, gender, dose, indication,
supervised by the investigator at a trial
are to be used to evaluate the clinical configuration).
site to perform critical trial-related
data in a trial. [ICH E9; from the Center procedures and/or to make important
for Advancement of Clinical Research] study design. Plan for the precise trial-related decisions (e.g., associates,
procedure to be followed in a clinical residents, research fellows). [ICH] See
statistical significance. State that trial, including planned and actual also investigator.
applies when a hypothesis is rejected. timing of events, choice of control
Whether or not a given result is group, method of allocating subject data event. A subject visit
significant depends on the significance treatments, blinding methods; assigns or other encounter where subject data
level adopted. For example, one may a subject to pass through one or more are collected, generated, or reviewed.
say “significant at the 5% level.” This epochs in the course of a trial. Specific [SDTM]
implies that when the null hypothesis is design elements (e.g., crossover,
true there is only a 1 in 20 chance of parallel, dose-escalation) [Modified
subject identification code. A
rejecting it. from Pocock, Clinical Trials: A Practical
unique identifier assigned by the
Approach] See Trial Design Model. See
investigator to each trial subject to
stem. The prompt, question, or also, arm, epoch, and visit.
protect the subject’s identity and used
instruction in a PRO item. See also in lieu of the subject’s name when the
response option, item. study design rationale. Reason for investigator reports adverse events
choosing the particular study design. and/or other trial-related data. [ICH]
stochastic. Involving a random
variable; involving chance or probability. study design schematic. subject trial contact. Any activity,
Schematic diagram (not tabular) of anticipated in the study protocol,
stopping rules. A statistical criterion study design, procedures, and stages. involving a subject and pertaining to
that, when met by the accumulating [example: ICH E3 Annexes IIIa and IIIb] collection of data. See visit.
data, indicates that the trial can or Compare to schedule of assessments.
should be stopped early to avoid subject/trial subject. An individual
putting participants at risk study initiation date. Date and who participates in a clinical trial,
unnecessarily or because the time of first subject enrollment into a either as recipient of the investigational
intervention effect is so great that study, as verifiable by a convention that product(s) or as a control. [ICH] See
further data collection is unnecessary. is consistent with authoritative also healthy volunteer, human subject.

subject-reported outcome (SRO). comments on PRO Guidance] Compare target study population.
An outcome reported directly by a to instrument. Demographic and health condition of
subject in a clinical trial. [Patrick, D.L., the population to be included in a
2003] See also patient-reported synopsis. Brief overview prepared at clinical study.
outcome (PRO). the conclusion of a study as a routine
part of a regulatory submission, technology provider. A person,
submission model. A set of data summarizing the study plan and company, or other entity who develops,
standards (including SDTM, ADaM, and results; includes numerical summary of produces, and sells software
define.xml) for representing data that efficacy and safety results, study applications and/or hardware for use in
are submitted to regulatory authorities objective, criteria for inclusion, conducting clinical trials and/or in
to support product marketing methodology, etc. [after ICH E3] analyzing clinical trial data and or
applications. NOTE: CDISC submission submitting clinical trial information for
data consist of: tabulations that regulatory approval. Synonym: vendor.
represent the essential data collected syntactic. The order, format, content
about patients; analysis data structured of clinical trial data and/or documents as
term. One or more words designating
to support analysis and interpretation; distinct from their meaning. NOTE:
something. NOTE: In a controlled
and metadata descriptions. Syntactic interoperability is achieved
vocabulary, terms are considered to
when information is correctly exchanged
refer to an underlying concept having a
superiority trial. A trial with the between two systems according to
single meaning. Concepts may be
primary objective of showing that the structured rules whether or not sensible
linked to several synonymous terms.
response to the investigational product meaning is preserved. See also semantic,
is superior to a comparative agent semantic interoperability.
termination (of subject). Now
(active or placebo control). [ICH E9] considered nonstandard. See
system. People, machines, software, discontinuation.
supplier. An organization that enters applications, and/or methods organized
into a contract with the acquirer for to accomplish a set of specific termination (of trial). Premature
the supply of a system, software functions or objectives. [ANSI] discontinuation of a trial prior to plan.
product, or software service under the [EU Clinical Trial Directive]
terms of a contract. [ISO/IEC/IEEE table of roles and responsibilities.
12207:1995 §3.30] A cumulative record documenting terminology. 1. Set of concepts,
operational access and authorizations designations, and relationships for a
supporting variables. See variable. of study personnel to electronic specialized subject area. See Glossary.
[FDA Drug Review Glossary] systems used in eClinical trials. 2. In the context of clinical research in
human subjects, a standardized, finite
surrogate marker. A measurement
tabulation dataset. A dataset set of terms (e.g., picklists, MedDRA
of a drug’s biological activity that
structured in a tabular format. NOTE: codes) that denote patient findings,
substitutes for a clinical endpoint such
The CDISC Study Data Tabulation circumstances, events, and
as death or pain relief.
Model (SDTM) defines standards for interventions. Compare with glossary,
tabulation datasets that fulfill FDA which is a list of words and their
surrogate variable. A variable that
requirements for submitting clinical definitions pertaining to usage in a
provides an indirect measurement of
trial data. particular field or context. Often used
effect in situations where direct
synonymously with vocabulary.
measurement of clinical effect is not
Contrast with nomenclature.
feasible or practical. [ICH E9] target enrollment. The number of
subjects in a class or group (including
survey. Any means (e.g., the total for the entire trial) intended therapeutic intervention. See
questionnaire, diary, interview script, to be enrolled in a trial to reach the intervention.
group of items) that is used to collect planned sample size. Target
PRO data. NOTE: Survey refers to the enrollments are set so that statistical token. Physical key that provides access
content of the group of items and does and scientific objectives of a trial will to a secure electronic system or location.
not necessarily include the training and have a likelihood of being met as
scoring documents generally not seen determined by agreement, algorithm, transcription. Process of transforming
by respondents. [from ISOQOL or other specified process. dictated or otherwise documented

information from one storage medium trial monitoring. Oversight of error made when calling the less effective
to another. NOTE: often refers explicitly quality of study conduct and statistical treatment the more effective one.
to data that is manually transcribed from interim analysis. [ICH E9]
source docs or measuring devices to type of comparison. How
CRFs or to eCRFs. trial site. Synonym for investigative treatment arms will be compared (e.g.,
site, investigator site, site, site of the Safety, Efficacy, PK/PD). May also
transition rule. A guide that trial, study site. [ICH E6] include comparison to data from other
governs the allocation of subjects to studies or sources (e.g., historical
operational options at a discrete trial statistician. A statistician who control). [ICH E9, EUDRACT (p.18)]
decision point or branch (e.g., has a combination of education/
assignment to a particular arm, training and experience sufficient to unblinding. Identification of the
discontinuation) within a clinical trial implement the principles in the ICH E9 treatment code of a subject or grouped
plan. See branch. guidance and who is responsible for the results in studies where the treatment
statistical aspects of the trial. [ICH E9] assignment is unknown to the subject
and investigators.
translation. Converting information
trial subject. Subject in a clinical trial.
from one natural language to another
See also participant, patient, subject. unequal randomization. See
while preserving meaning. Compare
randomization.
with mapping.
triple-blind study. A study in which
knowledge of the treatment unexpected adverse drug
transmit. To transfer data, usually
assignment(s) is concealed from the reaction. An adverse reaction, whose
electronically. NOTE: In eClinical
people who organize and analyze the nature, severity, specificity, or outcome
investigations data are commonly
data of a study as well as from subjects is not consistent with the term or
transmitted from subjects to clinical
and investigators. description used in the applicable
study sites, within or among clinical
product information. [ICH E2] See also
study sites, contract research
t-test. A statistical test used to adverse drug reaction.
organizations, data management
compare the means of two groups of
centers, and sponsors, or to regulatory
test data. uniform resource locator (URL).
authorities. [modified from CSUICI].
Address of a Web page, for example,
treatment effect. An effect trustworthy (electronic records). appliedclinicaltrialsonline.com.
attributed to a treatment in a clinical An attribute of records (data and
trial. In most clinical trials the documents) and signatures submitted use case. An explicit scenario designed
treatment effect of interest is a to regulatory agencies referring to their to help in determining whether a
comparison (or contrast) of two or suitability for making scientific findings system/process is capable of performing
more treatments. [ICH E9] of safety and efficacy that underlie the functions required for a particular
public policy decisions pertaining to use. A use case might describe, for
treatment-emergent adverse market authorization. Two key example, how a study coordinator
event. An event that emerges during dimensions that determine the would use a tablet computer to capture
treatment, having been absent trustworthiness of eClinical trial data medical history data.
pretreatment, or worsens relative to are data quality and data integrity.
the pretreatment state. [ICH E9] [after 21CFR Part 11] user site testing (UST). Any testing
that takes place outside of the
trial coordinator. See clinical type 1 (or type I) error. Error made developer’s controlled environment.
research coordinator. when a null hypothesis is rejected but NOTE: Terms such as beta test, site
is actually true. Synonym: false positive. validation, user acceptance test,
Trial Design Model. Defines a installation verification, and installation
standard structure for representing the type 2 (or type II) error. Error testing have all been used to describe
planned sequence of events and the made when an alternative hypothesis is user site testing. User site testing
treatment plan of a trial. NOTE: A rejected when it is actually true. encompasses all of these and any other
component of the SDTM that builds Synonym: false negative. testing that takes place outside of the
upon elements, arms epochs, visits; developer’s controlled environment. [from
suitable also for syntactic interpretation type 3 (or type III) error. Some General Principles of Software Validation;
by machines. [CDISC] See study design. statisticians use this designation for an Final Guidance, section 5.2.6]

valid. 1. Sound. 2. Well grounded on variable, there is a variable definition verification. 1. The act of reviewing,
principles of evidence. 3. Able to that describes what is varying, and inspecting, testing, checking, auditing,
withstand criticism or objection. [FDA there is a value for the variable. In the or otherwise establishing and
Glossary of Computerized System and context of a protocol, variables pertain documenting whether items, processes,
Software Development Terminology] to the study. 2. In SDTM a “study services, or documents conform to
variable” would be an observation. specified requirements. 2. (of software).
validation. 1. Process of Variable is an enveloping term that Provides objective evidence that the
establishing suitability to purpose. 2. includes specific subtypes used in design outputs of a particular phase of
For software and systems, establishing clinical research. “Study variable” is a the software development life cycle
documented evidence which provides term used in trial design to denote a meet all of the specified requirements
a high degree of assurance that a variable to be captured on the CRF. An for that phase. NOTE: 2. Software
specific process will consistently “assessment” is a study variable verification looks for consistency,
produce a product meeting its pertaining to the status of a subject. completeness, and correctness of the
predetermined specifications and Assessments are usually measured at a software and its supporting
quality attributes. NOTE: Validation is certain time, and usually are not documentation, as it is being developed,
accomplished by planning how to compounded significantly by combining and provides support for a subsequent
measure and/or evaluate suitability to several simultaneous measurements to conclusion that software is validated
purpose; then executing the plan and form a derived assessment (e.g., BMI) or [FDA General Principles of Software
documenting the results. [FDA a result of statistical analysis. An Validation; ANSI/ASQC A3-1978;
Glossary of Computerized System and “endpoint” is a variable that pertains to ISO/IEC Guide 25]. Verification is used in
Software Development Terminology] the trial objectives. Not all endpoints the sense of matching elements of a
are themselves assessments since report or results of system testing to
validation of data. 1. A process certain endpoints might apply to individual requirements. Compare to
used to determine if data are populations or emerge from analysis of validation where suitability to purpose is
inaccurate, incomplete, or results. That is, endpoints might be also established.
unreasonable. The process may include facts about assessments (e.g.,
format checks, completeness checks, prolongation of survival). When a verification of data. See source
check key tests, reasonableness checks “variable” is captured or measured, document verification (SDV).
and limit checks. 2. The checking of there is no necessary sense that any
data for correctness or compliance with visit. A clinical encounter that
evaluation or judgment is involved.
applicable standards, rules, and encompasses planned and unplanned
However, when a variable is to be
conventions. NOTE: Meaning 1 is not trial interventions, procedures, and
measured that obviously or actively
“data verification” but meaning 2 assessments that may be performed
pertains to subject status, which is
could be [1. ISO. 2. FDA Glossary of on a subject. A visit has a start and an
always the concern of the physician,
Computerized System and Software end, each described with a rule.
that variable becomes or will always be
Development Terminology] See source [CDISC Trial Design Project]
an assessment. The term assessment is
document verification. intended to invoke some degree of vocabulary. Terms that function in
evaluation or judgment concerning general reference to concepts that
validity. See validation.
subject status. A parameter is most apply over a variety of languages are
validity, psychometric. See properly a variable pertaining to words, and their totality is a
psychometric validation. statistical distributions though the word vocabulary. Synonym: terminology.
is often used synonymously with See controlled vocabulary.
variable. 1. Any entity that varies; any variable by engineers.
attribute, phenomenon, or event that volunteer. A person volunteering to
variance. A measure of the participate as a subject in a clinical
can have different qualitative or
variability in a sample or population. It trial, often a healthy person agreeing
quantitative values. 2. In SDTM
is calculated as the mean squared to participate in a Phase 1 trial. See
“variables” are used to describe
deviation (MSD) of the individual also Phase 1.
observations. Such describing variables
values from their common mean. In
have roles that determine the type of
calculating the MSD, the divisor n is vulnerable subjects. Individuals
information conveyed by the variable
commonly used for a population whose willingness to volunteer in a
about each observation and how it can
variance and the divisor n-1 for a clinical trial may be unduly influenced
be used. NOTE: 1. There is usually a
sample variance. by the expectation, whether justified
form of metadata that goes with the

or not, of benefits associated with Web server. A computer server that range from the subject’s complete
participation, or of a retaliatory delivers HTML pages or files over the withdrawal from study procedures and
response from senior members of a World Wide Web. See also server. follow-up activities, to the subject’s
hierarchy in case of refusal to withdrawal from study-related
participate. Examples are members of Web site. A collection of Web pages interventions while the subject permits
a group with a hierarchical structure, and other files. A site can consist of a continued access to his/her medical
such as medical, pharmacy, dental, and single Web page, thousands of pages, records or identifiable information.
nursing students, subordinate hospital or custom created pages that draw on Note that according to FDA
and laboratory personnel, employees a database associated with the site. regulations, when a subject withdraws
of the pharmaceutical industry, from a study, the data collected on
members of the armed forces, and the subject to the point of withdrawal
persons kept in detention. Other weighting. An adjustment in a value remain part of the study database and
vulnerable subjects include patients based on scientific observations within may not be removed. See also
with incurable diseases, persons in the data. discontinuation.
nursing homes, unemployed or
impoverished persons, patients in well-being (of the trial within-subject differences. In a
emergency situations, ethnic minority subjects). The physical and mental crossover trial, variability in each subject
groups, homeless persons, nomads, integrity of the subjects participating is used to assess treatment differences.
refugees, minors, and those incapable in a clinical trial. [ICH]
of giving consent. [ICH]
World Wide Web. All the resources
withdrawal. The subject-initiated and users on the Internet that are
Warning Letter. A written act of discontinuing participation in a using HTTP protocols. Also called the
communication from FDA notifying an clinical study. NOTE: Withdrawal can Web and www.
individual or firm that the agency
considers one or more products,
practices, processes, or other activities
to be in violation of the Federal FD&C
Act, or other acts, and that failure of
the responsible party to take
appropriate and prompt action to
correct and prevent any future repeat
of the violation may result in
administrative and/or regulatory
enforcement action without further
notice. [FDA]
washout period. A period in a

clinical study during which subjects
receive no treatment for the indication
under study and the effects of a
previous treatment are eliminated (or
assumed to be eliminated).
Web browser. A computer program

that interprets HTML and other Internet
languages and protocols and displays
Web pages on a computer monitor.
Web page. A single page on a Web

site, such as a home page.

Reference Citations
Note: The references below are cited in both the CDISC ■ Glossary of Computerized System and Software Development Terminology,
Glossary and Abbreviations & Acronyms. Division of Field Investigations, Office of Regional Operations, Office of Regu-
■ 21 CFR 820.20. Available at http://www.fda.gov (http://www.accessdata.fda. latory Affairs, Food and Drug Administration, August 1995. Available at:
gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.20 ) http://www.fda.gov/ora/inspect_ref/igs/gloss.html
■ 21 CFR Part 11. Electronic Records; Electronic Signatures Final Rule, 62 Fed- ■ Guidance For Industry: Computerized Systems Used in Clinical Trials (CSUCT),
eral Register 13430 (March 20, 1997). Available at http://www.fda.gov April 1999. Available at: http://www.fda.gov/ora/compliance_ref/bimo/
(Code of Federal Regulations) ffinalcct.htm
■ A Drug Review Glossary. Available at: http://www.fda.gov/fdac/special/new ■ Guidance for Industry: Computerized Systems Used in Clinical Investigations
drug/bengloss.html (CSUICI), U.S. Department of Health and Human Services, Food and Drug
■ C. Acquardo, C. Berzon et al. Incorporating the Patient's Perspective into Drug Administration (FDA), Office of the Commissioner (OC), May 2007. Available
Development and Communication: An Ad Hoc Task force Report of the Patient- at: http://www.fda.gov/cder/guidance/7359fnl.htm
Reported Outcomes (PRO) Harmonization Group Meeting at the Food and ■ G.H. Guyatt, D.H. Feeney, D.L. Patrick, “Measuring Health-Related Quality of
Drug Administration, Feb. 16, 2001, Value in Health, 6 (5) 522–531 (2001). Life,” Ann Intern Med., 118, 622–629 (1993).
■ D.G. Altman, K.F. Schultz, D. Moher et al., “The Revised CONSORT Statement ■ HL7 Glossary of Terms. January 2002. Available at: https://www.hl7.org/
for Reporting Randomized Trials: Explanation and Elaboration,” Ann Intern library/bookstore/
Med., 134, 663–694 (2001). Available at: http://www.consort-statement.org/
■ L. Huber, “In Search of Standard Definitions for Validation, Qualification, Veri-
■ American Medical Association Manual of Style, a guide for authors and
fication and Calibration,” BioPharm, 12 (4) 56–58 (1999).
editors. 9th Ed. (Baltimore, MD: Williams & Wilkins, 1998).
■ HyperStat Online Glossary. Available at: http://davidmlane.com/hyperstat/
■ Analysis Dataset Model (CDISC). Available at http://www.cdisc.org/standards/
glossary.html
index.html
■ ICH Efficacy Guideline page (E2a, E3, E6, E7, E8, E9, E10, E11). Available at:
■ Biomarkers Definitions Working Group: Biomarkers and Surrogate Endpoints:
http://www.ich.org/ or http://www.ich.org/cache/compo/276-254-1.html
Preferred Definitions and Conceptual Framework. Clin Pharmacol Ther,
69, 89–95 (2001). ■ IEEE Standard Computer Dictionary; a compilation of IEEE standard com-
■ CDER acronym list. Available at: http://www.fda.gov/cder/handbook/acronym. puter glossaries, 1990.
htm#W Drug Development and Review Definitions (CDER). Available at: ■ ISO 9000-3:1997, Quality management and quality assurance standards—
http://www.fda.gov/cder/about/smallbiz/definitions.htm Part 3: Guidelines for the application of ISO 9001:1994 to the development,
■ CDISC Glossary Project Team Members: Cathy Barrows, GSK; Patricia Beers supply, installation and maintenance of computer software. International
Block, Liaison from Office of Science and Health, FDA; Lori J. Brozena, Merck; Organization for Standardization, 1997.
Renee Creciun, Merck; Brenda Duggan, NCI; Julia Forjanic-Klapproth, Trilogy ■ ISO/IEC/IEEE 12207:1995 §3.35; from ISO/IEC 12207:1995, Information
Writing; Jane Ganter, Editor Emeritus, Applied Clinical Trials; technology—Software life cycle processes, Joint Technical Committee ISO/IEC
Helle-Mai Gawrylewski, Johnson & Johnson PRD; Art Gertel, Beardsworth JTC 1, Subcommittee SC 7, International Organization for Standardization and
Consulting; J. J. Hantsch, Takeda; Kathy Hollinger, FDA; Rebecca Kush, CDISC; International Electrotechnical Commission, 1995.
Elinor Lebner-Olesen, Novo Nordisk; Beverly Meadows, NCI; Stephen A. ■ R. Khosla, D.D. Verma, A. Kapur et al.,“Efficient Source Data Verification,”
Raymond, PHT Corporation; Anne Tompkins, NCI; Marcella Tordosinsky, Indian J. Pharm, 32, 180–186 (2000).
Merck; Cara Willoughby, Lilly.
■ Medicinces and Healthcare products Regulatory Agency in the UK, Web site:
■ Center for the Advancement of Clinical Research—Clinical Research Dic-
http://www.mhra.gov.uk
tionary. Available at: http://www.med.umich.edu/cacr/dictionary/A-B.htm
■ NIST: Minimum Security Requirements for Multi-user Operating Systems
■ Comments on Draft PRO Guidance, Docket 2006D-0044 by ISOQOL, 4 April
NISTIR 5153, March 1993, available at http://csrc.nist.gov/publications/
2006. Available at: http://www.fda.gov/ohrms/dockets/dockets/06d0044/
nistir/ir5153.txt section 3.2.1.1
06D-0044-EC17-Attach-1.pdf
■ D.L. Patrick, “Patient-Reported Outcomes (PROs): An Organizing Tool for Con-
■ CONSORT Statement (see D.G. Altman et al., above).
cepts, Measures, and Applications,” MAPI Quality of Life News Letter, 31,
■ CRIX and FIREBIRD projects, Available at: http://crix.nci.nih.gov/ and
1–5 (2003).
http://crix.nci.nih.gov/projects/Firebird/
■ PRO Draft Guidance, FDA, “Patient-Reported Outcome Measures: Use in Med-
■ CSUCT; see Guidance.
ical Product Development to Support Labeling Claims,” Feb. 2006. Available
■ Declaration of Helsinki available at: http://www.nihtraining.com/ohsrsite/
at: http://www.fda.gov/cder/guidance/5460dft.htm
guidelines/helsinki.html
■ Protocol Representation Group (PR Project), CDISC, Protocol Elements Spread-
■ Document type definition available at: http://www.XMLfiles.com
sheet, 2005. Available at: http://www.cdisc.org/standards/index.html
■ European Agency for the Evaluation of Medicinal Products (EMEA) Web site
■ M.L. Schuyl and T. Engel, “A Review of the Source Document Verification
http://www.emea.eu.int/
Process in Clinical Trials,” DIA Journal, 33, 789–797 (1999).
■ Federal Information Processing Standards (FIPS) Publication 46-2. 30 Decem-
ber 1993. Available at: http://www.itl.nist.gov/fipspubs/fip46-2.htm ■ Structured Product Labeling (SPL). Available at: https://www.hl7.org.library/
bookstore/
■ General Principles of Software Validation; Final Guidance for Industry and FDA
Staff, Jan 11, 2002. Available at: http://www.fda.gov/cdrh/comp/guidance/ ■ Study Data Tabulation Model (SDTM). Available at: http://www.cdisc.org/
938.pdf standards/index.html
■ Glossary for Healthcare Standards, W.E. Hammond, 1995. Available at: ■ The WHO Group, “The Development of the World Health Organization Quality
http://72.14.209.104/search?q=cache:Adz5tXfOdqEJ:dmi=www.mc.duke.ed of Life Assessment Instrument (WHOQOL),” in J. Orley and W. Kuyken (Eds.),
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CDISC Clinical Research Glossary

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adverse reaction. See adverse drug

algorithm. Step-by-step procedure

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disease. Any deviation from or

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laboratory (clinical). A laboratory mapping. In the context of Medicines and Healthcare

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Phase 3. Studies are expanded

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washout period. A period in a

Web browser. A computer program

Web page. A single page on a Web

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