Clinical Study Documents

Essential Documents
for the Conduct of a Clinical Trial

Wijittra Natthanonworakarn
Roche Thailand Ltd.
 What is the Purpose of Essential
Documents?
• Individually and collectively permit evaluation of the
conduct of a trial and the quality of the data
produced.
• Demonstrate the compliance of the investigator,
sponsor and monitor with GCP and other Applicable
Regulatory Requirement.
• Confirm the validity of the trial conduct and the
integrity of data
• Become part of a submission to Health Authority
• To assist in the successful management of a trial by
the investigator, sponsor and monitor
 Trial Master Files
• Trial master files should be established at the
beginning of the trial.
– Sponsor’s File
– Investigator’s File
• Should be kept in a secure location with limited
access
• GCP does not provide a guideline to organize
essential documents
• A final close-out of a trial can only be done when the
monitor has reviewed both investigator and sponsor
files and confirmed that all necessary documents are
in the appropriate files.
Hanging file
Sponsor’s File
Investigator’s File
 Which Documents are Essential?
• ICH-GCP
– A list of essential documents is provided in Chapter
8 of the ICH-GCP guideline.
• Additional documents required by regulations
– Form 1572 (required by US FDA)
– Financial disclosure (as Roche form: PD35)
• Defined by Sponsor
– Investigational Staff training (e.g. PD33)
– Lab Normal Values form (PD24)
GCP part 8
 Additional documents
required by regulations
Additional documents required by regulations

– Form 1572 (required by US FDA)

 Additional documents required by
regulations
– Financial disclosure (as Roche form: PD35)
Defined by Sponsor
 Defined by Sponsor
– Investigational Staff training (e.g. PD33)
 Defined by Sponsor
– Lab Normal Values form (PD24)
 The Minimum List of Essential
Documents by ICH-GCP
• The various documents are grouped in 3
sections:
Before the clinical phase of the trial
commences
During the clinical conduct of the trial
After completion or termination of the
trial
Before the clinical phase of the trial commences

Title of document Located in files of Located in files of

investigator sponsor
Investigator’s Brochure X X
Signed protocol and X X
amendments
Case Report Form (CRF) X X
Informed Consent Form X X
Financial aspect of the X X
trial
Insurance statement X X
(if required)
Before the clinical phase of the trial commences

Title of document Located in files of Located in files of

investigator sponsor
Signed agreement X X
between involved
parties
Dated, documented X X
approval of IRB/IEC
IRB/IEC composition X X
Investigator and sub- X X
investigator’s
curriculum vitae
Laboratory normal X X
range and certification
Before the clinical phase of the trial commences

Title of document Located in files of Located in files of

investigator sponsor
Instruction for X X
handling of
investigational product
Investigational product X X
label (if required)
Decoding procedures X X
for blinded trials
Randomization list X X
Pre-trial and initiation Site keeps minutes of X
monitoring report initiation visit
 During the clinical conduct of the trial
Title of document Located in files of Located in files of
investigator sponsor
Investigator’s Brochure X X
(update)
Any revision to X X
protocol, ICF, CRF etc.
and IRB/IEC approval
Update investigator’s X X
curriculum vitae
Update laboratory X X
normal range and
certification
Investigational product X X
label for new batch (if required)
 During the clinical conduct of the trial
Title of document Located in files of Located in files of
investigator sponsor
Monitoring report X
Relevant communication X X
Signed informed X
consent forms
Source documents X
Signed, dated and X X
completed CRF (copy) (original)
Documentation of CRF X X
correction (copy) (original)
Signature sheet X X
 During the clinical conduct of the trial
Title of document Located in files of Located in files of
investigator sponsor
Notification of SAEs X X
and related reports
Interim or annual X X
reports
Subject screening log X X
(if required)
Subject enrolment log X
Subject identification X
code list
Investigational X
products accountability
 After completion or termination of the trial
Title of document Located in files of Located in files of
investigator sponsor
Investigational X X
products accountability (original) (copy)
Documentation of X X
Investigational
products destruction
Completed subject X
identification code list
Audit certificate X
Final trial close out X
monitoring report
 After completion or termination of the trial
Title of document Located in files of Located in files of
investigator sponsor
Treatment allocation X
and decoding
documentation
Final report to IRB/EC X X
Clinical study report X X
 Additional Documents for the FDA
studies
• This is for the trial conducted under an IND.
• To be completed before the trial starts
 FDA 1572 form (Investigator Statement)
 Financial Disclosure Form
 Roche Documentations
• Pre-study visit report (PD20)
• Site initiation visit report (PD30)
• PD01
• Authorization (PD38)
• Financial (PD35)
• Lab normal value (PD24)
• Monitoring report (PD40)
• Inventory log
• Accountability log
• Drug dispensing log
• Temperature log
• Drug return (PD101)
 Roche Documentations
• Document dispatch form (PD52)
• CRF dispatch form (PD50)
• PD 60 (study close down)
• Training form (PD33)
• Protocol violation form (PD99)
• Database Re-open form (PD80)
• Decoding documentation form (PD65)
• Safety fax cover sheet (PD55)
 The End

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