CRF_NAME VERSION Verification of Informed Consent v1.

VERSION_DESCRIPTION Verification of Informed Consent

REVISION_NOTES Agoodwin 11.05.07

SECTION_LABEL Verification Form

SECTION_TITLE Verification Form

SUBTITLE

INSTRUCTIONS

PAGE_NUMBER PARENT_SECTION

BORDERS 0

GROUP_LABEL

GROUP_HEADER

GROUP_REPEAT_NUMBER

GROUP_REPEAT_MAX

ITEM_NAME ver_affirmation ver_initials ver_date

DESCRIPTION_LABEL Affirmation that a signed informed consent exists Verification Affirmation Initials Date

LEFT_ITEM_TEXT 1. I affirm that a signed informed consent form exists on file for this subject. 2. Verification Affirmation Initials: 3. Date:(MM/DD/YYYY)

UNITS

RIGHT_ITEM_TEXT

SECTION_LABEL Verification Form Verification Form Verification Form

GROUP_LABEL

HEADER

SUBHEADER

PARENT_ITEM

COLUMN_NUMBER PAGE_NUMBER

1 2

QUESTION_NUMBER RESPONSE_TYPE RESPONSE_LABEL single-select text text YN text text

RESPONSE_OPTIONS_TEXT Yes,No text

RESPONSE_VALUES_OR_CALCULATIONS 1,0

RESPONSE_LAYOUT

DEFAULT_VALUE (select one)

DATA_TYPE INT ST DATE

VALIDATION regexp: /0|1/ regexp: /[A-Za-z]{2,}/

VALIDATION_ERROR_MESSAGE Please make a selection. Please enter initials without spaces or punctuation (e.g. JCD).

PHI 0 0 0

REQUIRED 0 0 0

OpenClinica CRF Design Template Version: 2.5 Worksheet CRF CRF_NAME VERSION VERSION_DESCRIPTION REVISION_NOTES Sections Field

SECTION_LABEL SECTION_TITLE

SUBTITLE

INSTRUCTIONS

PAGE_NUMBER

PARENT_SECTION

BORDERS Groups

GROUP_LABEL GROUP_HEADER

GROUP_REPEAT_NUM GROUP_REPEAT_MAX

Items

ITEM_NAME

DESCRIPTION_LABEL

LEFT_ITEM_TEXT

UNITS

RIGHT_ITEM_TEXT

SECTION_LABEL

GROUP_LABEL

HEADER

SUBHEADER

PARENT_ITEM

COLUMN_NUMBER

PAGE_NUMBER

QUESTION_NUMBER

RESPONSE_TYPE

RESPONSE_LABEL

RESPONSE_OPTIONS_TEXT

RESPONSE_VALUES_OR_CALCULATIONS RESPONSE_LAYOUT DEFAULT_VALUE

DATA_TYPE

VALIDATION

VALIDATION_ERROR_MESSAGE PHI REQUIRED Validation Expressions Expression Type regexp

func

Field Description and Instructions

Allowable Values

Enter the name of your case report form (CRF) here. It must be between 1 and 255 characters long. This is a required field. Enter the name of this version of the case report form (CRF) here. It must be between 1 and 255 characters long. This is a required field. Enter a description of this version of the case report form (CRF) here. It must be between 1 and 3999 characters long. Enter revision notes for this version of the case report form (CRF) here. The revision notes must be between 1 and 255 characters long.

Text Text Text Text

Enter a label for each section of the CRF. It must be between 1 and 255 characters long, and can have spaces. Each section must have a valid section_label, and the CRF must have at least one section. Each item in the CRF must be assigned to a section. Alphanumeric text, no spaces Enter a name for each section of your case report form (CRF) here. It must be between 1 and 2000 characters long. This is a required field. Text Enter a subtitle and/or header text that should be shown at the top of the section. It must be between 1 and 2000 characters long. This field is optional. Text In addition to a subtitle for the section, you may add instructions to show at the top of the section. The instructions must be between 1 and 2000 characters long. This field is optional. Text Enter the page number on which the section begins. If you are using paper source documents and have a multi-page CRF, you may put in the printed page number. May be letters or numbers, 1 to 5 characters long. This field is optional. Text You may create sub-sections in OpenClinica CRFs by naming a parent section. To do so, enter the section_label of the parent section that this section is a part of. The value must be a valid section_label from this document. This field is optional. Text If set to 1, borders (aka gridlines) will be turned on for all items in this section that are part of a group. If 0 or blank, no borders around items will be generated (note: even when borders are off OpenClinica will still generate borders to delineate header information and major components of the form). 0 or 1 This is the name of the group and must be between 1 and 255 characters long. This is only a required field for grouped items. Ungrouped items should be left blank. In a horizontal table, the header name that will appear in bold at the top of a column. If left blank, nothing will be in its place. When the CRF is generated, grouped items will display as a row within a table. The repeat number is the number of instances the row will repeat when initially generated. If left blank, it is assumed the initial repetition is 1. Specify the maximum number of times the group can repeat. If left blank, it is assumed that the rows can repeat indefinitely.

Text Text

A number (e.g. 1, 2, 3). A number.

Enter the Item Name. This is the unique label or variable name for this data element and should be letters and numbers and no spaces. It should be 1 to 255 characters long. This field is required and must be unique within the spreadsheet. Alphanumeric text, no spaces Enter a description or definition for this item. The description should give an explanation of the data element and the value(s) it captures. It is not shown on the CRF but is in the data dictionary. It should be 1 to 4000 characters long. It is required. Enter the text that should appear to the left of the input on the CRF data entry form. This may be similar to the Description_Label, but phrased in the context of asking a question on the form. It should be 1 to 2000 characters long. This is an optional field. Enter the units that the value of this data element should be captured in. The units will appear to the right of the input field on the data entry form. It should be 1 to 64 characters long. It is not required. Enter the text that should appear to the right of the input (after units) on the CRF data entry form. It may include supplementary information or example values to guide the user. It should be 1 to 2000 characters long. It is not required. You must assign each item in a CRF to a section. To do so, enter the section_label of the section to which this item belongs. The value must be a valid section_label from this document. This field is required unless a parent_item is specified. The SECTION_LABEL corresponding to the section within which the question is located. (if different from parent question) Enter the group label to which this item belongs. The value must be a valid Group_Label from the 'Groups' worksheet. This field is only required for items that will be assigned to a group.For ungrouped items, this field should be left blank. Enter header, introductory, or instructive text that should be shown on top of the question. It must be between 1 and 2000 characters long. This field is optional. Enter sub-header, introductory, or instructive text that should be shown on top of the question but under the question header text. It must be between 1 and 240 characters long. This field is optional. Enter the item_name of the parent question. This will cause the child_item to show up indented to the right of the parent item's place in the CRF. The value bue be a valid item from this document with the same section_label. This field is optional. You may allow adjacent items or items with the same parent to be aligned together. To do so enter a column number for the item. For example, consecutive items with column numbers 1 & 2 will appear on the same row. This field is optional. IMPORTANT NOTE: IF YOU PLAN ON PRINTING THE CRF ON PAPER, DO NOT GO PAST 4 COLUMNS. OTHERWISE THE 5TH OR HIGHER COLUMNS WILL BE CUT OFF. Enter the page number of the item. If you use paper source documents and have a multi-page CRF, you may put in the printed page number. OpenClinica will create anchor links in the CRF. May be letters or numbers, 1 to 5 characters long, and is optional.

Must be the SECTION_LABEL of a section defined in 'Sections' worksheet Must be the GROUP_LABEL of a section defined in 'Groups' worksheet

Enter the question number. It will appear to the left of the left_item_text on the CRF data entry form. It may be 1 to 20 characters long, any characters. It is optional. Provide the input type of the form field for this item. text: a text input field which will display as a single line of text. This input field will allow for 255 characters. textarea: a text input field which will display as a box which will display several lines of text (e.g. a comments box). This input field will allow for 255 characters. single-select: a drop-down menu with a list of available options. This input field will allow a user to select one of the available response options. radio: an html radio button. This input will display each available response option with a button next to it. A user is allowed to select only one of the available response options. multi-select: a drop-down menu with a list of available options. This input field will allow a user to make multiple selections from the list of available response options by holding Ctrl and cliking on the appropriate responses. checkbox: This will display all of the available response options with a checkbox next to each. A user can make multiple selections (i.e. Check all that apply). calculation: is for fields which will contain a derrived value. group-calculation: is for fields which will contain a derrived values from Grouped items. Create a custom label associated with a response set. This label must be defined once and may be reused by other items with the same responses (eg Yes, No). Must be alphanumeric, 1 to 80 characters long, and is required for each unique response set. Text and Textarea RESPONSE_TYPES should not share a RESPONSE_LABEL Enter a list of the text values of the responses for this response set as a commadelimited string. Must be 1 to 4000 characters long. It is required for each unique response label but not for previously used response labels. RESPONSE VALUES: Enter a comma-delimited list of the encoded values that are answers to this question, in the same order as their corresponding text values in RESPONSE_OPTIONS_TEXT. Must be 1 to 4000 characters long. Only required for each unique response label. CALCULATIONS: For fields wich will will contain a calculation, the expression should be written here. For more information on Calculations within a CRF please see: http://www.openclinica.org/dokuwiki/doku.php?id=ocfunctionality:crf_calculations Specify the layout for checkboxes and radio buttons. Default text for RESPONSE_OPTIONS_TEXT of single-selected RESPONSE_TYPE Comma-delimited list of values Horizontal or Vertical

text textarea single-select radio multi-select checkbox calculation group-calculation

Alphanumeric text, no spaces

Comma-delimited list of values

Enter the data type of this item. You must enter a valid data type from the following list:

ST - Character String INT - Integer REAL - Floating DATE - Date

Enter a validation expression to run an edit check on this item at the point of data entry. The validation will run when the user hits 'save'. If the user has entered data which satisfy the needs of the validation, no action will happen. If the value entered does not meet the requirements of the validation, an error message will appear (i.e., the VALIDATION_ERROR_MESSAGE). The validation should be of the format "expressionType: expression". Must be between 1 and 1000 characters and is an optional field. If you entered a Validation Function, enter the error message that should appear if an entered value does not satisfy the validation criteria. Must be between 1 and 255 characters. This field is required if a Validation Function exists for the item. Enter 1 if this field contains PHI (Protected Health Information), or 0 if otherwise. Enter 1 if this field is required (eg a value must be entered for user to complete the CRF), or 0 if otherwise. Expression Syntax regexp: /regular expression/ Supports Java-style regular expressions (similar to Perl). For more information, see http://java.sun.com/j2se/1.4.2/docs/api/java/util/regex/Pattern.html func: func(args) Supports built-in library of basic integer functions. Currently supported functions include: (1) greater than - gt(int) or gt(real) (2) less than - lt(int) or lt(real) (3) range - range(int1, int2) or range(real1, real2) (4) gte(int) or gte(real) (5) lte(int) or lte(real) (6) ne(int) or ne(real) (7) eq(int) or eq(real) 0 or 1 blank, 0 or 1 Example regexp: /[A-Z]{3}/ This example requires a threeletter string (all uppercase) func: range(1, 10)

This example requires a number between 1 and 10

Required

Y Y Y Y

Y Y

Y N

N N

N N N

N Y Y