CRF_NAME VERSION VERSION_DESCRIPTION

REVISION_NOTES

SECTION_LABEL SECTION_TITLE

SUBTITLE INSTRUCTIONS PAGE_NUMBER

PARENT_SECTION BORDERS

GROUP_LABEL GROUP_HEADER GROUP_REPEAT_NUMBER GROUP_REPEAT_MAX

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 REPONSE_VALUES

RESPONSE_LAYOUT DEFAULT_VALUE DATA_TYPE

VALIDATION VALIDATION_ERROR_MESSAGE PHI REQUIRED

OpenClinica CRF Design TemplateVersion: 2.2

Worksheet Field

CRF

CRF_NAME

VERSION

VERSION_DESCRIPTION

REVISION_NOTES

Sections

SECTION_LABEL

SECTION_TITLE

SUBTITLE

INSTRUCTIONS

PAGE_NUMBER

PARENT_SECTION

BORDERSGroups

GROUP_LABEL

GROUP_HEADER

GROUP_REPEAT_NUM

GROUP_REPEAT_MAXItems

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

REPONSE_VALUESRESPONSE_LAYOUT

DEFAULT_VALUE

DATA_TYPE

VALIDATION

VALIDATION_ERROR_MESSAGE

PHI

REQUIREDValidation Expressions

Expression Typeregexp

func

Field Description and Instructions

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.

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.

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.

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.

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.

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.

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.

If set to 1, borders (aka gridlines) will be turned on for all items in this section. 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).

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.

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.

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 a required 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.

You may create groups of questions in OpenClinica CRFs by naming a parent item. To do so, enter the item_name of the parent question. The value must 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.

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.

Specify the layout for checkboxes and radio buttons.

Enter 1 if this field contains PHI (Protected Health Information), or 0 if otherwise.

Expression Syntaxregexp: /regular expression/

func: func(args)

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. You must enter a valid HTML form input input type from the following list:

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 comma-delimited string. Must be 1 to 4000 characters long. It is required for each unique response label but not for previously used response labels.

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.

Default text for RESPONSE_OPTIONS_TEXT of single-selected RESPONSE_TYPE

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

Enter a validation expression to run an edit check on this item at the point of entry. Should be of the format "expressionType: expression". Must be between 1 and 1000 characters, optional. For more on supported expressions, see Instructions worksheet.

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, required if a Validation Function exists for the item

Enter 1 if this field is required (eg a value must be entered for user to complete the CRF), or 0 if otherwise.

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

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)

Allowable Values Required

Text Y

Text Y

Text N

Text Y

Alphanumeric text, no spaces Y

Text Y

Text N

Text N

Text N

Text N

0 or 1 N

Text Y

Text N

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

A number. N

Alphanumeric text, no spaces Y

Y

N

N

N

Y

N

N

N

N

N

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

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

N

Y

Alphanumeric text, no spaces

N

NHorizontal or Vertical N

N

Y

N

N

0 or 1 Y

blank, 0 or 1 Y

Exampleregexp: /[A-Z]{3}/

func: range(1, 10)

texttextareasingle-selectradiomulti-selectcheckbox

Comma-delimited list of values

Comma-delimited list of values

ST - Character StringINT - IntegerREAL - FloatingDATE - Date

Requires a three-letter string (all uppercase)

Requires a number between 1 and 10