CRF_NAME VERSION VERSION_DESCRIPTION

Baseline medical history v1 initial version

REVISION_NOTES
baseline medical history data is obtained
SECTION_LABEL SECTION_TITLE
sec1 Baseline medical/surgical history
SUBTITLE INSTRUCTIONS PAGE_NUMBER
PARENT_SECTION
GROUP_LABEL GROUP_LAYOUT
G1 GRID
GROUP_HEADER GROUP_REPEAT_NUMBER
1
GROUP_REPEAT_MAX GROUP_DISPLAY_STATUS
13
ITEM_NAME DESCRIPTION_LABEL LEFT_ITEM_TEXT
INSCD Institution code Institution code
PID participant id participant id
VISIT visit type visit type
VISITDTC visit date visit date
BS body system body system
NOR normal normal
ABNOR abnormal abnormal
CAB comments (required if abnormal) comments (required if abnormal)
H/E/E/N/T H/E/E/N/T H/E/E/N/T
NECK neck neck
RESP respiratory respiratory
CARDVAS cardiovascular cardiovascular
GASTINT gastrointestinal gastrointestinal
MUSSKL muscular skeletal muscular skeletal
DERM dermatalogic dermatalogic
HEMAT hematopoietic/lymph hematopoietic/lymph
ENDOCR endocrine/metabolic endocrine/metabolic
GENITOURI genitourinary genitourinary
BREASTS breasts breasts
NEURO neurologic neurologic
ALLERGY allergy/drug sensitivity allergy/drug sensitivity
SPBS specify other body system/site specify other body system/site
NOR normal normal
ABNOR abnormal abnormal
CAB comments (required if abnormal) comments (required if abnormal)
UNITS RIGHT_ITEM_TEXT SECTION_LABEL GROHEADER SUBHPAREN
sec1 BASELINE MEDICAL/SURGICAL HISTORY
sec1
sec1
DD-MM-YY sec1
sec2
sec2
sec2
sec2
sec2
sec2
sec2
sec2
sec2
sec2
sec2
sec2
sec2
sec2
sec2
sec2
sec2
sec3
sec3
sec3
sec3
COL PA QU RESPONSE_TYPE RESPRESPRESPONSRESPO DEF DATA_TYPE WIDTH_DECIMAL
1 1 text INT
2 text INT
3 text ST
4 text DATE
1
2
3
4
1 checkbox
1 checkbox
1 checkbox
1 checkbox
1 checkbox
1 checkbox
1 checkbox
1 checkbox
1 checkbox
1 checkbox
1 checkbox
1 checkbox
1 checkbox
1
2
3
4
VALIDATION VALIDATION_ERROR_MESSAGE PHI
REQUIRED ITEM_DISPLAY_STATUS
SIMPLE_CONDITIONAL_DISPLAY
OpenClinica CRF Design Template
Version: 3.1.2

Worksheet Field

CRF
CRF_NAME
VERSION
VERSION_DESCRIPTION
REVISION_NOTES

Sections

SECTION_LABEL
SECTION_TITLE
SUBTITLE

INSTRUCTIONS

PAGE_NUMBER

PARENT_SECTION
Groups

GROUP_LABEL

GROUP_LAYOUT

GROUP_HEADER

GROUP_REPEAT_NUM

GROUP_REPEAT_MAX

GROUP_DISPLAY_STATUS
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

WIDTH_DECIMAL

VALIDATION

VALIDATION_ERROR_MESSAGE
PHI
REQUIRED

ITEM_DISPLAY_STATUS
 SIMPLE_CONDITIONAL_DISPLAY

Validation Expressions
Expression Type
regexp

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 req
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 charac

Enter a label for each section of the CRF. It must be between 1 and 255 characters long, and can have spaces. Each section
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
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 lo
In addition to a subtitle for the section, you may add instructions to show at the top of the section. The instructions must be be
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, yo
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 pare
The value must be a valid section_label from this document. This field is optional.

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.
blank.
GRID (default setting) will set items assigned to this group in a horizontal row and will allow the data entry person to add addit
assign these items to a group that will not repeat and will not appear in a horizontal row.
If GROUP_LAYOUT = GRID, the header namewill appear in bold at the top of the table. If this is NON-REPEATING, the value
the CRF. The value must be between 1 and 255 characters. This field is not required.
Grouped items will display as a row within a table if GROUP_LAYOUT = GRID. The repeat number is the number of instances
generated. If left blank, it is assumed the initial repetition is 1.

Specify the maximum number of times the group can repeat if GROUP_LAYOUT = GRID. If left blank, it is assumed that the r

This field allows you to specify if a group of items will be Shown or Hidden from an end user during the data entry process. If y
do not have to provide a response in the Items tab that the Item is hidden. The only way the Group of items will be shown is if
OpenClinica should display the fields. Please see https://community.openclinica.com/documentation for more information on w

Enter the Item Name. This is the unique label or variable name for this data element and should be letters and numbers and n
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) i
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_Lab
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 t
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 supplementar
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. T
section_label from this document. This field is required unless a parent_item is specified. The SECTION_LABEL correspondin
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 fie
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 cha
Enter sub-header, introductory, or instructive text that should be shown on top of the question but under the question header t
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'
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 it
with column numbers 1 & 2 will appear on the same row. This field is optional. IMPORTANT NOTE: IF YOU PLAN ON PRINT
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
create anchor links in the CRF. May be letters or numbers, 1 to 5 characters long, and is optional.

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 characte

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 f
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
radio: an html radio button. This input will display each available response option with a button next to it. A user is allowed to s
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 fro
options by holding Ctrl and clicking 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 selec
calculation: is for fields which will contain a derrived value.
group-calculation: is for fields which will contain a derrived values from Grouped items.
file: is for fields that will allow the user to upload a file which will be stored on a specified directory. The file size limit for each

Create a custom label associated with a response set. This label must be defined once and may be reused by other items with
Must be alphanumeric, 1 to 80 characters long, and is required for each unique response set. Text and Textarea RESPONSE
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
comma as a comma, rather than a delimiter you must preceed the comma with a double back slash; e.g.: \\, . It is required for
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
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
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. If the RESPONSE_TYPE is radio, defa

Enter the data type of this item. You must enter a valid data type from the following list. Partial Date will allow the data entry p
just a Year and not require the Day.

You can define the width (the length of the field) and the number of decimal places to use for the field. The first characters wil
the width is defined you can define the number of decimal places for the field. Decimal places is defined by the character betw
only be used for items with the ST, INT or REAL data types. Here are a few examples.
8(3) – This means the field can be a maximum of 8 characters long with only 3 decimal places
w(4) – This allows the maximum length of a field according to OpenClinica, which is 32, and round to the 4th decimal place.
20(d) – This allows a maximum length of 20 and the decimal will be set 4 which is the default within OpenClinica. This would b
there will be no decimals.

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 h
data which satisfy the needs of the validation, no action will happen. If the value entered does not meet the requirements of th
appear (i.e., the VALIDATION_ERROR_MESSAGE). The validation should be of the format "expressionType: expression". Mu
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 valida
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.
This field allows you to specify if an item will be Shown or Hidden from an end user during the data entry process. The Item w
specify when OpenClinica should display the field or if you use SIMPLE_CONDITIONAL_DISPLAY. Please see https://comm
for more information on writing the rule.
Simple Conditional Display works with items that have pre-determined values. The feature will only work with radio, checkbox
since they have defined response sets. The hidden item can be of any response type.

SIMPLE_CONDITIONAL_DISPLAY (SCD) works in conjunction with the ITEM_DISPLAY_STATUS (IDS) field when it is set to

The SCD field will contain 3 parts, all separated by a comma: ITEM_NAME, RESPONSE_VALUE, Message.

ITEM_NAME = This will be the item name of the field determining whether this hidden item becomes shown.
RESPONSE_VALUE = The value of the ITEM_NAME that will trigger this hidden item to be shown
Message = A validation message that will be displayed if this item has a value but should not be shown anymore.

As an example, there is a SEX field with the response options of Male, Female, and response values of 1,2. If the answer is F
questions about pregnancy. The SCD cell would look like:

SEX,2,Male was chosen for the SEX field but you have provided information about pregnancies. Please delete the information
subject is truly Male. If you can not delete the information about pregnancies you must provide a discrepancy note by clicking

The above would be repeated for however many items you are hiding about pregnancy.

As soon as the user chooses Female, the hidden items will become shown. The user does not have to hit Save. If they choos
will go back to hidden regardless if any data was selected. Once those hidden items are shown and then saved with a value,
explicit actions are taken by the data entry person.

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/jav
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)
Allowable Values Required

Text Y
Text Y
Text Y
Text Y

Alphanumeric text, no spaces

Y
Text Y
Text N
Text
N
Text
N
Text
N

Text
Y
TRUE, FALSE
Y
Text
N
A number (e.g. 1, 2, 3).
N
A number.
N
Hide, Show or leave blank

Alphanumeric text, no spaces

Y

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

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

Y
Alphanumeric text, no spaces

Comma-delimited list of
values
N
Comma-delimited list of
values

N
Horizontal or Vertical N
 N
ST - Character String
INT - Integer
REAL - Floating
DATE - Date
PDATE - Partial Date FILE
- File
Y

N
0 or 1 Y
blank, 0 or 1 Y
Hide, Show or leave blank

N
 N

Example
regexp: /[A-Z]{3}/
This example requires a three-
letter string (all uppercase)

func: range(1, 10)

This example requires a
number between 1 and 10