CRF_NAME* VERSION* VERSION_DESCRIPTION*

REVISION_NOTES*
SECTION_LABEL* SECTION_TITLE*
SUBTITLE INSTRUCTIONS
GROUP_LABEL GROUP_LAYOUT*
GROUP_HEADER GROUP_REPEAT_NUMBER
GROUP_REPEAT_MAX GROUP_DISPLAY_STATUS
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
OpenClinica CRF Design Template v3.10
This worksheet contains important additional information, tips, and best practices to help you better design your OpenClinica C

Note: Each CRF version should be defined in its own Excel file.
Worksheet Field Required

CRF
CRF_NAME Yes

VERSION Yes,
but does not
display in
Participate
forms

VERSION_DESCRIPTION Yes

REVISION_NOTES Yes

Sections
SECTION_LABEL Yes,
but does not
display in
Participate
form.
 SECTION_TITLE Yes,
but does not
display in
Participate
form.

SUBTITLE No

INSTRUCTIONS No

PAGE_NUMBER No

PARENT_SECTION No

Groups
GROUP_LABEL Yes
GROUP_LAYOUT Yes

GROUP_HEADER No, If used,

will not be
displayed in
Participate.

GROUP_REPEAT_NUM No

GROUP_REPEAT_MAX No
 GROUP_DISPLAY_STATUS No

Items
ITEM_NAME Yes

DESCRIPTION_LABEL Yes
LEFT_ITEM_TEXT No

UNITS No
RIGHT_ITEM_TEXT No

SECTION_LABEL Yes,
but does not
display in
Participate
form.
GROUP_LABEL Yes,
but does not
display in
Participate
form.
HEADER No
SUBHEADER No

PARENT_ITEM No

COLUMN_NUMBER No, If used,

will not be
displayed in
Participate.
PAGE_NUMBER No

QUESTION_NUMBER No, If used,

will not be
displayed in
Participate.
RESPONSE_TYPE Yes
RESPONSE_LABEL Yes

RESPONSE_OPTIONS_TEXT No

RESPONSE_VALUES_OR_CALCUL No
ATIONS

RESPONSE_LAYOUT No
DEFAULT_VALUE No, If used,
will not be
displayed in
Participate.

DATA_TYPE Yes
WIDTH_DECIMAL No, If used,
has no effect
in
Participate.
VALIDATION No, If used,
has no effect
in
Participate.

VALIDATION_ERROR_MESSAGE No, If used,

has no effect
in
Participate.

PHI Yes
REQUIRED Yes

ITEM_DISPLAY_STATUS No
SIMPLE_CONDITIONAL_DISPLAY No, If used,
has no effect
in
Participate.
on, tips, and best practices to help you better design your OpenClinica CRFs.

Can vary by CRF

Field Description and Instructions
Version

This worksheet should have no more than one row

Defines the name of the CRF as it will be displayed in the No
OpenClinica user interface. When a user is assigning CRFs to
an event definition, they will be viewing this name. A user
performing data entry will identify the form by this name.

Best Practice: Include a short study identifier as part of your

CRF name so that it is unique within your database instance.
The first 12 characters of your CRF_NAME should be unique.

Defines the version of the CRF as it will be displayed in the Yes

OpenClinica user interface. You cannot reuse a version number
for the same CRF that has already been assigned to an Even
Definition. If a particular CRF version has not been used in an
Event Definition, you may overwrite the CRF version.

This field is used for informational purposes to keep track of Yes

what this version of the CRF was created for.

This field is used to keep track of the revisions you made to this Yes
particular CRF.

Must be unique in the worksheet. The SECTION_LABEL is No (added or

referenced in the Items Worksheet to associate Items with the removed only)
appropriate section of the CRF. When the CRF is accessed for
data entry, each Section will be a page. The Items defined with
the corresponding SECTION_LABEL will be shown on that
single page.

This field is not displayed as part of the CRF but can be seen on
the CRF Metadata page.
The value in this field will be displayed at the top of each page Yes
when a user is performing data entry, as well as in the tabs and
drop down list used to navigate between Sections in a CRF. It
does not have to be unique but should be a readable value that
makes sense to people entering data. An example would be
'Inclusion Criteria'

A sub-title shown under the Section title. Yes

Instructions at the top of the Section (under the subtitle) that Yes
explains to the data entry person what to do on this section of
the form.

Note: Page_Number is a feature that will not be available in Yes

future versions of OpenClinica and should not be used.

The page number on which the section begins. If using paper

source documents and have a multi-page CRF, put in the
printed page number.

Note: Parent_Section is a feature that will not be available in Yes

future versions of OpenClinica and should not be used.

Sections can be sub-sections of ones that have been previously

defined. Provide the parent section for this sub-section in this
field.

Must be unique in the worksheet and contain no spaces. No (added or

GROUP_LABEL is referenced in the Items Worksheet to removed only)
associate Items with the appropriate Item group in the CRF. The
GROUP_LABEL value will be used to generate the GROUP OID
to be used in Rules, Data Import, and Export.

The field is not displayed as part of the CRF but can be seen on
the CRF Metadata page.

Best Practice: Each Item on the CRF should be associated

with a Group_Label. The first five characters of Group_Label
should be unique within your database instance.
REQUIRED. GRID formats associated Items into a table and Yes
allows rows to be added as needed. NON-REPEATING puts
Items into a named, logical grouping (useful for Show/Hide
functionality).

Defines the type of Item Group (GRID or NON-REPEATING). If

left blank will default to NON-REPEATING. A layout of GRID
means the Items defined as part of the Item Group will be
displayed in a table where each Item is represented as a
column, and users can add rows of data to the table as needed
during data entry. In Participate, Grids do not display as tables
but allow Participants to add repeating records as needed.
When viewed in OpenClinica those records will display as a
table.

If NON-REPEATING is chosen, the fields will be logically

grouped together in the CRF metadata, but cannot repeat, and
are displayed using the standard OpenClinica CRF layout.
Logically
The valueassociating
is displayedItems asthe
above a NON-REPEATING
GRID when a userGroup
is can Yes
performing data entry.

Used only when the GROUP_LAYOUT is equal to GRID.

Used only when the GROUP_LAYOUT is equal to GRID. Yes

Specifies the default initial number of repeats to be displayed on

the form. If left blank, only one row will be displayed by default.

Used only when the GROUP_LAYOUT is equal to GRID. Yes

This represents the total number of repeats a user will be

allowed to add in the Item Group. When left blank, the default
number of repeats is 40, but you can specify more than 40 if
necessary.
Used in conjunction with Rules. If set to HIDE, the Item Group Yes
will not appear in the CRF when a user is entering data until
certain criteria are met. This criteria is specified in a Rule using
the ShowAction.

If left blank, the Group defaults to SHOW.

The unique label or variable name for the data element. No (added or
removed only)
The field is not displayed as part of the CRF but can be viewed
as part of the CRF and Item Metadata, and is shown in the
Discrepancy Notes and Rules modules.

This field is case-sensitive. Items with names “item1” and

“Item1” will be treated as different Items. This can cause issues
with many data analysis tools and should be avoided in most
cases.

For Enterprise customers interested in using Datamart:

Please note that Datamart treat Items in case-insensitive
manner. Please treat all ITEM_NAMES as case-insensitive.

Also for use with Datamart, Postgres has a list of reserved

words and special characters, which should not be used as Item
Names. For a complete list, please see
http://www.postgresql.org/docs/8.4/static/sql-keywords-
appendix.html.

Best Practice: The first five characters of Item_Name should be

unique within your instance. If you are using SAS, Item_Name is
truncated to eight characters.

The description or definition of the Item. Should give an No

explanation of the data element and the value(s) it captures. It is
not shown on the CRF but is in the data dictionary.
Descriptive text that appears to the left of the input on the CRF. Yes
Often phrased in the form of a question, or descriptive label for
the form field input.

Used to define the type of values being collected. It appears to No

the right of the input field on the CRF.
Descriptive text that appears to the right of the form input on the Yes
CRF, and to the right of any UNITS that are specified too. Often
phrased in the form of a question, or supporting instructions for
the form field input.

All Items in a given Section are displayed on a single web page Yes
when the user is entering data, and appear in the order in which
they are entered on this Template.

Every Item must be assigned to a Section of the CRF.

SECTION_LABEL does not display in Participate.
Assigns Items to an Item Group. If the Group is GRID the Items Yes
need to have the same SECTION_LABEL as all other Items in
the Group, and must be consecutively defined in the ITEMS
worksheet.

Best practice: All Items should be assigned to a

GROUP_LABEL.

GROUP_LABEL does not display in Participate.

Contains text that used as a header for a particular Item. Using Yes
this field will break up the Items with a distinct line between the
header information and the next set of Items. The text is bolded
to call greater attention to it.
This field can contain text that will be used underneath the Yes
HEADER, or independently of a HEADER being provided. The
text will be separated by a line and have a grey background.

DO NOT USE. Yes

This will not be supported in future versions of OpenClinica and

should not be used.

Historically, this field could contain an ITEM_NAME that

immediately preceded this Item, and was in the same Section.
This would cause the child Item to be indented underneath the
ITEM_NAME specified.

Data entry screens are set up by columns. By default a blank Yes

value will put the Item in column 1. To have NON-REPEATING
Items show up on a horizontal plane next to each other, specify
column numbers greater than 1.
DO NOT USE. Yes

This will not be supported in future versions of OpenClinica and

should not be used.
This field is used to specify an identifier for each Item on the Yes
Items worksheet. It appears to the extreme left of the
LEFT_ITEM_TEXT. If LEFT_ITEM_TEXT was left blank, to the
left of the form input.
The type of input display you would like to use for a given Item Yes
on the CRF. It is different from DATA_TYPE.
RESPONSE_TYPE reflects the display; DATA_TYPE defines
how it is stored in the database.
Create a custom label associated with a response set. This label No
must be defined once and may be reused by other Items with
the same responses (e.g. Yes, No) and values.

A comma delimited string of values that will be used as the Yes (with limitations)
options to be chosen by a data entry person when they are
entering data in a CRF.

If the field is not a calculation or group-calculation, this will be a Yes (with limitations)
comma-delimited string of values that will be used as the values
saved to the database when a user chooses the corresponding
RESPONSE_OPTIONS_TEXT.

If this is a calculation or group-calculation field, it will be an

expression that takes the inputs of other Items in the Items
worksheet that are of INT or REAL data type to calculate a
value.

The layout of the options for radio and checkbox fields. The Yes
options can be HORIZONTAL (left to right) or VERTICAL (top to
bottom). In Participate the response layout will automatically
adjust to optimize display on the Participant's device.
Default text for RESPONSE_OPTIONS_TEXT Yes
Commonly used for response type single select to provide
additional instructions for data entry. For example, select one.

The data type is the format in which the value is stored in the No
database.
Specify the width (the length of the field) and the number of Yes
decimal places to use for the field

Has no effect in Participate.

Specify a validation expression to run an edit check on this Item Yes
at the point of data entry.

Has no effect in Participate; all validation for Participate must be

written in Rules.

Defines the error message provided on the data entry screen Yes
when a user enters data that does not meet the VALIDATION.

Has no effect in Participate.

Signifies whether this Item would be considered Protected No

Health Information
This field indicates whether a value must be entered in order to Yes
save the data entered in that Section.

In OpenClinica, for REQUIRED fields, users must either enter a

value or provide a discrepancy note.

In Participate, patients must enter information in required fields

to submit data to OpenClinica.

Used in conjunction with Dynamics in Rules or Yes

SIMPLE_CONDITIONAL_DISPLAY. If set to HIDE, the Item will
not appear in the CRF when a user is entering data unless
certain conditions are met. The conditions for display are
specified with a Rule using the ShowAction, or via
SIMPLE_CONDITIONAL_DISPLAY. If left blank, the value
defaults to SHOW.
Does not apply to Participate forms. Yes

Contains 3 parts, all separated by a comma: ITEM_NAME,

RESPONSE_VALUE, Message.

ITEM_NAME - 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.
 Restrictions When to use

Alpha-numeric characters are allowed If the field is blank, the CRF will be rejected at upload time.
255 characters max
UNIQUE

Alpha-numeric characters are allowed If this is a new version of a CRF that already exists, the
255 characters max CRF_NAME must match the CRF_NAME of the pre-existing
UNIQUE CRF in OpenClinica.

A new version of a CRF would be needed due to a protocol

change, adding or removing an Item from a CRF, or changing
some of the questions.

Alpha-numeric characters are allowed This information appears as part of the CRF Metadata when
4000 characters max the user clicks on View (original). This information is not
NOT UNIQUE displayed during data entry.

Alpha-numeric characters are allowed This information appears as part of the CRF Metadata when
255 characters max the user clicks on View (original). This information is not
displayed during data entry.

If this is the first version of the CRF, you can simply state this
is a brand new form. Going forward, as you make changes
and update the versions you can provide information on what
is different between the first version and each subsequent
version.

255 characters max This value will be used in the Items Worksheet to define where
UNIQUE the Items will appear during data entry.

A CRF must have at least one Section.

All characters allowed This field must be used at all times. If a CRF does not have a
2000 characters max value for SECTION_TITLE the form will be rejected at upload
time.

Long Section Titles may not display well.

All characters allowed HTML elements are supported for this field.
2000 characters max

All characters allowed HTML elements are supported for this field.
2000 characters max
This field should be used if there are particular data entry
instructions that should be conveyed or followed to users.

All characters allowed OpenClinica version 3.3 and above: Do not use.
5 characters max
OpenClinica versions prior to 3.3: For the most part, this field is
only used in studies collecting data on multi-page paper forms
and then having the data keyed in at a central location
performing double data entry.

255 characters max OpenClinica version 3.3 and above: Do not use.
Must equal a valid SECTION_TITLE
OpenClinica versions prior to 3.3: This field does not have any
effect in the User Interface. It does not affect data being
exported. This will be deprecated after version 3.1.3.

Alpha-numeric This field should be used in order to logically group Items

No spaces together. Item Groups may be used to define repeating Items
255 characters max in the CRF, or for logical grouping of NON-REPEATING Items
UNIQUE for easier data analysis once data has been exported from
OpenClinica. If you don't provide a Group_Label, all Items in
the CRF will be part of a single group called UNGROUPED.
This is not recommended.
GRID, NON-REPEATING (Blank) This field should be used to define the Item Groups as GRID
(repeating) or NON-REPEATING.

NON-REPEATING: Item Groups can span multiple Sections of

the CRF. Grouping is not a positional limitation but rather a
logical association of Items.

GRID: Item Groups must appear in the same Section and must
be placed together in the Items Worksheet. Definition of a
repeating Item Group activates the use of the attributes
GROUP_HEADER, GROUP_REPEAT_NUMBER and
GROUP_REPEAT_MAX.

All characters allowed Only use when the layout is set to GRID. This value is like a
255 characters max title for the group. An example of a GROUP_HEADER would
be “Medications Log.”

The field can be left blank if you do not want a title or header.
If the Layout is set to NON-REPEATING, the value will be
ignored and not displayed during data entry.

Integer This field should be used to specify how many rows of data
Should be left blank for non GRID layout should exist for the Item Group upon initiation of data entry, or
in printing of a blank CRF from OpenClinica. If three rows of
information, specify the number 3 in the field. When a user
accesses the CRF, the row is repeated 3 times by default.

A user will be allowed to add more rows up to the

GROUP_REPEAT_MAX and even remove some of the rows
displayed by default.

Integer This field should be used to restrict users to a certain number

There is no max value of repeats for the GRID. However, this restriction works only if
Should be left blank for non GRID layout data are entered through OpenClinica Web UI. If data are
imported using Task-> Import Data option or through web
services, all rows of data in the import file will be allowed to
import, even if the rows of data in the import exceed the
GROUP_REPEAT_MAX..
If GROUP_REPEAT_MAX is less than
GROUP_REPEAT_NUMBER, the Group will have the
GROUP_REPEAT_MAX number of rows on initial data entry
displayed, and no additional rows can be added.
Blank, SHOW, HIDE If set to SHOW, all Items in the Group are displayed in the
CRF.

If set to HIDE, this can be used with a Rule to conditionally

display an entire Group of Items.

If left blank, the default is SHOW.

English This field should be used at all times.

No spaces
255 characters max ITEM_NAME will be used to form the OID and the variable
Case-sensitive name when exporting data from OpenClinica. Brevity is
UNIQUE recommended for the value as it will be used to generate the
unique OC_OID.

Re-use of the same ITEM_NAME across CRF Versions

indicates the variable is the same Item. Once created, an Item
Name cannot be modified within the CRF. See “CRF
Versioning” and “Scope of CRFs and Items” in this document
for more detail.

Required This field must be used at all times. Provide a description that
All characters allowed will help explain what the variable means and what values it is
4000 characters max collecting.

For example, if the variable were looking to collect height, the

DESCRIPTION_LABEL would be “This variable collects the
height of the subject. It captures the value in inches.”

This field should not be changed in any subsequent versions

of the CRF. If you do change it and you are the owner of the
CRF the DESCRIPTION_LABEL attribute for this Item will be
changed for all versions of the CRF.
All characters allowed This field should be used as a way of describing the expected
2000 characters max input to users entering or reviewing CRF data. The value of
LEFT_ITEM_TEXT is displayed to the left of the form input.
The text wraps after the first 20 characters.

An example question would be “What is the subject’s height?”

Or, a simple one word “height” suffices as well.

If the Item is part of a GRID, the LEFT_ITEM_TEXT is

displayed as a column header above the field and not be
displayed to the left of the Item.

HTML elements are allowed; however, only a limited subset of

tags is officially supported (bold <b></b>, italics <i>, underline
<u>, superscript <sup>, subscript <sub>, line break <br>, link
<a href="">, image <img src="">).

Tokens can also be used to substitute Study Object values.

These can be used to display the Study Object value for use in
a URL or for use in other scripts (e.g. jquery). The supported
tokens are:
$ {studySubject}
$ {studySubjectOID}
$ {studyName}
$ {eventName}
$ {eventOrdinal}
$ {crfName}
$ {crfVersion}
$ {item[‘item_name’]}
For more information please see:
https://docs.openclinica.com/3.1/study-setup/build-study/
create-case-report-forms-crfs#content-title-5514

64 characters max If you are collecting data in inches, this field can specify your
units as inches, IN, or in.

This field should not be changed in any subsequent versions

of the CRF. If you do change it and you are the owner of the
CRF and no data have been entered for this Item, the UNITS
attribute for this Item will be changed for all versions of the
CRF.

There are no edit checks associated specifically with units.

This will appear as text to right of the input field and will be
displayed between parenthesis.

If you are exporting to CDISC ODM XML format, this will

appear in the metadata as measurement units.
All characters allowed 2000 characters This field can be used as a way of describing the expected
max input to users entering or for field-specific instructions. The
value of RIGHT_ITEM_TEXT is displayed to the right of the
form input. The text wraps after the first 20 characters.

An example of use of right Item text is “If other, please

specify”.

If the Item is part of a GRID, the RIGHT_ITEM_TEXT will be

ignored and never displayed.

HTML elements are allowed; however, only a limited subset of

tags is officially supported (bold <b></b>, italics <i>, underline
<u>, superscript <sup>, subscript <sub>, line break <br>, link
<a href="">, image <img src="">).

Tokens can also be used to substitute Study Object values.

These can be used to display the Study Object value for use in
a URL or for use in other scripts (e.g. jquery). The supported
tokens are:
$ {studySubject}
$ {studySubjectOID}
$ {studyName}
$ {eventName}
$ {eventOrdinal}
$ {crfName}
$ {crfVersion}
$ {item[‘item_name’]}
For more information please see:
https://docs.openclinica.com/3.1/study-setup/build-study/
create-case-report-forms-crfs#content-title-5514

Value must exist on the Sections For example, you might want all of the information collected as
Worksheet part of a physical exam such as height, weight, blood pressure,
and heart rate should be on the same Section.
Value must exist on the Groups GROUP_LABEL should be used to identify whether an Item
Worksheet belongs to an Item Group defined in the GROUPS worksheet.

If the Group is a repeating group (GRID layout), each Item in

the Group is displayed as a column in the grid.

Warning, too many Items in a Group, or use of long

LEFT_ITEM_TEXT values, will make the grid extremely wide
and force the data entry user to scroll the page to the right to
complete data entry.

For NON-REPEATING Items, specify a Group Label to be

used to logically assemble related Items together for easier
data analysis.

OpenClinica 3.1.2 and previous versions allowed Items to be

moved from one Item Group to another between versions (i.e.
UNGROUPED Items could later be grouped). While
OpenClinica allowed this functionality, CDISC ODM does not
support this type of structure change between different CRF
versions. As a result, these types of structural changes could
break extracts which contain the effected CRF. A new column
has been introduced to View CRF page to allow a user to
verify CRF integrity. The new table, called ‘Items’ gives a list of
Items in a CRF where the last two columns (‘Version(s)’ and
‘Integrity Check’) provide information about which version(s)
the Item belongs to and if the Item passes the integrity check
(verifying that the Item has not been assigned to more than
one Item Group).

OpenClinica 3.1.3 and future versions will not allow Items to be

assigned to different Item Groups between versions.
All characters allowed HTML elements are allowed; however, only a limited subset of
2000 characters max tags is officially supported (bold <b></b>, italics <i>, underline
<u>, superscript <sup>, subscript <sub>, line break <br>, link
<a href="">, image <img src="">).

Tokens can also be used to substitute Study Object values.

These can be used to display the Study Object value for use in
a URL or for use in other scripts (e.g. jquery). The supported
tokens are:
$ {studySubject}
$ {studySubjectOID}
$ {studyName}
$ {eventName}
$ {eventOrdinal}
$ {crfName}
$ {crfVersion}
$ {item[‘item_name’]}
For more information please see:
https://docs.openclinica.com/3.1/study-setup/build-study/
create-case-report-forms-crfs#content-title-5514

This field can be used as a replacement for left and right Item
text or as a replacement for instructions. It allows a greater
number of characters, along with bolding the text, to get the
data entry person’s attention.
All characters allowed HTML elements are allowed; however, only a limited subset of
240 characters max tags is officially supported (bold <b></b>, italics <i></i>,
underline <u></u>, superscript , subscript
, line break <br>, link <a href="">, image <img
src="">).

Tokens can also be used to substitute Study Object values.

These can be used to display the Study Object value for use in
a URL or for use in other scripts (e.g. jquery). The supported
tokens are:
$ {studySubject}
$ {studySubjectOID}
$ {studyName}
$ {eventName}
$ {eventOrdinal}
$ {crfName}
$ {crfVersion}
$ {item[‘item_name’]}
For more information please see:

https://docs.openclinica.com/3.1/study-setup/build-study/create
-case-report-forms-crfs#content-title-5514

This field can be used as a replacement or augmentation for

left and right item text or as a replacement/augmentation for
section/group instructions. It allows a greater number of
characters, along with providing a grey background to the text
in order to get the data entry user’s attention.

Value for ITEM_NAME must already Do not use Parent_Item in OpenClinica version 3.3 and
exist in the CRF and immediately above.
precede the current ITEM
Only one level of indention is allowed. In OpenClinica versions prior to version 3.3, this can only be
used with NON-REPEATING Items and must be a valid
ITEM_NAME. It is used strictly for visual purposes in the user
interface when people are entering data.

Use of this field is not recommended. It will be deprecated in a

future release.

Integer This is to be used with only NON-REPEATING Items and

controls the display of multiple Items on a single row. If you
set the column to 3 for an Item, the previous two Items in the
worksheet should have COLUMN_NUMBERS of 1 and 2.
Otherwise, your Item will be displayed in the first column.

Use of COLUMN_NUMBERS greater than 3 is not

recommended due to typical screen width limitations.
Alpha-numeric Note: Page_Number will not be available in future versions of
5 characters max OpenClinica, so it is recommended that you do not use it.

Alpha-numeric Used to display question numbers on a CRF.

20 characters max

Option must be selected from the drop Text: a rectangular box to enter information on a single line
down box: (3999 character limit)
-text
-textarea Textarea: a multi-line box for entering information
-single-select (3999 character limit)
-radio
-multi-select Radio and Single-Select only allow one option to be chosen for
-checkbox an Item. Radio buttons cannot be deselected in the user
-calculation interface once an option has been chosen.
-group-calculation
-file Multi-Select and Checkbox allow multiple options to be
-instant calculation selected at once.

File allows a file to be uploaded and attached to the CRF by

the data entry person. Any file type is acceptable.
(10MB size limit)

Calculation and Group-Calculation are used to derive values.

Calculations allow for the execution of arithmetic expressions
and support some basic functions. The calculations use values
from previous fields within the same CRF as variables. The
calculated field cannot be directly edited by the data entry
person and will appear “grayed out”. Group-calculation allows
the user to find a value based on the values in a column of a
GRID (e.g. sum).
The group-calculation should not be contained in a repeating
group, rather the variable that is being used in the calculation
should be in a GRID while the calculated field itself is NON-
REPEATING.

The values of calculated fields are generated when the user

saves the Section of the form.

Forced reason for change (when turned on) is not enforced for
calculated fields.
80 characters max In order to facilitate the creation of a CRF, unnecessary
Must be alphanumeric duplication of RESPONSE_OPTIONS_TEXT and
RESPONSE_VALUES_OR_CALCULATIONS values can be
mitigated by the RESPONSE_LABEL. If the same options and
values are going to be used for multiple Items like Yes, No and
1,2, provide the information once and enter a unique response
label. This label can be used throughout the rest of the Items
worksheet so other Items will use the exact same options and
values. If a RESPONSE_LABEL is reused within a CRF, the
RESPONSE_OPTIONS_TEXT and
RESPONSE_VALUES_OR_CALCULATIONS must be left
blank or exactly match the values of the original
RESPONSE_LABEL in the CRF.

Required for each unique This field is only used for checkbox, multi-select, radio and
RESPONSE_LABEL single-select fields. This will be the text displayed to the data
4000 characters max entry person, which they will choose for each Item. If the
options themselves contain commas (,) you must escape the
commas with a /
Required for each unique For checkbox, multi-select, radio and single-select fields, this
RESPONSE_LABEL will be the values that correspond to a
4000 characters max RESPONSE_OPTIONS_TEXT. The number of options and
values must match exactly or the CRF will be rejected when it
is uploaded into OpenClinica.

The following calculations are allowed in this field if the

RESPONSE_TYPE is calculation: sum(), avg(), min(), max(),
median(), stdev(), pow(), and decode().
Cumulative calculations on a group of repeating Items must be
of type group-calculation. Only cumulative calculations on the
entire set of repeating items are allowed. The allowed
functions are sum(), avg(), min(), max(), median(), and stdev().
For example, in an invoice with a repeating group of line Items,
the calculation for a total price would be the group-calculation
“func: (sum (LINE_ITEM_PRICE))”.
Instant calculation fields should use this field to define the
onchange() function with arguments of an Item Name (the
trigger Item) and value.

Blank, Horizontal, Vertical Leaving the field blank or selecting Vertical displays the Items
in a single column from top to bottom. Choosing Horizontal will
put the Items in a single row, left to right. Response Layout will
automatically adjust to optimize display on different devices.
4000 characters max Use this to specify an instruction (for example: "Select one")
that will appear in the input field. For single-select default value
does not have to be part of the response set. It will be
interpreted as a blank value if the user does not choose
anything.

Default values can be used for the following

RESPONSE_TYPEs:
• TEXT
• TEXTAREA
• SINGLE-SELECT
• MULTI-SELECT
• CHECKBOX

Note:
Be careful in using this field because if the default value
corresponds to an option in the response set, it will be saved
to the database even if the user does not select it.

Required ST (String): Any characters can be provided for this data type.
Option must be selected from the drop
down box: INT (Integer): Only numbers with no decimal places are
-ST allowed for this data type.
-INT
-REAL REAL: Numbers with decimal places.
-DATE
-PDATE (Not supported in Participate DATE: Only full dates are allowed for this data type. The
forms) default date format the user must provide the value in is DD-
-FILE MMM-YYYY.

PDATE: Partial dates are allowed for this data type. The
default date format is DD-MMM-YYYY so users can provide
either MMM-YYYY or YYYY values. (Not supported in
Participate forms.)

FILE: This data type allows files to be attached to the item. It

must be used in conjunction with a RESPONSE_TYPE of file.
The attached file is saved to the server and a URL is displayed
to the user viewing the form. The maximum file size that can
be uploaded is 10 megabytes. There is no file type restriction.

This field should not be changed in any subsequent versions

of the CRF. If you do change it and you are the owner of the
CRF and no data have been entered for this Item, the
DATA_TYPE attribute for this Item will be changed for all
versions of the CRF. If original DATA_TYPE for the Item was
DATE, owner of the CRF can change it to PDATE even if data
have been submitted for the CRF.
Not required. Defines the width (the maximum allowed length of the field)
and the number of decimal places to use for the field in the
If provided must be in the form w(d) as form w(d).
follows:
The first input defines the width of the field. The second input
w – integer from 1 to 26, or literal ‘w’ if specifies the number of decimal places for the field, if the item
INT or REAL. If ST, from 1 to 4000 is has a DATA_TYPE of ‘REAL’.
allowed.
The WIDTH_DECIMAL attribute should only be used for Items
d – literal ‘d’. if the item has with the ST, INT or REAL data types. The width attribute
DATA_TYPE of ‘REAL’, may also be an specifies the length of the field treated as a string, so even if
integer from 1 to 20. d cannot be larger the Item is of type INT or REAL, leading/trailing zeroes and
than w decimal points count towards the width.

For Items of type REAL, evaluation of the width occurs prior to

evaluation of the decimal, so values exceeding the specified or
system default width will be rejected even if they could be
rounded to a length within the width limit.

Examples.:
DATA_TYPE ‘REAL’, WIDTH_DECIMAL 5(1) – Allows a
maximum of 5 characters with only 1 decimal place.
OpenClinica will accept 12345 and 1234., 123.4, or 12.30 but
will not accept 012345 or 123456.

Inputs such as 12.345 or 1234.5678 or 012345 or 12.300 will

be allowed and rounded.

REAL w(4) –Allows up to OpenClinica’s maximum length for

an Item of ST, INT, or REAL (26 characters), with any decimal
in excess of 1/10000th rounded to the 4th decimal place.

REAL 20(d) –Allows a maximum length of 20 and decimal

length of 4 (the default in OpenClinica). .

ST 20(d) or INT 20(d) – Allows a maximum length of 20

characters.
1000 characters max The validation will run when the user hits 'save'. If the user has
entered data, which satisfy the validation expression, data will
save normally. If the value entered does not meet the
requirements of the validation, an error message will appear
(i.e., the VALIDATION_ERROR_MESSAGE) and the user will
need to correct the value or enter a discrepancy note to
continue. The validation should be of the format
"expressionType: expression". Must be between 1 and 1000
characters and is an optional field.

regexp:

This 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.h
tml

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

func:

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)

Examples:
This example requires a number between 1 and 10
func: func(args) = func: range(1, 10)
255 characters max Must be used when a VALIDATION is specified. The message should
Required if VALIDATION is provided be clear to the data entry person as to what the problem is.

Blank, 1, 0 Leaving the field blank or selecting 0 means the Item would
not be considered Protected Health Information. This flag
does not do anything to mask the data or prevent people from
seeing it. The field is used as a label only.
When creating a data set, this label will show in the metadata
and the user could choose to include this Item in the dataset
(create dataset step) or not based on this label.

This field should not be changed in any subsequent versions

of the CRF. If you do change it and you are an owner of the
CRF the PHI attribute for this Item will be changed for all
versions of the CRF.
Blank, 1, 0 This can be used for any RESPONSE_TYPE.

Leaving the field blank or selecting 0 means a value is not

required.

In OpenClinica, if 1 is selected, the data entry person must

provide a value or enter a discrepancy note explaining why the
field is left blank.

In Participate, if 1 is selected, patients must enter information

to submit data to OpenClinica.

Blank, SHOW, HIDE If you would like to design skip patterns and dynamic logic for
a single Item, set the display status to HIDE. When the form is
accessed for data entry, the Item will initially be hidden from
view from the user. With Rules, another value can trigger the
Group of Items to be shown instead of hidden.

Instead of Rules, you can also use the

SIMPLE_CONDITIONAL_DISPLAY field to decide when this
Item should be shown. SIMPLE_CONDITIONAL_DISPLAY
only works with Items set to HIDE.
Comma separated list Simple Conditional Display works with Items that have a
defined response set (radio, checkbox, multi-select and single-
select fields). The hidden Item can be of any response type.

SIMPLE_CONDITIONAL_DISPLAY (SCD) has an effect only

when ITEM_DISPLAY_STATUS (IDS) of the Item is set to
HIDE. Several levels of hierarchy of Simple Conditional fields
can be nested hierarchically. The Items must be in the same
section of the CRF

For example, assume there is a SEX Item with response

options of Male, Female, and response values of 1,2. If the
user chooses Female option, additional questions about
pregnancy are asked. If Male is chosen, these questions are
hidden. However, if the user chooses Female, fills in
pregnancy data and after that gets back to the SEX Item and
switches the answer to Male, the Items about pregnancy will
remain on the screen (not hidden). The user can delete
pregnancy answers and in that case the UI Items will get
hidden.

Note that the database gets updated only on SAVE. In the

above example the system will allow saving “inconsistent” data
(SEX = Male, but pregnancy Items filled), but it is up to a user
to create discrepancy fields for them explaining the situation.
Note that radio button controls cannot be deselected, meaning
there is no way to delete it’s value once it has been selected.
Allowable Values

Text

Text

Text

Text

Alphanumeric text
Text

Text

Text

Text

Text

Text
GRID, NON-REPEATING,
Blank

Text

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

A number
Hide, Show or leave blankH26

Alphanumeric text, no spaces

A valid SECTION_LABEL as
defined in the 'Sections'
worksheet
 Must be the GROUP_LABEL
of a section defined in 'Groups'
worksheet
Alphanumeric text, no spaces

Comma-delimited list of values

Comma-delimited list of values

Horizontal or Vertical
 ST - Character String
INT - Integer
REAL - Floating
DATE - Date PDATE
- Partial Date FILE - File
0 or 1
 blank, 0 or 1

Hide, Show or leave blank