CRF_NAME VERSION VERSION_DESCRIPTIONDM002 v3.0 pravin comments

REVISION_NOTESsection added

SECTION_LABEL SECTION_TITLEDEMO DemographicsLab Lab

SUBTITLE INSTRUCTIONS PAGE_NUMBER

PARENT_SECTION BORDERS

GROUP_LABEL GROUP_HEADER GROUP_REPEAT_NUMBER GROUP_REPEAT_MAXDOB Date of birthLAB Lab Values

ITEM_NAME DESCRIPTION_LABEL

DOB Date of birthVST VisitSEX Sex

ETY EthnicityRCE RaceOTHR Others

BLCT RBC

LEFT_ITEM_TEXT UNITS RIGHT_ITEM_TEXT

Date of birth MM-DD-YYPlease provide the date of birth of the subjectRecord the date of this visitRecord the appropriate sex

Ethnicity( as reported by subject)Race(as reported by subject)If others please specify

RBC Count M/µlnormal value-5.6 (male),normal value-5.1 (female)

SECTION_LABEL GROUP_LABEL HEADER

DEMODEMODEMO

DEMODEMO

Lab HEMATOLOGY

SUBHEADER PARENT_ITEM COLUMN_NUMBER PAGE_NUMBER

111

111

RED BLOOD CELLS

Study participants should self-report race and ethnicity whenever feasible, with ethnicity being asked about before race.

QUESTION_NUMBER RESPONSE_TYPE RESPONSE_LABEL RESPONSE_OPTIONS_TEXT

text date datetext date datesingle-select sex Male, Female

single-select ethnicity Hispanic or Latino, Not Hispanic or Lcheckbox race American Indian or Alaskan Native, Astext other race text

text count

RESPONSE_VALUES_OR_CALCULATIONS RESPONSE_LAYOUT

date horizontaldate horizontal1,2

1,2,3,41,2,3,4,5,6text horizontal

horizontal

DEFAULT_VALUE DATA_TYPE WIDTH_DECIMAL

DATEDATEINT

(select one) INTINTST

ST 2

VALIDATION

VALIDATION_ERROR_MESSAGE

Please enter the subject’s Date of Birth in the DD-MMM-YYYY format. If Birth Day is unknown please enter Date of Birth in MMM-YYYY format.

Please check on either male or female

PHI REQUIRED

0 10 10 1

0 10 10 0

1 1

OpenClinica CRF Design TemplateVersion: 3.0

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_NUMGROUP_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_CALCULATIONSRESPONSE_LAYOUT

DEFAULT_VALUE

DATA_TYPE

WIDTH_DECIMAL

VALIDATION

VALIDATION_ERROR_MESSAGEPHI

REQUIREDValidation Expressions

Expression Typeregexp

func

Field Description and Instructions

Specify the maximum number of times the group can repeat. If left blank, the limit will be forty.

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 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).

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. There is a 255 character limit for this field.

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.

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 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.

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.

Specify the layout for checkboxes and radio buttons.

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 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 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.file: is for fields that will allow the user to upload a file which will be stored on a specified directory.

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.

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

Default text for RESPONSE_OPTIONS_TEXT of single-selected RESPONSE_TYPE. If the RESPONSE_TYPE is radio, default values will not be supported.

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 person to select a Month and Year or just a Year and not require the Day.

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 Syntaxregexp: /regular expression/

func: func(args)

You can define the width (the length of the field) and the number of decimal places to use for the field. The first characters will define the width of the field. After the width is defined you can define the number of decimal places for the field. Decimal places is defined by the character between two parentheses (). This should 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 placesw(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 be used for a ST or INT field because 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 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.

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

TextY

TextY

TextY

TextY

Alphanumeric text, no spaces

Y

TextY

TextN

TextN

Text

N

Text

N

0 or 1

N

TextY

TextN

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

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

Y

Alphanumeric text, no spaces

N

N

Horizontal or Vertical N

N

Y

texttextareasingle-selectradiomulti-selectcheckboxcalculationgroup-calculation file

Comma-delimited list of values

Comma-delimited list of values

ST - Character StringINT - IntegerREAL - FloatingDATE - Date PDATE - Partial Date FILE - File

N

N

0 or 1 Y

blank, 0 or 1Y

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

func: range(1, 10)

This example requires a three-letter string (all uppercase)

This example requires a number between 1 and 10