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CRF NAME VERSION VERSION DESCRIPTION SampleCRF 1 Sample CRF for TrialDataSolutions REVISION NOTES CRF to show the different options for layout SECTION LABEL SECTION TITLE

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CRF NAME VERSION VERSION DESCRIPTION SampleCRF 1 Sample CRF for TrialDataSolutions REVISION NOTES CRF to show the different options for layout SECTION LABEL SECTION TITLE Powered By Docstoc
					CRF_NAME    VERSION     VERSION_DESCRIPTION
SampleCRF             1 Sample CRF for TrialDataSolutions
REVISION_NOTES
CRF to show the different options for layout
SECTION_LABEL   SECTION_TITLE            SUBTITLE
Section01       The title of section 1   A subtitle of section 1the section
                                         This is the subtitle of
Tabular         The title of section 2   showing entry-fields in tabular form
INSTRUCTIONS                                          PARENT_SECTION
                                             PAGE_NUMBER                            BORDERS
Instruction on how to use section1                  1                                                    1
                                                                                                         1
Delete a row by clicking on the <b>X</b> in the right column; add more rows by clicking the <b>ADD</b>-button (4 displayed, m
GROUP_LABEL   GROUP_HEADER      GROUP_REPEAT_NUMBER       GROUP_REPEAT_MAX
Group01       Repeating items                         4                      10
ITEM_NAME                DESCRIPTION_LABEL
SC_ITEM_01               Sample CRF item 1
SC_ITEM_02               Sample CRF item 2
SC_REPEATING_ITEM_01     Item 1 in a grid/table

SC_REPEATING_ITEM_02 Item 2 in a grid/table
LEFT_ITEM_TEXT                       UNITS      RIGHT_ITEM_TEXT             SECTION_LABEL
This is an example of a text field   no units   This item is not required   Section01
And this of a <b>text</b> area                  This item is required       Section01
                                                                            Tabular

                                                                            Tabular
GROUP_LABEL   HEADER   SUBHEADER   PARENT_ITEM   COLUMN_NUMBER
                                                              1
                                                              1
Group01       Date

Group01       Score
PAGE_NUMBER QUESTION_NUMBER RESPONSE_TYPE RESPONSE_LABEL
            1a              text
            1b              textarea
                            text

                            text
RESPONSE_OPTIONS_TEXT   RESPONSE_VALUES_OR_CALCULATIONS   RESPONSE_LAYOUT
DEFAULT_VALUE   DATA_TYPE   WIDTH_DECIMAL VALIDATION     VALIDATION_ERROR_MESSAGE
                ST
                ST
                DATE
                                                           Score must be an integer between 0
                INT                       func: range(0,7) and 7
PHI       REQUIRED
      0          0
      0          1
      0          0

      0          0
OpenClinica CRF Design Template
Version: 3.0

Worksheet    Field

CRF

             CRF_NAME

             VERSION

             VERSION_DESCRIPTION

             REVISION_NOTES

Sections


             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
             WIDTH_DECIMAL




             VALIDATION


             VALIDATION_ERROR_MESSAGE
             PHI

             REQUIRED
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 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.
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 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.
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

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, 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.
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 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 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.
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)
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
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
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

                                N


                                N




                                N


                                N

                                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


                                 N
0 or 1                           Y
blank, 0 or 1
                                 Y

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

				
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