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CRF_NAME DM002

VERSION v3.0

VERSION_DESCRIPTION pravin comments

REVISION_NOTES section added

SECTION_LABEL DEMO Lab SECTION_TITLE Demographics Lab .

SUBTITLE INSTRUCTIONS PAGE_NUMBER .

PARENT_SECTION BORDERS .

GROUP_LABEL DOB LAB GROUP_HEADER Date of birth Lab Values GROUP_REPEAT_NUMBER GROUP_REPEAT_MAX .

ITEM_NAME DOB VST SEX DESCRIPTION_LABEL Date of birth Visit Sex ETY RCE OTHR BLCT Ethnicity Race Others RBC .

normal value-5.1 (female) .LEFT_ITEM_TEXT Date of birth Record the date of this visit Record the appropriate sex UNITS RIGHT_ITEM_TEXT MM-DD-YYYY Please provide the date of birth of the subject Ethnicity( as reported by subject) Race(as reported by subject) If others please specify RBC Count M/µl normal value-5.6 (male).

SECTION_LABEL DEMO DEMO DEMO GROUP_LABEL HEADER DEMO DEMO Lab HEMATOLOGY .

1 1 1 RED BLOOD CELLS .SUBHEADER PARENT_ITEM COLUMN_NUMBER PAGE_NUMBER 1 1 1 Study participants should self-report race and ethnicity whenever feasible. with ethnicity being asked about before race.

QUESTION_NUMBER RESPONSE_TYPE RESPONSE_LABEL text text single-select date date sex RESPONSE_OPTIONS_TEXT date date Male. Asian. Female single-select checkbox text text ethnicity race other race count Hispanic or Latino. Not Hispanic or Latino. Not reporte American Indian or Alaskan Native. Black or A text .

2.2 RESPONSE_LAYOUT horizontal horizontal 1.RESPONSE_VALUES_OR_CALCULATIONS date date 1.4 1.3.6 text horizontal horizontal .4.3.5.2.

DEFAULT_VALUE DATA_TYPE DATE DATE INT WIDTH_DECIMAL (select one) INT INT ST ST 2 .

VALIDATION .

If Birth Day is unknown please enter Date of Birth in MM Please check on either male or female .VALIDATION_ERROR_MESSAGE Please enter the subject’s Date of Birth in the DD-MMM-YYYY format.

PHI 0 0 0 REQUIRED 1 1 1 0 0 0 1 1 1 0 1 .

0 Worksheet CRF CRF_NAME VERSION VERSION_DESCRIPTION REVISION_NOTES Sections Field 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 .OpenClinica CRF Design Template Version: 3.

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 .

you may put in the printed page number. 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. Enter the Item Name. The revision notes must be between 1 and 255 characters long. If you are using paper source documents and have a multi-page CRF. This field is optional. Each item in the CRF must be assigned to a section. It must be between 1 and 2000 characters long. The value must be a valid section_label from this document. You may create sub-sections in OpenClinica CRFs by naming a parent section. It is required. If left blank. Enter a description or definition for this item. Each section must have a valid section_label. the limit will be forty. This field is optional. borders (aka gridlines) will be turned on for all items in this section that are part of a group. nothing will be in its place. Enter a name for each section of your case report form (CRF) here. The description should give an explanation of the data element and the value(s) it captures. the header name that will appear in bold at the top of a column. Ungrouped items should be left blank. Enter revision notes for this version of the case report form (CRF) here. This field is optional. Enter a description of this version of the case report form (CRF) here. When the CRF is generated. and the CRF must have at least one section. Enter a subtitle and/or header text that should be shown at the top of the section. enter the section_label of the parent section that this section is a part of. Enter the name of this version of the case report form (CRF) here. It must be between 1 and 255 characters long.Field Description and Instructions Enter the name of your case report form (CRF) here. It must be between 1 and 255 characters long. There is a 255 character limit for this field. In addition to a subtitle for the section. It is not shown on the CRF but is in the data dictionary. It must be between 1 and 2000 characters long. This is a required field. and can have spaces. The instructions must be between 1 and 2000 characters long. If 0 or blank. May be letters or numbers. In a horizontal table. This field is required and must be unique within the spreadsheet. This is the name of the group and must be between 1 and 255 characters long. This is the unique label or variable name for this data element and should be letters and numbers and no spaces. This is a required field. This field is optional. It should be 1 to 4000 characters long. It should be 1 to 255 characters long. you may add instructions to show at the top of the section. It must be between 1 and 3999 characters long. 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 only a required field for grouped items. Specify the maximum number of times the group can repeat. 1 to 5 characters long. It must be between 1 and 255 characters long. . If set to 1. To do so. it is assumed the initial repetition is 1. If left blank. If left blank. Enter a label for each section of the CRF. Enter the page number on which the section begins. This is a required field.

For ungrouped items. The value must be a valid section_label from this document. This field is optional. For example. May be letters or numbers. This is an optional field. you may put in the printed page number. To do so enter a column number for the item. It should be 1 to 2000 characters long. It is optional. You may allow adjacent items or items with the same parent to be aligned together. The value bue be a valid item from this document with the same section_label. This may be similar to the Description_Label. This field is only required for items that will be assigned to a group. Enter the question number. It is not required. This field is required unless a parent_item is specified. introductory. consecutive items with column numbers 1 & 2 will appear on the same row. It should be 1 to 64 characters long. Enter the units that the value of this data element should be captured in. To do so. any characters. introductory. 1 to 5 characters long. This field is optional. Enter header. It is not required. Enter sub-header. The units will appear to the right of the input field on the data entry form. It must be between 1 and 2000 characters long. (if different from parent question) Enter the group label to which this item belongs. It must be between 1 and 240 characters long. It may include supplementary information or example values to guide the user. This field is optional. but phrased in the context of asking a question on the form. and is optional. The SECTION_LABEL corresponding to the section within which the question is located. It will appear to the left of the left_item_text on the CRF data entry form. OTHERWISE THE 5TH OR HIGHER COLUMNS WILL BE CUT OFF. It should be 1 to 2000 characters long. You must assign each item in a CRF to a section. . Enter the text that should appear to the right of the input (after units) on the CRF data entry form. This field is optional.Enter the text that should appear to the left of the input on the CRF data entry form. DO NOT GO PAST 4 COLUMNS. If you use paper source documents and have a multi-page CRF. Enter the page number of the item. or instructive text that should be shown on top of the question but under the question header text. This will cause the child_item to show up indented to the right of the parent item's place in the CRF. enter the section_label of the section to which this item belongs. The value must be a valid Group_Label from the 'Groups' worksheet. It may be 1 to 20 characters long. Enter the item_name of the parent question. this field should be left blank. OpenClinica will create anchor links in the CRF. or instructive text that should be shown on top of the question. IMPORTANT NOTE: IF YOU PLAN ON PRINTING THE CRF ON PAPER.

Must be alphanumeric.Provide the input type of the form field for this item. It is required for each unique response label but not for previously used response labels. No). Enter the data type of this item.org/dokuwiki/doku. radio: an html radio button. text: a text input field which will display as a single line of text. textarea: a text input field which will display as a box which will display several lines of text (e. calculation: is for fields which will contain a derrived value. file: is for fields that will allow the user to upload a file which will be stored on a specified directory. This input field will allow for 255 characters. This input field will allow for 255 characters. Must be 1 to 4000 characters long. If the RESPONSE_TYPE is radio. 1 to 80 characters long. the expression should be written here. Must be 1 to 4000 characters long. This input will display each available response option with a button next to it. 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. A user is allowed to select only one of the available response options. This input field will allow a user to select one of the available response options. Check all that apply). RESPONSE VALUES: Enter a comma-delimited list of the encoded values that are answers to this question. Default text for RESPONSE_OPTIONS_TEXT of single-selected RESPONSE_TYPE. For more information on Calculations within a CRF please see: http://www. You must enter a valid data type from the following list.php? id=ocfunctionality:crf_calculations Specify the layout for checkboxes and radio buttons. This label must be defined once and may be reused by other items with the same responses (eg Yes. Only required for each unique response label. single-select: a drop-down menu with a list of available options. . checkbox: This will display all of the available response options with a checkbox next to each. Partial Date will allow the data entry person to select a Month and Year or just a Year and not require the Day. a comments box). CALCULATIONS: For fields wich will will contain a calculation. default values will not be supported.openclinica. group-calculation: is for fields which will contain a derrived values from Grouped items. A user can make multiple selections (i.e.g. Create a custom label associated with a response set. multi-select: a drop-down menu with a list of available options. in the same order as their corresponding text values in RESPONSE_OPTIONS_TEXT. 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. and is required for each unique response set.

the VALIDATION_ERROR_MESSAGE).. After the width is defined you can define the number of decimal places for the field.4. Currently supported functions include: (1) greater than .You can define the width (the length of the field) and the number of decimal places to use for the field.gt(int) or gt(real) (2) less than . or 0 if otherwise. which is 32.sun. no action will happen. The validation will run when the user hits 'save'. see http://java. Must be between 1 and 255 characters. int2) or range(real1.html func: func(args) Supports built-in library of basic integer functions. Must be between 1 and 1000 characters and is an optional field. If you entered a Validation Function.range(int1.e. This would be used for a ST or INT field because there will be no decimals. Enter 1 if this field is required (eg a value must be entered for user to complete the CRF). 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. The first characters will define the width of the field. 20(d) – This allows a maximum length of 20 and the decimal will be set 4 which is the default within OpenClinica. The validation should be of the format "expressionType: expression". an error message will appear (i.lt(int) or lt(real) (3) range . For more information. If the value entered does not meet the requirements of the validation. If the user has entered data which satisfy the needs of the validation. INT or REAL data types. Enter 1 if this field contains PHI (Protected Health Information).com/j2se/1. Expression Syntax regexp: /regular expression/ Supports Java-style regular expressions (similar to Perl). Enter a validation expression to run an edit check on this item at the point of data entry. Decimal places is defined by the character between two parentheses ().2/docs/api/java/util/regex/Pattern. and round to the 4th decimal place. enter the error message that should appear if an entered value does not satisfy the validation criteria. 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) . This field is required if a Validation Function exists for the item. or 0 if otherwise. Here are a few examples. This should only be used for items with the ST.

no spaces Y Text Y Text N Text N Text N Text N 0 or 1 N Text Y Text N A number (e. no spaces Y Y .g. 2. 3). N N A number.Allowable Values Required Text Y Text Y Text Y Text Y Alphanumeric text. Alphanumeric text. 1.

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 .

Partial Date .File FILE Y .text textarea single-select radio multi-select checkbox calculation group-calculation file Y Alphanumeric text.Character String INT .Floating DATE . no spaces Comma-delimited list of values N Comma-delimited list of values Horizontal or Vertical N N N ST .Date PDATE .Integer REAL .

0 or 1 N Y Y Example regexp: /[A-Z]{3}/ This example requires a threeletter string (all uppercase) func: range(1.N 0 or 1 blank. 10) This example requires a number between 1 and 10 .