Inclusion/Exclusion Example 1

This is an example CRF used to collect the protocol milestone, informed consent.

Example CRF Completion Instructions

All procedures must be performed and the subject’s eligibility determined within <protocol-specified time period prior to study medication administration>.
(If applicable, include the following instructions) Complete the Inclusion/Exclusion Worksheet as source document by recording a “Yes” or “No” response to each criterion.
Record the criterion identification that was an exception.

Record Yes if all eligibility criteria were met at the time the subject was enrolled. Record No if the subject did not meet all criteria at the time the subject was enrolled.	Were all eligibility criteria met? IEYN Not Submitted	Yes No <NY codelist>
Record whether the criterion exception was Inclusion or Exclusion.	What was the category of the criterion? IECAT	Inclusion Exclusion <IECAT codelist>
If the subject was not eligible, record the identifying code for each criterion that was an exception.	What was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met? IETESTCD	_________________

CDASH Variable	Order	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target Variable	Controlled Terminology Code List Name	Permissible Values	List Style
IEYN	1	Were all eligibility criteria met?	Met Criteria	Record Yes if all eligibility criteria were met at the time the subject was enrolled. Record No if the subject did not meet all criteria at the time the subject was enrolled.	Text	N/A	(NY)	Yes; No	radio
IECAT	2	What was the category of the criterion?	Criterion Type	Record whether the criterion exception was Inclusion or Exclusion.	Text	IECAT	(IECAT)	Inclusion; Exclusion	radio
IETESTCD	3	What was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met?	Exception Criterion Identifier	If the subject was not eligible, record the identifying code for each criterion that was an exception.	Text	IETESTCD

This is an example of data that was collected on a protocol-deviations CRF. The DVDECOD column is for controlled terminology, whereas the DVTERM is free text.

Rows 1, 3:	Show examples of a TREATMENT DEVIATION type of protocol deviation.
Row 2:	Shows an example of a deviation due to the subject taking a prohibited concomitant medication.
Row 4:	Shows an example of a medication that should not be taken during the study.

dv.xpt

xx.xpt

Row	STUDYID	DOMAIN	USUBJID	DVSEQ	DVTERM	DVDECOD	EPOCH	DVSTDTC
1	ABC123	DV	123101	1	IVRS PROCESS DEVIATION - NO DOSE CALL PERFORMED.	TREATMENT DEVIATION	TREATMENT	2003-09-21
2	ABC123	DV	123103	1	DRUG XXX ADMINISTERED DURING STUDY TREATMENT PERIOD	EXCLUDED CONCOMITANT MEDICATION	TREATMENT	2003-10-30
3	ABC123	DV	123103	2	VISIT 3 DOSE <15 MG	TREATMENT DEVIATION	TREATMENT	2003-10-30
4	ABC123	DV	123104	1	TOOK ASPIRIN	PROHIBITED MEDS	TREATMENT	2003-11-30

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Inclusion/Exclusion Example 1