CDASH Example.Protocol Deviations

This example DV CRF has 2 section: Section 1 collects whether the the subject had any protocol deviations, and the second section creates a row/record for every deviation each subject experienced.

Section 1

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
1	Were there any protocol deviations?	Any Deviations	Enter Yes if a protocol deviation occurred and No if none occurred. Ensure that any adverse event which triggers a protocol deviation (e.g., concomitant medication use, newly discovered medical history) is noted on the respective CRF.	Text	DVYN		Not Submitted	(NY)	No;Yes;

Section 2

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Permissible Values
2	What is the protocol deviation identifier?	DV Number	If collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier.	Text	DVSPID	DVSPID
3	What was the protocol deviation?	Protocol Deviation	Record protocol deviations identified and/or select the appropriate code from the list of protocol deviation terms.	Text	DVDECOD	DVDECOD	INFORMED CONSENT NOT OBTAINED; INCLUSION CRITERIA NOT MET; STUDY PRODUCT ASSIGNMENT DEVIATION; STUDY PRODUCT ADMINSTRATION DEVIATION; EXCLUDED CONCOMITANT MEDICATION; OTHER
4	What was the protocol deviation term?	Specify Protocol Deviation	Record the protocol deviation	Text	DVTERM	DVTERM
5	What was the protocol deviation start date?	Start Date	Record the start date for the protocol deviation using this format (DD-MON-YYYY). This should be the start or occurrence of the protocol deviation, not the date it was discovered or reported.	Date	DVSTDTC	DVSTDTC
6	What was the protocol deviation end date?	End Date	Record the end date of the protocol deviation using this format (DD-MON-YYYY). This should be the date the protocol deviation stopped, not the date it was discovered or reported.	Date	DVENDTC	DVENDTC

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CDASH Example.Protocol Deviations