CDE Detailed Report

Disease: Traumatic Brain Injury
Subdomain Name: Off Treatment/Off Study
CRF: Study Discontinuation

Displaying 1 - 3 of 3
CDE ID CDE Name Variable Name Definition Short Description Question Text Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guidance) Subdomain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C02201 Off study intervention prematurely indicator OffStdyIntrvntPrematureInd Indicator that participant/subject discontinued study intervention before planned end of study Indicator that participant/subject discontinued study intervention before planned end of study Indicates that participant/subject prematurely discontinued study intervention Yes;No;Unknown Yes;No;Unknown Alphanumeric

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No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Study Discontinuation/Completion Off Treatment/Off Study Protocol Experience

Single Pre-Defined Value Selected

3180300
C02222 Off study intervention prematurely reason OffStdyIntrvntPrematurRsn Primary reason participant/subject discontinued study intervention before planned end of study Primary reason participant/subject discontinued study intervention before planned end of study Primary reason participant/subject prematurely discontinued study intervention Adverse event;Other clinical decision (e.g., investigator decision, primary care provider decision, etc.) OR other reason specified by the protocol (i.e., institutionalization, pregnancy, etc.);Death;Participant's/Subject's decision (e.g., unwilling/unable to commit time and/or resources, moved from area, etc.);Lost to follow-up;Other, specify Adverse event;Other clinical decision (e.g., investigator decision, primary care provider decision, etc.) OR other reason specified by the protocol (i.e., institutionalization, pregnancy, etc.);Death;Participant's/Subject's decision (e.g., unwilling/unable to commit time and/or resources, moved from area, etc.);Lost to follow-up;Other, specify Alphanumeric

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No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Study Discontinuation/Completion Off Treatment/Off Study Protocol Experience

Single Pre-Defined Value Selected

2956831
C18740 Off study intervention prematurely other text OffStdyIntrvntPrematurOTH The free-text field related to 'Off study intervention prematurely reason' specifying other text. Primary reason participant/subject discontinued study intervention before planned end of study The free-text field related to 'Off study intervention prematurely reason' specifying other text. Primary reason participant/subject discontinued study intervention before planned end of study Other, specify Alphanumeric

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No references available Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Study Discontinuation/Completion Off Treatment/Off Study Protocol Experience 4000

Free-Form Entry

2956831
CSV