CDE Detailed Report

Disease: General (For all diseases)
Sub-Domain: Off Treatment/Off Study
CRF: Study Discontinuation

Displaying 1 - 6 of 6
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (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 / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C02202 Off study date and time OffStdyDateTime Date (and time, if applicable and known) when participant/subject completes study or is prematurely withdrawn from study (i.e., is not being followed and will not receive intervention/treatment) Date (and time, if applicable and known) when participant/subject completes study or is prematurely withdrawn from study (i.e., is not being followed and will not receive intervention/treatment) Off study date Date or Date & Time

Record the date (and time) of the participant's/ subject's last study related-contact. This may be the study completion visit or follow-up visit/phone call. The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database.

No references available Adult;Pediatric Supplemental 3.00 2013-07-18 14:26:06.9 Study Discontinuation/Completion Off Treatment/Off Study Protocol Experience

Free-Form Entry

2003605
C02203 Off study reason OffStdyRsn Primary reason participant/ subject is no longer participating in study (i.e., is not being followed and will not receive intervention/treatment). Primary reason participant/ subject is no longer participating in study (i.e., is not being followed and will not receive intervention/treatment). Off study reason Completed study;Refused further participation (or withdrew consent);Lost to follow-up (or cannot be located);Died Completed study;Refused further participation (or withdrew consent);Lost to follow-up (or cannot be located);Died Alphanumeric

Choose one. Specify the status of the participant/ subject at his/her last study-related contact. If the final study contact status is "Dead" then a Death Report Form may need to be completed for this participant/ subject.

No references available Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Study Discontinuation/Completion Off Treatment/Off Study Protocol Experience

Single Pre-Defined Value Selected

2979313
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 Reason for premature intervention discontinuation 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

Choose most appropriate answer. Choose one. Specify the participant's/ subject's primary reason for intervention discontinuation. If the primary reason for interventions discontinuation is "Adverse Event" then an Adverse Event CRF must be completed for this participant/subject. This CDE is meaningful for clinical trials only. If this study is not a clinical trial it should be removed from the CRF.

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

Choose most appropriate answer. Choose one. Specify the participant's/ subject's primary reason for intervention discontinuation. If the primary reason for interventions discontinuation is "Adverse Event" then an Adverse Event CRF must be completed for this participant/subject. This CDE is meaningful for clinical trials only. If this study is not a clinical trial it should be removed from the CRF.

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
C02200 Last study intervention date and time LstStdyIntrvntDateTime Date (and time, if applicable) of the last known study intervention that the participant/subject received Date (and time, if applicable) of the last known study intervention that the participant/subject received Date of last known intervention Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database. This CDE is meaningful for clinical trials only. If this study is not a clinical trial it should be removed from the CRF.

No references available Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Study Discontinuation/Completion Off Treatment/Off Study Protocol Experience

Free-Form Entry

23
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 Did participant subject discontinue intervention before planned end of study? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. Record whether or not the participant/ subject discontinued the study intervention before the planned end of the study. This CDE is meaningful for clinical trials only. If this study is not a clinical trial it should be removed from the CRF.

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
CSV