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CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease: General (For all diseases)
Sub-Domain: Off Treatment/Off Study
CRF: Study Discontinuation/Completion
Item count: 6 (6 distinct CDEs)
CDE ID
CDE Name
Variable Name
Definition / Description
Question Text
Permissible Value
Description
Data Type
Instructions
References
Population
Classification (e.g., Core)
Version #
Version Date
Aliases for Variable Name
CRF Module / Guideline
© or TM
Sub-Domain
Domain
Previous Title
Size
Input Restrictions
Min Value
Max Value
Measurement Type
LOINC ID
SNOMED
caDSR ID
CDISC ID
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Date (and time, if applicable and known) when participant/subject completes study or is prematurely withdrawn from study (i.e., is not being followed and will not receive intervention/treatment)
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
3.0
7/18/2013
OFF_STUDY_DT
Study Discontinuation/Completion
Off Treatment/Off Study
Protocol Experience
Off study date and time
 
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).
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
3.0
7/18/2013
OFF_CLN_STUDY_RSN_CAT
Study Discontinuation/Completion
Off Treatment/Off Study
Protocol Experience
Off study reason
 
Single Pre-Defined Value Selected
     
2979313
 
C02201
Off study intervention prematurely indicator
OffStdyIntrvntPrematureInd
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
3.0
7/20/2013
Aliases for variable name not defined
Study Discontinuation/Completion
Off Treatment/Off Study
Protocol Experience
Off study intervention prematurely indicator
 
Single Pre-Defined Value Selected
     
3180300
 
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 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
3.0
7/18/2013
OTX_DATE
Study Discontinuation/Completion
Off Treatment/Off Study
Protocol Experience
Last study intervention date and time
 
Free-Form Entry
     
23
 
C02222
Off study intervention prematurely reason
OffStdyIntrvntPrematurRsn
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
3.0
7/20/2013
Aliases for variable name not defined
Study Discontinuation/Completion
Off Treatment/Off Study
Protocol Experience
Off study intervention prematurely reason
 
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
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
1.0
5/27/2014
Aliases for variable name not defined
Study Discontinuation/Completion
Off Treatment/Off Study
Protocol Experience
 
4000
Free-Form Entry
     
2956831
 
12-09-2018
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