Common Data Element: Off study reason
Listed below are the details for the data element.
FITBIR
1.2
Element Type
Common Data Element
Off study reason
OffStdyRsn
Short Description
Primary reason participant/ subject is no longer participating in study (i.e., is not being followed and will not receive intervention/treatment).
Definition
Primary reason participant/ subject is no longer participating in study (i.e., is not being followed and will not receive intervention/treatment).
Notes
Creation Date
Historical Notes
Off study reason
References
No references available
Data Type
Alphanumeric
Input Restrictions
Single Pre-Defined Value Selected
Population
Adult and Pediatric
Guidelines/Instructions
GENERAL: 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.
Preferred Question Text
Off study reason
Category Groups and Classifications
| Disease | Domain | Sub-Domain |
|---|---|---|
| General (For all diseases) | Protocol Experience | Off Treatment/Off Study |
Classification
General (For all diseases):
Core
Keywords
Labels
