If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended.
Text
DSCAT
DSCAT
(DSCAT)
DISPOSITION EVENT
2
What is the trial epoch for this disposition event?
Epoch
Select the study epoch for which disposition is being recorded.
Text
EPOCH
EPOCH
(EPOCH)
SCREENING; PRODUCT EXPOSURE; FOLLOW-UP;
3
What was the completion/discontinuation date?
Completion/Discontinuation Date
Record the date that the subject completed the study or study period using this format. If the subject did not complete the study or study period, record the date that the subject discontinued.
Date
DSSTDAT
DSSTDTC
4
What was the subject's status?
Status
Document the subject's status for the study or study period. If the subject discontinued prematurely, record the primary reason for discontinuation.
Text
DSDECOD
DSDECOD
(NCOMPLT)
COMPLETED; ADVERSE EXPERIENCE; DEATH; LOST TO FOLLOW-UP; NON-COMPLIANCE WITH STUDY PRODUCT; PHYSICIAN DECISION; PREGNANCY; PROTOCOL DEVIATION; SITE TERMINATED BY APPLICANT; STUDY TERMINATED BY APPLICANT; WITHDRAWAL BY SUBJECT; OTHER.
5
What was the verbatim reason for the subject status?
Specify
If Adverse Experiences, Death, Protocol Deviation or Other is selected from the Status list, provide the verbatim reason.
Text
DSTERM
DSTERM
6
Will the subject continue into the next epoch?
Continue
Record if the subject will be continuing to the next study period of this study.
Text
NOT SUBMITTED
(NY)
No; Yes
7
What is the next epoch the subject will continue to enter?
Next Epoch
Record the planned subsequent study epoch in which the subject intends to participate.
