CDEs
Forms
Date event reviewed
Event summary
Does the event qualify as a reportable protocol deviation/violation?
Confirm deviation/violation category
Deviation/Violation Num
Specify other
Confirm reason for deviation/violation
Specify other
Is this event reportable to the DSMB?
Date to be reported to the DSMB
Date to be reported to the DSMB year
Will this event be included in the Core Consortia Cneter Performance Report?
Does this event require additional site re-training or a CAPA?
If the event requires additional site re-training or a CAPA, specify
Review complete?
BMT CTN Project Director reviewed?
Date deviation/violation identified
Deviation/violation description
Did the deviation/violation result in the discontinuation of study therapy?
Does the deviation/violation meet IRB of record reporting requirements?
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