Einstein IRB
Reportable Event Follow-Up Report
Principal Investigator:
Name of Person Completing this Form:
Protocol Title:
IRB Number:
Medical Record Number
of subject(s) (if available):
1. What is the status of the event?
Resolved
Not resolved
2. Provide an update on the outcome:
Subject(s) ID:
3. Subject’s Study Status:
subject continuing participation
subject died
subject withdrawn by PI
subject chose to withdraw
subject completed the protocol intervention but is still being followed
subject completed the protocol intervention and the study
N/A - the event did not involve a research subject, (e.g. breach of confidentiality or systematic data
collection errors)
4. Data Safety Committee/Board Update:
This study has a Data Safety Monitoring Committee/Board (DSMC/DSMB) or Data Safety
Monitor (DSM) (if yes, choose one):
a copy of the DSMC, DSMB, or DSM’s review of the event/problem is attached.
the DSMC, DSMB, or DSM review is pending.
the DSMC, DSMB or DSM will not be reviewing this event.
the sponsor/CRO is responsible for providing reports to the DSMC/DSMB
This study does not have a Data Safety Monitoring Committee/Board or Data Safety Monitor
Signature of
Date
Principal Investigator
IRB Office Use Only
Additional Action Required?
Yes
No
Comments:
Name of Reviewer
D:\219468307.doc
Signature of Reviewer
Date
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8/16/13