Einstein IRB
Protocol Exception Request Form
A protocol exception is defined as any temporary deviation from the protocol that is approved by the IRB prior
to implementation, e.g., enrollment of a subject who does not meet the eligibility criteria. When required by the
sponsor, a waiver must be obtained from the sponsor of the study prior to implementation of the planned
deviation.
Principal Investigator:
Name of Person Completing this Form:
Protocol Title:
IRB Number:
1. Subject Number (or other participant identifier, if not available, state so here):
2. Medical Record Number (if available):
3. Briefly describe the protocol exception request. NOTE: For sponsored studies, you must also submit
documented approval of the protocol exception by the study sponsor.
4. Provide a justification for the request for deviating from the protocol:
Signature of
Principal Investigator
IRB Office Use Only
Comments:
Name of Reviewer
D:\219469471.doc
Date
Exception Approved?
Yes
No
Signature of Reviewer
Date
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8/16/13