Date: _______________

Research Protocol:

Principal Investigator:

Co-Investigators:

Number of subjects entered –
Total: ____________________ Past year: ________________

Summary of Results (ages, diagnosis, responses, adverse events/unanticipated problems, deaths, current status, etc). Use additional pages as needed.



Unanticipated Risks:

Risk/benefit assessment:

If adverse drug events and/or unanticipated problems are reportable, were they reported to the FDA or OHRP?

Tentative conclusions:

Abstracts, publications? _________ If yes, please attach copies.

Expected number of additional subjects: _________________

Expected duration of study: _________________

If a multi-institutional study, please attach most recent study report of the central operations office.
Signature of Principal Investigator: