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Event Reporting

July 18, 2007

Dear Colleagues,

We have added several new documents to the IRB Web site in response to faculty requests for clarification about how to report events to the IRBs when there are regulatory requirements and sponsor requirements that do not match. To address questions about when to report information to the IRB and the appropriate report form to use, we have posted the following new material:

Organization policy on reports of unanticipated problems involving risks to participants and others, a flow diagram, and a revised report form, R.F. 1: Unanticipated Problem/Event Report Form

Organization policy on reporting death of a JHM research participant, guidance on reporting death of a JHM research participant, and a new report form, R.F. 2: Report of Death of a JHM Research Participant

Guidance on reporting protocol deviations, a flow diagram, and a new deviation log form, R.F. 4: Protocol Deviation Summary Sheet

Guidance on reporting IND safety reports, a flow diagram, and a new IND safety report transmission form, R.F.5: IND Safety Report Transmission Report (for paper studies only)

These documents can be found at http://www.hopkinsmedicine.org/dev/irb/guidelines/reportingrequirements.html.

If you have any questions about the new material, please contact a member of the OHSR compliance team for assistance at 410-955-3008.

Sincerely,
Daniel E. Ford, M.D., M.P.H.
Vice Dean for Clinical Investigation