For current information (definitions, reporting requirements, etc.), please see 7/1/07 CPHS/OPHS Policies & Procedures, “Unanticipated Problems and Adverse Events.”

Any unanticipated problem or serious adverse event (as defined in the Policies & Procedures above) should be reported to the Director of the Office for Protection of Human Subjects as soon as possible, but within no more than one week (seven calendar days) of the Lead Investigator learning of the incident.

Initial reports may be made via fax, mail/delivery, phone, email, or during a site visit. However, investigators are required to submit an official CPHS (IRB) Report of Serious Adverse Event or Unanticipated Problem form as soon as possible, but within no more than two weeks (14 calendar days) of learning of the incident.

Note: Other reporting requirements/deadlines may apply for certain research, e.g., involving FDA.

(Additional information is available at “OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events” – issued 1/07.)