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University of Michigan Medical School

IRBMED
2800 Plymouth Road
Building 200, Room 2086
Ann Arbor , MI 48109-2800
Email: irbmed@umich.edu
Phone: (734) 763 4768
FAX (734) 763 1234

ORIO Guidance: Miscellaneous Information

Guidance on Routine Reporting of Audits, Inspections, Reports and Correspondence to/from Oversight Bodies/Agencies/Entity

Investigators and research staff are expected to cooperate with evaluations, inspections, and audits performed by authorized internal oversight authorities, including the IRB, the Office for Human Research Compliance Review (OHRCR), Cancer Center Clinical Trials Office and the Office of University Audits. Cooperation is also expected for external reviews (e.g., by Entities such as industry sponsors or Government Agencies such as the FDA, NCI or NIH Office of Research Integrity). Any internal or external investigation, inspection or other review and its outcome must be reported to the IRB responsible for the research in question. Researchers should consult with their administrators, the IRBs, MICHR, and as appropriate the Office of the Vice President for Research (OVPR) and/or General Counsel for assistance and representation.

Reports to or from oversight bodies, agencies or entities should be submitted to the IRBMED for review according to the table below for Adverse Events (AEs) or Other Reportable Information or Occurrences (ORIOs); OR as required in the IRBMED approved Study Specific Adverse Event Reporting Timetable which may allow for non-concurrent reporting.

Examples:

FDA conducts an inspection as part of the approval process for a New Drug Application. Study teams need to notify the IRB as soon as they are informed of the upcoming visit and submit any documentation received upon completion of the visit
FDA conducts a for-cause site visit and provides the investigator with a Form 483 that contains findings/observations.
National Cancer Institute releases a summary report about the use of a study agent being used in UM studies as well as agents being used in cancer studies not being conducted at UM.
A study sponsor conducts a routine or yearly audit.
Sponsor determines that Adverse Events were not reported to the IRBMED at the correct time and sends a packet of information containing AEs from multiple sites.
Study Teams must submit the results of an internal, not-for-cause audit, following the visit of the Office for Human Research Compliance Review.

Event or Information	Timing of Report to IRBMED
Notification of any of any Audit and/or Inspection	As soon as possible after notification of the audit and/or prior to a site visit by a sponsor.

	If one of the following criteria applies:
	Within 7 DAYS	Within 14 DAYS	Prior to Next SCR
Any of the following to and/or from Oversight Bodies / Agencies / Entities: General Summary Annual Reports Reports / letters Audit and/or Inspection Reports Voluntary Hold of some or all study activities	urgent subject safety issue(s) regulatory concerns serious and suggests research may place subjects or others at greater risk of harm than was previously known or recognized requires a change (amendment) to the research the risk/benefit ratio of the study is changed subjects' willingness to participate is affected PI response to oversight entity	when non-serious and suggests research may place subjects or others at greater risk of harm than was previously known or recognized AND/OR may jeopardize integrity of study results AND/OR may jeopardize potential benefits to subjects	when ORIO falls outside of other IRB timeframe parameters at the left

Guidance Updated 7/11/11