Guidance

Reports to or from Oversight Agencies, Boards, Committees, etc. (e.g., DSMB, FDA)

Nov 14, 2011 12:45 pm

The table below presents instructions and guidance on informing IRBMED of reports to or from oversight bodies.

  • Guidance on Reports to or from Oversight Agencies, Boards, Committees, Etc.

    Type of ORIO Brief Description, Examples and Additional Information Reporting (calendar days) eR Section
    Notification of Audit / Inspection / Inquiry

    Notify the IRBMED as soon as possible following notification of an audit and/or prior to a site visit.

    Example:

    • FDA conducts an inspection as part of the approval process for a New Drug Application. Study teams must (1) notify the IRB as soon as they are informed of the upcoming visit (section 9); and (2) submit any documentation received upon completion of the visit (section 10).
    ASAP or 7 days for urgent safety or regulatory issues or SCR for routine reports 9
    Investigator Responsibility on the Routine Reporting of Audits, Inspections, Reports and Correspondence to/from Oversight Bodies

    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 (CTO) 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 (OHRCR).
    7 days for urgent safety or regulatory issues or SCR for routine reports 10

     

     

    Guidance Updated: 10/20/2011; Website Updated: 11/14/11

Questions?

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Edited By: bpsea@umich.edu
Last Updated: June 1, 2018 2:00 PM