Bridging the Gap Between Human Research Participants, Investigators & Research Sponsors.
IND Safety Reports
Opus IRB will accept any safety report or IND that a site or sponsor wants to submit.
However, it is not mandatory that IND safety reports that occur outside the jurisdiction of
Opus IRB be submitted. The Sponsor is required to collect all IND safety reports.
REQUIRED SUBMISSION: IND Safety Reports that describe “unanticipated problems
involving risks to subject” (21 CFR 56,108(b)(1), 21 CFR 312.32 (c) and those for device
studies. IND Safety Reports should be submitted to OPUS IRB if it is the opinion of the
Sponsor or Principal Investigator, the report meets one of the below criteria:
- The Sponsor will submit IND Safety Reports on the behalf of multi-site studies, thus the
Investigator does not need to submit these again.
- The Principal Investigator must submit all IND Safety Reports for any single site study.
If a site has a question regarding submission of IND Safety Reports, please refer to the
OHRP draft guidance for IND Safety Reporting which can be found online at:
http://www.hhs.gov/ohrp/requests/acrg.html.
All IND Safety Reports will be acknowledged by Opus IRB.