Opus IRB

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Sponsor/CRO

Protocol Guidelines

Sponsors submitting a protocol on behalf of multiple sites should submit the following to Opus IRB:

• A complete copy of the protocol with all version dates and amendments to date attached
• IND/IDE number (if applicable)
• A complete list of all sites participating in the study to include full name of the Principal Investigator, Sub-Investigators, name of institution or practice, contact person at each site along with address, phone number, and email contact information
• The contact information on whom is responsible for the monitoring of the study to include name of organization, project manager name, phone number and email contact information
• Investigator Brochure/Manual

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:

• If the Sponsor submits IND Safety Reports on the behalf of multi-site studies, 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• If a site has a question regarding submission of IND Safety Reports, please refer to OHRP draft guidance for IND Safety Reporting which can be found online at: www.hhs.gov/ohrp/requests/acrg.html

Opus IRB will acknowledge all IND Safety Reports.