Procedure
This procedure describes how protocol records are organized to allow a reconstruction of a complete history of all IRB actions related to the review and approval of a protocol.
Submission documents are entered into protocol records in reverse chronological order in the electronic record. This applies to all submission types. Protocol records may include, but are not limited to the following materials:
- Original and revised IRB applications and any applicable special approvals (includes applications for initial and continuing review) undergoing convened or expedited review;
- Applications for exemption or non-human use designation;
- Sponsor’s protocol, if any;
- DHHS-approved sample informed consent document, if applicable;
- Investigator’s Brochure or package inserts, if applicable;
- Informed consent documents submitted by the investigator and final IRB-approved informed consent document(s);
- Serious adverse events or unanticipated problems including risks to subjects or others;
- Proposed amendments/revisions which may include significant new findings and revised informed consent document(s);
- Recruitment materials, if applicable;
- Monitoring reports, if any;
- Investigator's Progress Reports for continuing review;
- All correspondence generated between the IRB or OIRB staff and the investigator or research staff (including the contact personnel);
- All fully executed documentation of acknowledgement of review under the SMART IRB reliance platform, IRB Authorization Agreements, and/or Individual Investigator Agreements, which include key institutional contacts and contact information;
- All correspondence from sponsoring agencies; and
- Copies of IRB-issued approvals.
