Documents Required for IRB Review
Note: Additional Documents May Be Requested During The Course Of IRB Review
| Document | Initial Review | Amendment | Continuing Review(If Required)
| UAP | Study Closure |
| Cover Letter | Optional | Optional | Optional | Optional | Optional |
| COMIRB Application | All | If amended | All | | |
COMIRB Form
| | Change form
| Continuing Review Form | Unanticipated Problem Form | Continuing Review Form |
| PI Attestation/Mentor Agreement | All | | All | All | All |
| Tracked changes version of COMIRB Application and Attachments | | If amended | | | |
| Protocol | Full, Expedited, Secondary Research | If amended | Full, Expedited, Secondary Research | | |
| Tracked changes version of protocol | | If amended | | | |
| Clean copy of: Consent forms/Assent Forms | Full and Expedited | If amended | Full and Expedited | | |
| Tracked changes version of: Consent forms/Assent Forms/Information sheets/Verbal consent scripts | | If amended | | | |
| "Stamped" copy of Consent forms/Assent Forms | | | Full and Expedited | | |
| HIPAA A | Full and Expedited | If amended | | | |
| HIPAA B | Full and Expedited | If amended | VA Research | | |
| Grant Application | If primary recipient | If new or amended | If new funding | | |
| Surveys/Questionnaires/Interview or focus group guides/Diaries | All, if applicable | If amended | | | |
| Clean copy of: Information sheets/Verbal consent scripts | Full and Expedited | If amended | If applicable | | |
| Institutional approvals: VA Clearance Ltr., Denver Health SPARO Acknowledgement Ltr., HS Portal Approval Ltr., CHCO Start-Up Approval Lrt., etc. | All | If new or amended | | | |
| IRB Approvals from other sites (if UCD or affiliate is the lead site) | If applicable | If amended | If applicable | | |
| Data collection tools, sheets or forms | If applicable | If amended | | | |
| Recruitment materials (e.g. advertisements, invitations, solicitations) | If applicable | If amended | | | |
| Documentation of IND or IDE number (if appropriate) | Full Board | If amended | | | |
| Investigator's Brochure (for investigational drugs or devices) | Full Board | If amended | | If amended | |
| Product labeling (if studying an approved drug or device) | Full and Expedited | If amended | | | |
| Conflict of interest management plan (if applicable) | Full Board | If new or amended | Full Board | | |
| DSMB/DMC Charter | Full Board | | | | |
| DSMB/DMC Reports | If applicable | If applicable | If applicable | If applicable | If applicable |
| Other safety reports or multicenter trial updates | If applicable | If applicable | If applicable | If applicable | If applicable |
| Summary of pertinent recent literature/changes in the field | | If applicable | If applicable | If applicable | If applicable |
| Copies of any abstracts or publications from the research | | | If applicable | | If applicable |
| Summary table(s) of protocol deviations/violations, and/or adverse events, since last continuing review and did not require prior reporting | | | If applicable | | If applicable |
