Planned Outage: InfoEd eRA System
Fri, April 24, 5 p.m. (MST) - Mon, April 27, 8 a.m. (MST)
InfoEd eRA is used to manage the research lifecycle from start to finish, including: Grants and Contracts, Human Subjects Protocols and Conflict of Interest disclosures.
Questions?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 (unless study is limited to data analysis only) | ||
| Tracked changes version of: Consent forms/Assent Forms/Information sheets/Verbal consent scripts | If amended | Full and Expedited (unless study is limited to data analysis only) | |||
| "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 | |||
| 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 |