How to Read the New Retention Schedule Format
| Unique ID | VPR.0006 |
|---|---|
| Record Series Title | Human Research/IRB Records |
| Record Series Description | This series documents review activities of research protocols by the Institutional Review Board (IRB). This series may include, but is not limited to: Research protocols; consent forms and HIPAA authorizations; reports of injuries to subjects; minutes of IRB meetings; records of continuing review; correspondence between the IRB and the investigators; IRB Membership rosters; IRB SOPs; reliance agreement records; and HIPAA waiver documentation. This series documents the execution of research protocols that involve human participants by research investigators. Records to be maintained by investigators may include, but are not limited to: protocols; consent forms and HIPAA authorization; HIPAA waivers; test instruments or evaluations; other participant facing materials; participant files; study generated data; notebooks, binders, or journal records; copies of grant proposals; memoranda and correspondence with study regulatory sponsors. |
| Retention Period (Code+Years) | AC+3* OR AC+6* for HIPAA regulated research |
| Retention Definition | C=Submission of final report or *contractually agreed upon retention |
| Work Unit | Vice Provost - Research |
| Location(s) | Various |
| Data Risk Classification | High |
| Disposition Method | D |
| Format | Various |
| Authority/Notes | 45 CFR 164.316(b)(2)(i), 45 CFR 46.115 (b)(s1a); 45 CFR 46.115 (b)(s1b); 21 CFR 56.115 |