How to Read the New Retention Schedule Format
| Unique ID | VPR.0007 |
|---|---|
| Record Series Title | Clinical Trial Research and Investigational Drugs records |
| Record Series Description | This series documents interventional and observational clinical research conducted at Penn. This series may include, but is not limited to: Study design, protocol, purpose, and amendments, patient selection criteria, clinical procedures, patient care data, adverse event reports, history records, and case report. This series documents the order, procurement, use, inventory, and disposition of investigational drugs for use in research and teaching. This series may include, but is not limited to: order logs, receipts, use logs, and disposition instructions. |
| Retention Period (Code+Years) | AC+3* AC+6* for HIPAA regulated research |
| Retention Definition | C=Submission of final report/Disposition of Drug or filing of marketing application or *contractually agreed upon retention |
| Work Unit | Vice Provost - Research: Human Research Protections Program and PSOM-Office of Clinical Research |
| Location(s) | Various |
| Data Risk Classification | High |
| Disposition Method | D |
| Format | Various |
| Authority/Notes | 21 CFR 312.62 (c), ICH E6 (4.9.5), 21 C.F.R.§ D 312.57 |