| Activity | OP8610 Research Compliance Support |
| Records Series | 31 - Research Project Oversight |
| OPR | Research Compliance, Training and Ethics |
| Description | Records documenting the oversight provided by the Research Compliance Team to research projects involving human participants. This includes oversight from pre-approval compliance readiness reviews, inspection preparation, internal quality assurance reviews and all associated documentation, such as correspondence, reports, QA notes and worksheets, action plans, etc. |
| Retention Trigger | Case closed date. |
| Total Retention | 15 years |
| Final Action | D |
| Disposition Plan | |
| Retention Rationale | Food and Drug Regulations (C.R.C., c. 870) DIVISION 5 Drugs for Clinical Trials Involving Human Subjects - Records - C.05.012(4)The sponsor shall maintain all records referred to in this Division for a period of 15 years. Natural Health Products Regulations (SOR/2003-196) PART 4 Clinical Trials Involving Human Subjects - Records - 76(4)The sponsor shall maintain all records referred to in this Part for a period of 15 years. |
| PIB | No |
| Vital Records |
This schedule applies to official records in all media. Convenience or duplicate copies of official records are considered transitory and should not be kept longer than necessary, and in no event longer than the official copy.
GLOSSARY
- AR = Transfer to Archives
- AY = End of Academic Year
- CO = Continuous Overwrite
- CY = End of Calendar Year
- D = Destroy / Delete
- DP = Special Disposition Plan
- FY = End of Fiscal Year
- OPR = Office of Primary Responsibility
- P = Permanent
- PIB = Personal Information Bank
Printed on Friday, May 30 2025