| Activity | OP8610 Research Compliance Support |
| Records Series | 32 - Research Compliance Document Management |
| OPR | Research Compliance, Training and Ethics |
| Description | Records documenting the creation, approval, and implementation of templates of controlled documents for the conduct and oversight of human participant research overseen by the Research Compliance Team. It encompasses drafts, final versions, approval documentation, and any revisions or amendments to the templates. |
| Retention Trigger | Document superseded date.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