| Activity | OP8600 Research Ethics Administration |
| Records Series | 33 - Research Ethics Quality Assurance Review Files |
| OPR | Research Ethics Compliance |
| Description | Records documenting both internal Quality Assurance (QA) processes and external inspections and audits to monitor, evaluate, and improve the ethical conduct of research involving humans that fall under GREB's and HSREB's oversight. Includes but is not limited to: site visit checklist, correspondence, site visit reports, QA review reports and corrective action plans. |
| Retention Trigger | Trial closed or research concluded. |
| 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
- PIB = Personal Information Bank
Printed on Tuesday, Dec 3 2024