| Activity | OP8600 Research Ethics Administration |
| Records Series | 31 - Health Sciences Research Ethics Board Applications Files (Clinical Trial) |
| OPR | Research Ethics Compliance |
| Description | Includes but is not limited to: HSREB Application forms, amendment forms, annual renewal forms, event forms, protocols, safety information (e.g., IB/PM/Device Manual), recruitment materials and any other written information provided to participants. |
| Retention Trigger | Trials concluded or terminated. |
| 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 Thursday, Nov 21 2024