Research Involving Human Subjects
UCLASS Primary: RE125 – Clinical Trials
Retention Rule Number: Specific Retention Rule 2011.01
Function/Activity: To document the methods, conduct, and/or results of research involving human subjects.
Description/Type of Records: Consent forms, protocol documents, risk assessments, applications for regulatory approval, approvals, funding applications, contracts, invoices, staff timesheets, research data, lab certification, procedure manuals, x-rays, electrocardiograms, and medical scans. NOTE: This retention rule DOES NOT apply to records created by the Research Ethics Boards.
Retention Rules
| Office of Primary Responsibility (OPR) | Retention | Disposition |
|---|---|---|
| Principal Investigator | ||
| For research involving human subjects regulated by Health Canada: | 15 years from date project is closed. | Retain or destroy at the discretion of the principal investigator/University. |
| For all other research involving human subjects: | 5 years from date project is closed or in accordance with the terms and conditions of the research agreement or funding agency. | Retain or destroy at the discretion of the principal investigator/University or in accordance with the terms and conditions of the research agreement or funding agency. |
NOTE: A clinical study is considered to be closed when the principal investigator determines that the study has ended AND the Research Ethics Board has issued notice that the project has been closed.
NOTE: The principal investigator must retain financial records for personal/professional accounting purposes. The University maintains and retains the financial records necessary for institutional reporting/auditing purposes and to meet retention requirements under the Income Tax Act.
Citations:
For Offices of Primary Responsibilty (OPR):
Food and Drug Regulations – Section C.05.012 – Amendment (Schedule No. 1024) Clinical Trial Framework.
Records Management Instructions:
Data to be stored and destroyed in accordance with the Storage for Inactive Clinical Research Records Policy if applicable.
- Michael Hill, Associate Dean Clinical Research
- Jo-Ann Munn Gafuik, University Legal Services
- Lisa Atkinson, University Records Committee (Chair)
- Jacqueline Lacasse, General Council