RES-0630 Research Ethics Board: Adverse Events and Non-compliance

Description	Consists of records relating to participant complaints, adverse event reporting, reports of non-compliance and other incident reports. Includes investigation of these matters and any documentation of decisions made by the Research Ethics Board (REB) including suspension of research or protocol changes.
Retention Trigger	End of REB oversight of project and completion of project
Retention	Trigger + 7 years
Responsible Unit(s)	Research Services
Source
Records System	Romeo; paper
Citations	Research Ethics Policy Agreement on the Administration of Agency Grants and Awards by Research Institutions TCPS2 Article 6.17
Record Authority	VP Research Innovation and International
Disposition	Secure destruction
Records Arising from Activity	Formal Letter documenting outcome of Review Adverse/Unanticipated Event Report Form Change Request and Study Renewal Form Research Project Completion Form
Retention Rationale	Needed to demonstrate compliance while research is ongoing. 7 year retention period would align with administrative and funding compliance requirements.
Personal Information	No
Vital Record	Yes
Protection	High