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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