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ActivityOP8600 Research Ethics Administration
Records Series33 - Research Ethics Quality Assurance Review Files
OPRResearch Ethics Compliance
DescriptionRecords 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 TriggerTrial closed or research concluded.
Active (years)3
Semi-Active (years)22
Final ActionD
Disposition Plan
Retention Rationale

Records relevant to clinical trials and to the roles and responsibilities of the Research Ethics Boards are subject to the provisions of the record requirements. Records, such as membership, qualifications of members, procedures for the conduct of reviews for approval of biomedical research and communications with Qualified Investigators should be retained for 25 years.

PIBNo
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
  • 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, Apr 23 2019