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ActivityOP8600 Research Ethics Administration
Records Series31 - Health Sciences Research Ethics Board Applications Files (Clinical Trial)
OPRResearch Ethics Compliance
DescriptionIncludes 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 TriggerTrials concluded or terminated.
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. 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.

University Records exist in both physical and electronic formats, such as paper, email or data in a database. Paper records may or may not contain information that is duplicated in an electronic system. For technical reasons the retention assigned to the electronic records may be different from the retention of physical records. If there are differences, see instructions in this schedule for details.



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 Monday, Feb 18 2019