The LREB will retain documents and files in a manner that ensures a complete history of all LREB actions is preserved. This will include all reviews, approved sample consent documents, progress reports and any reports of injuries to participants. The LREB will also retain records related to LREB activities, minutes of meetings, correspondence, LREB membership lists and written procedures relating to review. These documents and files will be kept securely and be available for review at the administrative offices of the College.

All records related to any project or protocol application will be retained for a period of time not less than the time required by the agency to which the application is made. All records will be retained for a minimum period of 5 years and up to 25 years if the project is subject to Health Canada regulations.

The following specific study related documents will be retained:

  • The initial LREB submission
    • Application for ethical review
    • Research protocol and/or project description
    • Participant information and consent documents
    • Recruitment materials and any other brochures
    • Study instruments
    • Applications to granting agencies
    • Reports of adverse events
    • All safety reports
    • Any documents required by agencies such as Health Canada
    • Deviation from presented protocol forms
    • Amendment request forms
    • New event reports
    • Unintended or unanticipated event reports
    • Study completion reports
  • Copies of all correspondence between the LREB and investigators
  • Copies of all correspondence between the LREB and regulatory agencies
  • Copies of all submitted reports
  • Statements of significant new findings provided to participants
  • Reports of complaints received from particpants

The LREB office will also retain all agendas and minutes of all meetings of the LREB.

The LREB office will also maintain an up to date membership roster for the LREB. This roster will contain names, earned degrees and representative capacity of each LREB member. Detail will be sufficient to identify the contribution made by each participating member. Information about alternate members will also be maintained in this manner. The regular member for whom the alternate member is assigned must be identified. Old membership rosters will be archived.