REB Documentation

AC-AER-014
REB Documentation
DepartmentApplied Educational Research
Creation DateJanuary 27, 2011
Approval DateJanuary 27, 2011
Effective DateJanuary 27, 2011

Organizational Scope

This policy pertains to all staff, faculty, students or external persons intending to participate in or carry out research at and/or in collaboration with the Michener Institute.

Purpose

The purpose of this policy is to describe the requirements for retention and storage of submissions to the Research Ethics Board (REB).

Policy

The Research Office will retain, store and make accessible, in accordance with all applicable regulations, documents related to REB submissions including but not limited to: research projects submitted for review; amendments, modifications and change requests; updated safety information; approval renewal; unanticipated or Serious Adverse Event (SAE) reporting; protocol deviations; and meeting minutes, associated correspondences, and policies.                                                                                             

Responsibility:

This policy applies to the Chair, members of the Research Office and/or administration.

2.0 Procedures

2.1         Study related Documents

2.1.1      Upon receipt of submission (see Policy: REB Submission Requirements and Administrative Review), the coordinator or designate will log the date of submission, create a project file (if not previously created), add the submission to an existing file (if a file exists) and assess the submission for overall completeness using the Submission Checklist as a guide;

2.1.2      The coordinator or designate will add any research-related documentation received over time to the appropriate file (files may exist in hard copy and/or computerized on a secured server);

2.1.3      Retained research documents include, but are not limited to:

  • REB application form
  • Research Protocol
  • Investigator brochures and monographs
  • Recruitment materials
  • Consent documents (see Policy: Informed Consent Requirements and Documentation)
  • Study instruments
  • Amendment request forms and any other relevant forms (see Policy: REB Amendments, Changes, Notifications)
  • Granting Agency applications (where applicable)
  • Budgets
  • Health Canada correspondence
  • Correspondence with investigators, regulatory authorities, sponsors, and participants  (see Policies: REB Communication with Investigators and, REB Communication with Participants)
  • Reports including: investigator reports, monitoring reports, site visit reports and reports of new findings (see Policies: Adverse Event Reporting, REB Continuing Review and REB Study Completion)

2.2         Administrative Documents

2.2.1      Retained administrative documents include, but are not limited to:

  • Agendas and minutes;
  • REB member reviews/reports;
  • Conflict of Interest and Confidentiality Agreements;
  • Current and archived Policies and Procedures;
  • REB member records:
    • Membership lists
    • Training records
    • Curriculum Vitae

2.3         Document Storage

2.3.1      Documents will be retained in the Research Office for at least 3 years after completion of the study and/or as required by applicable regulation and guidance.

2.4         Confidentiality and Document Destruction

2.4.1      All documents that flow through the Research Office will be considered confidential;

2.4.2      Access to confidential documentation is limited to members of the Research Office and REB;

2.4.3      Documents will be stored in lockable cabinets in a locked office at the Michener Institute;

2.4.4      Electronic documentation is stored on the secured server accessible via a password protected computer in the Research Office;

2.4.5      Confidential material that no longer needs to be retained will be disposed of in a secure fashion.

3.0  References

  1. Tri-Council Policy Statement (TCPS 2). Ethical Conduct for Research Involving Humans, Medical research Council of Canada 2010. Article 6.17.

http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/

  1. ICH Harmonized Tripartite Guideline. Good Clinical Practice: Consolidated Guideline (E6)1996. Section 3.4.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php

  1. World Health Organization (WHO). Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants 2011. http://www.who.int/ethics/publications/research_standards_9789241502948/en/index.html
  2. Canadian General Standards Board. Research ethics oversight of biomedical trials 2010. (DRAFT)

Associated Documentation

Policy: REB Submission requirements and Administrative Review

Policy:  Informed Consent Requirements and Documentation

Policy: REB Amendments, Changes, Notifications

Policy: REB Communication with Investigators

Policy: REB Communication with Participants

Policy:  Adverse Event Reporting

Policy: REB Continuing Review

Policy:  REB Study Completion