Study Completion

AC-AER-024
Study Completion
DepartmentApplied Educational Research
Creation DateMarch 1, 2011
Approval DateMarch 1, 2011
Effective DateMarch 1, 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 procedures for closing a study at the Michener Institute.

Definitions

Study Closure: When investigators cease to enrol participants and all data collection, clarification and transfer is complete.

Policy

The REB must be notified of the closure of a study and be provided with a final report pertaining to the activities of the study.

Responsibility

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

Procedures

2.1         Determinations for study closure

2.1.1      Studies considered for closure include:

  1. studies that require direct participant contact where no further participant contact is required and all data collection procedures have been completed;
  2. studies that do not require direct participant contact (secondary use of data), where all data collection procedures have been completed;

iii.           studies utilizing human tissue, where no additional tissue samples will be acquired;

  1. industry sponsored trials, where an official “close-out” letter has been received from the sponsor.

2.2         Study closure

2.2.1      Investigators will inform the REB and Research Office that their study has closed and submit a final report;

2.2.2      Upon confirmation that the study has closed and all documentation is complete (see Policy: REB Documentation), the Research Office will close the file and the REB will cease to provide ethics oversight for the study.

2.3         Documentation

2.3.1      Investigators will complete and submit a final report via the End of Study Report Form (FORM 9);

2.3.2      The coordinator or designate will review the report and the contents of the study file and request any documentation or clarification required to assure its completion;

2.3.3      The completed file will be reviewed by the Chair of the REB;

2.3.4      The Chair will sign the End of Study Report Form and the coordinator or designate will log the date of study closure in the database;

2.3.5      The coordinator or designate will send a letter to the Investigator indicating that the study has been closed;

2.3.6      Study files will be stored securely.

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 4.13.

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. (Standard 9.6)

http://www.who.int/ethics/publications/research_standards_9789241502948/en/index.html

  1. Canadian General Standards Board. Research ethics oversight of biomedical trials 2010. (DRAFT) 4.4.8, 4.5

 

Associated Documentation

Policy: REB Documentation