|Department||Applied Educational Research|
|Creation Date||March 1, 2011|
|Approval Date||March 1, 2011|
|Effective Date||March 1, 2011|
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.
The purpose of this policy is to describe the procedures for closing a study at the Michener Institute.
Study Closure: When investigators cease to enrol participants and all data collection, clarification and transfer is complete.
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.
This policy applies to investigators, members of the REB, Research Office and/or administration.
2.1 Determinations for study closure
2.1.1 Studies considered for closure include:
- studies that require direct participant contact where no further participant contact is required and all data collection procedures have been completed;
- 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;
- 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.
2.3.1 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.
- Tri-Council Policy Statement (TCPS 2). Ethical Conduct for Research Involving Humans, Medical research Council of Canada 2010. Article 6.17.
- ICH Harmonized Tripartite Guideline. Good Clinical Practice: Consolidated Guideline (E6)1996. Section 4.13.
- World Health Organization (WHO). Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants 2011. (Standard 9.6)
- Canadian General Standards Board. Research ethics oversight of biomedical trials 2010. (DRAFT) 4.4.8, 4.5
Policy: REB Documentation