I have just obtained the last signature on my application. Is the application then automatically submitted in the eREB system?
NO! You must click the ‘submit’ button! Assuming you are signed in as the applicant, click on the folder/project containing the form you wish to submit. On the left hand side, under ‘Actions’, you need to click the ‘Submit’ tile. Now your application has been submitted.
How long do I have to keep my study data?
It is up to the researcher to determine for how long the study data should be retained. Any clinical trial with Health Canada oversight must retain the study information for 25 years. Apart from that legal requirement, it is a personal decision of the researcher.
For student studies we generally recommend 2-3 years, with the data then retained electronically by the Local Principal Investigator (LPI) after that. Or consider retaining the data for 2-3 years post-publication. Some sources now say data should never be destroyed, and that is certainly worth considering, given trends for combining and re-analyzing data sets.
Please note: Identifiable data should be destroyed as soon as possible. De-identified data may be retained indefinitely.
My sponsor says I have to submit the quarterly safety reports to the HiREB. Is that true?
No. Annual safety reports, safety summary line statements, or periodic safety reports do NOT need to be submitted to the HiREB. The only non-local SAEs to be reported to the HiREB are those that are unexpected; related/possibly related to the intervention; and require some revision to protocol, consent, and/or notification to participants.
Please see the guidance information at Forms and Downloads for full information.
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Disclaimer: The Hamilton Integrated Research Ethics Board (HiREB) represents the institutions of Hamilton Health Sciences, St. Joseph’s Healthcare Hamilton, Research St. Joseph's-Hamilton, and the Faculty of Health Sciences at McMaster University and operates in compliance with and is constituted in accordance with the requirements of: The Tri-Council Policy Statement on Ethical Conduct of Research Involving Humans; The International Conference on Harmonization of Good Clinical Practices; Part C Division 5 of the Food and Drug Regulations of Health Canada, and the provisions of the Ontario Personal Health Information Protection Act 2004 and its applicable Regulations; For studies conducted at St. Joseph's Healthcare Hamilton, HiREB complies with the Health Ethics Guide of the Catholic Alliance of Canada