Health Canada Approval
In August 2019, Health Canada, Regulatory Operations and Enforcement Branch (ROEB), released the long-awaited Guidance Document (GUI-0100), created to provide guidance in interpreting the regulations around conducting a regulated clinical trial in Canada.
“This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in human subjects in Canada to comply with Part C, Division 5 of the Food and Drug Regulations and to understand the International Council for Harmonisation (ICH) Guidance Document: Good Clinical Practice: Integrated Addendum to E6(R1) ICH Topic E6(R2) in the Canadian context.”
This link contains guidance notes and instructions in accessing RISe (Researcher Information Services), the UBC online tool to manage and track your ethics application and funding support information online. Note you must have a UBC CWL to start. Instructions for obtaining a CWL are also located here.
The PHC REB generally meets the last Friday of every month, and applications must be submitted three weeks in advance. For meeting dates, click here.
Trial Registration Requirements
Any clinical study involving human participants must be registered on a public clinical trial registration website. The most commonly used is clinicaltrials.gov. UBC provides assistance for UBC researchers. See here for assistance in getting your study registered.
As part of CIHR’s signing of the World Health Organization’s Joint Statement on Public Disclosure of Results from Clinical Trials, all CIHR-funded clinical trials must comply with the following:
- All study publications must include the registration number/Trial ID (to be specified in the article summary/abstract).
- Public disclosure of results must be done within a mandated time frame:
- publications describing clinical trial results must be open access from the date of publication;
- summary results must be publicly available within 12 months from the last visit of the last participant (for collection of data on the primary outcome)