Canada Profile Updated in ClinRegs
August 20, 2020
The Canada profile in ClinRegs now includes the following updates:
- Updates to Health Canada contact information (See Regulatory Authority)
- New information on the Research Ethics Board Attestation (See Scope of Review)
- Revised versions of the Clinical Trial Site Information (CTSI) form, CTSI Instructions, and the Clinical Trial Application/Attestation (See Submission Process and Submission Content)
- New guidance on implementation of eCTD for clinical trial regulatory activities (See Submission Process)
- Updated informed consent guidance (See Documentation Requirements, Required Elements, and Consent for Specimen)
COVID-19 Related Information
On August 13, 2020, Health Canada issued a Ministerial Order that temporarily extended the default period to review non-COVID-19 clinical trial applications and amendments by from 30 days to 45 days. More information is available in a Notice issued on August 14, 2020.
On August 5, 2020, Health Canada updated Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors, which provides guidance related to protocol deviation, participant safety, site monitoring, participant eligibility, pausing a study, and shipment of investigational products directly to patients. The guidance now notes the following:
- Until further notice, sponsors do not need to file clinical trial site forms for non-COVID trials
- Until further notice, sponsors do not need to submit notifications for non-safety-related changes for non-COVID trials