Module 5 Presentations

18/07/2024

 The Sponsor is required to notify Health Canada within 15 calendar days when a clinical trial is completed or a clinical trial site is closed  For End of Study Notifications, Health Canada requires a cover letter informing them that the study is closed. ● Health Canada also appreciates if they have the last patient, last visit (LPLV) date in the letter  Clinical Study Reports ● Not required by Health Canada, but may be requested Health Canada Notifications – End of Study and Site Closure

The Organisation for Professionals in Regulatory Affairs

39

Health Canada Forms

Clinical Trial Site Information (CTSI)

-Similar to the FDA 1572 (but not signed by the site); must be submitted to Health Canada prior to initiating a clinical trial or implementing a protocol amendment to a clinical trial at a site.

Qualified Investigator Undertaking (QIU)

-QI is the same as the PI, only one per site; form is signed by the PI and kept at the site (same for REBA). The QIU form should not be submitted to Health Canada, unless it is requested.

Research Ethics Board Attestation (REBA)

-This form only needs to be completed/collected if the REB approval letter or roster do not have the three compliance attestations, these are: – Membership of this REB complies with the requirements for REBs defined in Part C Division 5 of the Food and Drug Regulations; – This REB carries out its functions in a manner consistent with GCP; and – This REB has reviewed and approved the clinical trial protocol and ICF which is to be conducted by the qualified investigator at the specified site. This approval and the views of this REB have been documented in writing.

The Organisation for Professionals in Regulatory Affairs

40

20