Module 5 Presentations

18/07/2024

Canadian Research Ethics Board (REB)

 REB Review

● Either central or local REBs – Local REBs (often more particular), – Most REBs will NOT review/approve a study until they have received a copy of the NOL (No Objection Letter).  The refusal of the protocol for any reason by a local or foreign REB must be submitted to Health Canada.

 Provincial Central Ethics Committees: ● Primary application (for one primary site), ● Additional applications for each additional site.

 Canada has 2 official languages: English & French.

 Standard items for translation: ● ICFs and Patient Materials conducted on a site-by-site basis, ● All product labeling, including those used during clinical trials, must appear in both official languages.

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Learning Outcomes: Recap

 United States ● Brief overview of FDA organisation. ● FDA IND filing process.

● IND lifecycle and content. ● Ethics Committeereview.  Canada

● Brief overview Health Canada organisation. ● CTA filing process and lifecycle management. ● Ethics Committeereview.

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