Research Ethics Board Attestation
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An attestation must be completed by the Research Ethics Board that reviewed and approved the clinical trial protocol and informed consent form for this clinical trial at the site specified below. The completed attestation must be retained by the clinical trial sponsor for a period of 25 years.
Please note that is a template you can use to customize, it should not be submitted to Health Canada unless requested.
Part 1 - Clinical Trial Protocol Information
Please check one of the following:
- Clinical Trial Application (CTA)
- Clinicial Trial Application Amendment (CTA-A)
1. Clinical Trial Protocol Title
2. Clinical Trial Protocol Number
Part 2 - Drug Product / Sponsor Information
A) Drug Product Information
3. Brand Name
4. Proper or Common Name
B) Sponsor of Clinical Trial
5. Company Name (Full Name - No Abbreviations)
6. Street / Suite / PO Box
7. City / Town
8. Prov. / State
10. Postal/ZIP Code
C) Contact for THIS Clinical Trial
11. Contact Name
13. Company Name (Full Name - No Abbreviations)
14. Street / Suite / PO Box
15. City / Town
16. Prov. / State
18. Telephone No.
19. Fax No.
20. Postal/ZIP Code
Part 3 - Clinical Trial Site Information
A) Clinical Trial Site
21. Name of Site (Full Name - No Abbreviations)
22. Street / Suite / PO Box
23. City / Town
25. Postal Code
B) Qualified Investigator
28. Language Preferred
29. Street / Suite / PO Box
30. City / Town
32. Postal Code
34. Tel. No.
35. Fax No.
* Attach separate sheets (same format) for each Clinical Trial Site.
Number of pages attached:
C) Research Ethics Board Approval
36. Name of Research Ethics Board
37. Date of Approval
38. Street / Suite / PO Box
39. City / Town
41. Postal Code
42. Name of Research Ethics Board Chair
43. Telephone No.
44. Fax No.
45. Language Preferred
In respect of the identified clinical trial, I certify, as representative of this Research Ethics Board that:
- The membership of this Research Ethics Board complies with the membership requirements for Research Ethics Boards defined in Part C Division 5 of the Food and Drug Regulations;
- This Research Ethics Board carries out its functions in a manner consistent with Good Clinical Practices; and
- This Research Ethics Board has reviewed and approved the clinical trial protocol and informed consent form for the trial which is to be conducted by the qualified investigator named above at the specified clinical trial site. This approval and the views of this Research Ethics Board have been documented in writing.
48. Name, Title and Signature of Research Ethics Board Representative
49. Date YYYY M D
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