Research Ethics Board attestation

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(Microsoft Word version - 115 KB)

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 15 years.

Please note that the Research Ethics Board Attestation 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)
• Clinical 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. Province / State

9. Country

10. Postal/ZIP Code

C) Contact for this clinical trial

11. Contact name

12. E-mail

13. Company name (Full name - No abbreviations)

14. Street / Suite / PO Box

15. City / Town

16. Province / State

17. Country

18. Telephone number

19. Fax number

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

24. Province

25. Postal Code

B) Qualified investigator

26. Name

27. Title

28. Language preferred

• English
• French

29. Street / Suite / PO Box

30. City / Town

31. Province

32. Postal Code

33. E-mail

34. Telephone number

35. Fax number

* 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

40. Province

41. Postal Code

42. Name of Research Ethics Board chair

43. Telephone number

44. Fax number

45. Language preferred

• English
• French

46. Title

47. E-mail

In respect of the identified clinical trial, I certify, as representative of this Research Ethics Board that:

1. 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 or with the definition in the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations;
2. This Research Ethics Board carries out its functions in a manner consistent with Good Clinical Practices; and
3. 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

Name:

Title:

Signature: