Qualified investigator undertaking

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An undertaking must be completed by the qualified investigator responsible for the conduct of the clinical trial at the site specified below. The completed undertaking must be retained by the clinical trial sponsor for a period of 15 years.

Please note that that the Qualified Investigator Undertaking 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

In respect of the identified clinical trial, I certify, as the qualified investigator for this site that:

1. I am a physician or dentist and a member in good standing of a professional medical or dental association as defined in Part C Division 5 of the Food and Drug Regulations or a person who is a member in good standing of a professional association of persons entitled under the laws of a province to provide health care under their licence in that province or as defined in the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations;
2. I will supervise the medical care and medical decisions respecting this clinical trial at this site;
3. I will conduct this clinical trial in accordance with Good Clinical Practices; and
4. I will immediately on discontinuance of the clinical trial by the sponsor, in its entirety or at a clinical trial site, inform both the clinical trial subjects and the Research Ethics Board for this site of the discontinuance, provide them with the reasons for the discontinuance, and advise them in writing of any potential risks to the health of clinical trial subjects or other persons.

36. Signature of Qualified Investigator

37. Date YYYY M D

Name:

Title:

Signature: