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:
- 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;
- I will supervise the medical care and medical decisions respecting this clinical trial at this site;
- I will conduct this clinical trial in accordance with Good Clinical Practices; and
- 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:
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