Health Canada
www.hc-sc.gc.ca
Common menu bar links
Institutional links
Qualified Investigator Undertaking
This HTML document is not a form. Its purpose is to display the information as found on the form for viewing purposes only. If you wish to use the form, you must use the alternate format below.
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
(PDF Version - 31 K)
(Microsoft Word Version - 45 K)
(Wordperfect Version - 48 K)Contact: Office of Clinical Trials
Date: 2003-03-31
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 25 years.
Please note 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)
Clinicial Trial Application Amendment (CTA-A)
1. Clinical Trial Protocol Title
2. Clinical Trial Protocol Number
(If Applicable)
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
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. Prov. / State
17. Country
18. Telephone No.
19. Fax No.
20. Postal/ZIP Code
Part 3 - Qualified Investigator 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. Tel. No.
35. Fax No.
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;
- 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
