Qualified Investigator Undertaking Form

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For Viewing Purposes Only - Licence applicants must use the available WORD or PDF versions of this form when submitting it to the Natural and Non-prescription Health Products Directorate (NNHPD).

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)
    • Clinical 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

  1. Brand Name
  2. Proper or Common Name

B) Sponsor of Clinical Trial

  1. Company Name (Full Name - No Abbreviations)
  2. Street / Suite / PO Box
  3. City / Town
  4. Province / State
  5. Country
  6. Postal / ZIP Code

C) Contact for THIS Clinical Trial

  1. Contact Name
  2. E-mail
  3. Company Name (Full Name - No Abbreviations)
  4. Street / Suite / PO Box
  5. City / Town
  6. Province / State
  7. Country
  8. Telephone No.
  9. Fax No.
  10. Postal / ZIP Code

Part 3 - Qualified Investigator Information

A) Clinical Trial Site

  1. Name of Site (Full Name - No Abbreviations)
  2. Street / Suite / PO Box
  3. City / Town
  4. Province
  5. Postal Code

B) Qualified Investigator

  1. Name
  2. Title
  3. Language Preferred
    • English
    • French
  4. Street / Suite / PO Box
  5. City / Town
  6. Province
  7. Postal Code
  8. E-mail
  9. Telephone No.
  10. Fax No.

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;
  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.

  1. Signature of Qualified Investigator
  2. Date
    Year / Month / Date
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