Clinical Trial Site Information Form

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

Natural Health Products Directorate

A separate form for each clinical trial site must be completed by the Sponsor and filed with Health Canada.
All fields must be completed prior to submitting this form to Health Canada.

Part 1: Clinical Trial Protocol Information

Please check one of the following:

• Clinical Trial Application (CTA)
• Clinical Trial Application Amendment (CTA-A)
• Clinical Trial Notification

• Protocol Title
• Protocol # (if known)

Part 2: Natural Health Product (NHP) / Sponsor Information

A. NHP Information

• Brand Name / Product Code:
• Medicinal Ingredient(s):
  • See Clinical Trial Application and Attestation Form
• Submission Number (if known):

B. Sponsor of Clinical Trial

• Name of Sponsor (Full Name - No Abbreviations)
• Street / Suite / PO Box
• City / Town
• Province / State
• Country
• Postal / ZIP Code

Contact Information of Sponsor (if Sponsor is an individual) or Senior Official (if Sponsor is a company, institution, or organization)

• Name
• Telephone No.
• Fax No.
• Language Preferred
  • English
  • French
• Title
• E-mail

C. Contact for this Clinical Trial

• Contact Name
• E-mail
• Company Name (Full Name - No Abbreviations)
• Street / Suite / PO Box
• City / Town
• Province / State
• Country
• Postal / ZIP Code

Part 3: Clinical Trial Site Information

A. Clinical Trial Site

• Name of Site (Full Name - No Abbreviations)
• Street / Suite / PO Box
• City / Town
• Province / State
• Postal / ZIP Code
• Commencement Date of Clinical Trial or Clinical Trial Amendment^{Footnote 1}

B. Qualified Investigator

A Qualified Investigator Undertaking must be completed by the qualified investigator responsible for the conduct of the clinical trial at the site specified above. The completed undertaking must be retained by the clinical trial sponsor for a period of 25 years.

• Name
• Title
• Language Preferred
  • English
  • French
• Street / Suite / PO Box
• City / Town
• Province / State
• Postal / ZIP Code
• E-mail
• Telephone No.
• Fax No.

C. Research Ethics Board Approval

A Research Ethics Board Attestation must be completed by the Research Ethics Board that reviewed and approved the protocol and informed consent form for this clinical trial at the site specified above. The completed attestation must be retained by the clinical trial sponsor for a period of 25 years.

• Name of Research Ethics Board
• Date of Approval
• Street / Suite / PO Box
• City / Town
• Province / State
• Postal / ZIP Code
• Name
• Telephone No.
• Fax No.
• Language Preferred
  • English
  • French
• Title
• E-mail