Research Ethics Board Attestation

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

An attestation must be completed by the Research Ethics Board that reviewed and approved the clinical trial protocol and informed consent form for this clinical trial at the site below. The completed attestation must be retained by the clinical trial sponsor for a period of 15 years.

Part 1: Clinical Trial Protocol Information

• Please check one of the following:
• Clinical Trial Application (CTA)
• Clinical Trial Application Amendment (CTA-A)
• 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

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
• Telephone No.
• Fax No.

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 Code

B. Qualified Investigator

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

Attach separate sheets (same format) for each Clinical Trial Site.
Number of pages attached:

C. Research Ethics Board Approval

• Includes member knowledgeable in complementary or alternative health care (identify member and expertise in the cover letter)
• Name of Research Ethics Board
• Date of Approval
• Street / Suite / PO Box
• City / Town
• Province / State*
• Postal / ZIP Code
• Name of Research Ethics Board Chair
• Telephone No.
• Fax No.
• Language Preferred
  • English
  • French
• Title
• E-mail

In respect of the identified clinical trial, I certify, as representative of this Research Ethics Board that:

1. The membership of this Research Ethics Board complies with the membership requirements for Research Ethics Boards defined in Part 4 of the Natural Health Products Regulations;
2. This Research Ethics Board carries out its functions in a manner consistent with Good Clinical Practices; and
3. This Research Ethics Board has reviewed and approved the clinical trial protocol and informed consent form for the trial which is to be conducted by the qualified investigator named above at the specified clinical trial site. This approval and the views of this Research Board have been documented in writing.

• Name, Title and Signature of Research Ethics Board Representative
• Date YYYY M D
• Name:
• Title:
• Signature: