Submissions

All forms related to the review process can be access on the FORMS page. Please call our office (905) 681 8661 for assistance.

Requirements:

1. Submission Requirements (CTA / IND Trials – Phase I – III)

The following is a general list of items needed. Each trial may need additional information, based on the nature of the trial and the “invasiveness” of the therapeutic maneuver. For sites joining an already approved trial, some of these documents will already be on file.

a) Submission Package:

  • Initial Submission Checklist
  • Study Information Form (completed by Sponsor)
  • Site Information Form (one per site)
  • Protocol
  • Investigators Brochure
  • CPS / PDR information for comparator(s), if applicable
  • Consent form / information sheets
  • Data gathering instruments (diaries, scales, questionnaires)
  • Advertising materials
  • Principal Investigator information:
    • Curriculum Vitae
    • Current professional license showing the expiration date

2. Submission Requirements (Non CTA Trials – phase IV)

Sponsors and Investigators often wonder if phase IV trials require REB approval. These trials do not require submission or approval from Health Canada, so why do they need REB approval? The mandate of REBs is to ensure that, at minimum, the following are met:

  • Seeking REB approval provides the Sponsor and the physician with an independent assessment of the proposed program to ensure compliance with applicable government regulations and the Code of Marketing Practices supported by all pharmaceutical companies that will ensure the privacy and protection of the study participant. This review adds credibility to the program both to the physicians and study participants.
  • The patients’ rights to privacy and confidentiality are respected.
  • The patients are not subjected to unnecessary risks through their participation.

a) Submission Package:

  • Initial Review Checklist
  • Study Information Form (competed by Study Sponsor)
  • Investigator Information Form (simplified form, one per site only, no CV required)
  • Protocol
  • Product Monograph
  • CPS / PDR information for comparator, if applicable
  • Consent form / information leaflet
  • Data gathering instruments (diaries, scales, questionnaires)
  • Advertising materials
  • Principal Investigator (Co-coordinating Investigator)
  • Curriculum Vitae
  • Current professional license showing the expiration date