For Researchers by Researchers – Relevant REB Review

Canadian SHIELD strives to simplify field based research reviews while ensuring to meet the provisions of Canadian Food & Drug Regulations, Division 5 (1024 Clinical Trials), HHS Regulations for Protection of Human Subjects (21 CFR 50 & 56 and 45 CFR 46), and ICH (GCP E.6 section 3).

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.

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 and both 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.

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

What To Expect After Submission

The Board Review

After submitting your application, it will be checked for completeness and prepared for review by our Regulatory compliant Board. The REB Chair, in collaboration with an seasoned professional administrator, will decide if a full Board review is required, if additional, specialized expertise is required or if an Expedited Review would be appropriate.

Our administrative team will begin reviewing your submitted Informed Consent Form immediately for spelling and format issues. Once the REB review is complete, you will receive a WORD version of the properly formatted and potentially revised ICF for your final approval. Each Investigator site will receive a customized ICF as part of their approval package.

Disapprove

Defer

Conditionally Approve

Approve

Disapprove

Determination: Disapprove
When the initial, continuing, or modification submission does not meet the criteria for approval, the REB considers the research to have extensive deficiencies. They will then issue a “disapprove” determination with a summary of reasons and recommendations if any.

Veto on a Research Changes
Once the Board makes a “disapprove” determination on a change in research, this modification cannot be implemented. The Board expects the research will continue as previously approved.

Decision Reconsideration
You may request reconsideration of a “disapprove” determination and provide additional information to the Board for consideration. The investigator may appear before the Board in person or via teleconference if desired.

Defer

Determination: Defer
The Board issues a “defer” determination when the provided information does not meet the criteria for approval. They will request additional information to decide further.

Conditionally Approve

Determination: Conditionally Approve
When your initial, continuing, or modification submission meets the criteria for approval with minor/prescriptive changes or requirements, the board issues a "conditionally approve" determination.

Resulting Process
You will receive written notification of the conditions promptly after the review. Once you send the requested information, your submission will be re-reviewed. You will receive your approval documents when this additional process is complete and all the information is confirmed.

Important Note
The study, changes in research, or other submitted material are not approved until we confirm that any/all of the condition(s) are satisfied. You are not authorized to begin research-related activities until you receive final approval documents.

Approve

Determination: Approve
The Board issues an “approve” determination when your initial, continuing, or modification submission meets the criteria for approval. This approval is based on board-required consent form modifications. We’ll provide a finalized consent form with the required modifications. Then we will send you a Health Canada compliant Approval Package

The Outcome Documentation

When your study has been reviewed, we’ll prepare and send the outcome documents to you with all designated contacts, such as:

Approval Letter that outlines the submitted documents and clearly conveys the Board’s actions as well as any special determinations, requirements or other necessary information.
Research Ethics Board Attestation and Membership list
Copy of the Board-approved consent form, when applicable, that is ready for use.
Description of the changes to the consent form, depending on the type and extent of the Board’s changes
Explanatory notices relevant to the review

Reach Out to Our Research Review Board

For additional information about the requirements and process of our research review, feel free to get in touch with us today. It would be our pleasure to respond to your questions.