The Board meets the first and third Monday of each month. The Board is available to meet more frequently upon request. The Board should receive the request for submission and the submission package seven (7) business days prior to the meeting date.

To submit a study that requests an original protocol review, the following documents must be provided:

• Submission letter on site’s or sponsor’s letterhead (a draft of this can be found on our Submission Forms page)
• Investigator’s Brochure (2 copies) or Product Monograph, if available
• Protocol (14 copies)
• Proposed Informed Consent Form (hard copy and soft copy in MS Word)
• Proposed Pharmacogenetics Informed Consent Form (PGX) if applicable
• Proposed HIV Informed Consent Form if applicable
• All proposed advertisement/recruitment material including call centre scripts
• Emergency phone number for patient contact and/or 24-hour contact number
• Site list, complete with site name, company name and address and contact information
• Research Ethics Board Attestation form (REBA) for each site (a copy of the REBA is available on our Submission Forms page)
• CV’s of principal and sub-investigators (signed and dated)
• Medical license of principal investigator (current)

For multi-centre studies for which TEB has already reviewed the protocol, each site must submit all of the items listed above with the exception of the protocol, the approved Informed Consent and the Investigator’s Brochure.

If a site requires translation of an approved Informed Consent, recruitment materials or advertising tools, it is the sponsor’s responsibility to provide this.

A site questionnaire is to be completed if TEB has not approved a study for their site within the past 12-month period.  A copy of this questionnaire can be found on our forms page.

Amendments and Revised Consent Forms

Any protocol amendments or administrative changes to a protocol or an Informed Consent Form must be submitted to the Board for review and approval before implementation. Please note: minimal risk amendments or changes may not require full Board approval.

Advertising/Recruitment Material

All advertisements and recruitment materials must be submitted to the Board for review and approval prior to use.  The Board will review advertisements in accordance with all guidelines and regulations.  Recruitment materials must include all posters, patient cards, videos, patient information documents and any recruitment screening scripts used either by sites or central call centres.

Significant Protocol Deviations

The Board requires significant protocol deviations to be reported promptly to the Board.  Significant protocol deviations include any deviation that significantly affects the safety of the subjects or the scientific quality of the study.  Examples include:

• Deviations from the eligibility criteria that affect patient safety and rights
• Deviations (omission or delay) of safety monitoring procedures
• Deviations in the administration of study products
• Deviations in obtaining informed consent
• Show blatant disregard for GCP by investigator or staff
• Deviation may render data useless

Annual Reviews

Each approved site must request Annual Re-approval for each subsequent 12-month period that they continue to participate in the study.

An Annual Re-approval form will be required by each site to obtain Annual Re-Approval. A copy of this form can be found on the Submission Forms page.

Serious Adverse Events

TEB requires that all serious adverse events (SAEs) be submitted promptly (within 3 business days of the site becoming aware of the SAE).  The death of a subject must be immediately reported to TEB.  This report can be made in the form of a letter to the Board outlining the details of the SAE.  The Board will review the SAE. The Board may request additional information from the sponsor or investigator.  If the Board determines that additional information should be provided to subjects, the Board will request from the sponsor an addendum to the consent and/or a revision to the approved consent and will notify the investigator of the revisions.  The sponsor or investigator may also recommend that new safety information be provided to study subjects.

IND Safety Reports

Safety Reports: IND Safety reports, SUSARS, SADRs, receipt of these reports will not normally be acknowledged, unless upon review further information/action is required.

If Notification of IRB Review and acknowledgment letter is required a fee will apply.

Final Close-Out Report

The site must submit a Final Close-out Report to ensure proper close-out after all subjects have completed the study at your site.  A template of the report forms can be found under Submission Forms.