Register your project
How to register your study
Below you will find instructions on how to register your protocol at St. Mary's Hospital Center.
If you have any questions please contact the Research Review Office at rebecca.macdonald.chsm@ssss.gouv.qc.ca or by phone at (514) 345-3511 ext. 3698.
Some of these forms are PDF-fillable (
).
Minimum requirements for protocol registration
Every research or quality assessment protocol that is to be registered by the Research Review Office must be assigned a registration number. In order to be assigned a number, you must submit, at the minimum, the following:
- A completed Form A - Research Protocol Registration Form (). Form A must contain all the minimum signatures necessary for review. Any forms missing signatures will be considered incomplete and the protocol will not undergo review until all signatures have been obtained. As the required signatures vary depending on the study, please contact the Research Review Office for more detailed information
- The study protocol, which should include minimum requirements as specified in Form H - Protocol Evaluation (PDF). The investigator should use this checklist to ensure their protocol is complete.
MSSS multicentre mechanism
Please note that if your project involves more than 4 sites in the Québec Health Network (Réseau de santé et des services sociaux), then you must register your protocol as per the procedures adopted by the Ministère de la santé et des services sociaux. If you wish to add SMHC as a site using the MSSS multicentre mechanism, please submit Form A along with the M-ÉVAL or M-AJOUT form. Please visit the official MSSS multicentre website for more details.
Other requirements
Depending on the nature of your study, you may need to submit other forms and/or information to the Research Review Office. Please scroll through the list below to see if these requirements apply to your research project.
- Protocols involving human subjects:
If your protocol involves interviews with or observations of human subjects (e.g. patients or hospital staff), access to patients’ medical charts, nominative patient databases containing medical chart numbers or other identifiable information, or access to human specimens and blood samples, then you must ensure that your protocol addresses the criteria listed in the Form C - Human Subjects Review Summary (PDF). You may use this form as a checklist or submit it as a separate document along with your protocol.
- Protocols involving consent forms:
If human subject consent is required, then consent forms must be prepared as per requirements described in Form D - Consent Form Checklist (PDF). A sample consent form can be downloaded here.
- Research funds are being held (wholly or partially) at St. Mary’s Hospital Center:
A detailed budget justification must be prepared, as per standard format described in the Form I - Budget Justification Template (DOC). A copy of the funding approval letter must also be submitted to the Research Review Office.
- Protocols approved by the McGill Institutional Review Board:
In addition to the minimum requirements for protocol registration, you must submit a copy of the McGill Institutional Review Board approval letter, along with any other related documentation.
- Protocols involving a contract:
If your protocol involves a clinical trial agreement between private enterprise (ex. a pharmaceutical company) and St. Mary’s Hospital Center, or an inter-institutional agreement between various Hospitals, or any other type of legal contract that binds two or more parties, including St. Mary’s Hospital Center, then you must submit a copy of the latest version of the contract along with your application. Research activities may not begin until the contract has been signed by the Director General and Chief Executive Officer of St. Mary’s Hospital. Note: there cannot be a contract between a Principal Investigator and another party. Contracts must always be between the Hospital and the other party, and if applicable, the Principal Investigator.
We are always trying to improve our forms. If you have any suggestions or comments, please contact the Research Review Office at rebecca.macdonald.chsm@ssss.gouv.qc.ca or by phone at (514) 345-3511 ext. 3698.
We accept protocol submissions in English and French.
To learn about post-approval requirements, click here.
