Launching a Study or Project

Purpose: The COI Disclosure Requirements module is designed to outline and remind research teams of their responsibilities regarding conflict of interest (COI) disclosures.  The new module:

• Highlights relevant institutional policies that are related to relationship management/ conflict of interest
• Provides guidance on submitting disclosures annually through CMaRS (for PI/ Study Lead)

Background: As part of WCH’s commitment to transparency and consistent relationship management across TAHSN hospitals, all researchers/project leads at Women’s College Hospital are required to complete the Relationship Attestation and Disclosure Form through the CMaRS system on an annual basis.

This unified disclosure process ensures consistency across University of Toronto–affiliated hospitals and focuses on disclosing and managing relationships rather than identifying conflicts of interest.

The Training Attestation streamlines the oversight of institutional education and training requirements while ensuring that WCH research team members are appropriately qualified and trained to conduct research at WCH.  Process changes include:

• Documentation of training (certificates of completion) do not need to be submitted to the REB as part of the study application process.
• The PI/Study Lead will verify and attest that all WCH affiliated study personnel listed on the study application are appropriately qualified and have completed the required institutional training (via Project Launch).
• A summary PDF will be available for download for REB submission.
• Training completion will need to be appropriately documented and maintained for current and new WCH research team members involved in the study.
• Note for APQIP projects: There are no specific requirements at this time for APQIP personnel, as the project undertaken is not classified as research. However, all staff involved should be up-to-date on institutional training modules, including Privacy training, and requirements for regular practice.

Note: A template to help track staff’s research training is now available on REDCap under new project templates.  To view instructions, please see below.

This module aims to:

• Outline key resources, contacts, and considerations related to the privacy and data security of a study/project at WCH and improve practice around privacy and data security while conducting research, quality improvement projects, program evaluations, etc.
• Upon completion of the form, the PI/Study Lead will be electronically notified via REDCap to attest to the document to ensure understanding and implementation of the appropriate recommendation(s) and considerations as applicable.  This information will need to be conveyed to the team (including but not limited to staff, students, trainees, learners, etc.).
• A final PDF of the attestation, responses, and the appropriate recommendation(s) and considerations will be available to download for your ethics application.
• For additional information and FAQs on privacy and data security for research, please see our Operational Resources page here.

This mandatory section is only applicable if you will be using any WCH service(s) outlined below for your study/project.  This section allows you to electronically submit your Impact Analysis Forms for requests for the following service providers:

• Medical Imagining,
• Laboratory Services,
• Pharmacy, and/or
• Strategic Communications

Upon your electronic submission, a notification will be sent to the manager of the relevant department for their review and feedback. Expect further communication via email before the service provider agrees to provide the required service.

Note: Strategic Communications is required to review and approve all recruitment materials that will be used to recruit patients/members of the public (e.g., posters, social media, web content, etc.) prior to REB Submission

This mandatory electronic format now replaces the paper-based ‘Scientific Review’ form to help drive greater efficiency across processes.  Completing your list of internal and external reviewers (within the Central Form) will trigger an email notification to be sent directly to the listed reviewers.

Reviewers can access the ‘Scientific Review’ form simply by clicking on a survey link.

Note: Always follow up with reviewers directly in case of any delays, non-responses, or other challenges.  And please make sure that if an email notification has not been received, reviewers should check their junk folders for the email (from REDCap).

Activities that impact the clinical departments include participant scheduling, referrals, use of offices for participant visits, physical examinations, drug administration, or use of specific equipment. 

This electronic process aims to assess clinical impact(s) in the following clinical areas:

• Anesthesia
• Primary Care
• Gynecology
• Perioperative Services
• Mental Health
• Specialized Medicine (includes Cardiology, Dermatology, Endocrinology, General Internal Medicine, Geriatric Medicine, Gastroenterology, Infectious Diseases, Neurology, Respirology, Rheumatology)

Upon your electronic submission, a notification will be sent to both the Clinical Director and Department Head of the relevant clinical area(s) for their review and feedback.

Note: You will be required to have had prior consultation with a member of the clinical team (and include their name) as part of the electronic form submission.

The Financial Review section is designed to ensure that the necessary funding for a project/study has been secured prior to submitting the ethics application. This could include funding obtained through methods such as grant applications, negotiations with sponsors, or support from ministries or foundations.

• If the funds are sourced from non-traditional channels, such as foundations, ministries, or in-kind contributions, and have not been previously reviewed by the Research Finance Department, they will require a review from finance.
  • These teams can upload their budget within Project Launch.  A budget template is available on the Research Finance page within ‘forms’.
  • This process uses an electronic notification to the Research Finance Department to initiate communications and review of the budget.

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