Protocol Development

MICYRN can assist in the transition of an awarded grant application into a Health Canada preferred protocol.

Health Canada Regulatory Submissions

MICYRN will prepare and submit clinical trial applications and investigational testing authorizations for regulated clinical trials. MICYRN will also work with institutions looking to build local regulatory submission capacity by providing training opportunities, and mentorship.

Centralized Ethics Submissions

Working alongside the Canadian Collaboration for Child Health: Efficiency and Excellence in the Ethics Review of Research (CHEER) initiative and institutional REBs, MICYRN is offering a pediatric clinical research ethics submission consultation service.

Information Sheet

Monitoring

Maternal and child health institute leadership across Canada have highlighted a collective desire to develop a cross institutional monitoring program. At the request of the MICYRN Consortium, the program is designed with an experienced lead monitor supported centrally through MICYRN. The lead monitor will function as the intake point for ARO service consults for the maternal-child health investigator community for investigator-initiated, multicentre clinical trials. The role of the lead monitor will be to develop a protocol specific monitoring plan for each project. Site-based monitors that have either been trained through the MICYRN monitoring course or who are competently trained through other means will be contacted to serve as the point site-based monitor if their site is a participating site in the trial. The site-based monitor will receive protocol specific training from the MICYRN lead monitor for each project that they are participating in.

The cross-institutional monitoring program has been centrally developed with tools and templates specific to maternal-child health. Training sessions for the monitoring program will be offered and delivered at MICYRN’s expense, to nominated individuals across MICYRN member research organizations. Once those individuals successfully complete the training, they will become part of a resource pool to draw from for the cross-institutional monitoring program. This program enables MICYRN member institutes to build local quality assurance capacity while leveraging cost effective monitoring approaches for multicentre, regulated clinical trials in the maternal-child health space.

Monitoring Objectives: 

1. Ensure the protection of participants

2. Verify compliance of Division 5 regulations

3. Ensure that Good Clinical Practice is being followed

4. Validate and verify quality of data generated

5. Support study teams to build local capacity for quality assurance

6. Provide Health Canada auditing inspection support

Scope of Work:

• Multicentre, multi-jurisdictional

• Maternal-Child Health

• Health Canada Regulated Clinical Trial

• Funding to cover project specific monitoring activities in place (or anticipated to be in place)
  

Safety and Adverse Event Reporting

MICYRN is building capacity to facilitate a centralized data safety monitoring board (DSMB) to ensure participant safety and provide expertise on clinical trial conduct for the continuation, modification, or termination from a pediatric lens. MICYRN will assist in the development of a charter, and facilitate the DSMB meetings and generate reports.

MICYRN can also assist study sponsors in the adverse event reporting to Health Canada.

Data Management

MICYRN facilitates database creation, and data management support in a validated REDCap web-based application for clinical trials and also assists study teams to develop case report forms.

Project Management

MICYRN provides high-level study management to bridge gaps while grant or site resources are mobilizing or, if required, complete project management of study execution.

Single Patient Study

MICYRN is offering support for non-oncology single patient studies in pediatrics. The cost of the regulatory submission to Health Canada will be subsidized by MICYRN at a rate of 50%. For more information, click HERE.

Drug Development

MICYRN is able to assist study teams in sourcing study drugs or placebos. Those studies needing assistance in placebo development can contact MICYRN to connect with the Pharmacology Working Group, which is establishing placebo consultation and development services. Bay Logistics also provides placebo and drug development services.

For more information about these services, please contact Karin Kushniruk, MICYRN’s associate director of clinical trials.