This service is offered at a subsidized fee for service model where MICYRN will cover 50% of the cost. An experienced regulatory support staff member will submit CTAs, ITAs, and amendments (CTA-A or ITA-A) to Health Canada for investigator-initiated multicentred clinical trials. The applications are submitted on behalf of the investigator’s institution. At this stage, the principal investigator and their institution remains responsible for assuming the other roles of a sponsor. Please note that this initiative, not intended to be a mandatory process, will be offered for a period of 18 months, renewal depending on an evaluation of cost and effectiveness. In an attempt to streamline the submission process, we ask that the below criterion be met when considering a clinical trial for this service:

• The study is a multicentred, multijurisdiction (more than one province or territory) clinical trial or a pilot mono-centered trial conducted with the intention to become—or to provide the rational for—a multicentred multijurisdictional trial

• The PI is based in one of the MICYRN members organizations

• Funding is secured

• The protocol has been peer-reviewed

• If possible, the study has been reviewed by a research ethics board and has pending approval

 In addition to the above, a guidance document is available below to assist in the preparation of the Health Canada submission package.