CTA Application Service

MICYRN will be offering a regulatory submission service to Health Canada for investigator-initiated clinical trials in either the form of a Clinical Trial Application (CTA) for drug trials or an Investigational Testing Authorization (ITA) for medical device trials. service will be offered using a subsidized fee for service model where MICYRN will cover 50% of the cost. We will be contracting an experienced regulatory support staff member to submit CTAs, ITAs, and amendments (CTA-A/ITA-A) to Health Canada for investigator-initiated multi-centered clinical trials. The applications will be submitted on behalf of the investigator’s institution. At this stage, the Principal Investigator (PI) 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 multi-centered, multi-jurisdiction (more than 1 province/territory) clinical trial or a pilot mono-centered trial conducted with the intention to become (or to provide the rational for) a multicentered multi-jurisdiction trial.

  • The PI is based in one of the MICYRN Maternal/Child Academic Health Care Centre members.

  • 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, we are also attaching a guidance document to assist in the preparation of the package that will be submitted to Health Canada. If an investigator in your unit is interested in this service, please contact Breanne Stewart at breanne1@ualberta.ca.

CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)