A CTA is required for all Division 5 phase I, II and III studies, but not for phase IV studies that use a marketed drug within the parameters for which it has already been approved by Health Canada. Radiation Therapy trials, generally, do not require a CTA.
Sponsors must also submit a Clinical Trial Site Information form to Health Canada, which includes information on the various ethics committees involved and details on the participating investigators and the trial site.
Approval is also required from a Research Ethics Board (REB). The site of the clinical trial will dictate which REB you need to contact. There are three organizations with REBs in Alberta who have been designated by the province to review applications that use health information:
A study is not permitted to start until the CTA has been accepted and the REB of the clinical-trial site has approved the trial.
Investigators should prepare a protocol, a document that describes the objectives, design, methodology, statistical considerations and organization of a clinical trial. If a clinical trial is testing a drug, investigators are also required to prepare an Investigator’s Brochure, containing preclinical and clinical data on the drug, including information about patient safety.