Clinical Trial Applications
Investigator-initiated/sponsored trials
Prior to the initiation of a clinical trial in Canada, investigators (who are referred to as the sponsors in these types of trials) must file a Clinical Trial Application (CTA) with Health Canada and receive a No Objection Letter (NOL) indicating that the trial may commence and that importation of the drug may occur.
This web-based tool has been created in order to facilitate investigators and/or institutions in preparing a Clinical Trial Application (CTA) as required by regulation. The instructions have been prepared in accordance with Health Canada's "Guidance for Clinical Trial Sponsors: CTA" published by the authority of the Minister of Health, effective June 25, 2003.
These instructions put forth by Hoffmann-La Roche Limited are geared to facilitate the preparation of the forms and the presentation of the binder(s). It is still the responsibility of the investigator to read the guidance documents in order to satisfy all requirements for a CTA, see Useful Resources section. The investigator/institution is considered to be the sponsor of the trial and, therefore, must fulfill all the regulatory obligations of the sponsor as outlined in Part C, Division 5 of the Food and Drug Regulations. These instructions are geared for investigators affiliated with Hoffmann-La Roche Limited.