Clinical trials outline of process Frequently Asked Questions

Outline of the Process

1. What types of clinical trials must be filed?
2. How long does it take to receive authorization?
3. In what situation do I have to file an application?
4. What are the roles and responsibilities of a sponsor and a Qualified Investigator when conducting a clinical trial?
5. Do I need to apply for a pre-CTA meeting?
6. What data must be submitted to Health Canada?

1. What types of clinical trials must be filed?

Clinical Trial Applications (CTAs) must be filed with Health Canada for review and authorization for drugs not marketed in Canada for Phase I, II and III clinical trials, as well as for comparative bioavailability trials. If the drug has received a Notice of Compliance (NOC) or a Drug Identification Number (DIN), clinical trial applications must be filed where the use of the product in the clinical trial is outside the parameters of the NOC and/or DIN, i.e. one or more of the following is different:

• indication(s) and clinical use;
• target patient population(s);
• route(s) of administration; or
• dosage regimen(s)

If a new indication for a marketed drug is to be investigated, the clinical trial is considered to be a Phase II or Phase III trial.

For drugs that have received a Notice of Compliance with Conditions (NOC/c), clinical trials conducted within the parameters of the NOC/c must be filed with Health Canada for review and authorization. Please note that sponsors are not required to file a CTA for clinical trials involving marketed drugs where the investigation is to be conducted within the parameters of the authorized NOC or DIN application. These trials are referred to as Phase IV clinical trials.

2. How long does it take to receive authorization?

Health Canada commits to a 30-day default, review period for authorization. That is, if Health Canada does not issue a Non Satisfactory Notice, during the review period, the trial may proceed on the basis of default authorization. Health Canada has an administrative 7-day review target for comparative bioavailability trials, and some Phase I trials in healthy humans volunteers.

3. In what situation do I have to file an application?

A CTA has to be submitted:

• for a new drug
• for an already marketed drug, if one or more of the following is different than "label-use":
  • indications and clinical use
  • patient population
  • route of administration
  • dosage

A CTA is not required for Phase IV trials.

4. What are the roles and responsibilities of a sponsor and a Qualified Investigator when conducting a clinical trial?

Sponsor

The sponsor is defined as an individual, corporate body, institution or organization that applies for authorization to conduct a clinical trial in Canada and is responsible for meeting the regulatory requirements and conducting the trial according to the generally accepted principles of good clinical practices.

Qualified Investigator

The Qualified Investigator is a person who is:

• a physician and a member in good standing of a professional medical association
• in the case of a clinical trial of a dental drug, a physician or dentist and member in good standing of a professional medical or dental association
• responsible to the sponsor for the conduct of the clinical trial at the clinical trial site
• responsible for medical care and medical decisions at the clinical trial site
• entitled to provide health care under the laws of the province where that clinical trial site is located
• there may be only one Qualified Investigator per clinical trial site

5. Do I need to apply for a pre-CTA meeting?

Health Canada invites sponsors to request a pre-CTA consultation meeting, but such meetings are not mandatory. Such consultations may be particularly useful for new active substances or applications that will include complex issues that may be new to Health Canada. For more information please consult the section related to pre-CTA meetings. Details

6. What data must be submitted to Health Canada?

A Clinical Trial Application contains information and documentation to support the objectives and goals of the proposed clinical trial including scientific evidence supporting the use of the drug product within the context of a trial . It also includes data to support the quality of the drug product to be used in the trial. For more information please consult the section on Clinical Trial Applications. Details