Clinical Trials

A Clinical Trial Application (CTA) must be filed with Health Canada prior to the initiation of a clinical trial in Canada.

The Health Canada application includes:

• a protocol which details the objectives, benefits, risks, methods, and conditions for the trial to function

• Clinical Trial Site Information Form

• Clinical Trial Application (CTA)

• Qualified Investigator Undertaking

• Protocol Synopsis and Evaluation

• Research Ethics Board Attestation (if available at the time of submission)

All necessary forms, information and guidance documents are available at:

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/index_e.html

Of particular importance is the document entitled Guidance for Clinical Trial Sponsors: Clinical Trial Applications.

Health Canada normally reviews the application and notifies the Sponsor within 30 days if the application is found to be deficient.

Clinical Trial Application requirements are outlined in the Food and Drugs Act and Regulations, the Guidance for Clinical Trial Sponsors: Clinical Trial Applications document and Clinical Trial Application form, all available at the web site identified above. These documents also explain the requirements pertaining to local Research Ethics Board review and approval of clinical trials.

Institutional/Investigator-initiated CTAs must comply with the same regulatory requirements that apply to Industry-initiated CTAs, with some modification as outlined in the Guidance for Clinical Trial Sponsors: Clinical Trial Applications document referenced above.

If there is any uncertainty as to whether Health Canada approval is required, the researcher is encouraged to contact Health Canada at:

Senior Medical Advisor Bureau

Telephone: (610) 954-6493 
Fax: (610) 954-4474 
E-mail: [email protected]

All clinical researchers must be familiar with the details of the Regulations Amending the Food and Drug Regulations (1024 – Clinical Trials). These regulations apply to clinical trials for both new, investigational, drugs and some marketed drugs.

There must be ONE Qualified Investigator at each clinical trial site, who is responsible for the medical decisions and care provided to clinical trial subjects. A Qualified Investigator must be a licensed physician or dentist (for dental studies).

The Qualified Investigator must sign an undertaking that he/she will conduct the trial according to Good Clinical Practices.

Record-keeping:

• Health Canada requires that all clinical trial records be maintained for a period of 25 years.

• Documentation must include a Research Ethics Board Attestation that “for each clinical trial site, an attestation, signed and dated by the Research Ethics Board for that clinical trial site, stating that it has reviewed and approved the protocol and informed consent form and that the board carries out its functions in a manner “consistent with good clinical practices.” A “Research Ethics Board Attestation” form is available at the above web site for this purpose.

• More detailed information is provided in Health Canada’s Guidance for Clinical Trial Sponsors: Clinical Trial Applications document.

A Clinical Trial Application (CTA) must be filed with Health Canada prior to the initiation of a clinical trial in Canada.

The legal requirements for NHP clinical trials are found in the NHP Regulations which are administered by the Natural Health Products Directorate (NHPD). This Directorate of Health Canada is responsible for granting or denying authorization for these trials.

Not all clinical trials of natural health products require authorization from Health Canada.

To determine whether your trial requires authorization or not, please consult the NHP Regulations and the Clinical Trials for Natural Health Products guidance document, which are available at the web site referenced below.

All necessary forms, information and guidance documents are available at:

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index_e.html

Of particular importance is the guidance document entitled Clinical Trials For Natural Health Products.

In order to obtain approval from the NHPD, a Clinical Trial Application (CTA) must be submitted to the NHPD and authorized by the NHPD.

If there is any uncertainty as to whether Health Canada approval is required, the investigator is encouraged to contact Health Canada, Health Products & Food Branch - Natural Health Products Directorate

All clinical investigators must be familiar with the NHP Regulations. The regulations were published in Canada Gazette, Part II, on June 18, 2003 and are available at the web site referenced above.

There must be ONE Qualified Investigator at each clinical trial site who is responsible for, among other things, the safety of the clinical trial subjects. A Qualified Investigator is a licensed physician or dentist who is entitled to provide health care under the laws of the province where the clinical trial is located (see section 63 of the NHP Regulations). A Qualified Investigator may oversee more than one site.

The Qualified Investigator must sign an undertaking that he/she will conduct the trial according to Good Clinical Practices. Please see the “Qualified Investigator Undertaking” form available at the web site referenced above.

Therapeutic Products Directorate : Certain clinical trials may have to be submitted to the Therapeutic Products Directorate (TPD) rather than the NHPD. For more information, please refer to Health Canada’s guidance documents.

Record keeping : Health Canada requires that all clinical trial records be maintained for a period of 25 years. More information is provided in the Clinical Trials for Natural Health Products Guidance Document mentioned above.

Turnaround period : Health Canada’s turnaround period is approximately 30 days but can be longer.