Filing of clinical trials Frequently Asked Questions

Filing of Clinical Trials

1. My company currently has an ongoing IND in the USA, and would like to expand to include Canadian investigators. How is this done?
2. My trial was filed as an Investigational New Drug Submission (INDS) prior to September 1, 2001. Do amendments have to be filed?
3. I was not required to file my trial prior to September 1, 2001. Do amendments have to be filed?
4. The PSEAT-CTA is not requested in the Regulations. What is it, and why does the Guidance for Clinical Trial Sponsors request it for Pharmaceuticals (Section 5.2, 1.2.4)?
5. What are the fees for CTA and CTA-A submissions?
6. Are there any color requirements for the binders of various Modules?
7. Are there any requirements for the types of binders used?
8. My clinical trial involves a pharmaceutical and a biological / radiopharmaceutical drug. What do I have to submit?
9. My clinical trial involves a pharmaceutical drug and an investigational medical device. What do I have to submit?
10. My clinical trial involves a biological / radiopharmaceutical drug and an investigational medical device. What do I have to submit?
11. My clinical trial involves a pharmaceutical drug and a natural health product. What do I have to submit?
12. What documentation is required in order to ship an investigational drug into Canada?
13. How do the Therapeutic Products Directorate (TPD) and the Biologic and Genetic Therapies Directorate (BGTD) track Clinical Trial Applications (CTAs) and Clinical Trial Applications-Amendments (CTA-As)?
14. Are Annual Clinical Trial reports required?

1. My company currently has an ongoing IND in the USA, and would like to expand to include Canadian investigators. How is this done?

Submit a Clinical Trial Application to Health Canada for review and authorization. DETAILS

2. My trial was filed as an Investigational New Drug (IND) submission prior to September 1, 2001. Do amendments have to be filed?

Yes, amendments have to be filed.

Investigational New Drug (IND) submissions filed prior to September 1, 2001 are not subject to Part C, Division 5 of the Food and Drug Regulations. However, amendments to Investigational New Drug Submission(s) submitted prior to September 1, 2001 should be filed in accordance with the requirements of Part C, Division 5 of the Food and Drug Regulations.

3. I was not required to file my trial prior to September 1, 2001. Do amendments have to be filed?

It is recommended that amendments be filed for trials exempted from IND filing with a marketed drug for a new indication and initiated by a medical practitioner. State clearly on the cover letter that the original trial began on xx/xx/xx, prior to the requirements of Part C, Division 5 of the Food and Drug Regulations.

Amendments do not have to be filed for trials using a marketed drug as per NOC / DIN.

4. The PSEAT-CTA is not requested in the Regulations . What is it, and why does the Guidance for Clinical Trial Sponsors request it for Pharmaceuticals (Section 5.2, 1.2.4)?

PSEAT-CTA stands for: Protocol Safety and Efficacy Assessment Template - Clinical Trial Application. The "Protocol Synopsis & Evaluation" module of the PSEAT-CTA is tailored to provide a detailed summary of the protocol information required for the evaluation of the clinical trial(s) proposed in Canada. Information should be summarized under the various headings provided, where applicable. The PSEAT-CTA is an operational request, and is used to ensure that the target review times are met.

5. What are the fees for CTA and CTA-A submissions?

There are no fees.

6. Are there any color requirements for the binders of various Modules?

There are no color requirements.

7. Are there any requirements for the types of binders used?

While there are no requirements for the types of binders used, 3-ring binders are preferred.

8. My clinical trial involves a pharmaceutical and a biological / radiopharmaceutical drug. What do I have to submit?

• If the focus of the clinical trial pertains to the pharmaceutical drug, the Therapeutic Products Directorate (TPD) takes the lead, and the application is submitted to TPD in duplicate.
• If the focus of the clinical trial pertains to the biological / radiopharmaceutical drug, the Biologics and Genetic Therapies Directorate (BGTD) takes the lead, and the application is submitted to BGTD in duplicate.
• Authorization for use of the pharmaceutical, as well as authorization for use of the biological / radiopharmaceutical, must be obtained prior to the initiation of the clinical trial or implementation of a protocol amendment.
• The lead Directorate will be responsible for communicating the regulatory decision to the sponsor.

9. My clinical trial involves a pharmaceutical drug and an investigational medical device. What do I have to submit?

• If the focus of the clinical trial pertains to the pharmaceutical drug, the Office of Clinical Trials of TPD takes the lead, and the application is submitted to the Office of Clinical Trials in duplicate.
• If the focus of the clinical trial pertains to the medical device, the Medical Devices Bureau of TPD takes the lead, and the application is submitted to the Medical Devices Bureau in duplicate.
• Authorization for use of the pharmaceutical, as well as authorization for use of the investigational medical device, must be obtained prior to the initiation of the clinical trial or implementation of a protocol amendment.
• The lead Office/Bureau will be responsible for communicating the regulatory decision to the sponsor.
• It is advised that for Clinical Trial Applications and Clinical Trial Application Amendments that involve unauthorized medical devices, the sponsor first contact the Medical Devices Bureau to determine if there are additional filing requirements, for the device, which must be met prior to its use in the proposed clinical trial. A record of these communications should be included in the submission.

10. My clinical trial involves a biological / radiopharmaceutical drug and an investigational medical device. What do I have to submit?

• If the focus of the clinical trial pertains to the biological / radiopharmaceutical drug, the Biologics and Genetic Therapies Directorate (BGTD) takes the lead, and the application is submitted to the BGTD in duplicate.
• If the focus of the clinical trial pertains to the medical device, the Medical Devices Bureau of TPD takes the lead, and the application is submitted to the Medical Devices Bureau in duplicate.
• Authorization for use of the biological / radiopharmaceutical drug, as well as authorization for use of the investigational medical device, must be obtained prior to the initiation of the clinical trial or implementation of a protocol amendment.
• The lead Bureau/Directorate will be responsible for communicating the regulatory decision to the sponsor.
• It is advised that for Clinical Trial Applications and Clinical Trial Application Amendments that involve unauthorized medical devices, the sponsor first contact the Medical Devices Bureau to determine if there are additional filing requirements, for the device, which must be met prior to its use in the proposed clinical trial. A record of these communications should be included in the submission.

11. My clinical trial involves a pharmaceutical drug and a natural health product. What do I have to submit?

• If the focus of the clinical trial pertains to the pharmaceutical drug, the Therapeutic Products Directorate (TPD) takes the lead, and the application is submitted to the Office of Clinical Trials in duplicate.
• If the focus of the clinical trial pertains to the natural health product, the Natural Health Products Directorate (NHPD) takes the lead, and the application is submitted to the NHPD in duplicate.
• Authorization for use of the pharmaceutical, as well as authorization for use of the natural health product, must be obtained prior to the initiation of the clinical trial or implementation of a protocol amendment.
• The lead Directorate will be responsible for communicating the regulatory decision to the sponsor.

12. What documentation is required in order to ship an investigational drug into Canada?

When a drug is imported into Canada to be used within the context of a clinical trial, please include / attach a copy of the No Objection Letter (NOL) for the applicable trial with the drug shipment.

13. How do the Therapeutic Products Directorate (TPD) and the Biologic and Genetic Therapies Directorate (BGTD) track Clinical Trial Applications (CTAs) and Clinical Trial Applications-Amendments (CTA-As)?

New control numbers (i.e. a six digit number) are assigned to all CTAs, and any subsequent CTA-As, to enable tracking of protocols and their amendments within a given file. Cover letters accompanying CTA-As should clearly state the control number of the original (parent) CTA. A telephone enquiry / voice message about a protocol or its amendment should clearly state the assigned control number.

A CR file number (i.e. 9427-#####-##C) is the number assigned by HPFB's Central Registry to a file for a particular product from a particular sponsor. Data received for a product is added to the appropriate file and to the electronic database. The CR file number is used by HPFB to locate information pertaining to a particular product from a particular sponsor.

The control number, assigned by HPFB, is used to identify a particular trial for a particular product from a particular sponsor. Clinical trial data is added to the appropriate file and to the electronic database. The control number is used by both sponsor and HPFB to locate information pertaining to a particular trial.

All clinical trials involving drug products are also required to have a protocol number which is assigned by the sponsor. The protocol number, control number and CR file number all appear on the correspondence (e.g. the No Objection Letter) sent by the Directorate to the sponsor.

14 . Are Annual Clinical Trial reports required?

Annual Clinical Trial (Investigational New Drug (IND)) reports, under the old regulatory framework, have been replaced by the annual updated Investigator's Brochure.