Instructions for completing the Clinical Trial Site Information Form

November 29, 2019

General

The Clinical Trial Site Information (CTSI) form is required to be submitted by clinical trial sponsors prior to initiating a protocol or implementing subsequent amendment(s) at the clinical trial site for trials that are subject to Division 5 of Part C of the Food and Drug Regulations.

The updated CTSI form is developed to allow for the reporting of one site per form. If there are numerous sites that need to be reported for a Clinical Trial Application (CTA), then each should be submitted on a separate form. The sponsor continues to have the ability to save and revise a previously submitted form to facilitate updating site information.

All applicable fields should be completed prior to submitting this form to the appropriate Directorate. Based on the selections made, different fields become active, available and/or mandatory.

Note: There have been issues found with using some specific PDF software options. Health Canada recommends that the form be completed using the freely available Adobe Acrobat Reader.

Field instructions

General Fields

1. Clinical Trial Lead: The Sponsor must select either 'Pharmaceutical' or 'Biologic'. This field identifies to which Directorate the CTA has been filed. Based on the selection made, a different button appears on the bottom of the form, which allows for the form to be submitted to the appropriate Directorate [ie: 'Submit for Pharmaceutical Clinical Trial' for applications submitted to the Office of Clinical Trials, Therapeutic Products Directorate (TPD), and 'Submit for Biologic Clinical Trial' for applications submitted to the Biologics and Genetic Therapies Directorate (BGTD)].

2. Reason for Filing: The Sponsor must select either 'New Site' or 'Change to Existing Site'. Based on the selection, different fields become available and mandatory.

NOTE: If the Sponsor is using this form for the first time to make a change to the information for an existing site previously submitted to Health Canada using the older version of the form, they should:

This is required in order for Health Canada to determine exactly what information has been changed.

3. Changes: These check boxes are only available if the Sponsor selects 'Change to Existing Site' under field 2. Reason for Filing. Check all applicable boxes.

4. Protocol Number: Specify the clinical trial protocol number. This number should remain the same for the duration of the trial, and should match the protocol number identified in the Clinical Trial Application.

5. Clinical Trial Parent Control Number: Specify the original/parent clinical trial control number. Typically this is a 6-digit number.

6. Clinical Trial Amendment Control Number(s), if applicable: Specify the amendment clinical trial control number(s), if applicable. Typically this is a 6-digit number.

Clinical Trial Site fields

NOTE: Fields 7 to15 are only available if the Sponsor selects field 2. Reason for Filing, 'New Site', or field 2. Reason for Filing, 'Change to Existing Site', then field 3. Changes, 'Clinical Trial Site'.

7. Name of Site previously provided to Health Canada (full name, no abbreviations): If the Sponsor is changing the Clinical Trial Site, they should input the name of the Site previously provided to Health Canada, in order for Health Canada to find and update that specific record in their database.

8. Name of Site (full name, no abbreviations): This field should be used to provide the full name of the Clinical Trial Site. This information should also provide the name of the group or unit, and subsequent affiliations, if applicable (e.g., Eye Clinic, University Hospital, and University of XYZ). A Clinical Trial Site is the location at which the majority of the activities related to the conduct of the clinical trial are carried out under the supervision of a qualified investigator.

NOTE: If the site is a private practice, use the Physician's name, or the name of the practice, corporation or partnership. 

9 to 15. Site Address: These fields should be used to provide the full address of the clinical trial site identified in field 8. Name of Site. If a street address is used, provide the suite/unit/P.O. Box number (if applicable), in addition to the street name and street number, the city/town, the province/territory, and the postal code.

NOTE: Field 16 is only available if the Sponsor selects:

16. Commencement Date of the Clinical Trial Protocol (YYYY-MM-DD): For the purposes of the Clinical Trial Site Information form, the date of commencement of the trial is defined as the date when the clinical trial site is ready to enrol subjects. For an Amendment, this would be the date when a site is ready to implement the proposed changes. In either case, the commencement date is a date after which the sponsor has both the Health Canada authorization from the appropriate Directorate (date on the No Objection Letter (NOL)) AND approval from the relevant Research Ethics Board(s) (field 49. Date of Research Ethics Board Approval).

The commencement date would be the date where the sponsor implements the protocol, which includes the screening period that occurs prior to the check-in date. Therefore, the check-in date would not be considered as the commencement date.

In the event that an amendment must be implemented prior to the approval due to safety reasons (C.05.008(4) of the Food and Drug Regulations), the commencement date of the amendment should reflect the date the safety change(s) was implemented at the site. In this case, field 50. Safety Implementation Rationale must be completed. Refer to field 50. Safety Implementation Rationale for further instructions.

Qualified Investigator fields

Division 5 of Part C of the Food and Drug Regulations defines Qualified Investigator (QI) as the person responsible to the Sponsor for the conduct of the clinical trial at the clinical trial site, who is entitled to provide health care under the laws of the province where the clinical trial site is located and who is:

  1. in the case of a clinical trials respecting a drug to be used for dental purposes only, a physician or dentist and a member in good standing of a professional medical or dental association; and
  2. in any other case a physician and a member in good standing of a professional medical association.

NOTE: Fields 17 to 31 are only available if the Sponsor selects:

17 to 19. Qualified Investigator Identification: Provide the first and last name, and the medical designation(s) of the QI conducting the clinical trial (i.e., John Doe, MD, FRCPC, etc.).

20 to 31: Qualified Investigator Address and Contact Information: Provide the full address of the QI identified in fields 17-19. If a street address is used, provide the suite/unit/P.O. Box number (if applicable) in addition to the street name and street number, the city/town, the province/territory, and the postal code. Provide the email address, telephone number including area code and extension (if applicable), fax number (if applicable) and the language of preference.

NOTE: The address of the QI may be different than the address of the clinical trial site as identified in fields 9 to 15. 

Research Ethics Board fields

NOTE: Fields 32 to 50 are only available if the Sponsor selects:

32. Name of Research Ethics Board, including affiliations (if applicable) (full name, no abbreviations): Provide the name of the Research Ethics Board (REB) providing approval of the protocol and informed consent forms for this clinical trial. Provide the affiliation, if applicable (e.g., University of "XYZ" or "New Province Health Sciences" Research Ethics Review Board etc.).

33 to 48. Research Ethics Board Address and Contact Information: Provide the full address of the Research Ethics Board contact identified in field 32. Name of Research Ethics Board, including affiliations. If a street address is used, provide the suite/unit/P.O. Box number (if applicable) in addition to the street and street number, the city/town, the province/state and country, and the postal or zip code. Provide the email address, telephone number including area code and extension (if applicable), fax number (if applicable) and the language of preference.

49. Date of Research Ethics Board Approval (YYYY-MM-DD). This is the date where the Research Ethics Board Approval was received. It is required that this date be BEFORE the commencement date of the clinical trial (field 16. Commencement Date of the Clinical Trial Protocol). An error will appear if trying to input a date after the commencement date.

However, if 'Safety Amendment' is selected under field 3. Changes, then this date can be after the commencement date. In the event that an amendment must be implemented prior to approval due to safety reasons (C.05.008(4) of the Food and Drug Regulations), the commencement date of the amendment should reflect the date the amendment was implemented at the site. In this case, field 50. Safety Implementation Rationale must be completed. Refer to field 50. Safety Implementation Rationale for further instructions.

50. Safety Implementation Rationale: In the event that an amendment must be implemented prior to approval due to safety reasons (C.05.008(4) of the Food and Drug Regulations), sponsors should provide a brief rationale for implementing the safety change(s). Note the CTSI form related to the safety amendment should only be submitted following both the Health Canada authorization AND approval from the relevant Research Ethics Board(s).

Clear Safety Implementation Rationale: This button allows the Sponsor to clear these fields if they are sending a change to an existing site which no longer needs the Safety Implementation Rationale (field 50).

Filing instructions

Before submitting, please click the 'Save and rename before submitting' button. Name the document using the following format: <control #, QI name>.

CTSI forms should be filed by email. Each email should only contain one completed CTSI form as an attachment. Do not include any other attachments. Other documents, such as Appendix 1, should be submitted as a Clinical Trial Notification to hc.oct.ctan-ndec.bec.sc@canada.ca (Pharmaceuticals) or hc.bgtd.ctan-ndec.pbtg.sc@canada.ca (Biologics).

For Pharmaceutical Clinical Trials: 

Submit to the Office of Clinical Trials - Therapeutic Products Directorate: This button is available when 'Pharmaceutical' is selected under field 1. Clinical Trial Lead. By clicking this button, an email message should be auto-created using the Sponsor's default email program with the form attached. Before submitting, the Sponsor should input the Clinical Trial Parent Control Number and QI name in the Subject Line.

If an email was not automatically created, the Sponsor should save the completed form, create an email and include the following:

To: hc.clinical.trials.site-lieu.essai.clinique.sc@canada.ca
Subject: Drug Clinical Trial Site Information Form - [CTA Parent Control #, QI name]
Body: The attached file is the completed form.
Attachment: The saved completed CTSI form.

For Biologic Clinical Trials: 

Submit to the Office of Regulatory Affairs - Biologics and Genetic Therapies Directorate: This button is available when 'Biologic' is selected under field 1. Clinical Trial Lead. By clicking this button, an email message should be auto-created using the Sponsor's default email program with the form attached. Before submitting, the Sponsor should input the Clinical Trial Parent Control Number and QI name in the Subject Line.

If an email was not automatically created, the Sponsor should save the completed form, create an email and include the following:

To: hc.bgtd.ctsi-filec.pbtg.sc@canada.ca
Subject: Biologic Clinical Trial Site Information Form [CTA Parent Control #, QI name]
Body: The attached file is the completed form.
Attachment: The saved completed CTSI form.

For questions related to Pharmaceuticals, please contact hc.oct.enquiries-requetes.bec.sc@canada.ca

For questions related to Biologics, please contact hc.bgtd.ora.sc@canada.ca

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