Dossier ID request form for pharmaceutical clinical trial dossiers

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Footnote 1

Dossier is a collection of all regulatory activities throughout the life cycle of a single clinical trial protocol for a stakeholder. The format of the Dossier Identifier is lowercase letter followed by six (6) unique numbers depending on the dossier type.

A dossier ID must be requested prior^* to filing the first regulatory transaction:

• when filing in eCTD format
• when switching from non-eCTD electronic-only format to eCTD format

^*A request for a dossier ID should only be placed a maximum of eight weeks prior to filing a regulatory transaction

Dossier IDs for existing submissions filed with Health Canada can be obtained from the Drug Submission Tracking System - Industry Access (DSTS-IA). For information regarding DSTS-IA, or for account set up, please contact the Office of Submission and Intellectual Property by sending an e-mail to: client.information@hc-sc.gc.ca.

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Footnote 2

If you do not have a previously assigned Company ID, please input only Company Name.

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Footnote 3

As per the Part C, Division 5 of the Food and Drug Regulations (Drugs for Clinical Trials Involving Human Subjects) and Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications, the Clinical Protocol Number must be assigned by the sponsor for each protocol when submitting the CTA to Health Canada. Sponsors are encouraged to include a protocol number for Pre-CTA meeting requests if available.

In general, a protocol number is a variable length, alpha-numeric sequence used by sponsors to assign a reference number to their protocol. As per the Guidance for Completing the Drug Submission Application Form, the protocol number for clinical trials should remain the same for the duration of the trial.

When updating their documents, including protocols, sponsors should, in accordance with their internal record/document management practices, apply version control principles. When submitting a CTA-Amendment or Notification, sponsors should indicate the version or amendment number of the protocol; however, certain best practices apply, as outlined below. These practices help to avoid the incorrect issuance of dossier IDs, processing and tracking in Health Canada systems.

The correct numbering of the protocol version or amendment provided in CTA-A or CTA-N is:
E.x.: HCPM022 - Version dated xxxxxx (HCPM022 - Amendment 1)
Root/origin Versioning

Best practices:

1. The complete root/original protocol number must always be indicated on forms and documents where the protocol number is indicated eg: cover letter, protocol, HC/SC 3011, ICFs. It is not sufficient to only provide the version or amendment number
   1. Correct: HCPM022 - Amendment 1
   2. Correct: HCPM022 - Version dated xxxxx
   3. Incorrect: 001
   4. Incorrect: Amendment 1
2. Adding prefix or suffix to indicate amendment numbers is not acceptable.
   1. Correct: HCPM022 - Amendment 1
   2. Incorrect: 1-HCPM022-001
3. The amendment or version number should be indicated as outlined below:
   1. Correct: HCPM022 - Amendment 1
   2. Incorrect: HCPM022 - 001

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Footnote 4

Please enter the product name of the investigational product, and where there is more than one investigational product, all of them should be captured. An investigational product corresponds to a product involved in the conduct of a clinical trial. It could be a product not available in Canada, a product in development or a product already approved in Canada but used outside the approved indication.

If the product name has not yet been determined, the proper or common name of the drug or the research code may be used.

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Footnote 5

• The proper name for a product is the name assigned to the drug in Section C.01.002 of the Food and Drug Regulations, or in boldface type in other Sections of the Regulations or the name of the drug in its finished form identified in the title of a monograph or in any of the official publications listed in Schedule B to the Food and Drugs Act. Example: Acetaminophen, Ferrous Sulphate Tablets.
• The common name is the name by which a single ingredient drug is commonly known / designated in scientific or technical journals other than the publications referred to in Schedule B to the Food and Drugs Act. The common name includes the pharmaceutical form when used in relation to the finished drug product.
• If there is no proper name and the drug is comprised of a single medicinal ingredient, enter the common name.
• If there is no proper name and the drug is comprised of more than one medicinal ingredient, the proper name of the ingredients should be captured and separated by a forward slash (/).
• Where there is more than one investigational product, proper/common names of all of them should be listed.
• If the proper or common name has not yet been determined, the research code may be used.

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Footnote 6

Indicate what you will file as your first activity under this dossier ID

• Pre-Clinical Trial Application Consultation Meeting (Pre-CTA)
• Clinical Trial Application (CTA)
• Clinical Trial Applications - Amendments (CTA-A)

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Footnote 7

If yes, provide the name of the original protocol owner. In addition, indicate if there is a change to the product name and/or protocol number. Input N/A if there is no change in ownership, or merger/buyout.

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Footnote 8

The Primary contact is the person to be contacted by Health Canada if there are any issues or clarifications required when enrolling a dossier.

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Footnote 9

The Alternate contact is the person to be contacted by Health Canada if there are any issues or clarifications required when enrolling a dossier, in addition to the Primary contact.

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