Notice: Preparation of Clinical Trial Regulatory Activities in the "Non-eCTD Electronic-Only" Format
March 2, 2016
Our file number: 16-100975-599
Health Canada is pleased to announce the acceptance of Clinical Trial Applications in “non-eCTD electronic-only” format. This Notice serves as a revision to the Release of Electronic Specifications for Clinical Trial Applications and Amendments filed in accordance with Guidance Document for Clinical Trail Sponsors: Clinical Trial Applications, published on May 29, 2013.
Electronic documents will be uploaded onto the Health Canada viewing tool, where they will be immediately accessible to Health Canada staff involved in the review of the regulatory activities. This will contribute to effective record management and ensure authenticity, integrity, availability, traceability, and non-repudiation of the data.
Effective immediately the following regulatory activities will be accepted in “non-eCTD electronic-only” format:
- Clinical Trial Application (CTA)
- Clinical Trial Application -Amendment (CTA-A)
- Clinical Trial Application- Notification (CTA-N)
- Clinical Trial Site Information (CTSI) Forms
- Pre-CTA Meeting information
Any transactions related to the above regulatory activity types will also be accepted in “non-eCTD electronic-only” format. These transactions include, however are not limited to, the following:
- Response to a Clarification Request
- Response to Notice of Screening Deficiency Notice (SDN)
- Authorization for Sharing Information (Consent Letter)
As of June 1st, 2016, Health Canada will no longer accept paper copies of the above indicated regulatory activities or their related transactions.
Refer to the Guidance Document: Preparation of Drug Regulatory Activities in “Non-eCTD Electronic-Only” Format for detailed guidance on filing the above regulatory activities or transactions in the ‘non-eCTD electronic-only” format.
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