Guidance document on Public Release of Clinical Information: profile page

From: Health Canada

Overview

The purpose of this guidance document is to give drug and medical device manufacturers instructions on how to prepare clinical information documents for release and give members of the public instructions on how to request this information. This could include information that might need to be excluded for confidentiality or privacy reasons.

In this guide

• 1. Introduction
  • 1.1 Policy Objective
  • 1.2 Terminology and Definitions
  • 1.3 International Alignment
• 2. Scope and Application
  • 2.1 General scope and application
  • 2.2 Clinical Information in Drug Submissions
  • 2.3 Clinical Information in Medical Device Applications
  • 2.4 Summary
• 3. General Guidance on Implementation
  • 3.1 Consideration Regarding Interim Analyses
  • 3.2 Individual Patient Records (Individual Patient Listings and Case Report Forms)
  • 3.3 Implementation Schedule for the Proactive Disclosure of Clinical Information in Drug Submissions and Medical Device Applications
  • 3.4 On-request Release of Clinical Information in Past Drug Submissions and Medical Device Applications
• 4. Procedures for Clinical Information in Drug Submissions and Medical Device Applications
  • 4.1 PRCI Process Initiation Meeting
  • 4.2 Health Canada Initiation of the Publication of Clinical Information
  • 4.3 How to Request Clinical Information from Past Drug Submissions and Medical Device Applications
  • 4.4 Submission of Annotated Documents with Proposed CBI Redaction(s) and Anonymization
  • 4.5 Health Canada Review of Annotated Documents
  • 4.6 Finalization of Documents
  • 4.7 Publication of Final Documents
• 5. Requirements for the Redaction of Confidential Business Information
• 6. Anonymization of Personal Information
  • 6.1 Principles of Protecting Personal Information
  • 6.2 Anonymization Process
• 7. Contact Information
• 8. References
• 9. Appendices
  • Appendix A: Structure and Content of ICH CTD/eCTD M2.5, M2.7 and M5
  • Appendix B: Structure and Content of ICH CTD/eCTD Module 5.3 Clinical Study Reports
  • Appendix C: Process Flow Chart
  • Appendix D: Document Naming Convention for Submissions Through the CESG
  • Appendix E: Proposed Redaction Control Sheet
  • Appendix F: Anonymization Report Template
  • Appendix G: Certification Letter with Table of Previously Redacted Information
  • Appendix H: Terms of Use

View complete guide

Details and history

Published:

March 12, 2019

Contact us

Mailing address:
Information Science and Openness Division
Resource Management and Operations Directorate
Health Products and Food Branch
Health Canada
Graham Spry Building
250 Lanark Avenue
Ottawa, Ontario
K1A 0K9

Telephone:
613-960-4687

Email:
hc.clinicaldata-donneescliniques.sc@canada.ca