Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100) - Summary
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From Health Canada, Regulatory Operations and Enforcement Branch (ROEB)
Overview
This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in human subjects in Canada to comply with Part C, Division 5 of the Food and Drug Regulations (the Regulations) and to understand the International Council for Harmonisation (ICH) Guidance Document: Good Clinical Practice: Integrated Addendum to E6(R1) ICH Topic E6(R2) in the Canadian context.
Guidance documents are administrative instruments not having force of law. Alternate approaches to the principles and practices described in this guidance document and ICH E6(R2) may be acceptable provided they are supported by adequate scientific justification.
This guidance document was developed by Health Canada in consultation with stakeholders.
Who this guide is for
This guidance document is for any parties involved in the conduct of clinical trials of drugs in human subjects in Canada, such as:
- Sponsors
- Qualified Investigators (QIs)
- Contract Research Organizations (CROs)
- Site Management Organizations (SMOs)
Health Canada would like to inform stakeholders of a change to retain clinical trial records for drugs from 25 years to 15 years under the Food and Drug Regulations, effective February 11, 2022. The policies, guidance documents and other documents on Health Canada's website will be updated over time to reflect the change to a 15-year record retention period under the Food and Drug Regulations.
In this guide
- About this document
- Purpose
- Scope
- Introduction
- Guidance for implementation
- Regulations and Interpretations
- 5.1 Interpretation
- 5.2 Application
- 5.3 Prohibition
- 5.4 General
- 5.5 Application for Authorization
- 5.6 Authorization
- 5.7 Notification
- 5.8 Amendment
- 5.9 Additional Information and Samples
- 5.10 Good Clinical Practices
- 5.11 Labelling
- 5.12 Records
- 5.13 Submission of Information and Samples
- 5.14 Serious Unexpected Adverse Drug Reaction Reporting
- 5.15 Discontinuance of a Clinical Trial
- 5.16 Suspension and Cancellation (Intent to Suspend)
- 5.17 Suspension and Cancellation
View complete guide
Download PDF (795 KB, 99 pages)
Details and history
- Published:
- August 20, 2019
- Updated:
- New document
- Consulted:
- December 15, 2017 to April 15, 2018 (see the consultation)
- Part of topic:
- Interpretation of Part C, Division 5 of the Food and Drug Regulations
For assistance
Clinical Trial Compliance Program
Contact us by email: GCP_BPC@hc-sc.gc.ca
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