REGULATORY COMPLIANCE LEVEL
Health Canada Food and Drug Regulations Part C, Division 5
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COURSE DETAIL
Code
SA.L2.C2.EN.V1
Pre-Requisite
N/A
Overview
The Food and Drug Regulations are the federal requirements for the sale and importation of drugs used in human clinical trials in Canada. This course introduces the regulatory process and key requirements such as clinical trial applications, amendments, good clinical practice, reporting, and ending a clinical trial early. Upon completing this course, scientists, clinical research professionals, patient partners, and trainees will understand how to include regulatory requirements into clinical research.
Learning Objectives
• To identify the regulatory process for authorization of the use of drugs in human clinical trials, including applications and amendments
• To identify the sponsor’s responsibilities in terms of good clinical practice
• To recognize the requirements for the proper handling of drugs, including labels, records, and storage
• To identify the process for reporting serious unexpected adverse drug reactions during a clinical trial
• To identify the process for ending a clinical trial early, including by the sponsor or Health Canada
Targeted Audience
This course is recommended (and/or mandatory depending on the hiring institutions) for anyone involved in the conduct of clinical research
Duration
2 hours
Version Date
01 – March 15, 2024
Credits
In the future, this activity will qualify for Continuous Educational Credits (CEC) \ Continuous Medical Education (CME).
ACKNOWLEDGEMENTS:
Sourced from
Health Canada, Regulatory Operations and Enforcement Branch (ROEB)
Adapted from
Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100) – Summary
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/guidance-drugs-clinical-trials-human-subjects-gui-0100.html
Adapted by
CANTRAIN-Ottawa Health Research Institute (OHRI) (Jacquie van Ierssel) Centre for Clinical Research Education (CCRE) (Shamiza Hussein)
Created in Collaboration with Institution
CANTRAIN- Ottawa Health Research Institute (OHRI)
Centre for Clinical Research Education (CCRE)
* Authored by
N/A
‡ Non-Author Contributors
N/A
Subject Matter Experts (SME)
Content Contributors (CC)
CANTRAIN (Mei Li)
Production Contributors (PC)
Artificial Intelligence - Technology Assistance
N/A
Voice Artist
N/A
Course Design and Development by
CCRE (Shamiza Hussein)
CANTRAIN (Khoa Ha)
*Authorship is based on the following 4 criteria:
- Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; and
- Drafting the work or reviewing it critically for important intellectual content; and
- Final approval of the version to be published; and
- Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
‡ Non-Author Contributors
Contributors who meet fewer than all 4 of the above criteria for authorship. Non-Author Contributors aided in the development of the CANTRAIN content and include:
- Subject Matter Experts (SME): Served as scientific advisors and/or critically reviewed the course content;
- Content Contributors (CC): Provided background or foundational materials, including images, activities and/or assessments;
- Production Contributors (PC): Provided writing assistance, technical and/or language editing, proofreading.
Legal Disclaimer Exclusions and Limitations. The information on each course and the courses themselves is provided on an “as is” basis.
- This course and its contents were prepared by or for CANTRAIN. They are intended merely to provide background information and awareness to clinical trial investigators / trialists and clinical trial site personnel regarding investigator oversight in clinical trials. By using these materials, you signify your assent to the below terms of use. If you do not agree to the terms, please do not use these materials.
- This course and its contents are not tailored to any particular factual situation and are provided ‘as is’ without warranty of any kind, either expressed or implied, including, but not limited to, the implied warranties of merchantability, fairness for a particular purpose, or non-infringement. CANTRAIN and its members and/or partners do not accept any responsibility for any loss of any kind including loss of revenue, business, anticipated savings or profits, loss of goodwill or data or for any indirect consequential loss whatsoever to any person using this course and its contents or acting or refraining from action as a result of the information contained in these materials. Any party using this course and its contents bears sole and complete responsibility for ensuring that this course and its contents, whether modified or not, are suitable for the particular use and are accurate, current, commercially reasonable under the circumstances, and comply with all applicable laws and regulations.
- CANTRAIN does not certify, qualify, endorse, represent, or warrant that any clinical trial investigator / trialists or clinical trial site personnel that may review this course and its contents are competent to work on any particular clinical trial or clinical trials generally.
- CANTRAIN does not certify any and all representations and warranties relating to this course and its contents or which is or may be provided by any affiliates or any other third party, including in relation to any inaccuracies or omissions in this course and/or CANTRAIN’s literature.
- CANTRAIN excludes all liability for damages arising out of or in connection with your use of this course. This includes, without limitation, direct loss, loss of business or profits (whether or not the loss of such profits was foreseeable, arose in the normal course of things or you have advised this by CANTRAIN of the possibility of such potential loss), damage caused to your computer, computer software, systems and programs and the data thereon or any other direct or indirect, consequential and incidental damages.
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