REGULATORY COMPLIANCE LEVEL

ICH Guidance E6(R2) GCP
(International Council for Harmonization-Good Clinical Practice)

COURSE DETAIL

Code

SA.L2.C1.EN.V1

Pre-Requisite

N/A

Overview

This course is based on the International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. It introduces the principles of Good Clinical Practice which help ensure the safety of trial participants, the integrity of trial data and the overall quality of the study. The responsibilities of key players before, during, and after the study, as well as some of the best practices in clinical research are discussed in this course.

This course is an abridged version of the ICH GCP guidelines and has been co-developed by University Health Network (UHN) and CANTRAIN.

Learning Objectives

• To identify the principles of GCP in the conduct of research involving humans

• To recognize the roles and responsibilities of the investigator, sponsor, research ethics board, and research team members, before, during, and after the study

• To recognize best practices in clinical research and some of the common tools to help achieve regulatory compliance

Targeted Audience

This course is recommended (and/or mandatory depending on the hiring institutions) for anyone involved in the conduct of clinical research

Duration

60 minutes

Version Date

01 – March 15, 2024

Credits

This activity qualifies for credits. The course is now listed on the TransCelerate website and has been uploaded into the Shared Investigator Platform (SIP).

ACKNOWLEDGEMENTS:

Material Shared by

University Health Network (UHN)

Adapted by

University Health Network (UHN)
CANTRAIN

Created in Collaboration with Institution

N/A

* Authored by

UHN (Amanda Weston)

‡ Non-Author Contributors

Subject Matter Experts (SME)

Nova Scotia Health (Andrea Dean)

Content Contributors (CC)

CANTRAIN-Ottawa Health Research Institute (OHRI) (Jacquie van Ierssel)
CANTRAIN-Nfld & Lab Health Services (Krista Cuff)
CANTRAIN (Caroline Buote ; Katie Bainbridge; Monique Ostrout)

Production Contributors (PC)

CANTRAIN-SickKids (Renee Sakai)

Artificial Intelligence - Technology Assistance

N/A

Voice Artist

N/A

Course Design and Development by

CANTRAIN (Caroline Buote; Khoa Ha)
UNH (Amanda Weston)

*Authorship is based on the following 4 criteria:

  1. Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; and
  2. Drafting the work or reviewing it critically for important intellectual content; and
  3. Final approval of the version to be published; and
  4. 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.

Source: https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html

‡ 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:

  1. Subject Matter Experts (SME): Served as scientific advisors and/or critically reviewed the course content;
  2. Content Contributors (CC): Provided background or foundational materials, including images, activities and/or assessments;
  3. 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.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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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