COMMON CORE FOUNDATION
Good Documentation Practices
![](https://wecantrain.ca/wp-content/uploads/2023/09/Core-Good-Documentation-Practices@2x.png)
COURSE DETAIL
Code
SA.L3.C6.EN.V1
Pre-Requisite
N/A
Overview
Study records contribute to overall study data and provide documented evidence of study assessments. Good Documentation Practices (GDP) are critical to collecting and recording sound research data and complying with regulatory requirements. This course provides an overview of the principles of Good Documentation Practices, including the ALCOA+ (Attributable, Legible, Contemporaneous, Original, and Accurate) principles, and their importance in ensuring data integrity and quality.
Learning Objectives
To identify
• Good Documentation Practices and their rationale
• The ALCOA+ principles
• Best practices for recording data in clinical trial settings
Targeted Audience
Entry-level learners seeking to complement, extend, and enrich the regulatory compliance training
Duration
30 minutes
Version Date
01 – April 4, 2024
Credits
In the future, this activity will qualify for Continuous Educational Credits (CEC) \ Continuous Medical Education (CME).
ACKNOWLEDGEMENTS:
Material Shared by
N/A
Adapted from
N/A
Adapted by
N/A
Created in Collaboration with Institution
N/A
* Authored by
CANTRAIN (Caroline Buote)
‡ Non-Author Contributors
Subject Matter Experts (SME)
Horizon Health Network (HHN) (Stella Park)
Nova Scotia Health (Andrea Dean; Jocelyn Hiltz)
Q-CROC (Sara Paré)
uAlberta-Clinical Trials Office (Scott Jamieson)
Research Institute- McGill University Health Centre (RI-MUHC) (Angie Lombardo)
CANTRAIN (Linda Hunter; Monique Ostrout)
Content Contributors (CC)
CANTRAIN-Ottawa Hospital Research Institute (OHRI) (Jacquie van Ierssel)
CANTRAIN-uAlberta-Clinical Trials Office (Janis Cole; Jeffrey Narayan)
CANTRAIN (Mei Li)
Production Contributors (PC)
CANTRAIN (Sandra Peláez; Lisa Goos)
CANTRAIN-SickKids (Renee Sakai)
Artificial Intelligence - Technology Assistance
N/A
Voice Artist
CANTRAIN (Eleanor Yeoman)
Course Design and Development by
CANTRAIN (Caroline Buote; Lucie Couderc; 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.
![](https://wecantrain.ca/wp-content/uploads/2023/02/cropped-Cantrain-logo-1536x459-1-1024x306.png)