05/30/2023
Photo by krakenimages on Unsplash
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a draft guideline for ICH E6(R3) Good Clinical Practice, which reached step 2 on May 19, 2023 and is open for public consultation. This draft includes the GCP Principles and Annex 1, and updates to Annex 2 of the guideline are now underway. One main objective in revising the GCP guideline was to interweave themes from ICH E8(R1) General Considerations for Clinical Studies guideline throughout, including Quality by Design (QbD) - building quality into the study design, identifying factors that are Critical to Quality (CtQ), engaging stakeholders early and throughout the clinical trial process, using a proportionate risk based approach to quality management, and cultivating a culture of quality.
The GCP draft guideline modernized, expanded, and reorganized the ICH E6(R2) 2016 addendum. Overall themes of the updates include:
Expanded GCP principles and their objectives
11 principles expanded with additional sub sections from the original 12
Overall theme is that there is not a one size fits all approach to a clinical trial and that consideration of the special characteristics of the study are needed to ensure quality.
The principles are designed to be flexible based on the unique study characteristics and are intended to support innovative and efficient approaches to study design.
Study design should be informed by stakeholders to ensure quality and meaningful outcomes.
The focus remains on the rights, safety, and wellbeing of study participants and the reliability of the study data.
QbD should be used to identify risks to participant safety and data quality and to inform risk management activities.
Risk proportionate activities should be implemented to ensure participant safety and data quality.
Study design should be operationally feasible and should avoid procedures that are overly complex.
Updates in Annex 1 include:
Investigator responsibilities section is extensively changed.
Sponsor section is dramatically reorganized and expanded. Many new sections are added and others are expanded.
A Section on Data Governance for Investigator and Sponsor was added and includes:
Procedures for the Use of Computerized Systems
Training on use
Security of Computerized Systems
Computer System Validation
Contingency plans
Technical support
User management
Some content is moved out to the Appendices to simplify future updates.
A. Investigator’s Brochure
B. Protocol and Amendments
C. Essential Documents
The Annex 2 concept paper was approved May 2023. Content that will be added to the ICH E6(R3) guideline will include additional considerations for interventional clinical trials including:
Decentralized clinical trials
Pragmatic clinical trials (similar to routine clinical practice)
Real world data
It is expected to take approximately 12-18 months for the draft of Annex 2 to be released for public consultation. According to the work plan, the Principles and Annex 1 would complete Step 3 sign off in October to November 2023.
Need training for your team? Clinical Pathways offers Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline eLearning and live training.
This interactive eLearning course covers the importance of ICH and why a revision to E8 was needed, overarching themes of changes, the introduction of Quality by Design and Critical to Quality applied to clinical trials, an overview of the sections of the Guideline, and scenarios.
The course is available for purchase HERE.
Interested in GCP training on the latest revision? Sign up for our newsletter to keep in the know! Clinical Pathways will roll out the updated training soon after the guideline is finalized. Email us at info@clinicalpathwaysresearch.com for more information.
- The Clinical Pathways Team
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