In January 2025, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued the final version of its updated ICH E6(R3) Good Clinical Practice Guideline. ICH E6(R3) is intended to provide, “a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities.”

Thought Leadership on Interpreting ICH E6(R3)

To assist key industry stakeholders in easing challenges associated with operationalizing the requirements of the new ICH E6(R3) guidelines, ACRO has partnered with TransCelerate Biopharma Inc. to co-develop several resources focused on risk management and data governance. These adoption tools, frameworks, and templates are designed to support GCP stakeholders with compliance, data quality, and decision-making.

Resources

1. Data Governance Framework

The Data Governance Framework provides background on data governance, a new section within ICH E6(R3), and its utility in clinical research. The framework connects the entire toolkit of ACRO/TransCelerate data governance solutions to help GCP stakeholders develop a data governance framework.

2. Data Flow Diagram Framework & Template

The Data Flow Diagram Framework & Template assists companies in developing maps to illustrate relevant data flows between various data collection tools (e.g., EDC, ePRO, eCOA, central labs) and involved stakeholders (e.g., sponsor, CRO, third-party vendors) in a study. The objective of the tool is to increase clarity and coordination among all parties involved.

3. Safeguarding Blinding Considerations Tool

The Safeguarding Blinding in Data Governance Considerations Tool explains topics necessary to the concept of safeguarding blinding in clinical research. Topics include what blinded data is, why data is blinded, the importance of maintaining blinding, who may be unblinded, and steps to take in case of unblinding.

4. ICH E6(R3) Technology Framework 

The Technology Framework explains the computerized systems (CS) requirements outlined in ICH E6(R3). The framework details potential procedures for using computerized systems, training, security, validation, periodic reviews, system failure, technical support, and user management. Additionally, the framework includes ACRO and TransCelerate’s proposed definitions and outlines potential roles and responsibilities of those involved in the process.

5. Data Matrix Template

The Data Matrix Template is designed to assist companies as they outline their study data provenance and collection methods, review techniques and frequency (including references to functional plans where reviews are fully described), and conduct data analysis. The framework helps to facilitate the application of ICH E6(R3) requirements for data governance by providing a template to help stakeholders develop clear and structured approaches to managing study data.

6. Acceptable Ranges for Clinical Trials: Insights from ICH E6(R3)

The Acceptable Ranges Considerations tool, designed to support stakeholders’ internal development and implementation of acceptable ranges under the ICH E6(R3) guideline, details the introduction of acceptable ranges and comparison to E6(R2), key considerations and tips for implementation, and sample use case.

Access these resources in ACRO’s ICH E6(R3) Resource Library below: