Interpreting ICH E6(R3)

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.

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

ICH E6(R3) Resources

Filter Results:

ICH E6(R3) Technology Framework

Interpreting ICH E6(R3)
2025

Safeguarding Blinding Considerations Tool

Interpreting ICH E6(R3)
2025

Data Flow Diagram Framework & Template

Interpreting ICH E6(R3)
2025

Data Governance Framework

Interpreting ICH E6(R3)
2025
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