Navigating New Terminology in ICH-GCP E6(R3): Key Changes and Implications

The International Council for Harmonisation (ICH) recently released the updated guideline, Good Clinical Practice (GCP) E6(R3), introducing substantial terminology changes aimed at modernizing clinical trial practices and improving clarity and consistency across global trials. This article details these critical terminology shifts, their implications for clinical research stakeholders, and the specific impact these changes have on eClinical systems, including Clinical Trial Management Systems (CTMS), Clinical Trial Budget Management (CTBM), electronic Trial Master File (eTMF), Electronic Data Capture (EDC), eSource, and Safety solutions.

Key New Terminology Introduced

Assent

"Assent" acknowledges consent provided by minors or individuals unable to fully consent legally. This new term underscores ethical responsibilities, requiring clearer documentation and transparent processes ensuring participant understanding and voluntary participation, complementing informed consent from guardians or legal representatives. eClinical systems such as eConsent within EDC and eTMF solutions must now capture and track assent documentation effectively.

Data Acquisition Tool (DAT)

"Data Acquisition Tool" refers to either electronic or paper-based instruments designed explicitly for capturing clinical trial data and metadata according to trial protocols. The introduction of DAT necessitates enhancements in EDC and eSource systems to ensure standardized and validated data collection processes, facilitating seamless integration and data exchange.

Metadata

Defined as data providing context about other data, "Metadata" enhances data reliability, integrity, and traceability. eClinical systems across CTMS, eTMF, and EDC must expand their capabilities to capture, manage, and audit metadata, ensuring regulatory compliance and robust data governance.

Reference Safety Information (RSI)

RSI is a standardized reference dataset crucial for determining the expectedness of adverse events, vital for clear, compliant reporting and safety monitoring. Safety solutions and CTMS systems must integrate and manage RSI data effectively, enabling accurate and timely safety reporting and oversight.

Service Provider

This broader term encompasses any organization or individual providing specialized services essential to clinical trial activities. CTBM and CTMS systems must adjust to incorporate clearer delineation of service provider roles, responsibilities, and cost tracking, ensuring transparency and efficient budget management.

Suspected Unexpected Serious Adverse Reaction (SUSAR)

This specific term for serious and unexpected adverse reactions requiring expedited regulatory reporting enhances clarity and efficiency in safety management. Safety solutions must enhance reporting mechanisms to swiftly and accurately capture, assess, and communicate SUSARs.

Updated and Revised Terminology

Trial Participant (formerly "Subject")

The shift to "Trial Participant" promotes a participant-centric approach. eClinical systems, particularly participant-facing eConsent and patient engagement portals within EDC and CTMS, must reflect this terminological shift to ensure clear, participant-focused communication and data management.

Source Records (formerly "Source Documents")

The transition to "Source Records" broadens the scope to include digital sources. eSource and EDC systems must now emphasize robust digital source management, integrating seamlessly with CTMS and eTMF for comprehensive audit trails and data traceability.

Essential Records (formerly "Essential Documents")

Replacing "Essential Documents" with "Essential Records" highlights digital data inclusion. eTMF solutions must adapt to incorporate comprehensive electronic records management, linking directly with CTMS and EDC systems to ensure data integrity and regulatory readiness.

Investigator Site (formerly "Trial Site")

This change clarifies site-level responsibilities. CTMS systems must now clearly attribute tasks, workflows, and documentation oversight directly to investigator sites, supporting precise regulatory compliance and efficient operational management.

Removed Terminology

Several terms, including "Contract," "Coordinating Committee," and "Opinion" from ethics committees, have been replaced or removed to reduce ambiguity. CTBM and CTMS systems must reflect these changes by updating contractual templates, oversight processes, and committee structures within the systems to maintain clarity and compliance.

Broader Implications and Best Practices

The revised terminology in ICH-GCP E6(R3) significantly impacts clinical trial conduct, necessitating system-level adjustments across CTMS, CTBM, eTMF, EDC, eSource, and Safety platforms. Stakeholders must proactively adapt through:

• Comprehensive training programs updating staff on terminology shifts and eClinical system adjustments.

• Reviewing and revising existing documentation, SOPs, and eClinical system workflows to align with new terminology.

• Enhancing data governance frameworks within eClinical solutions, emphasizing digital data integrity, metadata management, and integrated audit trails.

Conclusion

The introduction of new and revised terminology in ICH-GCP E6(R3) signifies a crucial step toward modernizing clinical trial processes, enhancing participant protection, and embracing digital transformation. Stakeholders must leverage advanced eClinical systems and embrace these terminology changes to maintain compliance, improve trial quality, and align with global regulatory standards.