New ICH E6 R3 Guidelines overview

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E6: Good clinical practice (GCP), established in 1996

  • Describes all stakeholders’ roles and expectations in Action in clinical trials.
  • GCP includes aspects of clinical monitoring, reporting, and archiving Trials 
  • Addenda for important documentation and brochures for investigators

E6 (R2) -Completed in 2016

  • Addendum to promote improved and greater implementation of Effective Methods, consequently ensuring Safeguards for Protections of human subject matter.
  • Modified Electronic Record Requirements
  • Feedback from stakeholders on ICH E6 (R2) consulting

Letter from the External Stakeholders to EMA and ICH 31 Jan/26 Feb 2016

  • 22 countries’ academic stakeholders (5 organizations, 119 academic research) Factors
  • Need to intensify based on topics that are most important for test quality
  • One size does not suit all methods for various types of studies.
  • The ICH procedures should not include academic stakeholders.
  • ICH Meeting 2016 in Lisbon
  • Invited members of academic stakeholders to consult with management

Why E6 R3 required?

Clinical trials have become more complicated in terms of trial design, use of technology, implementation of decentralized methods, and the quantity of data obtained in the two decades after ICH E6 was first drafted.

On various topics, the ICH has established guidelines. 3 particular areas are protected by Guideline E6:

  • Safeguarding human subjects
  • Ensuring data integrity
  • Providing clinical researchers with a standard compliance guide

E6 has been essential to the achievement of trials around the world for years, but so much has changed since 1990, and the speed of change is growing faster than ever. In particular, this was increased in 2020, as CROs and sponsors had to adapt rapidly in view of the COVID-19 pandemic and its effects on clinical trial operations.

E6(R2) is not completely developed to address new technology, trial design technologies, the variety of data sources, research facilities and service providers, or to address other emerging complexities with regard to COVID-19 in the current clinical trial environment. Consequently, it is not possible to take full advantage of these technical developments by referring to the new E6 provisions.


It is challenging to apply the present standard to emerging technologies. There are new issues and concerns regarding data protection and patient privacy, due to the revolution of technical innovations and efficiencies in the past 5 years, combined with the ability to produce and quickly distribute large amounts of data on multiple channels. As a result, E6 is again under study.

E6(R3) is being established to provide guidelines relevant to various designs of clinical trials and to enable more sponsors and CROs to concentrate on risk-based approaches to the design and conduct of technology-focused clinical trials.

Work on E6 (R3) is ongoing as of June 2020 after a public web conference organized by the FDA and CTTI. A complete rewrite of E6 is expected to be a (R2). New topics will include decentralized clinical trials and guidelines on the effective and timely incorporation of real-world data.

Credit : Yogita Vaghasia

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