--- title: "ICH GCP E6 R3 draft guideline: main changes and clarifications" description: The ICH GCP E6 Working Group published the draft of the ICH GCP E6 R3 Guidance on May 19, 2023. Stakeholders can provide comments on the guideline until... image: https://blog.pqegroup.com/hubfs/New%20GCP_Site%20Banner.jpg --- [![Logo PQE Group - azzurro - 2024](https://blog.pqegroup.com/hs-fs/hubfs/Logo%20PQE%20Group%20-%20azzurro%20-%202024.png?width=2000&height=721&name=Logo%20PQE%20Group%20-%20azzurro%20-%202024.png "Logo PQE Group - azzurro - 2024")](https://www2.pqegroup.com) - [Home](https://www2.pqegroup.com/) - [Industry](https://www2.pqegroup.com/industry/) - [Pharma & API](https://www2.pqegroup.com/pharma-api/) - [Medical Device](https://www2.pqegroup.com/medical-device/) - [Biotech](https://www2.pqegroup.com/biotech/) - [Startup](https://www2.pqegroup.com/startup/) - [Veterinary](https://www2.pqegroup.com/veterinary/) - [Services](https://www2.pqegroup.com/services/) - [Data Integrity](https://www2.pqegroup.com/data-integrity/) - [Digital Governance](https://www2.pqegroup.com/digital-governance/) - [Engineering](https://www2.pqegroup.com/engineering/) - [Commissioning, Qualification and Validation (CQV)](https://www2.pqegroup.com/commissioning-qualification-validation/) - [Quality Compliance](https://www2.pqegroup.com/quality-compliance/) - [Laboratory Excellence](https://www2.pqegroup.com/laboratory-excellence/) - [Regulatory Affairs](https://www2.pqegroup.com/regulatory-affairs/) - [Audits](https://www2.pqegroup.com/audits/) - [Training](https://www2.pqegroup.com/training/) - [Clinical Research](https://www2.pqegroup.com/clinical-research-services/) - [Pharmacovigilance](https://www2.pqegroup.com/pharmacovigilance/) - About - [About Us](https://www2.pqegroup.com/about/) - [ESG](https://www2.pqegroup.com/about/csr/) - [Women in STEM](https://www2.pqegroup.com/about/women-in-stem/) - Resources - [News & Press](https://www2.pqegroup.com/news/) - [Webinars](https://www2.pqegroup.com/webinars/) - [Blog](https://blog.pqegroup.com/) - [Careers](https://www2.pqegroup.com/careers/) - [Contact Us](https://www2.pqegroup.com/contact-us/) ![](https://blog.pqegroup.com/hubfs/blank-user.png) Emanuela Ferrigno GCP Compliance Expert @PQE Group # **ICH GCP E6 R3 draft guideline: main changes and clarifications** [Clinical Research](https://blog.pqegroup.com/tag/clinical-research) The ICH GCP E6 Working Group published the draft of the **ICH GCP E6 R3 Guidance** on May 19th, 2023. Stakeholders have the opportunity to provide comments on the guideline until September 26th, 2023 by using the template available on the [EMA website](https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice-scientific-guideline#current-version--section).   #### **What is the purpose of the Guideline?**  The Guideline aims to adapt the GCP E6 to the evolution of new study designs and to the innovative technologies being used.  #### **What are the changes?**  Unlike the ICH GCP E6 R2 Guideline that is currently in force, the ICH GCP E6 R3 will not be an integrated addendum; the structure of the document has been totally revised.  This new layout will give the document greater clarity and readability.  In particular, the document will have the following structure: an introduction, a chapter focused on the ICH GCP Principle, two Annexes, a glossary and three appendices. Annex 1 is dedicated to the management of interventional clinical trials and consists of four sections: IRB/IEC, Investigator, Sponsor and Data Governance-Investigator and Sponsor.  Annex 2 is not yet available.  Below are some changes introduced by the Guideline in terms of content:  - The **glossary** has been enriched with new terms, many of which are related to the field of Computer System Validation and digitalization (i.e. Computer System Validation, metadata, data acquisition tool); - Several clarifications have been added regarding the principles; - The concept  of **electronic Informed Consent** has been introduced; - The implementation of **quality by design** and **risk mitigation** strategies is strongly encouraged; - Some responsibilities of the **Sponsor** relating to the following topics have been clarified: monitoring, investigational product, quality management and sponsor oversight; - The main clarifications regarding the **Investigator's responsibilities** concern the identification and maintenance of source records, the need to carry out the data review in a timely manner and the delegation of responsibilities to the staff;  - With regard to essential records, the guideline distinguishes between **essential records** (applicable for all studies) and **potential essential records** (to be implemented based on the characteristics of the study); - The most significant change concerns the introduction of the concept of **data governance** which applies to both Sponsor and Investigator.    #### **What is data governance?**  This new paragraph offers guidance both to investigators and sponsors on how to perform an appropriate management of data integrity, traceability and security.    #### **How can PQE support customers in complying with ICH GCP E6 R3?**  PQE can support customers in carrying out an impact assessment of the Guidance on their processes and in implementing the most suitable solutions for their needs  ![New GCP_Site Banner](https://blog.pqegroup.com/hubfs/New%20GCP_Site%20Banner.jpg) ## Need Support for Clinical Studies? We have developed a dedicated service just for you, to assist your business in the compliance and the operations related to clinical studies. Visit our dedicated page to [Clinical Research](https://www2.pqegroup.com/clinical-research-services/), and explore the entire scope of our service's. [Connect with us](https://www2.pqegroup.com/contact-us/) [Explore services](https://www2.pqegroup.com/clinical-research-services/) #### More on this topic [Clinical Research ![Orchestrating Innovation: Aligning Science, Strategy, and Market Success](https://blog.pqegroup.com/hubfs/Orchestrating%20Innovation_Blog%20(1)-1.webp)](https://blog.pqegroup.com/clinical-research/orchestrating-innovation-aligning-science-strategy-and-market-success) 02 Jul 2026 ## [Orchestrating Innovation: Aligning Science, Strategy, and Market Success The future of healthcare belongs to those who can turn innovation into impact. Read more.](https://blog.pqegroup.com/clinical-research/orchestrating-innovation-aligning-science-strategy-and-market-success) [Clinical Research ![How ICH E6 Revision 3 Is Redefining Our Understanding of Clinical Trials](https://blog.pqegroup.com/hubfs/BANNER-How%20ICH%20E6%20Revision%203%20%20Is%20Redefining%20Our%20Understanding%20%20of%20Clinical%20Trials%20_1_1_1.jpg)](https://blog.pqegroup.com/how-ich-e6-revision-3-is-redefining-our-understanding-of-clinical-trials) 10 Jun 2025 ## [How ICH E6 Revision 3 Is Redefining Our Understanding of Clinical Trials Discover how ICH E6(R3) is redefining clinical trials with a modern, flexible, and patient-centric approach](https://blog.pqegroup.com/how-ich-e6-revision-3-is-redefining-our-understanding-of-clinical-trials) [Clinical Research ![Why Small Pharma Companies Rely on CROs and What They Expect](https://blog.pqegroup.com/hubfs/Clinical%20Research_Baroldi_Blog%20Banner.jpg)](https://blog.pqegroup.com/clinical-research/why-small-pharma-companies-rely-on-cros-and-what-they-expect) 20 Feb 2025 ## [Why Small Pharma Companies Rely on CROs and What They Expect Small pharma companies rely on CROs for expertise, cost-effectiveness, flexibility, and strong communication in clinical trials.](https://blog.pqegroup.com/clinical-research/why-small-pharma-companies-rely-on-cros-and-what-they-expect) ![new PQE logo white tagline](https://blog.pqegroup.com/hubfs/new%20PQE%20logo%20white%20tagline.png) ISO 9001 Certified compliance services provider since 1998.   ![Logo ISO 9001](https://blog.pqegroup.com/hs-fs/hubfs/Logo%20ISO%209001.png?width=125&name=Logo%20ISO%209001.png)   - Discover PQE - [Work with PQE](https://www2.pqegroup.com/careers/) - [Locations](https://www2.pqegroup.com/contact-us/#locations) - [About](https://www2.pqegroup.com/about/) - [Blog](https://blog.pqegroup.com/) - Useful Links - [Privacy Notice](https://www2.pqegroup.com/privacy-notice/) - [Cookie Policy](https://www2.pqegroup.com/cookie-policy/) - [Model of Organization](https://www2.pqegroup.com/model-of-organization/) - [Ethical Code](https://www2.pqegroup.com/ethical-code/) English - [English](https://blog.pqegroup.com/clinical-studies/ich-gcp-e6-r3-draft-guideline-changes-and-clarifications) - [Français](https://blog.pqegroup.com/fr/recherche-clinique/ich-gcp-e6-r3-principaux-changements-et-clarifications) - [עברית](https://blog.pqegroup.com/he/clinical-studies/ich-gcp-e6-r3-draft-guideline-changes-and-clarifications) CHANGE LANGUAGE Copyright **2024** | Proudly powered by **PQE Group Creative Team** [LinkedIn](https://www.linkedin.com/company/pqe-group) [![twitter](https://blog.pqegroup.com/hubfs/twitter-w.png) Twitter](https://twitter.com/PQEGroup) [Facebook](https://www.facebook.com/PQEGroup/) [Instagram](https://www.instagram.com/lifeatpqe) [YouTube](https://www.youtube.com/c/PQEGroup) [Xing](https://www.xing.com/pages/pqegroup)