ICH GCP E6 (R3) draft

29-05-2023 / Daniela van 't Ent - Ifrim / Legislation

After it was issued almost 30 years ago and several minor additions were made in 2016, the revised guideline of ICH gCP E6 (R3) has been endorsed by ICH Expert Working Group on 19th May 2023. The draft document is available for public consultation until 26-Sep-2023.​​

Among the updates:

  • Structural reorganization by including Annex 1 (IRB/EC, Investigator, Sponsor, Data governance) and 3 Appendices (IB, Protocol, Essential records).
  • New chapter: Data governance.
  • Adapts a risk-based approach.
  • Accommodates new technologies (wearables, sensors, remote ICF).
  • Mentions public trial registration.
  • Mentions sponsor oversight responsibility.
  • Mentions that delegated tasks from the Sponsor or Investigators should be documented.
  • Clarifies the difference between “clinical trial” and “clinical study” vs interventional and observation study.
  • Nomenclature: 


  • “CROs” / other vendors -> “Service Providers”
  • “Essential Documents” -> “Essential Records”
  • “Trial participants” -> “Trial subjects”

new terms

  • metadata
  • data acquisition tools
  • assent
  • signature
  • service provider
  • trial coordinator