Revised ICH E6 (R3) GCP Training & Documentation Requirements
15 July 2025
Get ready for the ICH E6 (R3) GCP guidelines, effective 1 January 2026 in Singapore. Find training resources and learn how to keep proper records.
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The ICH E6 (R3) GCP Principles and Annex 1 will be effective 1 January 2026 in Singapore.
The E6 (R3) guideline outlines GCP principles within the changing environment of clinical trials, fostering innovations in trial design, operational methods, and technological progress. It advocates for a quality-by-design and risk-proportionate strategy in conducting clinical trials.
It is crucial for all investigators and other study team members involved in significant trial-related tasks to be knowledgeable about the ICH E6 (R3) GCP requirements to ensure ethical standards and subject safety in clinical trials, ultimately enhancing the credibility and reliability of trial outcomes.
Available ICH E6 (R3) GCP Training Resources:
Updated CITI GCP Training Course (opens in new tab) (from 23 July 2025)
Staff of NHG and partner institutions can register for CITI Training by following the instructions here (opens in new tab).
Records Keeping:
Training completion records should be filed in the Investigator Site File.
To ensure your ECOS training records remain contemporaneous, upload your ICH E6 (R3) GCP training records promptly. Refer to the ECOS Minimum Training User Guide (opens in new tab) for instructions on how to upload the information on ECOS.
Publicity EDMs:
ICH E6 (R3) GCP Training Publicity Poster (15 July 2025) (opens in new tab)
ICH E6 (R3) GCP Training Publicity Poster (16 September 2025) (opens in new tab)
ICH E6 (R3) GCP Education Poster (3 December 2025) (opens in new tab)