(For NHG Health Staff) ICH E6 (R3) GCP Training & Documentation
As the ICH E6 (R3) GCP guidelines will take effect from 1 Jan 2026 in Singapore, all NHG Health Investigators and study team members conducting significant trial-related tasks in clinical trials regulated by Health Sciences Authority (HSA) are requested to upkeep their knowledge and understanding of GCP so as to perform the gap analysis of existing clinical trial protocols, procedures and practices, by completing relevant ICH E6 (R3) GCP training by 1 Oct 2025,
[Important Action Required]
-
Read the updated CITI ICH E6(R3) GCP Training Course (available from 23 Jul 2025)
-
Upon completion, upload the CITI Cert on ECOS before 1 Oct 2025.
Note: From 1 Oct 2025, NHG Health Principal Investigators (PI), Site PIs and Co-Investigators without an updated ICG E6 (R3) training record will NOT be able to submit new IRB applications or study amendments for Clinical trials on ECOS. [Submissions of sub-forms (i.e., DNC, SAE, UPIRTSO, SSR, OTH) are not impacted].
Useful links:
ECOS Minimum Training User Guide for guidance on uploading training record on ECOS.
Revised ICH E6 (R3) GCP Training & Documentation Requirements