Kathmandu, September 4, 2025 — OUCRU Nepal hosted a three-day training workshop on the revised ICH GCP E6(R3) guidelines at the Malla Hotel, Kathmandu, from August 18–20, 2025. This was the first on-site training conducted in Nepal following the amendment of ICH GCP E6(R3). The event brought together a wide range of stakeholders committed to enhancing the quality and ethics of clinical research in Nepal and the region.
What’s New in ICH GCP E6(R3)?
ICH GCP E6(R3) is the third revision of the international guideline on Good Clinical Practice, updating E6(R2) to reflect modern trial methods and technologies. It emphasizes participant protection, inclusivity, and data reliability, while introducing flexibility for innovative trial designs such as decentralized and digital trials. The revision promotes a proportionate, risk-based approach to oversight, clearer sponsor–investigator responsibilities, stronger data governance, and simplified documentation—making GCP more adaptable to today’s diverse and evolving clinical research landscape.
The training was facilitated by the Pro Clin Institute of Medical Research, India, and focused on the latest updates to the ICH GCP guidelines. It brought together participants from OUCRU Nepal, collaborating hospitals, the NHRC Ethics Review Board, Institutional Review Committees, and the Department of Drug Administration.
During the first two days, the training provided a detailed overview of ICH GCP to more than 60 participants, highlighting the differences between the E6 (R3) and E6 (R2) guidelines. These sessions involved clinical team members from various collaborating hospitals, CTU members, IRBs, and investigators in interactive training and group discussions. The training concluded with a final day session with investigators from various collaborating hospitals, which focused on the roles and responsibilities of Principal Investigators, including group activities and a case study, along with a focused discussion addressing practical challenges with investigators.
For OUCRU Nepal and its collaborators, the updated guideline enables more flexible and efficient trial designs, reduces administrative burden, and ensures high data quality. For Institutional Review Boards (IRBs), E6(R3) offers clearer guidance on evaluating modern trials while safeguarding participant rights, inclusivity, and data governance.
This training marks a significant step in OUCRU Nepal’s ongoing efforts to align with international standards and promote ethical, inclusive, and innovative clinical research. The workshop represents a key milestone in aligning regional research efforts with global standards.
