Guest Blogger Andrew Milroy – HRPP and CQA Manager (Merita CQA)

For 19 years ICH GCP E6 has not changed. Now, nearly two decades after its initial release, change is coming. Perhaps the biggest difference is the focus and preeminence of Quality Management.

A modernized quality standard for clinical study processes is being espoused which is driving the adoption of Quality-by-Design and Quality Risk Management principles and methodologies by their full embrace throughout the guideline. Quality Management is expected to be risk-based, being applied to both the monitoring and auditing aspects of the clinical study process.

Going hand-in-hand with Quality Management is compliance. The draft addendum expands upon what is already written, by further stating that when there is significant non-compliance, it is the sponsors responsibility to perform a root cause analysis, implement corrective and preventive measures, and when needed, inform regulators. This facet of the Quality Management preeminence boosts the already existing quality-by-design and adaptive risk-based approach, with continuous improvement of the Quality Management processes themselves.

The changes being made to ICH GCP E6 (R1) reflect what is happening in the industry and are areas that have been highlighted by inspectors for several years. Some of these changes reflect guidance documents issued by regulatory authorities. These changes are expected to go into effect by November 2016. So mark your calendars.

For a consolidated list of the changes you can visit my blog, Ethics Nut, and scroll down to the post “Just the Additions – Consolidated Changes to ICH GCP E6 (R2).

For the full ICH GCP E6 (R2) you can access it here.

Andrew Milroy
Andrew Milroy

Andrew currently holds the position of HRPP and CQA Manager with Merita CQA Inc., a subsidiary of ethica Clinical Research Inc. Prior to his current position he worked with Clinical Trials Ontario developing an IRB audit manual for qualifying IRBs in Ontario to join a streamlined research ethics review process for multi-site clinical trials. Earlier work included time as a researcher for Mount Sinai Hospital during which time Andrew conducted audits to benchmark, track, and evaluate an educational intervention aimed at hospital staff. From 2008 - 2010 Andrew worked in International Development for the United Nations Development Program for Asia and the Pacific on the Capacity Development team, and with United Nations Millennium Campaign for Asia and the Pacific working on youth outreach and activism. Andrew brings academic knowledge of medical and research ethics to Merita CQA Inc. through a B.A. (Hon) Specializing in Bioethics from the University of Toronto, and additional ethics training through an M.A. (Distinction) in Applied Ethics from the Norwegian University of Science and Technology.