US FDA Guidance – Good Clinical Practice: Integrated Addendum to ICH E6(R1)

The US FDA just released their Guidance for Industry titled “E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)” (here).  The guidance provides a path forward for the mutual acceptance of clinical trial data across regulatory authorities from Canada, the European Union, Japan, Switzerland, and the United States.

The guidance clearly identifies the added revisions, making it easy for all of us to review and understand the changes.  Many of the revisions impact the sponsors of clinical trials.  The revisions to the guidance include how a risk-based approach should be taken for the quality management system and reminds sponsors of their responsibilities to ensure proper oversight and monitoring of their clinical studies.

For our subscribers from the clinical CROs, reading this blog and the revisions to this guidance will also apply to your teams as well, if the sponsor has transferred some or all trial-related duties to your organization.  For the sponsors, although transferring some or all trial-related duties to a CRO does not get you off the proverbial “hook”, it is still your overall responsibility to ensure your clinical trials are properly executed to ensure the integrity and quality of data generated is maintained.

Should you have any questions or need for support of your clinical research activities, please contact David O’Connor at D.OConnor@LachmanConsultants.com or Jim Davidson, PhD at J.Davidson@LachmanConsultants.com.