The long awaited new revisions to the ICH E6 GCP guidelines have been released! The European Medicines Agency (EMA) posted a version(s) for review. These updates have come about to encourage implementation of better approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and data integrity.
The new updates aim to cope with the rapid development of technologies and new processes in the industry in the areas of risk and data management. New definitions have been included such as monitoring plan, certified copy, validation of computerized systems and others have been expanded as is the case for the monitoring report. In this new era the global guideline proposes clearer standards for essential documents, electronic records and risk based monitoring.
Most roles within the clinical research field will be affected by the new guidances. The investigator/institution must now certify procedures and subcontracting parties acting on their behalf. There is also a new requirement for the implementation of a source document management plan. The biggest changes come at the Sponsor level such as the requirement for a study level quality management plan and new initiatives for risk identification, evaluation, control, communication, review and reporting.
We will be presenting the changes, impact and implementation plans in trainings very soon. We can work with your company as well on the impact and gap analysis for implementation plans. This is an exciting time for global updates! You can find the new revised ICH E6 guidelines here.