The largest addition to Good Clinical Practice in Release 2 is the addition of Quality Management ,section 5.0, which falls under Sponsor guidance. Although this section of the guidance is directed to the sponsor audience, clinical research sites would be wise to reflect on the content and adopt quality management into their site operations.
Good Clinical Practice now includes a guidance that sponsors should implement a quality management system to manage quality throughout the design, conduct, recording, evaluation, reporting and archiving of clinical trials. This system should focus on trial activities that are essential to ensuring human subjects protection and the reliability of trial results.
Over the past few years many sponsors have implemented clinical study level quality management systems, distinct from their quality management systems which may cover such processes as Good Manufacturing Processes. This update in the guidance recognizes these systems as a requirement for ensuring human subject protection and data reliability.
One common theme throughout this guidance is that quality management, processes etc. should focus not on everything, however should focus on areas that matter: Human Subject Protection and Reliability of Clinical Trial Results.
The guidance clearly states that sponsors should focus on quality management methods which are proportionate to the risks inherent in the trial and the importance of the information collected. Too often quality management plans are overly complex and ICH has recognized that in this guidance. Sponsors must now ensure that all aspects of the trial are operationally feasible, avoiding unnecessary complexity , procedures, and data collection. Protocols, case report forms, and other operational documents should be clear, concise and consistent.
Release 2 also states that such quality management systems should use a risk based approach. Interact with the image below to explore more about how quality management unfolds in the new Good Clinical Practice (GCP) addendum.
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