MHRA & FDA: First Joint Workshop on GCP in Washington

Regulatory authorities perform good clinical practice (GCP) inspections in order to verify the reliability of data gained in clinical studies, the appropriate protection of participants concerned, and to ensure that clinical studies have been conducted in accordance with the applicable rules. In the current era of global clinical trials, regulatory authorities have reinforced their cooperation to evaluate whether clinical studies are carried out adequately and to optimize the use of regulatory resources and the achieved level of control.

The workshop, which took place from 23-24 October, 2018, in Washington, was the first ever to be organized jointly by the US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), with the intention of conveying both agencies' views on the importance of quality management practices for data security.

Workshop Main Focus Areas

Some of the main foci were:

• Views of regulatory authorities on the importance of quality management systems for data security
• Effects of data management procedures on data reliability
• Effects of data blinding on data reliability
• Use of Audit Trails for evaluating data integrity

The workshop participants were primarily representatives from regulatory agencies, GCP inspectors, FDA and MHRA staff, data management experts, quality assurance experts for clinical studies, computerized system developers for clinical studies and other industry stakeholders. They had the opportunity to actively work on case studies on various topics. This included, for example, how to evaluate data integrity and reliability using practical examples. Further information, lectures and recordings can be downloaded on FDA's official website.

Source: Regulatory Education for Industry (REdI): FDA & MHRA Good Clinical Practice Workshop: Data Integrity in Global Clinical Trials – Are We There Yet?