01/10/2023

The European Medicines Agency (EMA) Good Clinical Practice Frequently Asked Questions (FAQ) webpage offers guidance on GCP and is updated regularly as additional questions are received. Several of the questions were previously revised in March 2022.

Under section “GCP matters”, questions 16 and 17 were added in late 2022. Question 17 is covered in part 2 of the blog.

Question 16 (October 2022): “Is the monitoring of bioequivalence clinical trials mandatory?”

Answer summary: Clinical trial monitoring is always required per the regulations. Sponsors are responsible for selection of appropriately trained and qualified monitors based on a risk assessment of the study design and participant population. CRA training and qualification must be documented to back the rationale for selection. Sponsors need to review trip reports and implement corrective and preventive actions for any deficiencies. The guidance points out that audits and other quality assurance activities are not a substitution for monitoring. The extent and nature of monitoring is decided based on a risk assessment and is to be described in the monitoring plan, the protocol, and the Clinical Study Report. Assessment of monitoring activities is likely to occur during the regulatory agency’s evaluation of a marketing application.