Monitoring Visit Activities For Clinical Trials Of Investigational Products

Overview ICH GCP E6(R2) Integrated Addendum

Monitoring continues to be the sponsor’s responsibility. By far, the most substantial changes to ICH E6 are related to study monitoring. The addendum incorporates elements from the FDA’s (2013) risk-based monitoring guidance, which supports alternative approaches (specifically, risk-based and combination activities) to monitoring.

  Activities, Monitoring