The GCP forum has been created as a tool to help those involved in clinical trials of Investigational Medicinal Products to comply with the clinical trials legislation and GCP requirements. It provides the ideal opportunity for extended communication between researchers and allows users to put forward their comments and get 'real-life' examples of ways in which they can manage robust quality procedures that ensure compliance and which dovetail with their own business needs and resources.
This forum should not be used for direct questions to the GCP Inspectorate/Clinical Trials Unit, reporting serious breaches or making formal complaints. These should follow the formal routes that are already in place.
Please read the Good Clinical Practice (GCP) Forum introduction and rules before posting on this forum.