GCP-Clinical Operations

The working group deals with current topics and questions regarding the conduct of clinical trials as well as the implementation of GCP and regulatory requirements in practice.

The working group has approximately 80 members who are active in pharmaceutical companies, CROs or freelancers in clinical research.

The working group meets three times a year, the working meetings take place at different locations, one member takes over the organization and hosts the meeting.

Topics are current legal and regulatory requirements (national and international) as well as practical issues such as e.g. electronic CRFs, SOPs, archiving, clinical studies in special patient groups, risk-based monitoring. Furthermore, members report on continuous education events. In addition to all this, the discussion and the exchange of experiences are an important part of these working group meetings.