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Model contract clauses for clinical trials

The conduct of clinical trials is often subject to time pressure, with the factor of time playing an important role in international competition, particularly in the period leading up to the start of a clinical trial. In order to be able to begin a clinical trial as early as possible, it should be possible to conclude the underlying contracts between the parties involved quickly and easily, with comprehensive content. For this purpose "Model contract clauses for clinical trials with drugs, conducted under the responsibility of a pharmaceutical company" in Germany were published for the first time in May 2019.

Since November 2023 a new version 2.0 of the model contract clauses is available and was published by the Verband der Universitätsklinika Deutschlands (VUD, German Association of University Clinics), the KKS-Netzwerk e. V. (KKS Network), the Verband forschender Arzneimittelhersteller (vfa, Association of Research-based Pharmaceutical Companies), the Bundesverband der Pharmazeutischen Industrie (BPI, German Pharmaceutical Industry Association) and the Bundesverband Medizinischer Austragsinstitute (BVMA, German Association of Medical Contractors).

The model contract clauses are intended as an orientation and starting point for concrete contract negotiations between all institutions involved in conducting a study in Germany.

The following documents are available for download: