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Standard Contractual Clauses

New standard contract template for clinical trials with medicinal products

To further simplify contract negotiations, German University Medicine (DHM), the Association of Research-Based Pharmaceutical Companies (vfa), the KKS Network, the German Pharmaceutical Industry Association (BPI) and the Federal Association of Contract Research Organisations (BVMA) have drawn up and published a comprehensive, regulation-compliant standard contract template that incorporates the standard contractual clauses.

From 18 December 2025, new contracts between hospitals and pharmaceutical companies regarding clinical trials must contain the standard contractual clauses laid down in September.

This standard contract template represents a fully formulated, completed contract template using the provisions of the regulation. Where the previous model contract clauses already contained agreed clarifications (e.g. for deadlines) and additions that went beyond the regulation, these were adopted where possible. The aim of this standard contract template is to support the application of the BMG's standard contract clauses and to bring them into widespread use quickly.

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.