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.
In May 2019 the Medizinischer Fakultätentag (MFT, German Association of Medical Faculties), the Verband der Universitätsklinika Deutschlands (VUD, German Association of University Clinics), the KKS-Netzwerk e. V. (KKS Network) and the Verband forschender Arzneimittelhersteller (vfa, Association of Research-based Pharmaceutical Companies) have published for the first time model contract clauses, which are intended to take into account the various interests of all involved: „Model contract clauses for clinical trials with drugs, conducted under the responsibility of a pharmaceutical company (industrial sponsor)“.
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. This also corresponds to a recommendation made by the German Science Council in 2018.
The following documents are available for download:
- Model contract clauses for clinical trials with drugs, conducted under the responsibility of a pharmaceutical company (industrial sponsor)PDF document or Word document
- Model annex on data protection declaration of consentPDF document or Word document
- Model Annex to Obligations within the scope of a clinical trial involving medicinal productsPDF document or Word document