Templates

With the publication of the standard contract template for three parties to clinical trials involving medicinal products, an important component of the Medical Research Act is now being implemented.
While the two-party model contract has already made a significant contribution to standardization between sponsors and trial sites, the new three-party version now closes the gap that previously existed in the collaboration between sponsors, trial sites, and CROs. This is because the vast majority of clinical trials today are conducted with the involvement of contract research organizations.

For contract negotiations for clinical trials for medicinal products, you will find here the further developed version of the "Model contract clauses for clinical trials with drugs under the responsibility of a pharmaceutical company" including various templates for annexes. These are published by The Deutsche Hochschulmedizin (German University Medicine), the KKS network, the pharmaceutical associations vfa and BPI and the CRO association BVMA. The parties involved would like to provide and use these templates to help speed up the contract negotiations for conducting a clinical trial.

Please refer to the document "Germany - Joint Model-Contract-Clauses 2.0" for the preamble and instructions for use.

Disclaimer: The model contract clauses above have been prepared by the representatives of the organisations involved to the best of their knowledge and on the basis of collective professional discussion and the respective practical experience gained by each. The legality and comparability of these clauses with German or European law may be assessed differently by any courts consulted. Furthermore, parties using the model contract clauses are not exempt from the requirement to document the specific facts and the intentions of the respective parties in each individual case, and on this basis to determine which individual model contract clauses to use. The authors are hereby exempted from all liability.