<p>The article aims to give an overview of the contractual situation in Germany, which arise in clinical studies. The goal of the authors is to show any potential sponsor of a clinical study, who is interested in cooperation with German partners such as universities or other study sites, what kind of agreements may be expected and to give a brief overview about necessary themes included within the contractual negotiations. The different contractual settings are considered from the perspective each different type of agreement. The authors have chosen amongst all possible types the ones which are the most common in a clinical study, such as CDA, MTA, grant agreement, clinical study agreement, CRO-service agreement etc. The authors show the complexity of the contractual setting of a clinical study and emphasize to pay close attention to the contractual settings. Even though the content of the agreement is mostly universal in nature, in some cases, Germany has some very special rules (e.g. regarding employees’ inventions), which any potential sponsor should keep in mind.</p>
The following article outlines the essential clauses within agreements about the funding of German Universities or German clinical trial sites in order for them to conduct a non-commercial clinical trial on their own, a so-called Investigator-Initiated-Trials or Investigator-Sponsored-Trials. The authors explain the basic legal principles and clauses for such an agreement and clarify certain German Law specialities, which any funder should be aware of, if they were to fund an Investigator-Initiated-Trial in Germany. It becomes clear, that it is very important for the funding pharmaceutical company or foundation, not to be confused with the regulatory sponsor of the given clinical trial. Unclear wording in the funding agreement could lead to the actual transfer of a sponsor’s responsibilities from the University or clinical trial site to the funding pharmaceutical company or foundation, with all legal and monetary risks. In order to avoid unwanted penalties and costs, it is imperative for the funding entity to draft the essential clauses carefully. This article aims to help with that.
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