Agreements for the financial or material support of a non-commercial clinical trial in Germany
| Autor: | Raees Ahmed, Theresa Möller, Matthias Siegert |
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| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | International Journal of Drug Regulatory Affairs. 10:25-31 |
| ISSN: | 2321-6794 2321-7162 |
| DOI: | 10.22270/ijdra.v10i3.550 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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