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What are the key documents or elements that a sponsor tends to forget when preparing a study?

Q&A with Florian Gilmer, Clinical Project Manager, genae Germany

Q: What are the key documents or elements that a sponsor tends to forget when preparing a study?

A: What we occasionally see, especially in smaller start-up companies, is that they tend to forget that they need a local legal representative in the European Union, if they are themselves not located in the EU. On the other hand, we see if they are located in the European Union that they tend to forget that they also need a legal representative in Switzerland if they want to submit in that country.

The second item is a thing that is not forgotten by the sponsors, but it is rather underestimated by means of the time that it takes, is about the negotiation of investigator contracts with the sites. We always recommend to start this negotiation process early in the phase, just to avoid bottlenecks later on when it turns out that the negotiation with the university administration takes longer than expected.

The third and last item I want to mention is not a document, but rather the content of a document. Especially the Competent Authority in Germany has a requirement that certain aspects have to be included into the protocol itself. These requirements might be different in other countries.

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