Q&A with Florian Gilmer, Clinical Project Manager, genae Germany
Q: Are there any aspects that should be considered during the site selection process which affect the submission?
A: The protocol and also the study procedures should be discussed already early in the start-up phase with all participating investigators. The aim of this discussion is to evaluate if the proposed procedures are in line with the site standard assessments that they do in their daily routine.
Feedback ofthe sites can be collected and should be incorporated early into the protocol and submitted as such to the Ethics Committee. Doing this can avoid discussions later on at the SIV’s when it turns out that certain study procedures are difficult to follow for the sites and have a limitation on the study recruitment.
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