Are there any guidelines for investigator initiated clinical trials?

07 July 2018 1 9K Report

for pharmaceuticals to conduct a study there are guidelines but are there any separate guidelines for investigator initiated clinical trial for academic purposes?

Michal Svoboda

There are no specific guidelines regulating investigator sponsored clinical trials. Rather, the clinical trials are assessed based in the involved risk.

You might wish to consult your national regulation for any differences between industry and investigator sponsored trials and requirements for the particular trial you plan to sponsor.

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