EFGCPEuropean Forum for Good Clinical Practice
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Should the texts be adopted in a form similar to what is being proposed, serious and unnecessary impediments will arise", EFGCP says.
According to EFGCP, the problem arises because the requirements are an accumulation of all the existing national requirements in the EU, instead of a simplification: "The past 12 years of debate on European good clinical practice and the need for a general European clinical trials framework is very much at stake in the specifics of what this set of guidance proposes".
The investigator is crucial in translating guidelines into practice, for ensuring the promotion of the health of the patient and the quality of data, says EFGCP. Trial subjects "deserve the best, but do not always get it", according to the Forum.