Is Good Clinical Practice Becoming Poor Clinical Care?

摘要

Year after year, clinical research teams and investigating physicians are subjected to an exponential growth in administrative burden, paperwork, and regulation associated with clinical trials. The universal explanation for this ever-increasing workload is that it represents “good clinical practice” and is all about the safety of the patient and the integrity of the research. So whenever an investigator asks the question “Why should I fill out this document again?,” “Why should I write this sentence in the patient's record again?,” “ Why should I sign all these electronic files?,” “Why should I write the date again,” the answer is immutably identical, it is GCP.