Abstract
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. This magic sentence stops all discussion because the risk for an investigator to be seen not to be respecting “good practices” could be a death sentence for his/her center and calls into questions his/her professional integrity and that of his (or her) collaborators. Once the words GCP have been pronounced, you have to resign yourself, obey and sign (or click, or write, or listen, or ask the patient to sign here and here, there and there, in two copies if not more).
DOI
10.1097/hs9.0000000000000004
Publication Date
2017-12-01
Publication Title
HemaSphere
Volume
1
Issue
1
Publisher
Lippincott, Williams & Wilkins
ISSN
2572-9241
Embargo Period
2024-11-19
First Page
e4
Last Page
e4
Recommended Citation
Le Gouill, S., Dreyling, M., Caballero, M., Andre, M., & et al. (2017) 'Is Good Clinical Practice Becoming Poor Clinical Care?', HemaSphere, 1(1), pp. e4-e4. Lippincott, Williams & Wilkins: Available at: https://doi.org/10.1097/hs9.0000000000000004
