[法国信贷投资公司的良好专业实践 - 版本2]

[Good professional practices of French CICs - version # 2].

作者信息

Chevassus Hugues, Duchesne Charlène, Sailly Annabelle, Vigouroux Céline, Foulon Christine, Kubiak Christine, Binquet Christine, Felin Alexandra Lamotte, Chaud Pascal, Thalamas Claire, Cornu Catherine

机构信息

Inserm, CIC1411, 34295 Montpellier, France; Centre d'investigation clinique plurithématique, CHU de Montpellier, 34295 Montpellier, France.

Inserm, CIC1413, 44093 Nantes, France; Centre d'investigation clinique plurithématique et biothérapies, CHU de Nantes, 44093 Nantes, France.

出版信息

Therapie. 2017 Oct;72(5):525-538. doi: 10.1016/j.therap.2017.01.006. Epub 2017 Feb 17.

DOI:10.1016/j.therap.2017.01.006

PMID:28389014

Abstract

French clinical investigation centers (CICs) are academic platforms dedicated to clinical research. The QUALI-CIC working group helps to improve and harmonize practices within the CIC network. After some years of implementation, the manual of good professional practices of CICs (MGPP CIC) completed in 2010, needed to be revised to best fit with the large panel of CIC activities. The aim was also to make it more accurate and to reinforce requirements about participants safety and data security. In its second version published in the present article, the MGPP CIC includes 255 items divided into 15 chapters. An explanatory document, currently being drafted, will complete the manual to facilitate its implementation.

摘要

法国临床研究中心（CICs）是致力于临床研究的学术平台。QUALI-CIC工作组有助于改进和统一CIC网络内的实践。经过数年实施，2010年完成的CIC良好专业实践手册（MGPP CIC）需要修订，以更好地适应CIC的大量活动。其目的还在于使其更加精确，并加强对参与者安全和数据安全的要求。在本文发表的第二版中，MGPP CIC包括255项，分为15章。一份解释性文件正在起草中，将完善该手册以促进其实施。