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

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

[Article in French]
Hugues Chevassus  1 , Charlène Duchesne  2 , Annabelle Sailly  3 , Céline Vigouroux  4 , Christine Foulon  5 , Christine Kubiak  6 , Christine Binquet  7 , Alexandra Lamotte Felin  8 , Pascal Chaud  3 , Claire Thalamas  9 , Catherine Cornu  4 ; QUALI-CIC
Affiliations

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

[Article in French]
Hugues Chevassus et al. Therapie. 2017 Oct.

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.

Keywords: Assurance qualité; Bonnes pratiques professionnelles; Clinical investigation; Clinical research; Good professional practices; Investigation clinique; Quality assurance; Recherche clinique.

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