title: [Good professional practices of French CICs - version # 2].
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.
authors.affiliation: Inserm, CIC1411, 34295 Montpellier, France; Centre d'investigation clinique plurithématique, CHU de Montpellier, 34295 Montpellier, France. Electronic address: h-chevassus@chu-montpellier.fr.
authors.forename: Hugues
authors.initials: H
authors.lastname: Chevassus
authors.affiliation: Inserm, CIC1413, 44093 Nantes, France; Centre d'investigation clinique plurithématique et biothérapies, CHU de Nantes, 44093 Nantes, France.
authors.forename: Charlène
authors.initials: C
authors.lastname: Duchesne
authors.affiliation: Inserm, CIC1403, 59037 Lille, France; Centre d'investigation clinique plurithématique et innovation technologique, CHU de Lille, 59037 Lille, France.
authors.forename: Annabelle
authors.initials: A
authors.lastname: Sailly
authors.affiliation: Inserm, CIC1407, 69500 Bron, France; Service de pharmacologie clinique, hospices civils de Lyon, 69500 Bron, France; Université Claude-Bernard-Lyon 1, 69100 Villeurbanne, France.
authors.forename: Céline
authors.initials: C
authors.lastname: Vigouroux
authors.affiliation: Inserm, pôle de recherche clinique, 75013 Paris, France; CIC1415, 37044 Tours, France; Centre d'investigation clinique plurithématique et innovation technologique, CHU de Tours, 37044 Tours, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Foulon
authors.affiliation: ECRIN, 75013 Paris, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Kubiak
authors.affiliation: Inserm, CIC1432, 21079 Dijon, France; Centre d'investigation clinique, epidémiologie clinique/essais cliniques, CHU de Dijon, 21079 Dijon, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Binquet
authors.affiliation: Inserm, CIC1436, 31059 Toulouse, France; Centre d'investigation clinique plurithématique et biothérapies, CHU de Toulouse, 31059 Toulouse, France.
authors.forename: Alexandra Lamotte
authors.initials: AL
authors.lastname: Felin
authors.affiliation: Inserm, CIC1403, 59037 Lille, France; Centre d'investigation clinique plurithématique et innovation technologique, CHU de Lille, 59037 Lille, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Chaud
authors.affiliation: Inserm, CIC1436, 31059 Toulouse, France; Centre d'investigation clinique plurithématique et biothérapies, CHU de Toulouse, 31059 Toulouse, France; Service de pharmacologie clinique, université de Toulouse 3, 31059 Toulouse, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Thalamas
authors.affiliation: Inserm, CIC1407, 69500 Bron, France; Service de pharmacologie clinique, hospices civils de Lyon, 69500 Bron, France; Université Claude-Bernard-Lyon 1, 69100 Villeurbanne, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Cornu
mesh_terms: D000046:Academic Medical Centers; D035843:Biomedical Research / Q000592:standards*; D005602:France; D006801:Humans; D008370:Manuals as Topic; D011785:Quality Assurance, Health Care
keywords: Assurance qualité; Bonnes pratiques professionnelles; Clinical investigation; Clinical research; Good professional practices; Investigation clinique; Quality assurance; Recherche clinique