title: [A manual of good professional practices for the Clinical Investigation Centres].
abstract: Clinical Investigation Centres (CICs) are academic organisations for performing clinical studies. They are a part of a national network which is co-ordinated by French national institute for health and medical research (Inserm), and the head office of healthcare provision (DGOS). There are working groups and specialised networks within the overall CIC network. The Harmonisation of CIC Procedures (HPCIC) group wrote a manual of good professional practices for clinical research. This manual is described here. This manual was written by consensus. It was approved by the coordinators of all CICs, external experts, and validated by representatives of both Inserm and the General directorate of healthcare provision (DGOS). The CIC Good Professional Practices manual is a guide divided into two sections. The first section covers the general management of a CIC (common to all CICs). The second section covers the core activities of CICs, running clinical studies (clinical study coordination, clinical investigation, data management, statistical analysis, valorisation). This manual is available for all CICs and any other clinical research organisations. It will serve as a basis for CIC self-quality evaluation, audits between CICs, and external audits. This manual shows how much the CICs want to standardise practices and procedures nationwide to offer their partners the best quality in performing clinical studies.
authors.affiliation: Inserm, CIC201, Lyon, France. catherine.cornu@chu-lyon.fr
authors.forename: Catherine
authors.initials: C
authors.lastname: Cornu
authors.forename: Clémence
authors.initials: C
authors.lastname: Camberlein
authors.forename: Christine
authors.initials: C
authors.lastname: Binquet
authors.forename: Carine
authors.initials: C
authors.lastname: Robert
authors.forename: Céline
authors.initials: C
authors.lastname: Vigouroux
authors.forename: Caroline
authors.initials: C
authors.lastname: Bouyssou
authors.forename: Alexandra
authors.initials: A
authors.lastname: Felin
authors.forename: Marie-Françoise
authors.initials: MF
authors.lastname: Dupont-Mordelet
authors.forename: Annabelle
authors.initials: A
authors.lastname: Sailly
authors.forename: Christine
authors.initials: C
authors.lastname: Kubiak
authors.forename: Géraldine
authors.initials: G
authors.lastname: Poli
authors.forename: Sonia
authors.initials: S
authors.lastname: Gueguen
authors.forename: Charlène
authors.initials: C
authors.lastname: Duchesne
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Ploix
authors.forename: Claire
authors.initials: C
authors.lastname: Thalamas
mesh_terms: D035843:Biomedical Research / Q000458:organization & administration / Q000592:standards*; D005602:France; D006801:Humans; D008330:Management Audit; D015203:Reproducibility of Results