title: [Not Available].
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 ; CHU Lyon, Service de Pharmacologie Clinique, Lyon, France ; Université Lyon, UMR 5558, Lyon, France. Electronic address: catherine.cornu@chu-lyon.fr.
authors.forename: Catherine
authors.initials: C
authors.lastname: Cornu
authors.affiliation: CIC 0004, Inserm, CHU Hôtel Dieu, Nantes, France.
authors.forename: Clémence
authors.initials: C
authors.lastname: Camberlein
authors.affiliation: Inserm, CIE1, Dijon, France ; CHRU Dijon, Centre d'Investigation Clinique - Épidémiologie Clinique/Essais Cliniques, Dijon, France ; Université de Bourgogne, Dijon, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Binquet
authors.affiliation: CIC P0901, Inserm, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, Paris, France ; Unité de Recherche Clinique Cochin Necker, Hôpitaux Universitaires Paris Centre, Assistance Publique - Hôpitaux de Paris, Paris, France.
authors.forename: Carine
authors.initials: C
authors.lastname: Robert
authors.affiliation: Inserm, CIC201, Lyon, France ; CHU Lyon, Service de Pharmacologie Clinique, Lyon, France ; Université Lyon, UMR 5558, Lyon, France.
authors.forename: Céline
authors.initials: C
authors.lastname: Vigouroux
authors.affiliation: Inserm, CIC-EC7, Bordeaux, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Bouyssou
authors.affiliation: Inserm, CIE1, Dijon, France ; CHRU Dijon, Centre d'Investigation Clinique - Épidémiologie Clinique/Essais Cliniques, Dijon, France ; Université de Bourgogne, Dijon, France.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Felin
authors.affiliation: Inserm CIC-P, CHU de Rennes, Rennes, France.
authors.forename: Marie-Françoise
authors.initials: MF
authors.lastname: Dupont-Mordelet
authors.affiliation: Inserm CIC-P, Centre de Ressources Biologiques, CHRU de Lille, Lille, France.
authors.forename: Annabelle
authors.initials: A
authors.lastname: Sailly
authors.affiliation: Inserm, ECRIN (European clinical Research Infrastructures Networks), Paris, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Kubiak
authors.affiliation: Inserm, Institut de Santé Publique, Pôle Recherche Clinique, Paris, France.
authors.forename: Géraldine
authors.initials: G
authors.lastname: Poli
authors.affiliation: Inserm, Institut de Santé Publique, Pôle Recherche Clinique, Paris, France.
authors.forename: Sonia
authors.initials: S
authors.lastname: Gueguen
authors.affiliation: CIC 0004, Inserm, CHU Hôtel Dieu, Nantes, France.
authors.forename: Charlène
authors.initials: C
authors.lastname: Duchesne
authors.affiliation: Inserm, U1015, CICBT507, Institut Gustave Roussy, Villejuif, France.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Ploix
authors.affiliation: Inserm, CIC 9302 Toulouse ; CHU Toulouse, Service de pharmacologie médicale et clinique, Toulouse, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Thalamas
keywords: bonnes pratiques; clinical investigation; clinical research; démarche qualité; good practices; investigation clinique; quality approach; recherche clinique