title: [Organising an investigation site: a national training reference document].
abstract: OBJECTIVE
  Several surveys have shown a declining performance of French investigators in conducting clinical trials. This is partly due to insufficient and heterogeneous investigator training and site organisation. A multidisciplinary group was set up to propose solutions. We describe the tools developed to improve study site organisation.
  
  
  RESULTS
  This working group was made up of clinical research experts from academia, industry, drug regulatory authorities, general practice, and consulting. Methods and tools were developed to improve site organisation.
  
  
  CONCLUSIONS
  The proposed tools mainly focus on increasing investigators' awareness of their responsibilities, their research environment, the importance of a thorough feasibility analysis, and the implementation of active patient recruitment strategies. These tools should be able to improve site organisation and performances in conducting clinical trials.
authors.affiliation: INSERM CIC201, CHU Lyon, Lyon, France - Service de Pharmacologie clinique, Lyon, France - Université de Lyon, UMR 5558, Lyon, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Cornu
authors.affiliation: Assurance qualité et de la gouvernance médicale, Laboratoire GSK, Paris, France.
authors.forename: Frédérique
authors.initials: F
authors.lastname: David
authors.affiliation: Coordination des projets transverses, Laboratoire Sanofi, Paris, France.
authors.forename: Luc
authors.initials: L
authors.lastname: Duchossoy
authors.affiliation: Faculté de Pharmacie, CHRU de Montpellier, Montpellier, France.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Hansel-Esteller
authors.affiliation: P-H Bertoye Conseil, Paris, France.
authors.forename: Pierre-Henri
authors.initials: PH
authors.lastname: Bertoye
authors.affiliation: Faculté de médecine de Tours ; Maison de santé pluri-professionnelle universitaire du Veron, Avoine, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Giacomino
authors.affiliation: Université Paris Cité-Diderot, AP-HP, Hôpital Lariboisière, Paris, France.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Mouly
authors.affiliation: French-Clinical Research Infrastructures Network, Toulouse, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Diebolt
authors.affiliation: Coordination opérationnelle-CIC plurithématique, CHU, Bordeaux, France.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Blazejewski
mesh_terms: D035843:Biomedical Research / Q000193:education / Q000379:methods / Q000458:organization & administration* / Q000592:standards; D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards; D003299:Cooperative Behavior; D005240:Feasibility Studies; D006801:Humans; D018579:Patient Selection; D024382:Professional Role; D011996:Records; D012107:Research Design / Q000592:standards; D012108:Research Personnel; D012941:Social Responsibility; D012985:Software Design