title: What is a clinical trial protocol?
abstract: Trial protocols are documents that describe the objectives, design, methodology, statistical considerations and aspects related to the organization of clinical trials. Trial protocols provide the background and rationale for conducting a study, highlighting specific research questions that are addressed, and taking into consideration ethical issues. Trial protocols must meet a standard that adheres to the principles of Good Clinical Practice, and are used to obtain ethics approval by local Ethics Committees or Institutional Review Boards.
authors.affiliation: Department of Medicine and Public Health, Section of Psychiatry and Clinical Psychology, University of Verona, Italy. andrea.cipriani@univr.it
authors.forename: Andrea
authors.initials: A
authors.lastname: Cipriani
authors.forename: Corrado
authors.initials: C
authors.lastname: Barbui
mesh_terms: D006801:Humans; D002986:Clinical Trials as Topic / Q000379:methods; D012107:Research Design