title: Development and implementation of clinical trial protocol templates at the National Institute of Allergy and Infectious Diseases.
abstract: BACKGROUND
  A clinical research protocol document must reflect both sound scientific rationale as well as local, national and, when applicable, international regulatory and human subject protections requirements. These requirements originate from a variety of sources, undergo frequent revision and are subject to interpretation. Tools to assist clinical investigators in the production of clinical protocols could facilitate navigating these requirements and ultimately increase the efficiency of clinical research.
  
  
  OBJECTIVE
  The National Institute of Allergy and Infectious Diseases (NIAID) developed templates for investigators to serve as the foundation for protocol development. These protocol templates are designed as tools to support investigators in developing clinical protocols.
  
  
  METHODS
  NIAID established a series of working groups to determine how to improve its capacity to conduct clinical research more efficiently and effectively. The Protocol Template Working Group was convened to determine what protocol templates currently existed within NIAID and whether standard NIAID protocol templates should be produced. After review and assessment of existing protocol documents and requirements, the group reached consensus about required and optional content, determined the format and identified methods for distribution as well as education of investigators in the use of these templates.
  
  
  RESULTS
  The templates were approved by the NIAID Executive Committee in 2006 and posted as part of the NIAID Clinical Research Toolkit [1] website for broad access. These documents require scheduled revisions to stay current with regulatory and policy changes.
  
  
  CONCLUSIONS
  The structure of any clinical protocol template, whether comprehensive or specific to a particular study phase, setting or design, affects how it is used by investigators. Each structure presents its own set of advantages and disadvantages. While useful, protocol templates are not stand-alone tools for creating an optimal protocol document, but must be complemented by institutional resources and support. Education and guidance of investigators in the appropriate use of templates is necessary to ensure a complete yet concise protocol document. Due to changing regulatory requirements, clinical protocol templates cannot become static, but require frequent revisions.
authors.affiliation: National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA. bridgeh@mail.nih.gov
authors.forename: Heather
authors.initials: H
authors.lastname: Bridge
authors.forename: Mary
authors.initials: M
authors.lastname: Smolskis
authors.forename: Peter
authors.initials: P
authors.lastname: Bianchine
authors.forename: Dennis O
authors.initials: DO
authors.lastname: Dixon
authors.forename: Grace
authors.initials: G
authors.lastname: Kelly
authors.forename: Betsey
authors.initials: B
authors.lastname: Herpin
authors.forename: Jorge
authors.initials: J
authors.lastname: Tavel
mesh_terms: D002985:Clinical Protocols / Q000592:standards*; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D033161:Government Regulation; D006801:Humans; D054579:National Institute of Allergy and Infectious Diseases (U.S.); D014481:United States; D014486:United States Food and Drug Administration