title: INVESTIGATING THE EFFICACY OF CLINICAL TRIAL MONITORING STRATEGIES: Design and Implementation of the Cluster Randomized START Monitoring Substudy.
abstract: BACKGROUND
  Trial monitoring protects participant safety and study integrity. While monitors commonly go on-site to verify source data, there is little evidence that this practice is efficient or effective. An ongoing international HIV treatment trial (START) provides an opportunity to explore the usefulness of different monitoring approaches.
  
  
  METHODS
  All START sites are centrally monitored and required to follow a local monitoring plan requiring specific quality assurance activities. Additionally, sites were randomized (1:1) to receive, or not receive, annual on-site monitoring. The study will determine if on-site monitoring increases the identification of major protocol deviations (eligibility or consent violations, improper study drug use, primary or serious event underreporting, data alteration or fraud).
  
  
  RESULTS
  The START study completed enrollment in December 2013, with planned follow-up through December 2016. The monitoring study is ongoing at 196 sites in 34 countries. Results are expected when the START study concludes in December 2016.
authors.affiliation: Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis MN, USA.
authors.forename: Katherine Huppler
authors.initials: KH
authors.lastname: Hullsiek
authors.affiliation: Division of Clinical Research, National Institute of Allergy and Infectious Diseases, NIH, US DHHS, Bethesda MD USA.
authors.forename: Jonathan M
authors.initials: JM
authors.lastname: Kagan
authors.affiliation: Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis MN, USA.
authors.forename: Nicole
authors.initials: N
authors.lastname: Engen
authors.affiliation: Copenhagen HIV Programme, Department of Infectious Diseases and Rheumatology, Rigshospitalet, University of Copenhagen, Denmark.
authors.forename: Jesper
authors.initials: J
authors.lastname: Grarup
authors.affiliation: Medical Research Council Clinical Trials Unit at UCL, London, UK.
authors.forename: Fleur
authors.initials: F
authors.lastname: Hudson
authors.affiliation: Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis MN, USA.
authors.forename: Eileen T
authors.initials: ET
authors.lastname: Denning
authors.affiliation: The Kirby Institute, University of New South Wales, Sydney, Australia.
authors.forename: Catherine
authors.initials: C
authors.lastname: Carey
authors.affiliation: The Kirby Institute, University of New South Wales, Sydney, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Courtney-Rodgers
authors.affiliation: Washington DC Veterans Affairs Medical Center, District of Columbia, USA.
authors.forename: Elizabeth B
authors.initials: EB
authors.lastname: Finley
authors.affiliation: Copenhagen HIV Programme, Department of Infectious Diseases and Rheumatology, Rigshospitalet, University of Copenhagen, Denmark.
authors.forename: Per O
authors.initials: PO
authors.lastname: Jansson
authors.affiliation: Copenhagen HIV Programme, Department of Infectious Diseases and Rheumatology, Rigshospitalet, University of Copenhagen, Denmark.
authors.forename: Mary T
authors.initials: MT
authors.lastname: Pearson
authors.affiliation: Newark EMA Health Services Council, Newark, NJ, USA.
authors.forename: Dwight E
authors.initials: DE
authors.lastname: Peavy
authors.affiliation: CICAL and Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Waldo H
authors.initials: WH
authors.lastname: Belloso
keywords: Data monitoring; centralized monitoring; clinical trials; on-site monitoring; quality assurance