title: TOPS: an internet-based system to prevent healthy subjects from over-volunteering for clinical trials.
abstract: OBJECTIVE
  Our aim was to set up a system to help UK clinical research units to prevent healthy volunteers from participating in more than one non-therapeutic trial simultaneously, or from starting a second trial too soon after the first.
  
  
  METHODS
  TOPS (The Over-volunteering Prevention System) is internet-based, simple and quick to use, free to users and a charity run by a Board of Trustees. Users enter only two or three pieces of information: (1) 'National Insurance number' (NINO) of UK citizens, or 'passport number' and country of origin of non-UK citizens, as their identifier, (2) 'date of last dose' of trial medicine or (3) 'never dosed'. Subjects must consent, but TOPS collects only non-personal data, so it does not require Ethics Committee approval and is not covered by the Data Protection Act.
  
  
  RESULTS
  A total of 55 research units (29 clinical research organisations, 5 pharmaceutical companies, 13 universities and 8 hospitals) throughout the UK have registered to use TOPS, and have entered 124,906 volunteers since we launched it. All commercial and many non-commercial units now use TOPS. In our unit, no subject has to the best of our knowledge participated in two trials simultaneously. TOPS has reduced to <1% the incidence of subjects attempting to volunteer within 3 months of completing another trial elsewhere, and very few have to our knowledge succeeded.
  
  
  CONCLUSIONS
  TOPS is widely used and effective, and helps research units to comply with UK clinical trial regulations.
authors.affiliation: Hammersmith Medicines Research, Cumberland Avenue, London NW10 7EW, UK. mboyce@hmrlondon.com
authors.forename: M
authors.initials: M
authors.lastname: Boyce
authors.forename: M
authors.initials: M
authors.lastname: Walther
authors.forename: H
authors.initials: H
authors.lastname: Nentwich
authors.forename: J
authors.initials: J
authors.lastname: Kirk
authors.forename: S
authors.initials: S
authors.lastname: Smith
authors.forename: S
authors.initials: S
authors.lastname: Warrington
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*; D033161:Government Regulation; D006801:Humans; D020407:Internet; D033281:Nontherapeutic Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*; D035842:Research Subjects / Q000331:legislation & jurisprudence; D006113:United Kingdom