TOPS: an internet-based system to prevent healthy subjects from over-volunteering for clinical trials...The Over-volunteering Prevention System
Aim: 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...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 68; no. 7; pp. 1019 - 1025 |
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| Autores principales: | , , , , , |
| Formato: | pictorial research tables/charts Journal Article |
| Publicado: |
Springer Nature
Jul2012
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=104354930&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 104354930 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Jul2012 vid: 68 iid: 7 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 104354930 76487856 10.1007/s00228-012-1231-8 NLM22349161 PMC3374109 104354930 ppf: 1019 ppct: 6 formats: fmt: @attributes: type: P tig: atl: TOPS: an internet-based system to prevent healthy subjects from over-volunteering for clinical trials...The Over-volunteering Prevention System aug: au: Boyce, M. Walther, M. Nentwich, H. Kirk, J. Smith, S. Warrington, S. affil: Hammersmith Medicines Research (HMR), Cumberland Avenue London NW10 7EW UK sug: subj: Research Subjects Clinical Trials Internet Program Evaluation Human United Kingdom Descriptive Statistics Software Research Subject Recruitment Time Factors ab: Aim: 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. Conclusion: TOPS is widely used and effective, and helps research units to comply with UK clinical trial regulations. pubtype: Academic Journal doctype: pictorial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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