A pan-European registration system for volunteer participation is within sight

Berelowitz, K.; Täubel, Jörg

doi:10.1007/s00228-012-1349-8

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“…Concerns have led to increased regulatory measures such as The Overvolunteering Prevention Strategy (TOPS) installed to facilitate tracking and curb indiscriminate repeat volunteering (Allen et al, 2017). Its effectiveness is highly contested in the CRO community (Berelowitz and Taubel, 2013) and this debate is beyond the scope of this paper. However, the installation of this measure signals the significance of the challenges repeat volunteering poses to the business of clinical drug trials.…”

Section: Introductionmentioning

confidence: 99%

‘Becoming-with’ a repeat healthy volunteer: Managing and negotiating trust among repeat healthy volunteers in commercial clinical drug trials

Mwale

2020

Social Science & Medicine

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Section: Introductionmentioning

confidence: 99%

‘Becoming-with’ a repeat healthy volunteer: Managing and negotiating trust among repeat healthy volunteers in commercial clinical drug trials

Mwale

2020

Social Science & Medicine

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Regulatory experience of TOPS: an internet-based system to prevent healthy subjects from over-volunteering for UK clinical trials

Allen

Francis²,

Martín³

et al. 2017

Eur J Clin Pharmacol

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The findings continue to support the concept that TOPS not only helps to prevent over-volunteering, but also deters subjects from trying to do so. Regulation of TOPS by the HRA and MHRA has enhanced its effectiveness, benefited all users and helped to improve the safety of volunteers who participate in non-therapeutic trials in the UK. The UK is still the only country with a national database to prevent over-volunteering that has published data on its widespread use and effectiveness.

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A pan-European registration system for volunteer participation is within sight

Cited by 2 publications

References 2 publications

‘Becoming-with’ a repeat healthy volunteer: Managing and negotiating trust among repeat healthy volunteers in commercial clinical drug trials

‘Becoming-with’ a repeat healthy volunteer: Managing and negotiating trust among repeat healthy volunteers in commercial clinical drug trials

Regulatory experience of TOPS: an internet-based system to prevent healthy subjects from over-volunteering for UK clinical trials

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