A systematic review of on-site monitoring methods for health-care randomised controlled trials

Rhiannon C Macefield; Andrew D Beswick; Jane M Blazeby; J Athene Lane

doi:10.1177/1740774512467405

A systematic review of on-site monitoring methods for health-care randomised controlled trials

Rhiannon C Macefield, Andrew D Beswick, Jane M Blazeby, J Athene Lane

Research output: Contribution to journal › Article (Academic Journal) › peer-review

33 Citations (Scopus)

Abstract

Monitoring the conduct of clinical trials is recommended by International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidelines and is integral to trial quality assurance. On-site monitoring, that is, visiting trial sites, is one part of this process but little is known about the procedures that are performed in practice.

Translated title of the contribution	A systematic review of on-site monitoring methods for healthcare randomised control trials
Original language	English
Pages (from-to)	104-124
Number of pages	21
Journal	Clinical Trials
Volume	10
Issue number	1
DOIs	https://doi.org/10.1177/1740774512467405
Publication status	Published - Feb 2013

Research Groups and Themes

BTC (Bristol Trials Centre)
Centre for Surgical Research

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COLLABORATION AND INNOVATION IN DIFFICULT OR RANDOMISED CONTROLLED TRIALS
Blazeby, J. (Principal Investigator)
1/04/09 → 1/04/14
Project: Research

Cite this

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abstract = "Monitoring the conduct of clinical trials is recommended by International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidelines and is integral to trial quality assurance. On-site monitoring, that is, visiting trial sites, is one part of this process but little is known about the procedures that are performed in practice.",

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AB - Monitoring the conduct of clinical trials is recommended by International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidelines and is integral to trial quality assurance. On-site monitoring, that is, visiting trial sites, is one part of this process but little is known about the procedures that are performed in practice.

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A systematic review of on-site monitoring methods for health-care randomised controlled trials

Abstract

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COLLABORATION AND INNOVATION IN DIFFICULT OR RANDOMISED CONTROLLED TRIALS

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