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Monitoring strategies for clinical intervention studies

Klatte, K; Pauli-Magnus, C; Love, SB; Sydes, MR; Benkert, P; Bruni, N; Ewald, H; ... Briel, M; + view all (2021) Monitoring strategies for clinical intervention studies. Cochrane Database of Systematic Reviews , 12 , Article MR000051. 10.1002/14651858.MR000051.pub2. Green open access

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Abstract

Background: Trial monitoring is an important component of good clinical practice to ensure the safety and rights of study participants, confidentiality of personal information, and quality of data. However, the effectiveness of various existing monitoring approaches is unclear. Information to guide the choice of monitoring methods in clinical intervention studies may help trialists, support units, and monitors to effectively adjust their approaches to current knowledge and evidence. // Objectives: To evaluate the advantages and disadvantages of different monitoring strategies (including risk‐based strategies and others) for clinical intervention studies examined in prospective comparative studies of monitoring interventions. // Search methods: We systematically searched CENTRAL, PubMed, and Embase via Ovid for relevant published literature up to March 2021. We searched the online 'Studies within A Trial' (SWAT) repository, grey literature, and trial registries for ongoing or unpublished studies.

Type: Article
Title: Monitoring strategies for clinical intervention studies
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1002/14651858.MR000051.pub2
Publisher version: https://doi.org/10.1002/14651858.MR000051.pub2
Language: English
Additional information: This version is the version of record. For information on re-use, please refer to the publisher's terms and conditions.
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10140800
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