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Molloy, SF; Henley, P (2016)
Publisher: John Wiley & Sons
Languages: English
Types: Article
Subjects:
Identifiers:doi:10.1111/tmi.12781
This paper describes the processes and procedures involved in planning, conducting and reporting monitoring activities for large clinical trials of investigational medicinal products, focusing on those conducted in resource-limited settings.
  • The results below are discovered through our pilot algorithms. Let us know how we are doing!

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    • DAMOCLES study group (2005) A proposed charter for clinical trial data monitoring committees: helping them to do their job well. The Lancet 2005; 365:711-722
    • European Medicines Agency (EMA) (2010) Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials, available at: dhttp://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_gui deline/2010/08/WC500095754.pdf
    • Food and Drug Administration (FDA) (2003) Guidance for Industry Part 11, Electronic Records; eElectronic Signatures - Scope and Application, available at: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125125.pdf
    • Food tand Drug Administration (FDA) (2013a) Guidance for industry - electronic source data for clinical investigations, available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances p/ucm328691.pdf
    • Food and Drug Administration (FDA) (2013b) Guidance for Industry Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring, available at: ehttp://www.fda.gov/downloads/Drugs/.../Guidances/UCM269919.pdf
    • International Council for HarmonisationGood Clinical Practice (ICH GCP) (1996), available at: http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinicalcpractice.html Relevant sections on monitoring are 5.18, 5.20.2, 5.1.2, 5.6.3, 5.15.2,5.15.1, 6.10, 4.1.4, 6.3.3
    • Kirkwood A & Hackshaw A (2011) Central statistical monitoring in clinical trials. Trials. 2011; c12(Suppl 1): A55.
    • Medical Research Council (MRC) (1998) Guidelines for GCP, available at: https://www.mrc.ac.uk/documents/pdf/good-clinical-practice-in-clinical-trials/
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