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. 2021 Jun;18(3):386-388.
doi: 10.1177/1740774520976617. Epub 2021 Mar 2.

Making a distinction between data cleaning and central monitoring in clinical trials

Sharon B Love  1 , Victoria Yorke-Edwards  1 , Carlos Diaz-Montana  1 , Macey L Murray  1 , Lindsey Masters  1 , Michelle Gabriel  1 , Nicola Joffe  1 , Matthew R Sydes  1
Affiliations

Making a distinction between data cleaning and central monitoring in clinical trials

Sharon B Love et al. Clin Trials. 2021 Jun.
No abstract available

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Conflict of interest statement

Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship and/or publication of this article: M.R.S. reports grants and non-financial support from Astellas, Janssen, Novartis and Sanofi; grants from Clovis; and personal fees from Lilly Oncology and Janssen, outside the submitted work. The remaining authors declare that there is no conflict of interest.

References

    1. Gibson D, Harvey AJ, Everett V, et al. Is double data entry necessary? The CHART trials. CHART Steering Committee. Continuous, Hyperfractionated, Accelerated Radiotherapy. Control Clin Trials 1994; 15(6): 482–488. - PubMed
    1. Van den Broeck J, Cunningham SA, Eeckels R, et al. Data cleaning: detecting, diagnosing, and editing data abnormalities. PLoS Med 2005; 2(10): e267. - PMC - PubMed
    1. International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Guideline for good clinical practice E6(R2), 2018, https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-6-r2-g... (accessed 14 July 2020).
    1. Federal Drugs Agency. Guidance for industry. Oversight of clinical investigations – a risk-based approach to monitoring, https://www.fda.gov/downloads/Drugs/Guidances/UCM269919.pdf (2013, accessed 24 July 2020).
    1. European Medicines Agency. Reflection paper on risk based quality management in clinical trials, https://www.ema.europa.eu/documents/scientific-guideline/reflection-pape... (2013, accessed 24 July 2020).

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