References

  1. TransCelerate BioPharma Inc. (2013). Position paper: Risk-based monitoring methodology. Available at: http://transceleratebiopharmainc.com/.
  2. Scannell JW, Blanckley A, Boldon H & Warrington B. (2012). Diagnosing the decline in pharmaceutical R&D efficiency. Nature Reviews Drug Discovery 11: 191–200.
  3. US Food & Drug Administration. (2013). Guidance for industry: Oversight of clinical investigations―a risk-based approach to monitoring. Available at: http://www.fda.gov/downloads/Drugs/.../Guidances/UCM269919.pdf.
  4. Venet D, Doffagne E, Burzykowski T, Beckers F, Tellier Y, Genevois-Marlin E, Becker U, Bee V, Wilson V, Legrand C & Buyse M. (2012). A statistical approach to central monitoring of data quality in clinical ...

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