References

  1. TransCelerate BioPharma Inc. (2013). Position paper: Risk-based monitoring methodology. Available at: http://transceleratebiopharmainc.com/.
  2. 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 trials. Clinical Trials 9: 705–713.
  3. Eisenstein EL, Lemons PW, Tardiff BE, Schulman KA, Jolly MK & Califf RM. (2005). Reducing the costs of phase III cardiovascular clinical trials. American Heart Journal 149: 482–488.
  4. Tantsyura V, Grimes I, Mitchel J, Fendt K, Sirichenko S, Waters J, Crowe J & Tardiff B. (2010). Risk-based source data verification approaches: pros and ...

Get Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS now with the O’Reilly learning platform.

O’Reilly members experience books, live events, courses curated by job role, and more from O’Reilly and nearly 200 top publishers.

Start your free trial