Computerized Systems Used In Clinical Trials (CSUCT) is a guidance document established by the U.S. Food and Drug Administration in 1999 and revised in 2007. It is legally binding in the United States.
External links
References
Singer, Donald C. (2001). A Laboratory Quality Handbook of Best Practices. ASQ Quality Press. pp. 40–48. ISBN 9780873894913. 9780873894913 ↩
Ene-Iordache, B.; Carminati, S.; Antiga, L.; Rubis, N.; Ruggenenti, P.; Remuzzi, G.; Remuzzi, A. (2009). "Developing Regulatory-compliant Electronic Case Report Forms for Clinical Trials: Experience with the Demand Trial". Journal of the American Medical Informatics Association. 16 (3): 404–408. doi:10.1197/jamia.M2787. PMC 2732224. PMID 19261946. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2732224 ↩
Ohmann, C.; Kuchinke, W.; Canham, S.; Lauritsen, J.; Salas, N.; Schade-Brittinger, C.; Wittenberg, M.; McPherson, G.; McCourt, J.; Gueyffier, F.; Lorimer, A.; Torres, F. N.; ECRIN Working Group on Data Centres (2011). "Standard requirements for GCP-compliant data management in multinational clinical trials". Trials. 12: 85. doi:10.1186/1745-6215-12-85. PMC 3074516. PMID 21426576. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3074516 ↩