Computerized Systems Used In Clinical Trials

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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.^[1]^[2] It is legally binding in the United States.^[3]

References

^ Singer, Donald C. (2001). A Laboratory Quality Handbook of Best Practices. ASQ Quality Press. pp. 40–48. ISBN 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.
^ 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.

External links

Text of the guidance

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[1] Singer, Donald C. (2001). A Laboratory Quality Handbook of Best Practices. ASQ Quality Press. pp. 40–48. ISBN 9780873894913.

[2] 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.

[3] 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.

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