imported>GreenC bot: Rescued 1 archive link. Wayback Medic 2.5 per WP:URLREQ#fda.gov

2025-05-29T20:25:39Z

Rescued 1 archive link. Wayback Medic 2.5 per WP:URLREQ#fda.gov

New page

'''''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.<ref>{{cite book |title=A Laboratory Quality Handbook of Best Practices |last=Singer |first=Donald C. |pages=40–48 |year=2001 |publisher=ASQ Quality Press |isbn=9780873894913 }}</ref><ref>{{Cite journal | last1 = Ene-Iordache | first1 = B. | last2 = Carminati | first2 = S. | last3 = Antiga | first3 = L. | last4 = Rubis | first4 = N. | last5 = Ruggenenti | first5 = P. | last6 = Remuzzi | first6 = G. | last7 = Remuzzi | first7 = A. | doi = 10.1197/jamia.M2787 | title = Developing Regulatory-compliant Electronic Case Report Forms for Clinical Trials: Experience with the Demand Trial | journal = Journal of the American Medical Informatics Association | volume = 16 | issue = 3 | pages = 404–408 | year = 2009 | pmid = 19261946| pmc =2732224 }}</ref> It is legally binding in the [[United States]].<ref>{{Cite journal | last1 = Ohmann | first1 = C. | last2 = Kuchinke | first2 = W. | last3 = Canham | first3 = S. | last4 = Lauritsen | first4 = J. | last5 = Salas | first5 = N. | last6 = Schade-Brittinger | first6 = C. | last7 = Wittenberg | first7 = M. | last8 = McPherson | first8 = G. | last9 = McCourt | first9 = J. | last10 = Gueyffier | first10 = F. | last11 = Lorimer | first11 = A. | last12 = Torres | first12 = F. N. | author13 = ECRIN Working Group on Data Centres | title = Standard requirements for GCP-compliant data management in multinational clinical trials | doi = 10.1186/1745-6215-12-85 | journal = Trials | volume = 12 | pages = 85 | year = 2011 | pmid = 21426576| pmc =3074516 | doi-access = free }}</ref>

==References==
{{reflist}}

==External links==
*[https://web.archive.org/web/20090605201305/http://www.fda.gov/RegulatoryInformation/Guidances/ucm126402.htm Text of the guidance]

[[Category:Food and Drug Administration]]

{{US-gov-stub}}

Computerized Systems Used In Clinical Trials - Revision history

imported>GreenC bot: Rescued 1 archive link. Wayback Medic 2.5 per WP:URLREQ#fda.gov