- FDA. Driving biomedical innovation: initiatives to improve products for patients.
October, 2011. Available from:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM274464.pdf
accessed 1/29/13. - CDISC. The Clinical Data Interchange Standards Consortium Study data tabulation
model. 2012. Available from: http://www.cdisc.org/sdtm, accessed 1/29/2013. - DHHS. Guidance for industry: computerized systems used in clinical trials. May,
2007. Available from:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070266.pdf
accessed 1/29/2013. - DHHS. Protecting personal health information in research: understanding the
HIPAA Privacy Rule. 2003. Available from:
http://privacyruleandresearch.nih.gov/pr_02.asp, accessed 1/29/2013.
albertobarroso
(AlbertoBarroso)
#1