Useful Links

Food and Drug Administration www.fda.gov

CDER: www.fda.gov/cder

CBER: www.fda.gov/cber

Clinical research guidances: www.fda.gov/cder/guidance/index.htm

International Conference on Harmonisation and ICH Guidelines: www.ich.org

European Medicines Agency: www.emea.europa.eu

CDISC and submission data standards: www.cdisc.org

SDTM (Study Data Tabulation Model, electronic data submission requirements): http://www.cdisc.org/models/sdtm/v1.1/index.html

CDASH (Clinical Data Acquisition Standards Harmonization, data capture standards): www.cdisc.org/standards/cdash/index.html

FDA’s Critical Path Initiative: www.fda.gov/oc/initiatives/criticalpath/

Proceedings from the meeting that launched CDASH, among other initiatives:

Drug Development Science: Obstacles and Opportunities for Collaboration Among Academia, Industry and Government. Click Here

Society for Clinical Data Management: www.scdm.org

Society for Clinical Research Associations: www.socra.org

Society for Clinical Trials: www.sctweb.org

Society for Quality Assurance: www.sqa.org