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Resources
Useful Resources
FDA Resources
E6 Good Clinical Practice: Consolidance Guidences - http://private.ich.org/LOB/media/MEDIA482.pdf
Electronic Regulatory Submission - http://www.fda.gov/cder/regulatory/ersr/default.htm
SAS Programming validation
General Principles of Software validation; Final Guidance for industry and FDA Staff - http://www.fda.gov/cdrh/comp/guidance/938.pdf
Guide to Inspection of computerized system in Drug Processing - http://www.fda.gov/ora/inspect_ref/igs/csd.html
Computer Systems used in Clinical Trials - http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.pdf
Industry Standards
International Conference on Harmonization - http://www.ich.org/
Society for Clinical Data management - http://www.scdm.org/
Association for Clinical Data Management - http://www.acdm.org.uk/
Drug Information Association - http://www.diahome.org/
Statisticians in the Pharmaceutical Industry (PSI) - http://www.psiweb.org/