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

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

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/