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Regulatory

FDA Home Page
http://www.fda.gov
FDA CBER What's New
http://www.fda.gov/cber/whatsnew.htm
FDA Electronic Common Technical Document (eCTD) Information
http://www.fda.gov/cder/regulatory/ersr/ectd.htm
International Conference on Harmonization (ICH)
http://www.ich.org/
European Agency for the Evaluation of Medicinal Products (EMEA)
http://www.emea.eu.int/
Medicines Control Agency (MCA)
http://www.mca.gov.uk/
Canadian Heath Products and Food Branch
http://www.hc-sc.gc.ca/hpfb-dgpsa/index_e.html
21CFR Part 11 Information
http://www.21cfrpart11.com/

Professional Associations

Drug Information Association (DIA)
http://www.diahome.org
Pharmaceutical Research and Manufacturers of America (PhRMA)
http://www.phrma.org
BioPharmaceutical Network - PhRMA Working Group on Adaptive Trials
http://biopharmnet.com/biosketch.html
Society for Clinical Trials (SCT)
http://www.sctweb.org
American Statistical Association (ASA)
http://www.amstat.org
ASA Biopharmaceutical Section
http://www.amstat.org/sections/SBIOP/
Eastern North American Region/International Biometric Society (ENAR)
http://www.enar.org
Western North American Region/International Biometric Society (WNAR)
http://www.wnar.org
Regulatory Professionals Society (RAPS)
http://www.raps.org
International Society for Pharmacoepidemiology (ISPE)
http://www.pharmacoepi.org

Implementation

Clinical Data Interchange Standards Consortium (CDISC)
http://www.cdisc.org
Association for Clinical Data Management
http://www.acdm.org.uk/
Society for Clinical Data Management, Inc.
http://www.scdm.org/
Computer Systems Validation for Clinical Research
http://www.cr-csv.org/
Project Management Institute
http://www.pmi.org/
Medical Dictionary for Regulatory Activities (MEDRA)
http://www.meddramsso.com/
Applied Clinical Trials
http://www.actmagazine.com/appliedclinicaltrials/

Journals

Drug Information Journal
http://www.diahome.org/docs/Journal/DIAJournal_index.cfm?PageID=dijindex
Controlled Clinical Trials
http://www.sciencedirect.com/science/journal/01972456
Clinical Trials Journal
http://www.sctjournal.com
Journal of the American Statistical Association
http://www.amstat.org/publications/jasa
A Journal of the International Biometric Society
http://tibs.org/biometrics/
Statistics in Medicine
http://gort.ucsd.edu/newjour/s/msg02859.html
Statistical Methods in Medical Research
http://www.arnoldpublishers.com/journals/pages/sta_met/09622802.htm

Ethics

The Declaration of Helsinki
http://www.wma.net/e/policy/b3.htm
The Nuremberg Code
http://researchethics.mc.duke.edu/clinethics2.nsf/webpages/the+nuremburg+code
CIOMS International Ethical Guidelines for Biomedical Research Involving
Human Subjects
http://www.cioms.ch/frame_guidelines_nov_2002.htm
IRB Guidebook, OHRP
http://www.hhs.gov/ohrp/irb/irb_guidebook.htm
Ethical Guidelines for Statistical Practice
http://www.amstat.org/profession/index.cfm?fuseaction=ethicalstatistics


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