Helpful Resources
CDER Guidance Document home page, including International Conference on Harmonization documents:
http://www.fda.gov/Drugs/GuidanceCompliance...
Compliance programs for the field investigators who conduct the inspections, including a manual that shows what the investigators are looking for:
http://www.fda.gov/ora/compliance_ref/default.htm
Office of Scientific Investigations:
http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090085.htm
Institutional Review Board with information sheets, frequently asked questions:
http://www.fda.gov/oc/gcp/
List of clinical investigators who have been disqualified or have entered into restricted agreements with FDA:
http://www.fda.gov/ICECI/EnforcementActions/ucm321308.htm
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