Master of Science in Clinical Research Organization and Management

Clinical Research Regulatory Compliance Reference Links

Clinical research involving human participants is highly regulated, as are the required steps guiding the pursuit of product registration. The purpose of this list of websites is to provide you with easy access to source information which complements, as well as supplements, your knowledge of the vast area of clinical trials. Please note that within each of the listed URLs there is a considerable amount of useful information not listed here. Take the time to familiarize yourself with what is there.

FDA Websites	URL
Food and Drug Administration (General website) Look for regulations covering drugs and biologics - 21 CFR §§ 11, 50, 54, 56, 312, 314	www.fda.gov Use the FDA's search engine to locate anything you need.
Center for Drug Evaluation and Research (CDER)	www.fda.gov/cder
Center for Biologic Evaluation and Research (CBER)	www.fda.gov/cdrh
Good Clinical Practices (GCPs)	www.fda.gov/oc/gcp
ICH (all parts)	www.ich.org
Information Sheets for Clinical Investigators and IRBs	www.fda.gov/oc/gcp/guidance.html
Drug Application Approval Process	www.fda.gov/cder/regulatory/applications
CDER Handbook - excellent references New drug development and review Generic drug review Over-the-Counter drug review Post Approval drug process Communicating with CDER Other activities Acronyms CDER people	www.fda.gov/cder/handbook
Forms used in clinical research	www.fda.gov/cder/offices/dsi/forms
Expedited safety reporting	www.fda.gov/cder/regulatory
MedWatch	www.fda.gov/medwatch
Health (CDRH) - Look for regulations covering devices - 21 CFR §§ 812, 814, 820	www.fda.gov/cdrh
CDRH Bioresearch Monitoring Program	www.fda.gov/cdrh/comp/bimo.html
CDRH Organization chart	www.fda.gov/cdrh/organiz.html
CDRH device reporting	www.fda.gov/cdrh/manual/mdrman.html
CDRH Good Guidance Documents	www.fda.gov/cdrh/guidance.html
HIPAA (21 CFR §54)	www.hhs.gov/ocr/hipaa

Non-FDA Websites
Research ethics	www.sskrplaw.com
Professional organizations offering certification Society of Clinical Research Associates Association of Clinical Research Professionals	www.socra.org www.acrpnet.org
Biotechnology Industry Organization	www.bio.org/ataglance
Miller Analogies Test information	www.milleranalogies.com

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