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Sponsor/CRO Regulatory Guidance Center for Drug Evaluation and Research (CDER) Contains important information concerning the conduct of FDA-regulated studies. U.S. Food and Drug Administration (FDA) Provides a wealth of information on all aspects of the drug and device approval processes, including the protection of human research subjects. National Institutes of Health (NIH) Dedicated to the latest information regarding health issues and ongoing scientific research and special reports. Office for Human Research Protections (OHRP) Provides guidelines for human research subject protection. International Conference on Harmonisation (ICH) Provides access to all available guidance issued by the ICH organization. The President's Council on Bioethics (PCB) Offers current information on national meetings regarding research subject protection with use of biologic materials as well as other ethical dilemmas. The Belmont Report Important reading for every researcher and every person deciding whether or not to be a subject in a research study. This report was written in 1979 by a national commission investigating the conduct of clinical research with human subjects. CenterWatch Clinical Trials Networking Clinical trial information and listing of available research studies being conducted in the U.S. Clinical Trials Information Provides patients, family members and members of the public with current information about clinical research studies for a wide range of disease and conditions. FDA Information Sheet Guidances - IRB Operations and Clinical Investigations Information on IRB makeup, conduct and questions regarding clinical research. Good Clinical Practice (GCP) Guidance in FDA-regulated Clinical Trials This is the website for the FDA division that is responsible for overseeing Good Clinical Practice (GCP). GCP is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting for clinical trials. FDA Center for Devices and Radiological Health (CDRH) Provides information regarding specific requirements for conducting research studies of medical devices. Title 21 CFR (Code of Federal Regulations) Federal regulations governing the proper conduct of clinical research and the makeup of IRBs. Elements of informed consent documents are also discussed. Title 45 CFR (Code of Federal Regulations) Federal regulations governing the proper conduct of clinical research and the makeup of IRBs pertaining to federally funded research. Elements of informed consent documents are also discussed. |
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