Master Media Component Content Below are useful resources related to clinical research: Heading General Resources Content Baylor College of Medicine (BCM) Office of ResearchBCM Clinical Research Center Federal Agencies National Institutes of Health (NIH)Food and Drug Administration (FDA)Code of Federal Regulations (CFR) Title 21 IND and IDE Information Food and Drug Administration (FDA)Guidances for Investigational New Drug (IND) Applications Human Subject Protection U.S. Department of Health and Human Services (HHS): Office for Human Research Protections (OHRP)The Belmont ReportThe Common Rule Regulatory Guidance BCM Institutional Review Board (IRB)BRAIN (BCM Electronic Submission of Proposals and Protocols)Standards Council of CanadaCenter for Biologic Research and Evaluation (CBER)Center for Devices and Radiological Health (CDRH)Center for Drug Evaluation and Research (CDER)Department of Health and Human Services (HHS)Food and Drug Administration (FDA) - Main SiteHealth Canada SiteICH - International Conference on HarmonizationICH GuidelinesISO - International Standards OrganizationNIH OnlineOHRP (Office of Human Research Protections)The Belmont Report Clinical Research Information FDA Websites with Information about Clinical TrialsICH Guidance Documents: Good Clinical PracticeNIH Clinical Research Trials and YouChildren and Clinical Studies (NHLBI) Grants and Contracts BCM Sponsored ProgramsBRAIN (BCM Electronic Submission of Proposals and Protocols)NIH Office of Extramural ResearchNIH Research Portfolio Online Reporting Tools (NIH RePORTER)
Federal Agencies National Institutes of Health (NIH)Food and Drug Administration (FDA)Code of Federal Regulations (CFR) Title 21
IND and IDE Information Food and Drug Administration (FDA)Guidances for Investigational New Drug (IND) Applications
Human Subject Protection U.S. Department of Health and Human Services (HHS): Office for Human Research Protections (OHRP)The Belmont ReportThe Common Rule
Regulatory Guidance BCM Institutional Review Board (IRB)BRAIN (BCM Electronic Submission of Proposals and Protocols)Standards Council of CanadaCenter for Biologic Research and Evaluation (CBER)Center for Devices and Radiological Health (CDRH)Center for Drug Evaluation and Research (CDER)Department of Health and Human Services (HHS)Food and Drug Administration (FDA) - Main SiteHealth Canada SiteICH - International Conference on HarmonizationICH GuidelinesISO - International Standards OrganizationNIH OnlineOHRP (Office of Human Research Protections)The Belmont Report
Clinical Research Information FDA Websites with Information about Clinical TrialsICH Guidance Documents: Good Clinical PracticeNIH Clinical Research Trials and YouChildren and Clinical Studies (NHLBI)
Grants and Contracts BCM Sponsored ProgramsBRAIN (BCM Electronic Submission of Proposals and Protocols)NIH Office of Extramural ResearchNIH Research Portfolio Online Reporting Tools (NIH RePORTER)