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Microbiology and Infectious Diseases Clinical Research

Selected References

The references on this page are cited on this website and in many of the Division of Microbiology and Infectious Diseases documents. They are some of the most referred to in clinical research. There are many other sources of information available on line, and this list should not be considered inclusive.
·       Assent - NCI guidance
· is a registry and results database of federally and privately supported clinical trials conducted in the United States and around the world.
·       Data and Safety Monitoring
·       DMART
·       DMID Clinical Research Operations and Management Support CROMS)—provides support for DMID staff and clinical investigators—authorized users
·       EMMES Statistical and Data Coordinating Center —provides statistical and data management support for DMID clinical trials—authorized users
·       Ethics Codes and Standards
o    CIOMS International Ethical Guidelines —Council for International Organizations of Medical Sciences
o    International Compilation of Human Research Standards—contains by country key organizations, legislation, regulations, and guidelines
o    NIH Bioethics Websites—Information and links for research ethics, human subjects research, IRBs, international issues, conflict of interest, use of human tissue, neuroethics, genetics/genomics, gene therapy, and training
·       Federal Wide Assurances
o    Federal Wide Assurance OHRP website
·       Food and Drug Administration (FDA) Guidances, Regulations, and Information sheets
o    Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors—represents the agency's current thinking on protection of human subjects in research including IRB guidance and interactions, charging for investigational product, screening prior to enrollment, recruitment, payment of volunteers, off-label use
·       Grant Capture
·       Human Subjects Protections
o    45 Code of Federal Regulations part 46 HHS Human Subjects Protections Regulations
o    Genetic Privacy Laws —provides listing by state
o    Office for Human Research Protections (OHRP)—Comprehensive information on human subject research including regulations, policy, guidance for research supported by Health and Human Services. The site also includes international human subjects regulations.
·       Institutional Review Boards and Ethics committees
o    FDA IRB Registration Rule (21 CFR 56.106) (printable PDF version)
·       International Conference on Harmonisation . Below are some of the most frequently used ICH guidance. Some of the guidance also have concept papers, frequently asked questions and examples associated with them on the main ICH page.
·       International Research
o    International Clinical Sciences Support Center provides support for DMID international investigators
o    International Compilation of Human Research Standards contains by country key organizations, legislation, regulations, and guidelines
·       NIAID References
·       NIH References
·       Record Retention
·       Safety Reporting
o  MedWatch: The FDA Safety Information and Adverse Event Reporting Program
·       Specimens- see FDA, and Human Subjects headings

Last Updated December 01, 2015