Microbiology and Infectious Diseases Clinical Research Policies, Guidance, and Tools
Selected References
The references on this page are cited on this website and in many of the DMID 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
- ClinicalTrials.gov 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
- Belmont Report
- CIOMS International Ethical Guidelines—Council for International Organizations of Medical Sciences
- Declaration of Helsinki
- International Conference on Harmonization – Guideline for Good Clinical Practice
- Nuremberg Code
- International Compilation of Human Research Standards—contains by country key organizations, legislation, regulations, and guidelines
- 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
- Fogarty Center Bioethics Information and Resources
- Federal Wide Assurances
- Food and Drug Administration (FDA) Guidances, Regulations, and Information sheets
- Computerized Systems Used in Clinical Trials Electronic Source Documentation in Clinical Investigations
- Electronic Records; Electronic Signatures (21 CFR Part 11)
- Electronic Source Documentation in Clinical Investigations
- FDA IRB Registration Rule (21 CFR 56.106) (printable PDF version)
- FDA Inspections of Clinical Investigators
- Financial Disclosure by Clinical Investigators (21 CFR Part 54)
- Foreign Clinical Trials not conducted under an IND (21 CFR 312.120)
- Form 1572 Q & As
- Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58)
- Guidance on Establishment and Operation of Clinical Trial Data Monitoring Committees
- Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are not Individually Identifiable
- Investigational Device Exemption (IDE) Regulations (21 CFR part 812)
- Investigator Responsibilities & Protecting the Rights, Safety, and Welfare of Study Subjects, Guidance for Industry
- 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
- Informed Consent Elements (21 CFR 50.25(c))
- Institutional Review Boards (21 CFR Part 56)
- Investigational New Drug Application (21 CFR Part 312)
- Protection of Human Subjects (Informed Consent) (21 CFR Part 50)
- Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring -Draft
- Race and Ethnicity Data in Clinical Trials
- Running Clinical Trials
- Structure And Content Of Clinical Study Reports
- Statistical Principles for Clinical Trials
- Grant Capture
- Human Subjects Protections
- Institutional Review Boards and Ethics committees
- 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
- NIAID References
- NIH References
- Record Retention
- Safety Reporting
- Specimens- see FDA, and Human Subjects headings