Resources
Salus IRB Guidances
FDA Regulations
FDA Guidance
- Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs — Improving Human Subject Protection
- Device Advice: Comprehensive Regulatory Assistance
- Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
- Investigational New Drug Applications (INDs) – Determining Whether Human Research Can Be Conducted Without an IND
- Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects
- IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed
- Pediatrics
- Selected FDA GCP/Clinical Trial Guidance Documents
- Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials
- Vaccines, Blood & Biologics: Guidance, Compliance & Regulatory Information
ICH
National Institutes of Health (NIH)
OHRP Regulations
OHRP Guidance
International
Additional Resources