Resources
Salus IRB Guidances
FDA Regulations
- Electronic Records/Electronic Signatures 21 CFR 11
- Financial Disclosure by Clinical Investigators 21 CFR 54
- Good Clinical Practice and Clinical Trials
- Institutional Review Boards 21 CFR 56
- Investigational Device Exemption (IDE) 21 CFR 812
- Investigational New Drug (IND) 21 CFR 312
- Premarket Approval of Devices 21 CFR 814
- Protection of Human Subjects 21 CFR 50
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
OHRP Regulations
- Protection of Human Subjects 45 CFR 46
- HIPAA: The Privacy Rule and the Security Rule 45 CFR Parts 160 and 164
OHRP Guidance
- Biological Materials & Data
- Federalwide Assurances (FWAs)
- HIPAA: Understanding Health Information Privacy
- Informed Consent
- Investigators
- OHRP Policy & Guidance
- Reviewing and Reporting Unanticipated Problems – Video
- Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
- Vulnerable Populations
Investigator-Initiated/Sponsored Research
International
- Council for International Organizations of Medical Sciences (CIOMS)
- International Compilation of Human Research Standards, Ethical Codes, Research Standards, Equivalent Protections (OHRP)
- World Health Organization (WHO)
Additional Resources
- Alion Science and Technology HRPP Accreditation Services
- Association for the Accreditation of Human Research Protection Programs (AAHRPP)
- Association of Clinical Pharmacology Units
- Association of Clinical Research Professionals (ACRP)
- CenterWatch
- Drug Information Association (DIA)
- National Institutes of Health (NIH)
- Regulatory Affairs Professional Society (RAPS)
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