Resources

Salus IRB Guidances

• Administering Informed Consent (Form 640)
• Recruitment and Study Material (Form 610)

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

• ICH E6: Good Clinical Practice: Consolidated Guidance

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

• Association of Clinical Research Professionals Special Interest Group

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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