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(R2): Good Clinical Practice: Consolidated Guidance

National Institutes of Health (NIH)

  • National Institutes of Health (NIH)
  • Certificates of Confidentiality
  • Research and Training

OHRP Regulations

  • Protection of Human Subjects 45 CFR 46
  • HIPAA: The Privacy Rule and the Security Rule 45 CFR Parts 160 and 164
  • HIPAA: The Privacy Rule and Research

OHRP Guidance

  • Biological Materials & Data
  • Certificates of Confidentiality – Privacy Protection for Research Subjects
  • Federalwide Assurances (FWAs)
  • HIPAA: Understanding Health Information Privacy
  • Informed Consent
  • Investigators
  • OHRP Policy & Guidance
  • Reviewing and Reporting Unanticipated Problems – Video
  • Revised Common Rule Educational Materials
  • Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
  • Vulnerable Populations

International

  • Compilation of European GDPR Guidances
  • Council for International Organizations of Medical Sciences (CIOMS)
  • International Compilation of Human Research Standards
  • Social Behavior Research Standards
  • World Health Organization (WHO)

Additional Resources

  • 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)
  • Regulatory Affairs Professional Society (RAPS)

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