Human Clinical Studies

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  • Sponsor agreements
  • Principle investigator responsibilities
    • Obtain study approvals
    • Hire and train team
    • Identify and secure resources
    • Communications
  • Protocol development
    • Determination of study type
      • Clinical Study
      • Clinical Trial
      • Applicable Clinical Trial (ACT)
      • Investigator Initiated Trials (IITs)
      • Industry Sponsored Trials
    • Study design
    • Study endpoints
    • Authorized investigators and designees
    • Consent guidelines
    • HIPAA requirements
  • IRB review
    • Submit a Protocol
    • Training videos
    • Registration of Trial on clinicaltrials.gov
    • Recruitment tool planning (IRB oversight, compliance, research integrity)
    • Investigator Brochures (IB)
    • Research team staffing and training
    • Patient documentation
      • Informed consents
        • Consent process
      • Case Report Forms (CRFs)
    • Good Clinical Practices (GCP)
    • Standard Operating Procedures
      • Training videos
      • NIH SOP toolbox
    • Data collection and integrity
    • Data analysis and statistical considerations
    • Trial adverse events
    • Monitoring and site audits
    • Closeout procedures
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