Sample data safety & monitoring plan outline

  1. Study Identification Information
    • Study title
    • Principal Investigator
  2. Study Overview
    • Brief description of the purpose of the study
    • Adherence statement
  3. Confidentiality
    • Protection of subject privacy
    • Database protection
    • Confidentiality during adverse events reporting
  4. Adverse Event Information
    • Definition of adverse event/serious adverse event
    • Classification of adverse event severity
    • Adverse event attribution scale
    • Expected risks
    • Adverse event/serious adverse event reporting
  5. Data Quality and Safety Review Plan and Monitoring
    • Data quality and management
    • Assessment of subject accrual and compliance
    • Justification of sample size
    • Stopping rules (if applicable)
    • Designation of Independent Monitor(s) and CVs
    • Safety review plan
  6. Informed Consent
    • Process to obtain and ensure informed consent