Sponsor Oversight Plan

Sponsor Oversight includes the comprehensive monitoring and management responsibilities that a sponsor has over the conduct of a clinical trial.

According to the ICH E6(R3) guidelines, Sponsor Oversight is crucial for:
  • Ensuring the quality and integrity of the clinical trial
  •    Safeguarding the rights, safety, and well-being of
       clinical trial participants
  • Guaranteeing the reliability of clinical trial results
With this template, you will not start from 0 but will be guided through all aspects of Sponsor Oversight based on many examples given.

  • User Group

    Professionals Involved in Clinical Trials


  • Format

    Microsoft Excel


  • Content

    • Classify per Functional Area and Phase
    • Define your “Critical-to-Quality” Factor
    • Define your Sponsor Oversight Activity and Responsibility
    • Define your Quality Tolerance Limits
    • Document your Sponsor Oversight Activities

  • Benefits

    • Structured Documentation for your Sponsor Oversight Plan
    • Structured Documentation for your Sponsor Oversight Activities
With a robust Sponsor Oversight, you will
  • Improve the Quality and Efficiency of your Clinical Trial
  • Ensure Compliance with ICH E6(R3) and other Guidelines
  • Enhance Collaboration and Transparency among your Stakeholders
  • Facilitate your Audit and Inspection Readiness
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