Course curriculum

    1. Introduction

    2. What is the Role of the Staff Assigned to a Study?

    3. What is a Study Protocol?

    4. What Questions does the Protocol Answer?

    5. Sections of the Protocol

    6. Background Information

    7. Objectives and Purpose of the Study

    8. Study Design

    9. Selection and Exclusion of Subjects

    10. Treatment of Subjects

    11. Safety Assessments and Handling Adverse Events

    12. Assessment of Efficacy

    13. Statistics

    14. Quality Control and Assurance

    15. Ethics

    16. Data Handling and Record Keeping

    17. Publication Policy and other Administrative Procedures

    18. Project Timetable/Flowchart

    19. References

    20. Supplements/Appendices

    21. CRC Responsibilities

    22. Writing and Reviewing Protocol References

    23. Post Learning Assessment

    24. Conclusion

About this course

  • $40.00
  • 24 lessons
  • 120 minutes

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