Randomized Clinical Trials:

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Conduct of a Randomized Clinical Trial

Lesson 5 of 5: Overseeing the Conduct of a Randomized Clinical Trial

After completing this lesson, you will be able to:

1.          Describe the oversight responsibilities of various groups involved in a randomized clinical trial, including:

•        Steering Committee

•        Data Safety Monitoring Committee

•        IRB/IEC

•        Regulatory Authorities

 

2. List the safety elements the investigator should consider when designing the study and preparing the protocol.