Fda reporting - PowerPoint PPT Presentation

Unanticipated Risk in Clinical Research

Unanticipated Risk in Clinical Research. Principles and Practice of Clinical Research November 18, 2003 Stephen E. Straus, M.D. Clinical research involves risks and benefits both for the participant and the investigator

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Reportable New Information

Stanley Estime, MSCI QA/QI Specialist January 17, 2013. Reportable New Information. Agenda. Why is reporting required? Types of Reportable New Information Creating an RNI Submission in ESTR Post Reporting Reporting Scenarios. Why is reporting required?.

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351 views • 19 slides

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