Module 15 2022

20/05/2022

Clinical Investigation: Planning

Things to be considered, when a study is planned: What should be assessed?  Hypothesis?  Objective?  Which Endpoints?  Which Study Design?

What needs to be in place?  Devices?  Databases?  Vendors e.g. Core Labs?  Committees e.g. Data Monitoring, Adjudication? What is the “regulatory ecology”?  Competent Authority?

How should this be assessed?  Assessments?

 Timings?  Logistics?  Which countries?  Resources?

 Ethics Committees?  Other Authorities?

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

43

Data Protection

Module 15 Lecture 8

The Organisation for Professionals in Regulatory Affairs

44

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