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SAS Specialist II Advanced SAS — Clinical Trials Topics
Class 1: SAS application in Clinical Trials
1. Clinical Trials and SAS applications.
- Four phases of clinical trials
- Some important terms and abbreviations:
- Control, Controlled Study, Uncontrolled Study, Randomization, Open Label, Double Blind, PK and PD, CRF, AE, Vitals Signs and Demographics …
- Protocols, Statistical Analysis Plan and Study Report
- Roles of CRS, CRA, Medical Writer, Statistician and SAS Programmer
- Individual studies and Integrated Summary
- Individual Study:
- ISS: Integrated Summary of Safety
- ISE: Integrated Summary of Efficacy
2. A Real Industry Example: Project
- Explanation of data and analysis requirements
- Brief explanation of data preparation and analysis methods
Class 2: Advance SAS Topics:
Common procedures and tools in clinical trials and in this project.
1.Some important SAS/STAT procedures:
Class 3: Project results and discussions
Show the solutions (programs), explain my analysis ideas and interpret of results.
Answer questions.
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