Clinical Trials Process Using SAS 9
- Describe the clinical research process (phases, key roles, key organizations)
- Interpret a Statistical Analysis Plan.
- Accessing, managing and transforming clinical trials data.
- Derive programming requirements from an SAP and an annotated Case Report.
- Statistical procedures and macro programming.
- Reporting clinical trials results.
- Describe regulatory requirements (principles of 21 CFR Part 11, International Conference on Harmonization, Good Clinical Practices)