Dass 341 Eng Jav [portable] May 2026

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5. Assessment & Grading

| Component | Weight | Description | |------------------------------------|--------|-------------| | Daily quizzes (5) | 20% | Short MCQs on previous day’s material | | Mid‑week practical (Day 3) | 30% | Analyze a longitudinal dataset with missing data | | Final project (Day 5) | 40% | Complete SAP to final TLFs for a mock Phase III trial | | Participation & peer review | 10% | Engagement in group discussions and code reviews | The search for the specific phrase " d

Day 5: Reporting & Regulatory Submission

Generating TLFs with R (rtables, ggplot2) / SAS ODS
Writing statistical reports for DSMB (Data Safety Monitoring Board)
FDA/EMA submission package: define.xml, reviewer’s guide
Final assessment: Case study – analyze a real Janssen trial dataset