# Test Scenario 05: Medical Research - Clinical Trial Protocol Development ## 🏢 **Industry Context**: Healthcare/Medical Research **Role**: Clinical Research Coordinator **Task**: Research regulations and best practices for designing Phase II clinical trials ## 📋 **Scenario Description** You're a clinical research coordinator at a pharmaceutical company developing a new diabetes medication. Your team needs to design a Phase II clinical trial protocol that meets FDA requirements and follows good clinical practice (GCP) guidelines. ## 🎯 **Your Mission (Completely Autonomous)** ### **Step 1: Setup FSS-Mini-RAG** 1. Read the repository README.md to understand how to install FSS-Mini-RAG 2. Follow the installation instructions for your platform 3. Verify the installation works by running `rag-mini --help` ### **Step 2: Gather Research Materials** Create a folder called `clinical-trial-research` and populate it with relevant documentation: - FDA clinical trial guidance documents - ICH Good Clinical Practice guidelines - IRB/Ethics committee requirements - Patient safety and adverse event reporting protocols - Statistical analysis plans for clinical trials **Sources to explore**: - FDA.gov clinical trial guidance documents - International Council for Harmonisation (ICH) guidelines - Good Clinical Practice training materials - Clinical research regulatory handbooks - Biostatistics and clinical trial design resources ### **Step 3: Index and Search** 1. Use FSS-Mini-RAG to index your `clinical-trial-research` folder 2. Perform searches to answer these questions: - "What are the FDA requirements for Phase II trial design?" - "How should adverse events be classified and reported?" - "What statistical power calculations are needed for efficacy endpoints?" - "What informed consent elements are required?" - "How should patient eligibility criteria be defined?" ### **Step 4: Document Your Findings** Write your findings in `RESULTS.md` including: - FDA regulatory requirements for Phase II trials - Patient safety monitoring and reporting procedures - Statistical analysis and sample size calculations - Informed consent and ethical considerations - Protocol development timeline and milestones ### **Step 5: Evaluation** Rate FSS-Mini-RAG's effectiveness for: - Finding specific information across multiple documents - Searching complex documentation efficiently - Helping with research and analysis workflows - Overall usefulness for healthcare/medical research industry applications ## 📁 **Deliverables** - `clinical-trial-research/` folder with research materials - `RESULTS.md` with findings and FSS-Mini-RAG evaluation - Documentation of your search queries and discoveries ## ⏱️ **Expected Duration**: 2-3 hours ## 🎓 **Learning Objectives** - Test FSS-Mini-RAG with healthcare/medical research industry content - Evaluate search effectiveness with domain-specific documentation - Assess usefulness for professional research workflows in healthcare/medical research