Course curriculum

    1. Certified Healthcare to Research Accelerator Academy (HTRAA) Course

    2. Lesson 2: Regulatory Bodies (FDA, EMA, ICH-GCP)

    3. Lesson 3: Introduction to Good Clinical Practice (GCP)

    4. Lesson 4: Case Study: Clinical Trial Ethics Violations

    5. Lesson 5: Real World Applications -Vaccine Trials (2020-Present)

    6. Lesson 6- SARS-CoV-2 mRNA Vaccine

    7. Homework Assignment: 💡Summarize the mechanism of how the SARS-CoV-2 mRNA vaccine (BNT162b1) works

    8. Quiz: Understanding mRNA Vaccine Basics

    1. Lesson 2: The Role of the European Medicines Agency (EMA):

    2. Lesson 3: Intro to ICH-GCP

    1. Quiz 1: Clinical Research & Regulatory Framework

    1. Welcome To Week 2: Clinical Trial Site Operations

      FREE PREVIEW

    2. Module 1: Clinical Research Coordinator (CRC)

    3. Homework: Draft a checklist & SOP for CRCs to ensure all AEs are reported within 24 hours.

    4. Module 2: Clinical Research Associate (CRA)

    5. Creating a Mock Monitoring Report

    6. Module 3: Principle Investigator (PIs) & Sub-I’s

    7. Create a delegation log template aligning with ICH-GCP 4.1.5.

    8. Module 4: Data Management & Finance

    9. Build a sample budget for a Phase III trial (include PI fees, IRB, staffing)

    1. Retention and Communication

    1. Networking and Job Search Strategies

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