Erasmus+ Programme

Key Action: Cooperation for Innovation and the Exchange of Good Practices

Action: Strategic Partnerships for Higher Education

Project: Curriculum Development of Human Clinical Trials for the Next Generation Biomedical Students – CONSCIOUS

 

Partners in the CONSCIOUS Project

• Lead Partner: University of Pécs, Hungary
• Masaryk University, Brno, Czech Republic
• Université de Paris, Frances
• Universidade NOVA de Lisboa, Portugal
• University College Cork, Ireland

 

CONSCIOUS Project Outputs

1. Intellectual Outputs (IOs)
   • 14 Lesson module on clinical trials for undergraduate biomedical students
   • Teacher guide/tutorial for each lesson
   • Assessment for each lesson
2. Project Management (PM)
   • Finance and personnel management, reporting.
3. Platform and Instructional Design
   • Moodle
4. Multiplier Events

 

Ireland’s Participation in the CONSCIOUS Project

• HRB Clinical Research Facility at University College Cork, Mercy University Hospital, Cork, Ireland.
• Responsibilities in the CONSCIOUS Project:
  • Developing the structure for:
    • IO1 Syllabus
    • IO2 Development of e-learning materials for the Moodle platform (14 Lessons at approximately 90 minutes each divided into chapters)
      • Lesson 1: What is a clinical trial
      • Lesson 2: Why clinical trials are the gold standard
      • Lesson 3: Case Study: Tuskegee
      • Lesson 6: Equipoise, forming a research question and defining the outcome
    • IO3 Teacher’s Guide

 

Syllabus

• Lesson 1: What is a Clinical Trial
• Lesson 2: Why Clinical Trials are the Gold Standard
• Lesson 3: Case Study: Tuskegee
• Lesson 4: Ethics in Clinical Trials
• Lesson 5: What Patients Should Know – Informed Consent
• Lesson 6: Equipoise, forming a research question & defining the outcome
• Lesson 7: Clinical Trial Phases
• Lesson 8: Phase III trial design
• Lesson 9: Clinical Trial Protocol and Case Report Form
• Lesson 10: The numbers…sample size, Why it’s Important; Interpreting the Results
• Lesson 11: Medical Devices and Advance Therapies
• Lesson 12: Trial Management
• Lesson 13: Adverse Events and Reporting Responsibilities
• Lesson 14: Critical Appraisal and How to Read a Paper

 

Methodology

• Interactive lessons
• Text interspersed with:
  • Videos (sourced from those freely available; TMRN, TMRP, TED etc.). Not too long.
  • Reading (Journal articles) with thought questions (suitable with simple design)
  • Self-test questions
  • Recorded interviews with trial professionals
  • Discussion boards
    • e.g., Chapter 1.6 Discussion Board 4. I underlined the terms volunteers, Spanish immigrants, and the fact that some of the volunteers refused to move between the experimental groups as per the protocol.
      1. Were the people “volunteers” or “not volunteers” in your opinion?
      2. What would be the potential impact on the experiment of the violation of that protocol, if any? Justify your answers, referencing as appropriate.
  • End of module quiz

 

Teacher’s Guide

• Teachers‘ guide to each lesson – recommended activities with study texts, additional information to the self-tests, guiding questions, timelines (designed for 90min lesson)
• The guide presents the objectives and learning outcomes under headings;
  1. Personal and Professional Development: General
  2. Basic information, explanation of terms, content
  3. Teacher and Student
  4. From theory to practice, impact of the learning unit, practical outcomes
  5. Do you understand properly?
• The guide provides a tutorial to accompany each chapter within the lesson
• Quite detailed