Lectures

Print a copy of the Course Checklist (PDF document) to help you keep track of your progress in completing the Lectures and Exercises in the Good Practices in Clinical Research course.

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1. Clinical Research: An Overview
- Robert H. Rubin, MD

2. Historical Development of International Regulations in Clinical Research
- Guillermo Rodríguez Gómez, MD

3. Overview of the ICH GCP Guidelines
- Noemi Rosa, BS

4. The Institutional Review Board/The Ethics Committee
- Alan C. Moses, MD

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5. Informed Consent
- Robert H. Rubin, MD

6. Phases of Drug Development
- Honorio Silva, MD

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7. Clinical Trial Design
- Guillermo Rodríguez Gómez, MD

8. Basic Concepts in Applied Statistics
- Alan C. Moses, MD

9. Publishing Clinical Trial Results
- Robert H. Rubin, MD

10. Evaluation of a Clinical Research Site
- Julio Camps, MD

11. The Protocol as a Clinical Research Tool
- Pierre Etienne, MD

12. Trial Documents
- Lillian Marinovich, BS

13. The Responsibilities of Conducting a Clinical Trial
- Guillermo Rodríguez Gómez, MD

14. Clinical Supplies Management
- Patrick Floody, BA

15. Safety Reporting Responsibilities
- Noemi Rosa, BS

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16. Guidelines for CRF Completion
- Brian Peters, BS

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17. Trial Monitoring
- Ana María Valderrama, MD

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18. Audit of a Clinical Trial Site
- Barbara O'Neill, BS

19. Clinical Research in the 21st Century: Areas for Future Research
- Robert H. Rubin, MD

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20. ICIC: A Model of a Private Health Institution for Clinical Research
- Guillermo Rodríguez Gómez, MD

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Interactive Exercises:

Reviewing a Published Paper
- Alan C. Moses, MD

By doing this exercise, you will understand how the various elements in a paper work to communicate the authors' intentions, methods and results. In addition, you will also benefit from the guidance of an experienced reviewer, who will show you how to assess a paper's worth and give you the confidence to be a more discerning reader.

Safety Reporting Case Studies
- Noemi Rosa, BS

The purpose of this exercise is to help you learn to identify and report adverse events in medical situations. Before completing this exercise, please view Lecture 15, Safety Reporting Responsibilities.

Closing Remarks

- Robert H. Rubin, MD

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