C2-M4 Clinical Trials

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Learning outcomes module 4:

4A  Outline the key strategic and operational issues in the clinical trial process, including legal, regulatory, & practical aspects and the possibilities of collaboration of different stakeholders

4B  Appraise the principles and practical relevance of ethics in clinical research and the role patients can play e.g in ethics committees

4C  Explain and demonstrate the clinical trial approval process including the required documentation and the possible role of Patients/POs and provisions for special/vulnerable patient populations

4D  Describe the main statistical methods used in clinical research

4E  Critically evaluate the concept of benefit-risk, the collection, evaluation and reporting of adverse event data and risk management in clinical trials and the various roles patient can play

4F  Describe the principles of data management and the associated study documentation and quality measures in clinical trials

4G  Appraise the relevant aspects of patient compliance for study medication including its labelling, handling

4H  Critically evaluate the content of clinical trial websites and their use in identification of trials in your disease area. (Including reporting of adverse events)

4I  Differentiate types of clinical trials and their design, and Good Clinical Practice (GCP)

4J  Discuss all aspects of the interpretation, publication and communication to patients of all clinical trial results


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