Module I: Monitoring Clinical Trials
- Overview
- Assessment methods
- Learning objectives
- Contents
- Bibliography
- Teaching methods
- Contacts/Info
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Individual PowerPoint presentations on a topic exploring specific aspects of clinical research and trial monitoring.
By the end of this module, the students will:
• know the international standards for clinical research,
• be familiar with the regulatory environment for clinical trials,
• be able to identify laws, rules, regulations, essential document requirements and guidelines pertinent to study design, implementation, evaluation and reporting,
• have the means to search for and identify appropriate clinical research literature, identify essential monitoring skills and list key interactions within the study team as part of the clinical trial/research process.
• understand essential marketing aspects for delivery of a new product.
Overall, the students will develop/have a systematic understanding of relevant good clinical practice tools essential for conducting, managing and monitoring clinical trials.
Methods and protocols, drug and medical device development
• Human subject protection and essentials of Good Clinical Practice
• Ethical committees, informed consent, confidentiality in clinical trials
• Trial protocol, monitoring, organization and record keeping
• Clinical research personnel, site selection, recruitment and retention strategies
• Safety monitoring, adverse events, data management, final report
• Liability, audits and inspections
Slides and notes uploaded onto the e-learning platform.
Lectures. Interactive learning, problem-oriented exercises and group work. In an evidence-based, collaborative approach, students will be trained to bring together concepts, principles and applications into a pre-defined research project. Guest lectures. “Real world” encounters facilitated via on-site visits.
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