This module is designed to equip the learner with advanced competencies in designing, conducting, analysis and reporting clinical trials in pharmaceutical and biopharmaceutical development. It will cover different components related to phases of clinical trials, clinical trial types, protocol development, trial design, sample size determination, data management, trial inspection and monitoring and iethical considerations and good clinical practice in implementing clinical trials
The module is composed of 4 unites which introduce students to phases, types and designs of clinical trials, protocol development, sample size determination, data management, oversight of clinical trials, the basic ethical principles and principles and standards of good clinical practice.
- Teacher: Prof. Eyasu Makonnen
- Teacher: Lazare Ntirenganya