I M.PHARM – II Sem
CLINICAL RESEARCH AND PHARMACOVIGILANCE (MPL 204T)
After a successful completion of the course the students will be able to
| Course outcome number | Course Outcomes | Cognitive level |
| CO1 | List key principles of international regulatory guidelines such as ICH-GCP, ethical considerations outlined by Institutional Review Boards, and ethical guidelines for biomedical research as per Schedule Y and ICMR. | C1 |
| CO2 | Discuss the different types and designs of clinical trials, including experimental studies like RCTs and non-RCTs, as well as observational studies like cohort, case-control, and cross-sectional studies. | C2 |
| CO3 | Implement their understanding of the roles and responsibilities of clinical trial personnel, including investigators, study coordinators, sponsors, and contract research organizations. They will also apply guidelines for preparing clinical trial documents. | C3 |
| CO4 | Categorize safety monitoring in clinical trials, including the definition, types, detection, reporting, severity, seriousness, predictability, preventability, and management of adverse drug reactions (ADRs). | C4 |
| CO5 | Justify the historical progress of pharmacovigilance, its significance in medication safety, and its international and national aspects. They will assess roles and responsibilities in pharmacovigilance and methods/tools used, including spontaneous reporting systems and statistical methods. | C5 |
| CO6 | Develop knowledge by creating pharmacovigilance strategies, developing safety evaluation methods, and understanding pharmacoeconomics, safety pharmacology, and pharmacoepidemiology concepts. | C6 |
Remembering (C1), Understanding (C2), Applying (C3), Analyzing (C4), Evaluating (C5) and Creating (C6)
