V PHARM. D/CLINICAL RESEARCH THEORY
After a successful completion of the course the students will be able to
| Course outcome number | Course Outcomes | Cognitive level |
|
CO1 |
Recall the Various Approaches to Drug Discovery involves recalling and recognizing the diverse methods and strategies used in the pharmaceutical industry to identify and develop new drugs, including pharmacological, toxicological, regulatory, and ethical aspects, to create a foundation for effective drug development processes. |
C1 |
|
CO2 |
Describe the Phases of Clinical Trials encompasses explaining the sequential stages involved in clinical research, from initial human testing to large-scale trials, highlighting their objectives, methodologies, and the increasing rigor and scrutiny at each phase to ensure safety and efficacy of new drugs before market approval. |
C2 |
|
CO3 |
Apply Good Clinical Practice (GCP) Guidelines and Regulatory Requirements involves the practical application of internationally recognized ethical and scientific quality standards in clinical research to ensure the integrity, credibility, and safety of clinical trials, adhering to regulatory obligations and ethical considerations. |
C3 |
|
CO4 |
Analyze Challenges in Implementing Clinical Trial Guidelines entails a critical examination of the obstacles and complexities faced by researchers, sponsors, and regulatory authorities in the practical implementation of stringent clinical trial guidelines, addressing issues related to ethics, logistics, patient recruitment, and data quality to enhance the efficiency and reliability of drug development processes. |
C4 |
|
CO5 |
Evaluate Ethical Guidelines in Clinical Research involves a thorough assessment and judgment of the moral and ethical principles that govern human research, considering issues like informed consent, patient rights, confidentiality, and the overall ethical conduct of clinical trials to ensure the highest standards of participant well-being and scientific integrity. |
C5 |
|
CO6 |
Develop Clinical Study Documents and Understand Informed Consent Process encompasses the creation of essential documentation such as research protocols, case report forms, and informed consent documents, while also comprehending the critical process of obtaining informed consent from study participants, ensuring clarity, transparency, and ethical conduct in clinical research. |
C6 |
Remembering (C1), Understanding (C2), Applying (C3), Analyzing (C4), Evaluating (C5) and Creating (C6)
