Clinical Trials, Bioethics detailed syllabus for Biotechnology & Biochemical Engineering (BBE) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the BBE students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below.
For Biotechnology & Biochemical Engineering 6th Sem scheme and its subjects, do visit BBE 6th Sem 2021 regulation scheme. For Professional Elective-V scheme and its subjects refer to BBE Professional Elective-V syllabus scheme. The detailed syllabus of clinical trials, bioethics is as follows.
Course Objectives:
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Unit I
INTRODUCTION TO DRUG DISCOVERY AND DEVELOPMENT 9
Origin and History of Clinical Research, Introduction to Drug Discovery and drug Development, Clinical Trials in India-The National Perspective, Clinical Trial Phase I, Clinical Trial Phase II, Clinical Trial Phase III, Clinical Trial Phase IV -methods, Principles of sampling -Inclusion and exclusion criteria, Methods of allocation and randomization, Termination of trial.
Unit II
ETHICAL REGULATION 9
Historical guidelines in Clinical Research -Nuremberg code, Declaration of Helsinki, Belmont report, Research ethics and Bioethics -Principles of research ethics; ethical issues in clinical trials; Use of humans in Scientific Experiments; the informed consent; Introduction to ethical codes and conduct; Introduction to animal ethics; Animal rights and use of animals in the advancement of medical technology
Unit III
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Unit IV
CLINICAL TRIAL IMPORTANT DOCUMENTATION 9
Essential Documents in Clinical Trials: SOP, Clinical Trial Protocol and 95Protocol Amendment(S), Investigator Brochure, Master Files, Informed Consent Forms, Consort statement, Case Record Form
Unit V
CLINICAL DATA MONITORING 9
CRF Review & Source Data Verification, Drug Safety Reporting, Drug Accountability Work, Routine Site Monitoring, Site Close Out Visit. Case study in recent epidemics-clinical trials.
Course Outcomes:
The students will be able to
- Understands the principles and methodology of clinical trials
- Comprehend the theory and practical aspects of important techniques
- Develop analytical skills and expertise to formulate and implement a research oriented real time problem.
- Asses in major high throughput statistical methods in clinical research.
- Evaluate experimental component to undertake interdisciplinary work.
- Equips skills to pursue a career either in academia or industry.
Text Books:
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Reference Books:
- Shein-Chung Chow, Jen-Pei Liu.Design and Analysis of Clinical Trials: Concepts and Methodologies, 3rd Edition. Publisher: Wiley. (2014)
- Lionel D. Edwards, Anthony W. Fox, Peter D. Stonier. Principles and Practice of Pharmaceutical Medicine, 3rdEdition. Publisher: Wiley-Blackwell. (2011)
- 0Murray Longmore, Ian Wilkinson, Andrew Baldwin, and Elizabeth Wallin.Oxford Handbook of Clinical Medicine, 9th Edition. Oxford Medical Handbooks.(2014)
For detailed syllabus of all the other subjects of Biotechnology & Biochemical Engineering 6th Sem, visit BBE 6th Sem subject syllabuses for 2021 regulation.
For all Biotechnology & Biochemical Engineering results, visit Anna University BBE all semester results direct link.