Clinical Trials and Health care Policies in Biotechnology detailed syllabus for Biotechnology (BioTech) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the BioTech 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 6th Sem scheme and its subjects, do visit BioTech 6th Sem 2021 regulation scheme. For Professional Elective-VII scheme and its subjects refer to BioTech Professional Elective-VII syllabus scheme. The detailed syllabus of clinical trials and health care policies in biotechnology is as follows.
Course Objectives:
Download the iStudy App for all syllabus and other updates.
Unit I
REQUIREMENTS IN CLINICAL RESEARCH 9
Good clinical practice (ICH GCP E6), Clinical trial materials (Documentation, Investigational drugs, logistical materials)
Unit II
TYPES AND DESIGNS IN CLINICAL RESEARCH AND SAFETY MONITORING
IN CLINICAL TRIALS 9
Types of research designs based on Controlling Method (Experimental, Quasi experimental, and Observational methods) Randomization techniques (Simple randomization, restricted randomization, blocking method and stratification),Time Sequences (Prospective and Retrospective), Sampling methods (Cohort study, case Control study and cross sectional study), Health outcome measures (Clinical & Physiological, Humanistic and economic)
Unit III
Download the iStudy App for all syllabus and other updates.
Unit IV
OVERVIEW TO UNDERSTANDING THE HEALTHCARE SYSTEM 9
HEALTH CARE SYSTEM COMPONENTS, Elements of a Health Care System, The Role and Financing Methods of Third-Party Payers, The Production of Medical Services, An Overview of the U.S. Health Care System, Production of Health Services and Provider Choice in the United States.
Unit V
HEALTH CARE POLICIES 9
Health care policy- overview- Private health care sectors, Health policy and planning
Course Outcomes:
The student will be able to
- Explain key concepts in the design of clinical trials.
- Describe study designs used, identify key issues in data management for clinical trials.
- Describe the roles of regulatory affairs in clinical trials.
Text Books:
Download the iStudy App for all syllabus and other updates.
For detailed syllabus of all the other subjects of Biotechnology 6th Sem, visit BioTech 6th Sem subject syllabuses for 2021 regulation.
For all Biotechnology results, visit Anna University BioTech all semester results direct link.