Clinical Trials Med Ele 7th Sem Syllabus for BE 2017 Regulation Anna Univ (Open Elective II) detail syllabus for Medical Electronics (Med Ele), 2017 regulation is collected from the Anna Univ official website and presented for students of Anna University. The details of the course are: course code (OPY751), Category (OE), Contact Periods/week (3), Teaching hours/week (3), Practical Hours/week (0). The total course credits are given in combined syllabus.
For all other med ele 7th sem syllabus for be 2017 regulation anna univ you can visit Med Ele 7th Sem syllabus for BE 2017 regulation Anna Univ Subjects. For all other Open Elective II subjects do refer to Open Elective II. The detail syllabus for clinical trials is as follows.
Course Objective:
- To highlight the epidemiologic methods, study design, protocol preparation
- To gain knowledge in the basic bio-statistical techniques involved in clinical research.
- To describe the principles involved in ethical, legal and regulatory issues in clinical trials.
Unit I
For complete syllabus and results, class timetable and more pls download iStudy. Its a light weight, easy to use, no images, no pdfs platform to make students life easier.
Unit II
Fundamentals of Trial Design
Randomised clinical trials, uncontrolled trials. Protocol development, endpoints, patient selection, source and control of bias, randomization, blinding, sample size and power.
Unit III
Alternate Trial Designs
Crossover design, factorial design, equivalence trials, bioequivalence trials, non-inferiority trials, cluster randomized trials, multi-center trials.
Unit IV
For complete syllabus and results, class timetable and more pls download iStudy. Its a light weight, easy to use, no images, no pdfs platform to make students life easier.
Unit V
Reporting of Trials
Overview of reporting, trial profile, presenting baseline data, use of tables, figures, critical appraisal of report, meta-analysis.
Course Outcome:
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:
- Fundamentals of Clinical Trials, Lawrence M. Friedman, Springer Science and Business Media, 2010
- Textbook of Clinical Trials, David Machin, Simon Day, Sylvan Green, John Wiley and Sons, 2007
- Clinical Trials: A Practical Approach, Stuart J. Pocock, John Wiley and Sons, 17-Jul-2013
References:
- Clinical trials, A practical guide to design, analysis and reporting. Duolao Wang and AmeetBakhai. Remedica. 2006.
- Introduction to statistics in pharmaceutical clinical trials. T.A. Durham and J Rick Turner. Pharmaceutical Press.
- Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines, Tom Brody, Academic Press, 2016.
For detail syllabus of all other subjects of BE Med Ele, 2017 regulation do visit Med Ele 7th Sem syllabus for 2017 Regulation.
Dont forget to download iStudy for latest syllabus and results, class timetable and more.