Clinical Trials detailed syllabus for Information Technology (IT) for 2019 regulation curriculum has been taken from the Anna Universities official website and presented for the IT 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 Information Technology 7th Sem scheme and its subjects, do visit IT 7th Sem 2019 regulation scheme. For Open Elective-II scheme and its subjects refer to IT Open Elective-II syllabus scheme. The detailed syllabus of clinical trials is as follows.
Course Objective:
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Unit I
Role of Clinical Trials in New Drug Development
Drug Discovery, regulatory guidance and governance, pharmaceutical manufacturing, nonclinical research, clinical trials, post-marketing surveillance, ethical conduct during clinical trials.
Unit II
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Unit III
Alternate Trial Designs
Crossover design, factorial design, equivalence trials, bioequivalence trials, non-inferiority trials, cluster randomized trials, multi-center trials.
Unit IV
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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:
For the complete syllabus, results, class timetable, and many other features kindly download the iStudy App
It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier..
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 detailed syllabus of all the other subjects of Information Technology 7th Sem, visit IT 7th Sem subject syllabuses for 2019 regulation.
For all Information Technology results, visit Anna University IT all semester results direct link.