{"id":27482,"date":"2020-07-06T05:59:43","date_gmt":"2020-07-06T05:59:43","guid":{"rendered":"https:\/\/www.inspirenignite.com\/anna-university\/clinical-trials-cc-7th-sem-syllabus-for-be-2017-regulation-anna-univ-open-elective-ii\/"},"modified":"2020-07-06T05:59:43","modified_gmt":"2020-07-06T05:59:43","slug":"clinical-trials-cc-7th-sem-syllabus-for-be-2017-regulation-anna-univ-open-elective-ii","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/anna-university\/clinical-trials-cc-7th-sem-syllabus-for-be-2017-regulation-anna-univ-open-elective-ii\/","title":{"rendered":"Clinical Trials C&amp;C 7th Sem Syllabus for BE 2017 Regulation Anna Univ (Open Elective II)"},"content":{"rendered":"<p>Clinical Trials C&amp;C 7th Sem Syllabus for BE 2017 Regulation Anna Univ (Open Elective II) detail syllabus for Computer &amp; Communication Engineering (C&amp;C), 2017 regulation is collected from the <a href=\"https:\/\/www.annauniv.edu\/\" target=\"_blank\" rel=\"noopener\">Anna Univ<\/a> 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.<\/p>\n<p>For all other c&amp;c 7th sem syllabus for be 2017 regulation anna univ you can visit <a href=\"..\/cc-7th-sem-syllabus-for-be-2017-regulation-anna-univ\">C&amp;C 7th Sem syllabus for BE 2017 regulation Anna Univ Subjects<\/a>. For all other Open Elective II subjects do refer to <a href=\"..\/open-elective-ii-cc-7th-sem-syllabus-for-be-2017-regulation-anna-univ\">Open Elective II<\/a>. The detail syllabus for clinical trials is as follows.<\/p>\n<p><h4>Course Objective:<\/h4>\n<ul>\n<li>To highlight the epidemiologic methods, study design, protocol preparation<\/li>\n<li>To gain knowledge in the basic bio-statistical techniques involved in clinical research.<\/li>\n<li>To describe the principles involved in ethical, legal and regulatory issues in clinical trials.<\/li>\n<\/ul>\n<p><h4>Unit I<\/h4>\n<p>For complete syllabus and results, class timetable and more pls <a href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy\" target=\"_blank\" rel=\"noopener\">download iStudy<\/a>. Its a light weight, easy to use, no images, no pdfs platform to make students life easier.<\/p>\n<p><h4>Unit II<\/h4>\n<\/p>\n<p><strong> Fundamentals of Trial Design<\/strong><Br><br \/>\nRandomised clinical trials, uncontrolled trials. Protocol development, endpoints, patient selection, source and control of bias, randomization, blinding, sample size and power.\n<\/p>\n<p><h4>Unit III<\/h4>\n<\/p>\n<p><strong> Alternate Trial Designs<\/strong><Br><br \/>\nCrossover design, factorial design, equivalence trials, bioequivalence trials, non-inferiority trials, cluster randomized trials, multi-center trials.\n<\/p>\n<p><h4>Unit IV<\/h4>\n<p>For complete syllabus and results, class timetable and more pls <a href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy\" target=\"_blank\" rel=\"noopener\">download iStudy<\/a>. Its a light weight, easy to use, no images, no pdfs platform to make students life easier.<\/p>\n<p><h4>Unit V<\/h4>\n<\/p>\n<p><strong> Reporting of Trials<\/strong><Br><br \/>\nOverview of reporting, trial profile, presenting baseline data, use of tables, figures, critical appraisal of report, meta-analysis.\n<\/p>\n<p><h4>Course Outcome:<\/h4>\n<p>The student will be able to<\/p>\n<ul>\n<li>Explain key concepts in the design of clinical trials.<\/li>\n<li>Describe study designs used, identify key issues in data management for clinical trials.<\/li>\n<li>Describe the roles of regulatory affairs in clinical trials.<\/li>\n<\/ul>\n<p><h4>Text Books:<\/h4>\n<ol>\n<li>Fundamentals of Clinical Trials, Lawrence M. Friedman, Springer Science and Business Media, 2010<\/li>\n<li>Textbook of Clinical Trials, David Machin, Simon Day, Sylvan Green, John Wiley and Sons, 2007<\/li>\n<li>Clinical Trials: A Practical Approach, Stuart J. Pocock, John Wiley and Sons, 17-Jul-2013<\/li>\n<\/ol>\n<p><h4>References:<\/h4>\n<ol>\n<li>Clinical trials, A practical guide to design, analysis and reporting. Duolao Wang and AmeetBakhai. Remedica. 2006.<\/li>\n<li>Introduction to statistics in pharmaceutical clinical trials. T.A. Durham and J Rick Turner. Pharmaceutical Press.<\/li>\n<li>Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines, Tom Brody, Academic Press, 2016.<\/li>\n<\/li>\n<\/ol>\n<p>For detail syllabus of all other subjects of BE C&amp;C, 2017 regulation do visit <a href=\"..\/category\/cc+7th-sem\">C&amp;C 7th Sem syllabus for 2017 Regulation<\/a>.<\/p>\n<p>Dont forget to <a href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy\" target=\"_blank\" rel=\"noopener\">download iStudy<\/a> for latest syllabus and results, class timetable and more.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Clinical Trials C&amp;C 7th Sem Syllabus for BE 2017 Regulation Anna Univ (Open Elective II) detail syllabus for Computer &amp; Communication Engineering (C&amp;C), 2017 regulation is collected from the Anna [&hellip;]<\/p>\n","protected":false},"author":2297,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[50,68],"tags":[],"class_list":["post-27482","post","type-post","status-publish","format-standard","hentry","category-7th-sem","category-cc"],"_links":{"self":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/27482","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/users\/2297"}],"replies":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/comments?post=27482"}],"version-history":[{"count":0,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/27482\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/media?parent=27482"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/categories?post=27482"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/tags?post=27482"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}