{"id":59495,"date":"2023-09-06T07:56:02","date_gmt":"2023-09-06T07:56:02","guid":{"rendered":"https:\/\/www.inspirenignite.com\/anna-university\/bi3020-clinical-trials-bioethics-syllabus-for-bbe-2021-regulation-professional-elective-v\/"},"modified":"2023-09-06T07:56:02","modified_gmt":"2023-09-06T07:56:02","slug":"bi3020-clinical-trials-bioethics-syllabus-for-bbe-2021-regulation-professional-elective-v","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/anna-university\/bi3020-clinical-trials-bioethics-syllabus-for-bbe-2021-regulation-professional-elective-v\/","title":{"rendered":"BI3020: Clinical Trials, Bioethics syllabus for BBE 2021 regulation (Professional Elective-V)"},"content":{"rendered":"

Clinical Trials, Bioethics detailed syllabus for Biotechnology & Biochemical Engineering (BBE) for 2021 regulation curriculum has been taken from the Anna Universities<\/a> 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. <\/p>\n

For Biotechnology & Biochemical Engineering 6th Sem scheme and its subjects, do visit BBE 6th Sem 2021 regulation scheme<\/a>. For Professional Elective-V scheme and its subjects refer to BBE Professional Elective-V syllabus scheme<\/a>. The detailed syllabus of clinical trials, bioethics is as follows. <\/p>\n

Course Objectives:<\/h4>\n

Download the iStudy App for all syllabus and other updates.<\/a>
\"Get<\/a><\/h4>\n

Unit I<\/h4>\n

INTRODUCTION TO DRUG DISCOVERY AND DEVELOPMENT\t9<\/strong>
\nOrigin 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.\n<\/p>\n

Unit II<\/h4>\n

ETHICAL REGULATION\t9<\/strong>
\nHistorical 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\n<\/p>\n

Unit III<\/h4>\n

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\"Get<\/a><\/h4>\n

Unit IV<\/h4>\n

CLINICAL TRIAL IMPORTANT DOCUMENTATION\t9<\/strong>
\nEssential Documents in Clinical Trials: SOP, Clinical Trial Protocol and 95Protocol Amendment(S), Investigator Brochure, Master Files, Informed Consent Forms, Consort statement, Case Record Form\n<\/p>\n

Unit V<\/h4>\n

CLINICAL DATA MONITORING\t9<\/strong>
\nCRF Review & Source Data Verification, Drug Safety Reporting, Drug Accountability Work, Routine Site Monitoring, Site Close Out Visit. Case study in recent epidemics-clinical trials.\n<\/p>\n

Course Outcomes:<\/h4>\n

The students will be able to<\/p>\n

    \n
  1. Understands the principles and methodology of clinical trials<\/li>\n
  2. Comprehend the theory and practical aspects of important techniques<\/li>\n
  3. Develop analytical skills and expertise to formulate and implement a research oriented real time problem.<\/li>\n
  4. Asses in major high throughput statistical methods in clinical research.<\/li>\n
  5. Evaluate experimental component to undertake interdisciplinary work.<\/li>\n
  6. Equips skills to pursue a career either in academia or industry.<\/li>\n<\/ol>\n

    Text Books:<\/h4>\n

    Download the iStudy App for all syllabus and other updates.<\/a>
    \"Get<\/a><\/h4>\n

    Reference Books:<\/h4>\n
      \n
    1. Shein-Chung Chow, Jen-Pei Liu.Design and Analysis of Clinical Trials: Concepts and Methodologies, 3rd Edition. Publisher: Wiley. (2014)<\/li>\n
    2. Lionel D. Edwards, Anthony W. Fox, Peter D. Stonier. Principles and Practice of Pharmaceutical Medicine, 3rdEdition. Publisher: Wiley-Blackwell. (2011)<\/li>\n
    3. 0Murray Longmore, Ian Wilkinson, Andrew Baldwin, and Elizabeth Wallin.Oxford Handbook of Clinical Medicine, 9th Edition. Oxford Medical Handbooks.(2014)<\/li>\n<\/li>\n<\/ol>\n

      For detailed syllabus of all the other subjects of Biotechnology & Biochemical Engineering 6th Sem, visit BBE 6th Sem subject syllabuses for 2021 regulation<\/a>. <\/p>\n

      For all Biotechnology & Biochemical Engineering results, visit Anna University BBE all semester results<\/a> direct link. <\/p>\n","protected":false},"excerpt":{"rendered":"

      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. […]<\/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":[154],"tags":[],"class_list":["post-59495","post","type-post","status-publish","format-standard","hentry","category-bbe"],"_links":{"self":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/59495","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=59495"}],"version-history":[{"count":0,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/59495\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/media?parent=59495"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/categories?post=59495"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/tags?post=59495"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}