BT8012 - BIOETHICS (Syllabus) 2017-regulation Anna University

BT8012 - BIOETHICS (Syllabus) 2017-regulation Anna University

BT8012

BIOETHICS

 LPTC
3003

OBJECTIVE:
• The course will provide Fundamental ethical to Advanced clinical trial management including drug development and trial planning; Project management in clinical trials; Consent and data protection; Quality assurance and governance.

UNIT I

INTRODUCTION TO CLINICAL TRIALS

9
Fundamentals of clinical trials; Basic statistics for clinical trials; Clinical trials in practice; Reporting and reviewing clinical trials; Legislation and good clinical practice - overview of the European directives and legislation governing clinical trials in the 21stcentury; International perspectives; Principles of the International Committee on Harmonisation (ICH)-GCP.

UNIT II

REGULATIONS OF CLINICAL TRIALS

9
Drug development and trial planning - pre-study requirements for clinical trials; Regulatory approvals for clinical trials; Consort statement; Trial responsibilities and protocols - roles and responsibilities of investigators, sponsors and others; Requirements of clinical trials protocols; Legislative requirements for investigational medicinal products.


UNIT III

MANAGEMENT AND ETHICS OF CLINICAL TRIALS

9
Project management in clinical trials - principles of project management; Application in clinical trial management; Risk assessment; Research ethics and Bioethics - Principles of research ethics; Ethicalissues in clinical trials; Use of humans in Scientific Experiments; Ethical committee system including ahistorical overview; 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; Introduction to laws and regulation regarding useof animals in research.

UNIT IV

INFORMED CONSENT

9
Consent and data protection- the principles of informed consent; Consent processes; Dataprotection; Legislation and its application; Data management – Introduction to trial masterfiles and essential documents; Data management.

UNIT V

QUALITY CONTROL AND GUIDELINES

9
Quality assurance and governance - quality control in clinical trials; Monitoring and audit; Inspections; Pharmacovigilance; Research governance; Trial closure and pitfalls-trial closure; Reporting and legal requirements; Common pitfalls in clinical trial management.

TOTAL : 45 PERIODS

OUTCOME:
• The students will acquire knowledge in all aspect of clinical trials, management and ethical standards required to conduct clinical trials.

REFERENCES:
1. Lee, Chi-Jen; etal., “Clinical Trials or Drugs and Biopharmaceuticals.” CRC / Taylor & Francis,2011.
2. Matoren, Gary M. “The Clinical Research Process in the Pharmaceutical Industry.”Marcel Dekker,1984.
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