On this module students will learn about the regulatory and legislative infrastructure that affects and influences clinical research. International and national examples will be used to demonstrate a range of perspectives so that students can explore how this area can directly impact on the design, conduct and reporting of clinical research within the students’ country of practice. Completion of this module will enhance the ability to undertake the clinical research assistant role, other clinical research roles and assist in student’s development within the field of Clinical Research.This module will provide the knowledge and skills to be able to critically appraise how the legislative and regulatory infrastructure influence clinical research and/or student’s role within the clinical research environment. The module will focus on Good Clinical Practice; Singapore, European and United States and other country/region Clinical Trials Regulations; Research Governance; Roles, impact and responsibly of Regulatory Authorities; Independent Ethics Committees/Institutional Review Boards (IRBs); Fraud and Misconduct; Safety regulations; Local Approval and Inspections/Audits