Ethical theories and principles relevant to clinical research practice; Critical Reflection; Monitoring and audit of Clinical Trials; Sponsor and site specific trial responsibilities; Standard Operating Procedures; Ethical and managerial approval; Data management; Informed consent; Drug accountability and Communications skills; Study monitoring; roles and responsibilities; Pharmacovigilance; Exploration of issues related to professional roles in clinical research. The online element of the delivery includes searching, locating and reviewing the literature, the reflective cycle, ethical dilemmas and informed consent.