"The Clinical Research Post Graduate Diploma Program is designed for a wide range of students including International Medical Graduates (IMGs); Health Care Professionals (HCPs); and Science, Technology, Engineering and Mathematics (STEM) graduates. The program provides theoretical and practical understanding of clinical research and increases opportunities for employment and job advancement.
Students will learn how to generate and validate hypothesis; research bibliographic database; design clinical trial study; write clinical trial protocol; collect clinical research data; apply statistical tests for analysis of collected clinical research data; and work with stakeholders including pharmaceutical, biotechnology, and medical device companies; contract research organizations, regulatory agencies; principal investigators; and research institutions. Students also learn how to deal with ethical challenges, apply quality standards, submit human research ethics application, monitor clinical and safety database, assess received adverse events, familiarize with Medical Coding and MedDRA, submit safety reports to the regulatory authorities and comply with the laws, regulations, guidelines and specifications, write case narrative, Standard Operating Procedures and Internal Working Instructions, Data Safety and Monitoring Board report, Medical Monitor clinical data review checklist, Investigational New Drug Application, and Clinical Trial Application.