Executive Development Programmes on Good Clinical Practice (GCP) in Clinical Research

Course Objectives:
– To understand international rules on medical ethics
– To learn the Indian and international drug development processes
– To acquire skills to carry out different phases of clinical trials
– To provide insights into monitoring, data management, and reporting requirements for conducting studies of the highest quality meeting national and international standard
Topics to be covered: Drug discovery and development process, Pre-clinical studies, Phase I, II, III, IV clinical trials, Ethics in clinical research- historic perspective, International conference on harmonization (ICH), Good clinical practice (GCP) guidelines, IRB/IEC role and responsibilities, Investigator’s role and responsibilities, Sponsor’s role and responsibilities, Regulatory authority’s role and responsibilities, Clinical data management overview, Designing protocols and CRFs, and Reporting of SAEs/AEs. This course will also include mock trials, audits, and reporting.

EDP on Good Clinical Practice (GCP) in Clinical Research (6 Credit units)