This course is designed to discuss the elements involved in implementing and managing a clinical study from the perspective of the Data Manager. Topics include development of the data management plan, coordination of data collection and capture, plan the closure and archival of study materials and participate in project management activities. Upon completion, students should be able to design, prepare and execute a complete data management plan for the implementation and management of a sample clinical research project.
This course will also provide an introduction to clinical research and drug safety data entry, computer systems, ICH guidelines for electronic data management, biostatistical concepts and methods required in the development of clinical research, drug safety and pharmacovigilance data analysis, signal detection and interpretation of data from various sources.
This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry, in Clinical Research, Drug Safety, and Pharmacovigilance.