CLI 8302 Advanced Clinical and Translational Research Methods
This course introduces students to advanced clinical and translational research methods including clinical trial designs for all phases and complex data analysis methods. Contemporary variations of clinical trial designs will be presented. In addition, students will learn the fundamental principles of good clinical data management practices, and an understanding of database design. Topics discussed include creation of case report forms, types of database systems including relational databases, data validation, standards, missing data, data security and integrity, data entry, and queries and reporting. Students are also introduced to resources for clinical trial data management available at St. Jude. This course will also introduce basic concepts from the standpoint of implementing and managing a clinical research project including multi-site studies, financials and budgeting, and contracts/agreements. The class walks through these management components of clinical trial methods and processes in the same sequence that they will use in the workplace. As part of the class, students will apply some of the techniques and tools to real projects.