SC CTSI Staff

This module provides a detailed understanding of the auditing process in clinical research and how it ensures compliance with study protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. Learners are introduced to the distinctions between monitoring, auditing, and inspection, as well as the purpose, scope, and procedures that define an effective audit. The course outlines auditor qualifications, essential steps before, during, and after an audit, and the documentation required for evaluation, including regulatory binders and investigator credentials.

This course is designed for residents, fellows, faculty, and staff as a practical introduction to clinical and translational research methods. Held every other week between August and December, the course includes a combination of asynchronous videos, didactic lectures, discussions, and practical applications.

This module introduces the fundamental principles and practices involved in monitoring clinical trial sites. It covers definitions and types of clinical trials, the application of Good Clinical Practices, and the roles and responsibilities of sponsors, investigators, and institutional review boards. Learners will review essential documentation processes and quality functions such as data capture, quality control, and assurance. The module also explains the purpose and scope of trial monitoring, including the qualifications and responsibilities of monitors, data standards like ALCOA + CCEA, and the different types of monitoring activities.