Study & Site Management

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.

The Clinical Trials Special Interest Group seeks to enhance expertise in clinical trials research amongst faculty to create opportunities for methodological innovation, cross-disciplinary insights, and robust research outcomes.

The CTSI Horizons program enhances clinical and translational research (CTR) by bringing together faculty at all career stages to collaborate in key focus areas such as qualitative research, clinical trials and CHLA Research Data. Leveraging SC-CTSI resources, the program supports small, topic-driven special interest groups and fosters partnerships between USC and CHLA investigators, to also help USC faculty connect with pediatric collaborators.