The Southern California Clinical and Translational Science Institute (SC-CTSI) has developed a freely available self-study module that can be used to train academic researchers in essential concepts and practical approaches to monitoring of clinical studies. The module addresses the need for quality management across the clinical trial lifecycle as stated in the latest addendum to ICH Guideline for Good Clinical Practice (GCP), E6(R2).

Background: Study monitoring is an essential and routine quality function in industry-sponsored trials. However, access to high quality study monitoring is often lacking in investigator-initiated trials conducted in academic medical centers. Indeed, two separate surveys of research professionals in Southern California revealed that only about 65% reported monitoring in their investigator-initiated trials. Similar results were found at poll of attendees at a national ACRP meeting and TIN online forum. Findings from literature and web-based searches revealed that although numerous GCP training resources seem to be available, most are not readily accessible because they often require fees or institutional affiliations. Moreover, trainings often lack the practical approaches to meet the complex requirements of monitoring. Many academic, government, and private institutions have voiced an interest in accessible tools that can help to ensure quality management in clinical trials.

About the New Module: This new training module includes templates for study monitoring plans and reports, as well as SOPs and checklists for conducting monitoring visits. It is the first of a trio of resources for ensuring quality of clinical trials. Future modules will include "Auditing of a Clinical Trial Site" and "Site Readiness for an FDA Inspection".