The D.K. Kim International Center for Regulatory Science, in conjunction with the Southern California Clinical and Translational Science Institute, has developed an open-access, self-study module that trains academic researchers in essential concepts and practical approaches to clinical trial monitoring. 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).
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 a monitoring in their investigator-initiated trials. Similar results were found at poll of attendees at a national Association of Clinical Research Professionals (ACRP) meeting and a Trial Innovation Network (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 Module
This training module includes templates for study monitoring plans and reports, as well as standard operating procedures (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”.
How to Access the Module
– Go to the following site: https://uscregsci.remote-learner.net/login/index.php
– Create new account (located on the right side)
– Type in your details and click Create my new account (bottom of page)
– Open your email used to create the account
– Click the link to confirm your account
– Click Continue
– Scroll down (a little) and under Available courses click Clinical Trial Monitoring
– Click Enroll Me
To see highlights of all Education Initiatives, click here.
For more information on modules, email Apurva Uniyal at uniyal(at)usc.edu