The D.K. Kim International Center for Regulatory Science, in conjunction with the Southern California Clinical and Translational Science Institute Regulatory Science team, has developed open-access, self-study modules that train academic researchers in essential concepts and practical approaches to monitoring and auditing and preparing clinical study sites for FDA inspection. The module series addresses the need for quality management across the clinical trial lifecycle as stated in the most recent addendum to ICH Guideline for Good Clinical Practice (GCP), E6(R2).
Background
There is a lack of qualified clinical research professionals skilled in clinical trial regulatory management in the academic setting. In addition, professional training courses are costly and/or require institutional affiliation. The SC CTSI’s Regulatory Knowledge and Support (RKS) core created a series of free, online, self-study modules to address this deficit in regulatory knowledge and training. These modules are designed to educate learners with fundamental and practical knowledge of clinical research monitoring, auditing, and FDA site visit readiness, with an emphasis on investigator-initiated trials. The goal is to create a pool of clinical research professionals who are skilled in regulatory quality management for clinical research in academic settings. Training research personnel in monitoring and auditing concepts will help them to be prepared for regulatory authorities visit as well as ensure proper research conduct.
About the Modules
These self-study modules allow you to learn and familiarize yourself with the concepts of monitoring and auditing of clinical research. These high-quality modules employ a multifaceted approach including educational videos, case studies, interactive quizzes, and provision of core regulatory document templates such as standard operating procedures and review checklists. Three modules in the training series on ensuring data quality in clinical trials:
- Module I: Monitoring of a Clinical Trial Site
- Module II: Auditing of a Clinical Research Site
- Module III: Site Preparedness for an FDA Inspection
Access this free Series at the SC CTSI Learning Network
NEW! Special Considerations for Emerging Technologies Series
- Module I: Cell and Gene Therapy Trials - find out about it HERE.