Clinical Trial Quality Training Series

The D.K. Kim International Center for Regulatory Science, in conjunction with the Southern California Clinical and Translational Science Institute, has developed open-access, self-study modules that trains academic researchers in essential concepts and practical approaches to monitoring and auditing clinical studies. The module series 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).

Tagged: regulatory science, clinical trials, auditing and monitoring plans, investigator-initiated trials (iits), human subjects, international conference of harmonization (ich)

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.