The Regulatory Core oversees safety of the research conducted at the clinical facilities of the Clinical Translational Research Center (CTRC) as well as research conducted through the Child Health and Community Engagement Cores.
A Quality Assurance (QA) Review Program is in place to provide oversight of the research conducted at these sites and by these Cores. The main objective of the QA Review Program is to enhance the quality of clinical research and to ensure proper documentation, record keeping, and adherence to all components that constitute good clinical practice.
During the QA review, the conduct of a research protocol, adequacy of study documentation, and compliance with regulatory and institutional requirements are evaluated. These reviews are a means to provide investigator/study teams with recommendations and improvements for the research protocol.
The Regulatory Core will also help TraCS investigators to meet their obligation for study monitoring by offering a study-specific monitoring services.