The University of Alabama at Birmingham (UAB) Radiology Data and Safety Monitoring Board (RDSMB) provides independent clinical study oversight for diagnostic imaging–focused research protocols that are non-oncology in nature.
The RDSMB serves as the formal monitoring mechanism for studies conducted under U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) applications, grant-funded projects, and other clinical investigations requiring structured safety monitoring in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines.
Responsibilities
- Monitoring participant safety and study conduct
- Reviewing study protocols and safety reports
- Evaluating data integrity and interim findings
- Assessing risk–benefit considerations throughout the study lifecycle
- Ensuring adherence to regulatory and institutional requirements
The Board is coordinated by the Committee Chair and operates independently from trial sponsors, regulatory agencies, Institutional Review Boards (IRBs), and investigators associated with the studies under review. This independence ensures objective oversight and protects the integrity of the research process.
Contact
For additional information regarding the Radiology RDSMB, please contact April Riddle.