Office of Clinical Trials Operations and Management
The Office of Clinical Trials Operations and Management (OCTOM) provides operational and management support for NIDCR’s intramural and extramural clinical research programs including clinical trials, behavioral research and epidemiological studies. The OCTOM coordinates and facilitates implementation of clinical research studies. It provides tools, training and resources to ensure that clinical research supported by the NIDCR is conducted with high quality and efficiency, and complies with requirements for human subject safety. The OCTOM supports safety oversight and quality clinical research by ensuring compliance with applicable regulations, standards, policies and Good Clinical Practice guidelines. The OCTOM provides support and expertise in the areas of safety and data monitoring, pharmacovigilance, protocol development, regulatory submissions and human subject protections, clinical site monitoring and reporting, protocol development, regulatory submissions, and human subject protections for clinical research.