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. Studies may involve social and behavioral observations or interventions; drugs, biologics or devices; collection of biospecimens; administration of questionnaires, diagnostics, procedures and assessments; and other interventions involving human subjects. OCTOM oversees, coordinates and facilitates clinical research implementation by providing tools, training and resources to ensure compliance with applicable human subjects regulations, standards, policies, and Good Clinical Practice. Its areas of expertise include data and safety monitoring, development of study documentation, quality management, regulatory submissions, and clinical site monitoring and reporting.