The primary mission of the Clinical Monitoring Research Program Directorate (CMRPD) is to provide comprehensive, dedicated clinical research support to major programs within NIH. CMRPD is structured to optimize approaches to satisfy customer requirements. The directorate maintains expertise in regulatory affairs, clinical trials management, pharmacovigilance, protocol development and navigation, and project/program management services to more than 400 domestic and international clinical trials.
CMRPD operates human clinical trials for diseases and viruses such as cancer and AIDS, influenza, malaria, Zika, Ebola, Chikungunya, parasitic diseases and a wide range of other emerging and re-emerging infectious diseases. It provides support for programs and initiatives such as the Brain Tumor Trials Collaborative, NCI-MATCH and other precision medicine initiatives, NCI Center for Global Health, and NIAID Vaccine Research Center and Division of Clinical Research.
Recognizing the expanding and emerging challenges faced by NIH researchers, CMRPD offers high-quality clinical research support services to help navigate the numerous barriers to conducting clinical research domestically and internationally. The directorate ensures research is compliant with applicable regulations and guidelines, maintains data integrity, and contributes to the overall goal of protecting human subjects.
CMRPD is comprised of a highly qualified and diverse workforce, enabling the program to respond rapidly to new research initiatives. Staff backgrounds include medical and scientific experts, regulatory and clinical trials management specialists, assurance professionals, GCP/Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP) experts, project managers, clinical informaticists, and business professionals.
The directorate maintains robust and direct lines of communication to address the comprehensive and complex management activities for domestic and international programs and special projects. These activities include, but are not limited to: managing domestic, international, single-site, and multi-site research programs; providing programmatic guidance and support; providing cradle-to-grave technical project and fiscal management of research agreements with clinical sites, consultants, clinical research organizations, and for laboratory services and correlative studies; developing infrastructures, creating and implementing strategic and operational plans; facilitating logistical support for pharmaceuticals and research materials; offering professional development opportunities; providing document control services; as well as coordinating events, managing travel logistics, and planning conferences.
Additionally, to accommodate the demands of supporting clinical research operations and management, CMRPD’s Information Technology (IT) group provides a suite of services that are facilitated by IT specialists. The IT staff are integrated into projects/programs supported by CMRPD, allowing appropriate responses to clinical research requirements.