Clinical Monitoring Research Program

Program Overview

The Clinical Monitoring Research Program Directorate facilitates strategic support of clinical research programs by providing comprehensive clinical trials operations and program/project management services to support research sponsored by the National Institutes of Health. We support researchers conducting clinical research in domestic and international settings.

The program addresses emerging challenges, ensures clinical research complies with applicable regulations and guidelines, maintains data integrity, protects human subjects, and supports the goal of increasing the capability of international sites to participate and partner in clinical research. We facilitate the conduct of clinical trials and research initiatives investigating the prevention, detection, and treatment of cancer, HIV/AIDS, influenza, and other infectious diseases such as Ebola virus and COVID-19.   

Our capabilities include comprehensive clinical trials management, regulatory affairs expertise, clinical safety oversight, clinical data management, information technology support, protocol navigation and protocol development, programmatic support, and project management.   

Program Innovations

  • We partnered with the U.S. Department of Health and Human Services, National Institutes of health, and subcontractors to create and manage a website to publish government-recommended treatment guidelines for various stages of COVID-19 infection.
  • Beginning in February, 2020, we provided support to the international, multi-center clinical trial evaluating remdesivir for the treatment of hospitalized patients with COVID-19. The U.S. Food and Drug Administration granted emergency use authorization based on trial results.  
  • We supported the clinical trial PALM 1 in the Democratic Republic of the Congo evaluating investigational drugs for the treatment of Ebola virus disease. The study fast-tracked U.S Food and Drug Administration approval of both MAb114 and REGN-EB3 as therapeutics for Ebola virus infection in adults and children.   
  •  In a collaboration with the Biopharmaceutical Development Program, we supported two new cancer immunotherapy studies: neoantigen vaccine trials and a CAR-T cell study.

Program Focus

COVID-19 clinical trials  

  • Support several National Institute of Allergy and Infectious Diseases (NIAID) clinical trials evaluating safety and efficacy of novel therapeutic agents to treat patients infected with COVID-19.   
  • The Adaptive COVID-19 Treatment Trials (ACTT), which was the first clinical trial in the United  States  to evaluate  an experimental treatment for SARS-CoV-2. The study found the antiviral remdesivir accelerated recovery for COVID-19 patients.  
  • The Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) study, which evaluated the combination of remdesivir and a highly concentrated solution of antibodies that neutralize SARS-CoV-2.  
  • The monoclonal antibody study known as ACTIV-3/TICO, assesses whether new treatments are effective against COVID-19.  
  • Facilitate coordination and management of multi-site activities, regulatory inspections and approvals.  
  • Monitor clinical trial sites, manage research subcontractors, and coordinate logistics/shipping of materials and supplies.  
  • Facilitate launch of studies using INSIGHT network, prepare regulatory submissions, translate documents, manage research subcontractors, and provide medical monitoring support.

Ebola clinical research  

  • Support PREVAIL clinical research studies in Liberia, Guinea, Sierra Leone, and Mali.  
  • Enhance clinical research capacity in West Africa and the Democratic Republic of the Congo.  
  • Renovate facilities, improve infrastructures, and provide training opportunities for local staff.  
  • Support operational and logistical needs through procurement, shipping, inventory management, and travel coordination.  
  • Provide IT support by building infrastructure, optimizing internet connectivity, and creating a social analytics platform.  
  • Support study goals to better understand the Ebola virus, therapeutic options, and vaccine safety and efficacy.  

Brain tumor trials collaborative  

  • Provide the National Cancer Institute with clinical and administrative infrastructure support to the network of 30+ medical centers participating in the collaborative investigating new treatments for malignant brain tumors and rare adult central nervous system cancers.  
  • Assist with protocol development/navigation.  
  • Coordinate communications for the collaborative.  
  • Manage subcontracts for drug distribution and lab analysis.  

Project and program management  

  • Manage domestic, international, single-site, and multi-site clinical research programs.  
  • Provide rapid response to urgent clinical research initiatives.  
  • Foster collaborations with internal and external organizations.  
  • Organize and implement program management infrastructures.  
  • Provide technical project management of research subcontracts.  
  • Support correlative studies through collaborative research and development agreements.  
  • Provide procurement and supply chain management for office and laboratory equipment, materials, and supplies.  
  • Coordinate events/meetings, manage travel logistics.  
  • Facilitate logistical support for shipping pharmaceuticals and clinical research materials.  

  Clinical trials management  

  • Facilitate and manage domestic and international clinical research studies and investigational new drug trials.  
  • Conduct pre-study site assessments, site initiation visits, site monitoring, and study close-out visits.  
  • Provide protocol training to clinical research sites.  
  • Design, prepare, submit, distribute, and track essential study documents.  
  • Track study agents.  
  • Ensure compliance with the research protocol, ICH/GCP guidelines, and applicable regulations.  
  • Facilitate communications between the clinical research sites and IND sponsor entities.  
  • Coordinate investigator meetings.  
  • Prepare for the U.S. Food and Drug Administration and drug-sponsored audits.  
  • Develop case report form templates and load them into databases.  

Clinical research team support  

  • Support National Institutes of Health clinics and program initiatives.  
  • Provide clinical research professionals for direct patient care and research support.  
  • Support research subject recruitment, schedule patient appointments, create clinic schedules.  
  • Provide bioinformatics support, statistical support, mathematical programming, and imaging informatics support.  
  • Coordinate and perform clinical research protocol responsibilities related to research participants.  

Protocol navigation, development, and coordination  

  • Streamline clinical research protocol writing and approval processes.  
  • Function as liaison between customers and review offices.  
  • Navigate investigators through regulatory and administrative requirements for protocol submission.  
  • Collect metric data, track milestone dates, categorize and respond to Institutional Review Board  stipulations.  
  • Provide administrative coordination to support regulatory activities.  
  • Coordinate protocol review submissions.  

Pharmacovigilance  

  • Promote protection of clinical trial participants.  
  • Perform protocol safety oversight and review safety data.  
  • Evaluate safety data and reportability to the U.S. Food and Drug Administration.  
  • Coordinate and manage Data Safety and Monitoring Boards.  
  • Prepare safety reports. 

Regulatory affairs expertise  

  • Prepare, submit, and maintain compliant regulatory applications (INDs, CTAs, IDEs, DMFs).  
  • Conduct regulatory review of clinical protocols, informed consent documents, and other clinical documents.  
  • Act as regulatory liaison with trial sponsors, the U.S. Food and Drug Administration, and regulatory bodies.  
  • Offer regulatory strategy and support to investigator.  
  • Provide current good manufacturing practice guidance on product storage, shipping, labeling, and manufacturing issues.  

Learning and professional development

  • Provide continuing education and customized training events to directorate staff and government customers.  
  • Address required regulatory, technical, and professional skills competencies.  
  • Conduct training needs assessments and respond to training needs.  
  • Identify, develop, and facilitate professional development opportunities.  

 Information technology support and clinical data management 

  • Manage IT solutions, support business continuity, and provide user support.  
  • Develop websites and databases.  
  • Customize enterprise applications.  
  • Create and maintain clinical trial summary records.  
  • Perform clinical data abstraction, curation, and management.  
  • Determine data management and IT requirements at clinical sites.  
  • Establish validated data flows and provide data management training.  
  • Support database locking and data archiving. 

Support to additional institutes

Institute Infrastructure development for program management services   Regulatory support   Protocol navigation   Clinical trials management   Clinical care professionals  
National Heart, Lung, and Blood Institute   X X X    
National Institute of Arthritis and Musculoskeletal Skin Diseases     X   X  
National Institute of Neurological Disorders and Stroke     X   X X
National Human Genome Research Institute         X X
National Center for Advancing Translational Sciences     X      
National Institute of Environmental Health Sciences           X
National Institute of Mental Health     X X    
National Institute of Environmental Health Sciences           X
National Institute of Diabetes and Digestive and Kidney Diseases       X