Participant and Clinical Interactions Resources (Clinical Research Unit)
The Participant and Clinical Interactions (PCI) provides facilities and resources to enable investigators to successfully conduct their clinical research
Clinical Research Units (CRUs) based at Georgetown University and Howard University provide specialized in-patient and out-patient resources which allow clinical and translational investigators to observe and study human physiology as well as study and treat disease with innovative approaches. Similarly, the Washington DC Veterans Affairs Medical Center (VAMC) has a CRU that supports clinical investigators throughout the DC VAMC.
Community Engagement Resources (CE) CE services are designed to foster long-term collaborations that promote translation of health research into effective practice and public policy. Services for investigators include: consultations, training, and communications.
Biostatistics, Epidemiology and Research Design (BERD)
BERD team provides quality statistical assistance, biomedical informatics, and data resource management support to facilitate collaborations for a wide range of clinical and translational studies. Services include: biomedical informatics and data management services (e.g., creating study-specific databases using REDCap and/or other databases), building and overseeing data entry and management systems, archiving data for long-term storage, performing quality control for data collection and management, and managing and extracting data from EHRs (Explorys).
Research Participant Recruitment Support & Multi-Site Study Support
Multiple barriers delay both the activation and the completion of multi-center clinical trials. In partnership with the Trial Innovation Network, a network created to leverage the expertise and resources of the CTSA program, our goal is to enhance the speed and efficiency of multi-site clinical trials across all GHUCCTS institutions.
Biomedical Informatics Support
The Biomedical Informatics (BI) component of GHUCCTS provides analytical and computational support with the goal of promoting clinical and translational research. Specific activities include support for common standards development, workflow tracking, molecular and clinical data integration, brokering secure access to de-identified patient data by physician researchers at GHUCCTS institutions, dissemination of the translational research data and results and support with all clinical trial management systems and tools.
Regulatory, Ethics, Knowledge and Support (REKS)
The regulatory team is resource iinvestigators and research team on engagement, protection and consenting of study participants. Our research participants specialists help investigators and study coordinators comply with the ethical guidelines and regulatory requirements related to the engagement and protection of study participants. Areas of assistance include: informed consent development; data and safety monitoring (DSMP); and informed consent process.