NINDS Center for Clinical Research Data Management, Methodology, Monitoring Services, Statistical Design, and Quality Control
Client: National Institute of Neurological Disease and Stroke (NINDS), NIH
Client/study focus and needs: For over two decades, we provided an array of clinical research support services for NINDS. Serving as the Center for Clinical Trial Research Data Management, Methodology, Statistical Design, and Quality Control, we monitored quality assurance in clinical trials, developed a research project classification system and database to support detailed analytics for grant portfolios, created data warehouses and archives for completed studies, provided statistical and methodological support to clinical trials, and monitored both extramural and intramural research studies. The primary objectives of this contract were to assist the Institute with assuring the clinical studies it supports:
- Protect the safety and confidentiality of study participants and comply with the Department of Health and Human Services, NIH, and NINDS regulations and guidelines for human subject protection and safety monitoring
- Produce accurate, valid data and results accepted by the scientific and clinical communities
- Use resources efficiently
Our customized approach: We worked closely with NINDS to implement services in a way to encourage acceptance, adoption, and use by the NINDS clinical research community. We provided data management, monitoring, and quality assurance for treatment intervention studies spanning an array of disease areas including, but not limited to, stroke, vascular dementia, Alzheimer’s disease, Parkinson’s disease, epilepsy, and multiple sclerosis. We facilitated the development and maintenance of the NINDS Common Data Elements (CDEs). In addition, we used our knowledge of NIH administrative data variables to create and implement the Clinical Information Project System (CLIPS), a relational database designed to manage and analyze data from NINDS human subject research grant portfolios. Finally, we aggregated data and developed a data repository website for the SPOTRIAS (Specialized Program of Transitional Research in Acute Stroke) network, a national network of eight stroke centers.
Services: Data management, including data standardization, data archiving and data warehouse services, clinical monitoring , clinical study documentation development, statistical programming , quality assurance reviews
Results: Navitas Clinical Research, Inc. consistently and successfully supported NINDS in highly specialized clinical research activities including:
- Data Standardization: We developed 14 disease-area CDE packages, which involved the coordination of 700 CDE Working Group members, the development of over 5000 CDEs/300 CDE supporting documents, 4 publications, and support of over 20 scientific presentations. We also worked with the Clinical Data Interchange Standards Consortium (CDISC) to release the Parkinson’s disease data standards package.
- Quality Assurance/Control: Over 5 years, we performed over 35 NINDS extramural and intramural site visits, and developed quality assistance and assurance checklists for NINDS clinical research studies.
- Clinical Data Archiving, Acquisition, and Storage: We archived approximately 30 datasets from completed NINDS clinical trials, and released datasets following the review and approval of formal requests.
- Statistical and Methodological Support: We provided consultation and statistical analysis on clinical trial design and power analysis.