Clinical Studies Coordinating and Biostatistical Data Management Support

Collaborative Studies Coordinating Center (CSCC) statisticians and experienced research staff help investigators design, conduct, report and analyze multi-center clinical trials and observational studies. CSCC services are provided on a cost basis to investigators with research grants. Fees depend upon the requested work scope, complexity, and duration of individual studies.

Study coordination and data management support includes:

• Study Design: provide grant development, protocol design, sample size calculation, data collection case report form (CRF) design, randomization schemes and the design and implementation of adaptive and SMART designs.
• Electronic Data Management: develop and implement a rigorous Electronic Data Capture (EDC) system with graphical interfaces, built-in eligibility and scoring algorithms, complex subject randomizations, laboratory data loading and reporting, and dictionary coding of AEs and medications at data entry. The service features the Carolina Data Acquisition & Reporting Tool (CDART), UNC's web- and standards-based, FDA-compliant, scaled data management system co-developed by the CSCC and the NC TraCS Biomedical Informatics Service group. Capabilities include integration of CDART data with genomics and electronic medical records such as the Carolina Data Warehouse for Health, UNC's data federation of electronic medical records and administrative claims data from UNC Health Care.
• Study Conduct: oversee the quality of clinical trial and observational study data by ensuring that all study sites follow identical procedures through site training and coordination, ongoing data quality review through central data monitoring and site visit monitoring.
• Reporting: oversee patient safety reporting through SAE processing, event abstracting and adjudication, interim analysis and DSMB reports. Provides reports in ClinicalTrials.gov.
• Analysis: provide statistical analysis for manuscripts, and well-documented investigator-use and public-use data sets. Faculty and staff are experienced with application of novel statistical techniques and the use of simulations to provide clients with statistical solutions for their data analytic approach.