Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases
Summary
The government seeks to establish and manage a Statistical and Data Coordinating Center (SDCC) to support the National Institute of Allergy and Infectious Diseases' extramural clinical research programs. The notice highlights requirements for 21 CFR Part 11‑compliant data systems, statistical analysis, specimen tracking, and optional incorporation of artificial intelligence while ensuring privacy and regulatory compliance.