Clinical Coordinating Center for NIDA’s Clinical Trials Network

This Special Notice from the Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse amends a request for proposals for a Clinical Coordinating Center for the agency's Clinical Trials Network. The coordinating center will be responsible for product safety services such as monitoring adverse events, safety reporting, and data and safety monitoring board coordination and support.

The amendment provides responses to 22 questions from potential offerors to clarify requirements, with the proposal due date remaining February 9, 2024. Transition of up to 15-20 ongoing studies from the incumbent contractor to the new center is expected within 90 days of award. The coordinating center scope of work involves regulatory documentation, safety databases, protocol development, monitoring visits, and working with the existing data and statistics center. Eligible contractors will coordinate clinical trials and associated product safety services for the National Institute on Drug Abuse's Clinical Trials Network initiative through regulatory and safety oversight, data management, and collaboration with network members and contractors.