Site monitoring visits
Concerning trends identified through centralized monitoring and/or re-abstraction may prompt site monitoring visits. Staff from the Coordinating Center and NIH/NICHD personnel will visit the site(s) with concerning trends in order to ensure data quality and regulatory compliance and to evaluate the performance of site investigators and staff. Site monitoring visits will be structured and planned in advance. They will involve onsite review and inspection of study participant charts, essential documents, and research staff qualifications and responsibilities. It may also include direct observation of study procedures and protocol implementation, as well as inspection of facilities and pharmacies and interviews with key stakeholders and senior leadership at the sites. If pandemic-related travel restrictions remain in place, such site monitoring visits may also be conducted virtually.