Driving Pressure-Limited Ventilation in Hypoxemic Respiratory Failure (DRIVE-USA)

SCOPE OF WORK The scope of work includes: 1. Conducting all study activities for the “Driving Pressure-Limited Ventilation in Hypoxemic Respiratory Failure (DRIVE-USA)” Phase III Randomized Controlled Trial at our site, including IRB-related issues (with a Central IRB), subject screening and enrollment, conduct of the study intervention (as described below), and timely data collection for case report forms, including phone follow-up for 6-month outcomes. a. conduct of study intervention includes responsibility for implementation of the assigned ventilator protocol and related aspects of respiratory failure management, monitoring participant safety, and reporting adverse events and serious adverse events as outlined in the protocol. 2. Attending monthly conference calls between the site investigators and the nCCC-USA. The nCCC-USA will review the study site’s screening activities and participant enrollment, along with protocol adherence, data collection and safety data. If a site is deemed to be under- performing without improvement, the nCCC-USA may suspend PI support and/or stop conduct of the study at the site.