Applicants responding to this NOSI must have appropriate capabilities, infrastructure, and attributes. These key components are expected to ensure qualified personnel and site capabilities for the safe conduct of Phase I-Phase I/II (bridging) for COVID-19.
Initiation of Enrollment
Investigators applying for this NOSI must be prepared to initiate enrollment within the first quarter of the award.
Experience in the Conduct of Clinical Trials
It is essential that investigators applying for these awards have expertise and well-documented past performance in the conduct of Phase I-III clinical trials.
Coordination of Clinical Trials and Associated Activities
The awardees will be responsible for all administrative duties, filing adverse event reports, maintenance of all regulatory documents, communications, protocol, consent and forms development, quality control, milestone tracking, and analysis and reporting of outcomes.
Personnel
While necessary personnel may be added to implement the study, the original team must have relevant expertise already in place, along with an appropriate infrastructure to enable the leveraging of existing HLB trials.