Logistical and IT support for the NCI CIRB   3

Background
The National Cancer Institute’s (NCI) Central Institutional Review Board (CIRB) is the country’s largest federally funded single/central IRB, responsible for the development, implementation, and management of a centralized model of Institutional Review Board (IRB) review for multi-site, NCI-sponsored clinical trials. The goal of this initiative is to streamline regulatory compliance and decrease the duplicative burden of protocol review that currently occurs at hundreds of local IRBs nationwide by providing a single, centralized review that can be utilized by local IRBs participating in NCI-sponsored multi-center trials; and to maintain and enhance the protection of research participants by providing consistent, expert IRB review at the national level. The NCI requires that the entire proposed professional team, and the organization as a whole, possess an expert depth of knowledge and documented experience in IRB, federal and other applicable regulations.

Work Details
The purpose of the contract is to provide expertise in IRB and other Federal regulations, IRB operations, ethics, quality, information technology, and program management necessary to manage the NCI CIRB and support the institutions that rely on it. The major activities include CIRB Central Operations, CIRB Local Operations, CIRB Helpdesk services, Communication and Education activities, ensuring uninterrupted continuation of the NCI CIRB’s full accreditation status with AAHRPP, Quality Assurance (QA) and Quality Improvement programs, providing IT software and support for all CIRB activities, collaboration with other NCI contractors, project management following PMI standards, planning and executing CIRB Education Days every two years based on member evaluations and expressed educational needs. Additionally, transition activities are required.

Period of Performance
It is anticipated that one cost-reimbursement, level of effort contract with a base period of one (1) year and four (4), one-year option periods may be awarded with an anticipated start date of September 1, 2024.

Place of Performance
The contract will be performed for the National Cancer Institute's Central Institutional Review Board (CIRB).