The Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute's (NCI) Division of Cancer Treatment and Diagnosis (DCTD) has a continuing requirement to provide comprehensive support for the NCI's Central Institutional Review Board (CIRB) Initiative. This support is supplied using a contract mechanism for the CIRB Operations Office. The CIRB is designed to reduce the administrative burden on local IRBs and investigators while continuing a high level of protection for human research participants in Cooperative Group cancer clinical trials. Since 2007, the EMMES Corporation has provided Operations Office support for the CIRB and has served as the prime contractor for the CIRB since June 2008.
The specific aims of this contract are to provide the following services: Manage and provide administrative and regulatory support for the operations of an adult and a pediatric Central IRB (CIRB) as they review Cooperative Group cancer clinical trials Manage and support current and newly enrolled local sites using the CIRB Support recruitment and integration of new sites to the CIRB Initiative Provide informatics systems to support all CIRB operations, including continuation of an existing CIRB website Support effective communications with and between NCI and stakeholders regarding all aspects of the CIRB Initiative Implement and manage an Initiative-wide Quality Improvement Plan.
