Limited Competition for the Continuation of Multisite Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Optional)

This Funding Opportunity Announcement (FOA), utilizing the U24 grant funding mechanism, encourages applications for competing renewal of Data Coordinating Center (DCC) for ongoing clinical trials supported by NCCIH. Extension of an ongoing clinical trial will be supported when there is need for additional time to complete the trial or when an extended period of follow up is well justified to assess longer term outcomes. The DCC competing renewal application must propose a comprehensive plan for completion of the clinical trial data collection that provides overall project coordination and administrative; data management; and biostatistical support for the ongoing clinical trial. Both a DCC application and a corresponding Clinical Coordinating Center application can be submitted simultaneously for consideration by NCCIH if both are needed to complete the ongoing. If clinical trial data collection and follow up can be completed centrally by the DCC and no study visits at clinical sites are needed, a single application for competing renewal for the DCC can be submitted. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact for the ongoing clinical trial for which they are planning a competing renewal application prior to submitting to this FOA.