RFA-CA-23-022
Is more than one application per institution permitted?
No. Only one application per institution is permitted.
What role will the CCC have in Network leadership, the CSRN Steering Committee, and in overall trial development?
The CCC will have a significant role in CSRN leadership, the Steering Committee, trial development, and study implementation. The CCC will be involved in the leadership of the CSRN Steering Committee. The Steering Committee is responsible for protocol approvals and has study management responsibility for Network trials. The CCC PI(s) are expected to have expertise in disease screening trials, including recruitment and retention methodologies, in order to successfully support Network trial development and study implementation activities.
On the application face page, should CCC applicants answer “yes” to human subjects involved?
Yes. The CCC will be involved study design and may have access to personally identifiable information of study participants.
Is the CCC expected to establish subcontracts with each of the ACCESS Hubs?
Yes. The CCC is expected to establish formal subcontract agreements with each ACCESS Hub, as needed, to support Network activities. This may include agreements for technology transfer, data sharing, and, potentially additional funding from the CCC to ACCESS Hubs to cover unanticipated costs such as diagnostic workups. Because this is a new network, the agreements are intended to be put into place during the first year of funding.
What is the role of the CCC in facilitating communication between CSRN components and the Central IRB (CIRB)?
The CCC will submit protocol documents on behalf of the steering committee to the CIRB. This will include the initial application, protocol documents, subsequent amendments, and an annual continuing review. The CCC also will facilitate ACCESS Hub Site enrollment in the CIRB as needed.
Should the CCC budget include development and management of the web portal for participants and a study website?
Yes. The CCC should budget for development and management of a participant web portal and a study website. Although they may be linked, the study website is meant to provide general information about the study to potential participants and to the broader scientific community. The web portal is designed for active participants only and should provide study-related information and support.
Last updated: 02/14/2023