NCI Central Institutional Review Board (CIRB)
The NCI CIRB is dedicated to protecting the rights and welfare of participants in DCP cancer prevention trials. The CIRB membership satisfies the requirements of 45 CFR 46 and 21 CFR 56, and provides special expertise as needed to adequately assess human subjects protection concerns for each study that it reviews. The CIRB is responsible for conducting initial, amendment, and continuing reviews of studies, as well as the review of other study-specificdocuments (e.g., participant accrual materials) submitted by the Study Chair.
Regulatory Support Program
The Regulatory Support Program receives, reviews, and compiles scientific, safety, and clinical data for inclusion in Investigational New Drug Applications (INDs) and other regulatory submissions. In addition, the program provides adverse event data for the development of the Investigator's Brochures, and for safety data submissions to regulatory agencies and investigators. For multinational research efforts, DCP may direct the program to prepare submissions to international regulatory bodies. The program also maintains files of agreement documents and other documents from pharmaceutical companies including the use of agreements such as CRADAs (Cooperative Research and Development Agreement), Clinical Trial Agreements (CTAs), Confidential Disclosure Agreements (CDAs), and Material Transfer Agreements (MTAs). The Regulatory Support Program works with physician investigators, non-physician investigators, and Associate Plus staff to register annually via the NCI Registration and Credential Repository (RCR) system.
Drug Repository Program
The Drug Repository Program serves as the centralized source of investigational agents and provides development services necessary to support early phase cancer prevention studies. The repository provides logistic organization for the procurement, tracking, labeling, storage, shipping, maintenance, testing, quality control, and distribution of investigational agents.
NCI anticipates a long-term solution for storing and sharing of biospecimens collected within CP-CTNet clinical trials.
Protocol Information Office (PIO) Support Program
The PIO support program oversees the process for receipt of concepts and protocols and for the review, documentation, and notification of concept/protocol review results. The program is responsible for electronic maintenance, tracking, and storage of all cancer prevention study files (e.g., documents, correspondence, reports, and other study-related information) from the concept stage all the way through implementation and completion of studies, including serving as the programmatic conduit to the CIRB for study protocol and patient-facing materials submissions.