CTEP Branch Support Contracts Forms and Surveys (NCI)

OMB 0925-0753

OMB 0925-0753

This is a revised information collection for OMB control number #0925-0753, expiration 6/30/2020 for three years. The National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) and the Division of Cancer Prevention (DCP) fund an extensive national program of cancer research, sponsoring clinical trials in cancer prevention, symptom management and treatment for qualified clinical investigators. As part of this effort, CTEP implements programs to register clinical site investigators and clinical site staff, and to oversee the conduct of research at the clinical sites. CTEP and DCP also oversee two support programs, the NCI Central Institutional Review Board (CIRB) and the Cancer Trial Support Unit (CTSU). The combined systems and processes for initiating and managing clinical trials is termed the Clinical Oncology Research Enterprise (CORE) and represents an integrated set of information systems and processes which support investigator registration, trial oversight, patient enrollment, and clinical data collection. The information collected is required to ensure compliance with applicable federal regulations governing the conduct of human subjects research (45 CFR 46 and 21 CRF 50), and when CTEP acts as the Investigational New Drug (IND) holder (FDA regulations pertaining to the sponsor of clinical trials and the selection of qualified investigators under 21 CRF 312.53).

The latest form for CTEP Branch Support Contracts Forms and Surveys (NCI) expires 2021-07-31 and can be found here.

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OMB Details

CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1)

Federal Enterprise Architecture: Health - Public Health Monitoring

Form 1IRB TransmittalFillable FileableForm and instruction

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