Investigational Agent Accountability Record Forms in the Conduct of Investigational Trials in Cancer Treatment (NCI)

This is a request for the Office of Management and Budget (OMB) to approve a Revision of the “Investigational Agent Accountability Record Forms in the Conduct of Investigational Trials for the Treatment of Cancer” for an additional three-year period. The U.S. Food and Drug Administration (FDA) holds the National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis/Cancer Therapy Evaluation Program (NCI/DCTD/CTEP), and the Division of Cancer Prevention (DCP) responsible as a sponsor of investigational agent trials, to assure the FDA that investigators in its clinical trials program are maintaining systems for accountability. Data obtained from the Investigational Agent Accountability Record Forms are used to track the dispensing of investigational anticancer agents from receipt from the NCI to dispensing or administration to patients. Requirements for the tracking of investigational agents under an Investigational New Drug Application are outlined in Title 21 Code of Federal Regulations (CRF) Part 312. NCI and/or its auditors use this information to ensure compliance with federal regulations and NCI policies

The latest form for Investigational Agent Accountability Record Forms in the Conduct of Investigational Trials in Cancer Treatment (NCI) expires 2027-11-30 and can be found here.

Investigational Agent Accountability Record Form (DARF)

Federal Enterprise Architecture: Health - Health Care Services

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