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

OMB 0925-0613

This information collection is a revision for a 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 drug trials, to assure the FDA that systems for accountability are being maintained by investigators in its clinical trials program. 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.

The latest form for Investigational Agent Accountability Record Forms in the Conduct of Investigational Trials in Cancer Treatment (NCI) expires 2022-03-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form 4 International Investigator Statement (IIS) Form and Instruction
Form 1 Electronic Agent Accountability Record Form (eDARF) Form
Form 1 Investigational Agent Accountability Record for Oral Agents Form (DARF-Oral) Form
Form 1 Investigational Agent Accountability Record Form (DARF) Form
SSA 0925-0613.docx Supporting Statement A
Attachment 5 - Privacy Act Memo.pdf Supplementary Document
Attachment 4 - Privacy Impact Assessment (PIA).pdf Supplementary Document
30day 0613.pdf Supplementary Document
International Investigator Statement (IIS) Form and Instruction
Electronic Agent Accountability Record Form (eDARF) Form
Investigational Agent Accountability Record for Oral Agents Form (DARF-Oral) Form
Investigational Agent Accountability Record Form (DARF) Form

All Historical Document Collections

202409-0925-001	Revision of a currently approved collection	2024-09-30
202111-0925-005 Approved without change	Revision of a currently approved collection	2021-11-29
201901-0925-002 Approved without change	Revision of a currently approved collection	2019-02-01
201602-0925-006 Approved without change	Revision of a currently approved collection	2016-02-10
201302-0925-005 Approved with change	Revision of a currently approved collection	2013-02-15
201001-0925-002 Approved without change	Existing collection in use without an OMB Control Number	2010-01-28
200909-0925-003 Withdrawn	Existing collection in use without an OMB Control Number	2009-09-17
200908-0925-003 Improperly submitted	Existing collection in use without an OMB Control Number	2009-08-19

OMB Details

Financial Disclosure Form (Attachments 5A or 5B)

Federal Enterprise Architecture: Health - Health Care Services

Form 6	Attach 5B Financial Disclosure DCP	Fillable Fileable	Form and instruction
Form 5	Attach 5 Financial Disclosure Form	Fillable Fileable	Form and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.