Form 1 A3: Electronic Agent Accountability Record Form (eDARF)

Attachment A3: Electronic Agent Accountability Record Form
Form Approved: OMB No: 0925-0613
Expires:
Collection of this information is authorized under 21.CRF.312.57. This information is collected to ensure compliance with Food and Drug Administration (FDA) requirements for NCI as an IND sponsor and that
investigational agents are under the control and accounted for by competent authority. The information may be disclosed to researchers for investigational purposes, sponsors of clinical trials and their company
collaborators, the applicable Institutional Review Board, NCI, FDA, and Department of Health and Human Services. Submission of this information is voluntary, however, in order for you to conduct a study in
accordance with relevant, current protocols, you must complete all fields.
Public reporting burden for this collection of information is estimated to average 1 minute per response, including the time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless
it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to NIH
Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN PRA (0925-0613). Do not return the completed form to this address.

Link to OMB Burden Statement