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Collection of this information is authorized under 21 CFR 312.57. The 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 the 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.
OMB No. 0925-0613
Expires: 11/30/2013
NIH-2564
Public reporting burden for this collection of information is estimated to average 4 minutes 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.
Division of Cancer Treatment and Diagnosis
Cancer Therapy Evaluation Program
National Institutes of Health
National Cancer Institute
Investigational Agent Accountability Record
PAGE NO.
SATELLITE RECORD
CONTROL RECORD
Name of Institution:
NCI Protocol No.:
Agent Name:
Dose Form and Strength:
Protocol Title:
Dispensing Area:
Investigator Name:
NCI Investigator No.:
Line
No.
1.
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Date
Patient’s
Initials
Patient’s ID No.
Dose
Quantity
Dispensed or
Received
Balance Forward
Balance
Manufacturer
and Lot No.
Recorder’s
Initials
File Type | application/pdf |
File Title | Microsoft Word - Agent Accountability 11_23_10 Final.doc |
Author | fordm |
File Modified | 2012-07-03 |
File Created | 2010-11-23 |