Form 1 Investigational Agent Accountability Record for Oral Age

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Collection of this information is authorized under 21 CFR 312.57. This information is collected to ensure compliance with Food and Drug Administration (FDA) requirements for NCI as an I1' 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.

OMB No. 0925-0613
Expires:

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.

National Institutes of Health
National Cancer Institute
Division of Cancer Treatment and Diagnosis

Investigational Agent Accountability Record
Oral agents ONLY

Cancer Therapy Evaluation Program

Name of Institution:

Investigator Name:

Protocol Title:

NCI Protocol No:

Agent Name:

Dose Form and Strength

Line
No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
1.
1.

Date

Patient’s
Initials

Patient’s ID No.

Dose

Quantity
Dispensed or
Received

Balance Forward
Balance

PAGE NO.
CONTROL RECORD



SATELLITE RECORD


CTEP Investigator ID

Local Protocol No:

Dispensing Area:

Bottle size (e.g., # tablets/bottle):

Manufacturer
and Lot No.

Recorder’s
Initials

Expiration
Date (if
available)

Date
Patient
Returned

Quantity
Patient
Returned

Recorder’s
Initials