8 Attach 2 DARF Oral agent accountability

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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.

Form Approved:
OMB No. 0925-0613
Expires: 03/31/2016

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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