| 1. |
What is
a CSA or Controlled Substances Application?
This document authorizes Principle Investigators to use controlled
substances, as defined by the United States Drug Enforcement
Agency (DEA), for research purposes. |
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| 2. |
Who must
apply for a CSA?
If your research requires the use of DEA
regulated substances
you must have an approved CSA issued by the Office of Environmental
Health and Safety (OEH&S). Please refer to the UCSF Controlled
Substances Manual for further information. The controlled substances
manual is available on the OEsH&S website at http://www.ehs.ucsf.edu.
Controlled Substances Application forms can be obtained from
your Departmental Safety Advisor (DSA) or downloaded from the
OEH&S website at http://www.ehs.ucsf.edu/FORMS/forms.htm.
Note: The CSAs described here are only required
for UCSF campus PIs and do not apply to medical center personnel.
Medical center controlled substance users must make other arrangements
with the DEA. |
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| 3. |
The CSA
Application
The basic CSA consists of
a minimum of the following forms (1) Controlled
Substances Use Application Form (with narrative information
as described below
under 4f) (2) Information
of Authorized User of Controlled Substances, (3) Controlled
Substance Security Form, (4) Controlled
Substance Release Signature Card and (4) Controlled Substances Inventory
Form |
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| 4. |
How to
complete the application
The forms are
largely self explanatory: however, the following should be considered: |
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a. |
Both pages of controlled substances application
form must be completed and then second page must be signed by
the PI |
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b. |
As part of an individual background check “Authorized
User Forms” must be filled out and signed by each potential
authorized user. |
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c. |
PI representative must complete Controlled Substances
Security form as noted on the first page of Controlled Substance
Application. |
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d. |
Controlled Substances Signature Release Card
must also be completed and signed by the PI for signature verification
for ordering and picking up controlled substances. A separate
card must also be completed for each individual assigned to pick
up controlled substances in the absence of the PI. The Department
Chairperson is only required to sign a card if Chair will order
controlled substances in the absence of the PI. |
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e. |
A Controlled Substance Inventory
form must also be completed to verify that there are no Controlled Substances
in the lab at the time of application. If Controlled Substances
are present this must be indicated on form. |
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f. |
On a separate sheet of paper the following information
must be provided: |
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|
i. |
Title of project |
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ii. |
Statement of purpose |
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iii. |
Name of the Controlled Substances involved and the amount of
each needed |
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iv. |
Description of research protocol including the number and species
of research subjects |
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v. |
The dosage to be administered |
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vi. |
The duration of the project, and |
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vii. |
Indication of approval of Committee on Human Research
(CHR) for human studies. |
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viii. |
IACUC approval number and status of IACUC
application for animal studies. |
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After enrollment, OEH&S assigns a controlled
substances number to Program members. Members must use this internal
number instead of a DEA registration number on all DEA correspondence
and requisitions. Approved enrollees are required to comply with
all aspects of this program including maintenance of usage log,
performance of biennial inventory, implementation of security
measures, proper disposal of Controlled Substances, etc In the
event of an unannounced DEA inspection, all of the above referenced
paperwork, including all application materials, must be available
in PI file. |
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| 5. |
Modifications |
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|
1. |
If adding a user, an Authorized User form must be completed
and signed by the user, and PI . |
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2. |
Other changes in authorization including adding Controlled
Substances can be made with Form 3101 Universal
Use Authorization Modification Request Form found on the forms section of the OEH&S
website. When adding a Controlled Substance the narrative described
above in 4f should also be included. |
