The United States Food and Drug Administration
(FDA) regulates all Good Laboratory Practices (GLP) under Code of
Federal Regulations (CFR) 21. The FDA regulations specify a set
of specific procedures that must be followed if the data generated
during the study are to be acceptable by the FDA.
The following document is designed to provide
the Investigators with guidance on how to meet the requirements
of the regulations.
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ROLES AND RESPONSIBILITIES
The Associate Vice Chancellor, Research
(AVC-R), in the Office of Research:
has been delegated overall responsibility for compliance with
the requirements of the GLP and has appointed specific individuals
to be responsible for elements of the program.
Within the Office of Research:
- Attending Veterinarian: has
been delegated responsibility for review and approval of GLP studies
involving the use of animals.
- Director of Animal Welfare Assurance
Program (AWAP): has been delegated responsibility for
oversight and approval of the overall Quality Assurance Program.
Principal Investigator: has the overall responsibility
for the conduct of the study in accordance with the applicable
regulatory and UCSF Policy requirements. These include:
- Submitting an Application, and obtaining an
approval, for GLP to the Office of Research, prior to
starting the study
- Notification to the Office of Research
of any changes in the approved study, prior to their implementation
- Obtaining an approval form the Committee for
Animal Research (CAR), if animals are used in the GLP study
- Providing adequate resources for the conduct
of the study
- Review and Approval of Standard Operating Procedures
(SOP) applicable to the study
- Review and Approval of all changes from established
Study Director (if different from the Principal
Investigator): responsible for conducting the study, in accordance
with the provisions of the GLP study, approved by the Principal
Investigator Individual Users: responsible for
complying with the provisions of approved study protocols, SOPs
and other regulatory requirements.
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In order to obtain approval for conducting
a GLP study, the Principal Investigator must submit an Application
for Good Laboratory Practice for Non-Clinical Laboratory Studies
Office of Research
Box 0962 * New Box #
Upon receipt of the Application:
- The completed Application will be reviewed
by the appropriate personnel within AVC-R and may be followed
by site visits to review specific SOPs, equipment and facilities
described in the Application.
- After the review has been completed, a meeting
will be set with the reviewers, the PI, and the study Director
to assess the findings.
- After the completion of the meeting, and resolution
of any outstanding issues, a signed copy of the approved Application
will be returned to the PI.
- The Approved protocol will include details
of additional, specific conditions which may have been agreed
upon during the review process.
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QUALITY ASSURANCE PROGRAM
UCSF does not have a central Quality Assurance (QA)
unit. Therefore, each Principal Investigator must appoint an individual
to be responsible for the overall QA elements of the study. This
individual may be given responsibility for multiple studies. As
indicated above, the Director of AWAP will be responsible for oversight
and coordination of the QA programs identified in each study proposal
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The Office of Research
will conduct periodic inspections of all approved studies to
verify that they are in compliance with the provisions of the
approved protocol. The inspections will include site visits,
review of the records and procedures, adequacy of personnel
training, and other pertinent elements of the study as appropriate.