Guidance for an FDA Audit, Sponsor/CRO Monitoring Visit, and Other Resources Available on The HUB. Presented by Marlene Berro, MS, RAC, UCSF. Access the UCSF Clinical Research Resource HUB at http://hub.ucsf.edu/

1. Guidance for an
FDA Audit, Sponsor/
CRO Monitoring
Visit, and Other
Resources Available
Marlene Berro, MS, RAC
Special Projects
Office of Ethics and Compliance
on The HUB
ClinicalTrials.gov Campus Administrator
CTSI Regulatory Consultant
January 10, 2012

2. What Will be Covered
Overview of FDA & OHRP - What to do:
• When notified of FDA or OHRP Inspection
• Before the Site Inspection
• During the Site Inspection
• After the Inspection
• Related Guidance, Tools & Templates
• HUB resources: http://hub.ucsf.edu/
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3. School of Medicine
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4. FDA & OHRP Inspection Overview
Notice of Inspection
May be pre-announced by telephone
• Work with FDA Inspector to schedule inspection
• Do not delay inspection
• Notify UCSF and sponsor (if industry sponsored) of
planned inspection
• UCSF and Sponsor may conduct audit in
preparation for FDA inspection
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5. What is the HUB ?
• A user-centric web-based resource focused on
the needs of researchers, staff, community
partners, affiliates, and research participants
• The HUB is a resource that will:
– Provide a single portal of resources, expertise, and
best practices for investigators and research staff
– Offer clinical research tools, templates, guidance and
go-to for the UCSF research community
– Facilitate efficient, compliant and ethical study
conduct and management
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6. Phase II HUB Projects
• Coordinator HUB
• ClinicalTrials.gov Record Creation from iMedRIS
• Electronic FDA Submissions
• Consent Builder
• SOP Builder
Want to Help?
• Contact Marlene: marlene.berro@ucsf.edu
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7. For More Information please contact:
Marlene Berro
Office of Ethics and Compliance
415.476.9439
Marlene.berro@ucsf.edu