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Marlene Berro, MS, RAC Special Projects Office of Ethics and Compliance ClinicalTrials.gov Campus Administrator CTSI Regulatory Consultant
January 10, 2012
Guidance for an FDA Audit, Sponsor/
CRO Monitoring Visit, and Other
Resources Available on The HUB
School of Medicine
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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School of Medicine
3
School of Medicine
FDA & OHRP Inspection Overview
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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
School of Medicine
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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
School of Medicine
Phase II HUB Projects
• Coordinator HUB • ClinicalTrials.gov Record Creation from iMedRIS • Electronic FDA Submissions • Consent Builder • SOP Builder
Want to Help? • Contact Marlene: [email protected]
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For More Information please contact:
Marlene Berro
Office of Ethics and Compliance
415.476.9439