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

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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: marlene.berro@ucsf.edu

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For More Information please contact:

Marlene Berro

Office of Ethics and Compliance

415.476.9439

Marlene.berro@ucsf.edu