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Preparing for a Clinical Research Monitoring Visit: Guidance for an FDA Audit, Sponsor/CRO Monitoring Visit, and more...

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Guidance for an FDA Audit, Sponsor/CRO Monitoring Visit, and Other Resources Available on The HUB. Presented by Marlene Berro, MS, RAC, UCSF. …

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/

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  • 1. Guidance for an FDA Audit, Sponsor/ CRO Monitoring Visit, and Other Resources AvailableMarlene Berro, MS, RACSpecial ProjectsOffice of Ethics and Compliance on The HUBClinicalTrials.gov Campus AdministratorCTSI 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/School of Medicine 2
  • 3. School of Medicine 3
  • 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 inspectionSchool of Medicine 4
  • 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 managementSchool of Medicine 5
  • 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.eduSchool of Medicine 6
  • 7. For More Information please contact: Marlene Berro Office of Ethics and Compliance 415.476.9439 Marlene.berro@ucsf.edu

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