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/
Preparing for a Clinical Research Monitoring Visit: Guidance for an FDA Audit, Sponsor/CRO Monitoring Visit, and more...
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
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
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
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
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@example.comSchool of Medicine 6
For More Information please contact: Marlene Berro Office of Ethics and Compliance 415.476.9439 Marlene.firstname.lastname@example.org