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The Stanford Center for Clinical and Translational Research and Education
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Regulatory & Compliance — Support Services, Resources and QuickLinks

OTC

Spectrum Operations, Training and Compliance (OTC) serves faculty and clinical research personnel at Stanford School of Medicine, Stanford University Medical Center, Lucile Packard Children's Hospital, and the Veterans Affairs Palo Alto Health Care System.

Services Provided
  • Budget & Billing Support
  • Regulatory/Compliance Support
  • Study Facilitators
  • Training & Education
  • Point of Contact for questions about clinical research
Contact Information

Spectrum
Operations, Training & Compliance
800 Welch Road
MC: 5737
Palo Alto, CA 94304
(650) 498-6498
Fax (650) 723-8552

Regulatory and Compliance support services provided by OTC include:

  • FDA audit preparation and facilitation
  • Sponsor audit preparation and assistance when requested
  • Support for IND and IDE submissions
  • Good Clinical Practice support and study review
  • Regulatory Binder preparation and compliance review
  • Consultation for any regulatory or compliance question, whether FDA, OHRP, or ICH/GCP.
  • Support for billing compliance questions, liaison with hospital billing and risk management
  • Study document management: storage/archiving coordination and contract services
  • Liaison services for complex regulatory or compliance questions between RMG, OSR and the IRB
  • Liaison to Stanford Hospital and Clinics (SHC) and Lucile Packard Children’s Hospital (LPCH) compliance department

QuickLinks

Next Steps
  • Questions?
    Email OTC Regulatory Services Manager Jennifer Brown  email if you have clinical research compliance and regulatory questions.
  • Questions about your cancer study?
    Email Lee Doherty  email at the Cancer Clinical Trials Office if you have regulatory questions about your cancer study.