The Stanford Center for Clinical and Translational Research and Education

FDA Submissions – Devices (IDE)


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

OnCore for Non-Cancer Studies

» Resources & Links
» OnCore Login - Pilot Users

Contact Information

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

The U.S. Food and Drug Administration website provides information for regulated industry on determining how to comply with the federal laws and regulations governing medical devices. See their Device Advice: Device Regulation and Guidance page for the following information and more:

  • Overview of Medical Device Regulation
  • Compliance Activities (Medical Devices)
  • Postmarket Requirements
  • Standards


Spectrum works in collaboration with the IRB and the Cancer Clinical Trials Office to provide education and training for investigators and research teams conducting research with INDs and IDEs held by a Stanford investigator.

Next Steps