Stanford

Regulatory & Compliance — Support Services, Resources and QuickLinks

SDD

Spectrum support for Clinical Research is divided into four stages, the first of which is DESIGNING YOUR STUDY.

This stage includes tasks and activities that occur early in the design & development of a study, such as:

  • biostatistics consultations
  • informatics consultations
  • bioethics consultations
  • identifying co-investigators and collaborators
  • exploring funding opportunities

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