FDA Submissions – Drugs & Biologics (IND)

Set-Up Your Study

The STUDY SET-UP stage includes activities that occur after the study has been designed and developed, and before you begin to enroll patients.

This stage includes activities in areas such as:

  • contracts & grant proposals
  • IRB approval
  • research management compliance
  • study budgeting & billing
  • required registration of trial

The U.S. Food and Drug Administration website provides information for the Investigational New Drug (IND) Application. The site includes information and resources including:

  • Pre-IND Consultation Program
  • Guidance Documents for INDs
  • Laws, Regulations, Policies and Procedures
  • Emergency Use of an Investigational Drug or Biologic
  • Related Resources, including Applications


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