The Stanford Center for Clinical and Translational Research and Education

GUIDANCE — Consult with a Study Facilitator


Spectrum support for Clinical Research is divided into four stages, the last of which is Close Out and Publish Study.
This stage includes regulatory and compliance information and required citation information when publishing your study.

Primary Contact

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Contact Spectrum  email

(650) 498-6498

OTC provides Study Facilitators who guide investigators and study personnel through the clinical research process, from study idea and design through close-out and publication, for clinical and translational research projects.

Study Facilitators are health professionals with extensive clinical research experience and expertise in navigating the Stanford clinical and translational research system. A Study Facilitator will advise you and consult appropriate experts regarding:

Getting Started

  • Do I need help with my study design?
  • What is a Case Report Form and how do I create one?
  • Can I do my study at Stanford?
  • What resources are available to support my project?

Regulatory Requirements

  • What are FDA requirements?
  • Do I need IRB approval?
  • Do I need an IND or IDE for my research project?
  • What does it mean to be a Sponsor-Investigator?
  • What documents are essential for my research?

Budget and Billing Matters

  • What is RMG and who is my RPM?
  • What is Medicare Pre-authorization?
  • How do I get started with my budget?
  • Who do I contact for billing issues?
  • What is the workbook?

Staffing Needs

  • Do I need a coordinator?
  • What does a coordinator do?
  • How much will a coordinator cost?

Grant and Contract Processes

  • When do I need a contract?
  • What is the Office of Sponsored Research (OSR) and who is my contract officer?
  • How do I finance my study?
  • Do I need a contract if I am getting equipment on loan?
  • Who do I contact about my grant?