Stanford

Planning research - Items to consider

OTC

Spectrum 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
  • Training & Education
  • Point of Contact for questions about clinical research

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Contact Information

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

The clinical research process for clinical and translational research projects, from study idea and design through close-out and publication, requires consideration and often consultation with 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?