GUIDANCE — Consult with a Study Facilitator
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
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:
- 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?
- 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?
- 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?