Protocol

The Study Protocol or document describing a clinical trial scope of work:

Defines hypothesis, study objectives, study design, methodology, planned statistical analysis
Schedule of Events (i.e. table with procedures listed at each timepoint)
Protects the safety of the study subject
Ensures integrity of data collected

A study protocol authored by a sponsor is an industry initiated clinical trials. A study protocol authored by a Stanford investigator is an Investigator Initiated clinical trials (IIT) with industry funding.

How does CT RMG use the Study Protocol in the Study Set-up Process?

The Study Protocol is one of the Minimum Documents that a study team submits to CT RMG’s Intake Team.

During the study set-up process, CT RMG:

Reviews objectives in the Study Protocol to confirm whether or not the study meets the industry funded clinical trial criteria and qualifies for the Clinical Trial F&A (Facilities and Administrative) cost rate
Accepts the Study Protocol as the sponsored project’s Scope of Work
Confirms if Coverage Analysis is required

How is confidentiality of the Study Protocol protected?

Before a PI receives a Study Protocol from an industry sponsor, the sponsor will require Stanford to sign a Nondisclosure Agreement (NDA). The Clinical Trial Contract Officer (CT CO) signs the NDA on behalf of Stanford. In signing the NDA, Stanford attests that the institution will manage the protected, confidential information and will not disclose or distribute the information to anyone not involved in the project.

Find a doctor

Clinics & Services

Research Resources

Professional Training

Education Resources

Protocol

Resources