The Study Protocol describes how a clinical trial will be conducted:
- Defines hypothesis, study objectives, study design, methodology, planned statistical analysis
- Protects the safety of the study subject
- Ensures integrity of data collected
The Study Protocol informs the Clinical Trial Research Management Group (CT RMG) study set up process.
Study Protocols authored by a sponsor are industry initiated clinical trials. Study Protocols authored by a Stanford investigator are investigator initiated clinical trials with industry funding. All industry sponsored protocols must be treated as confidential information.
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 determine whether or not the study meets the industry sponsored 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 status of Investigational New Drug (IND) or Investigational Device Exemption (IDE) (e.g. is IND held by sponsor)
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.