Regulatory Resources
Investigator Initiated Studies
Investigator Initiated (also known as Investigator Authored) clinical trials are studies largely designed and written by Stanford investigators. Stanford Cancer Institute investigators are required to design their protocol documents in conformance with the Stanford Cancer Institute Investigator Initiated Protocol document template, modeled after the NCI Cancer Therapy Evaluation Program. The CCTO Clinical Trials Facilitators are available to assist with the development of investigator-initiated studies, including behavioral, correlational, and epidemiological and tissue banking studies.
Stanford Investigators must use the below protocol templates and guidelines for new protocol development.
Investigator Initiated Resources
- Responsibilities of the Sponsor-Investigator IND Holder
Mar 12, 2007 - Protocol Template for Investigator Initiated Interventional Studies
Dec 14, 2011 - Protocol Template for Investigator Initiated Multisite Interventional Studies Dec 14, 2011
- Protocol Template for Investigator Initiated Non-Interventional Studies Oct 4, 2011
- Conducting Investigator Initiated Multi-Site Trials SOP Feb 28, 2013
Trial Administration