Investigator Initiated Studies
Investigator Initiated (also known as Investigator Authored) clinical trials are studies largely designed and written by Stanford investigators. Stanford Cancer Center investigators are required to design their protocol documents in conformance with the Stanford Cancer Center Investigator Initiated Protocol document template, modeled after the NCI Cancer Therapy Evaluation Program. The CCTO Regulatory Manager and 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
- Investigator Initiated Clinical Trials Template Jul 11, 2007
- Investigator Initiated Multi-Site Trials Template Jul 10, 2007
- Conducting Investigator Initiated Multi-Site Trials SOP Jul 10, 2007
Trial Administration