Standard Operating Procedures (SOPs), Guidelines and Templates
SOPs
All faculty and staff participating in research at Stanford Cancer Institute are required to review and follow the below SOPs.
At the start of employment, all SCI staff members must complete a short web document to confirm review of the SOPs.
For questions regarding SOPs, please contact the CCTO Regulatory Manager.
- Responsibilities of the Sponsor-Investigator IND Holder
Mar 12, 2007 - Conducting Investigator Initiated Multi-Site Trials SOP Jul 7, 2007
- How to complete an FDA Form 1572 SOP Oct 17, 2012
- Management of Site Regulatory Files SOP Oct 17, 2012
- Obtaining Informed Consent SOP Nov 1, 2006
- Adverse Event SOP May 30, 2012
- Documenting and Reporting Protocol Deviations SOP Oct 16, 2012
- FDA Audit SOP Dec 18, 2008
Guidelines
- Clinical Trial Record Retention Mar 16, 2011
- Procedure for Obtaining a Waiver/Exception to Protocol Eligibility Criteria Apr 3, 2012
Investigator Initiated Protocol Templates
- Interventional Studies
Aug 30, 2011 - Multisite Interventional Studies Sep 1, 2011
- Non-Interventional Studies Oct 4, 2011
- Cancer Imaging Trials Sep 10, 2012
Trial Administration