Cancer Institute A national cancer institute
designated cancer center
Cancer Clinical Trials Office

Regulatory Resources

Standard Operating Procedures

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.

Sponsor Standard Operating Procedures
GXP-001 Preparation and Management of SOPs Coming Soon
GXP-002 Trial Documents and Change Control August 20, 2014
GCP-001 Outsourced Services May 9, 2014
GCP-002 Clinical Site Selection June 4, 2014
GCP-003 Monitoring Clinical Investigations May 9, 2014
GCP-004 Pharmacovigilance Coming Soon
GCP-005 Supplying and Handling Investigational Products May 9, 2014
GCP-006 Record Retention June 4, 2014
QA-001 Quality Assurance Activities to Support Drug Development June 3, 2014

Site Standard Operating Procedures
Documentation of Chemotherapy and Biotherapy Orders in Clinical Research December 18, 2013
Responsibilities of the Sponsor-Investigator IND Holder March 12, 2007
Conducting Investigator Initiated Multi-Site Trials SOP February 28, 2013
How to complete an FDA Form 1572 SOP October 17, 2012
Management of Site Regulatory Files SOP October 17, 2012
Obtaining Informed Consent SOP April 30, 2013
Adverse Event SOP July 30, 2014
Documenting and Reporting Protocol Deviations SOP July 30, 2014
FDA Inspection of Clinical Investigators March 5, 2013

Guidance Documents
Clinical Trial Record Retention March 16, 2011
Compliance with FDA 21 CFR 11 Electronic Records and Signatures October 3, 2013
Guidance for Obtaining Eligibility Waivers March 5, 2013

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