Clinical Regulatory Operations and Procedures (CROP)
Mission
Provide quality regulatory support to researchers, research staff, staff affiliates, research sponsors, and research participants involved in cancer cell therapies at Stanford Medicine.
Vision
Create resources and strategies to provide excellent quality services and regulatory guidance to the Center for Cancer Cell Therapy research community to align with external accreditation organizations and regulatory bodies.
Values
- Honesty, Respect and Integrity
- Excellence and Service
- Communication and Collaboration
- Education and Development
Our Services
- Protocol writing
- FDA submissions
- Draft Investigational New Drug Applications (IND) and amendments
- Support Institutional regulatory submissions: Institutional Review Board (IRB), Administrative Panel on Biosafety (APB), Scientific Review Committee (SRC)
- Assist with Sponsor’s oversight responsibilities
- Offer training for IND Holders, Principal Investigators, new investigators, and research staff