Clinical Trial Protocol Development
Cellular Therapy Operations Program (CTOP)
CTOP is a sponsored clinical project support team.
About CTOP
The Cellular Therapy Operations Program (CTOP) is a team of experienced clinical research professionals that support investigator-initiated clinical trials testing therapeutic agents produced at the Gates Biomanufacturing Facility (GBF).
CTOP works on behalf of CU Anschutz, acting as the sponsor team, and is comprised of a Scientific and Medical Director, Regulatory and Operations Director, Project Manager, Pharmacovigilance Specialist, and Protocol Development Specialist. The team works closely with the PI, study team, GBF, and the Office of Regulatory Compliance to develop and operationalize cell therapy clinical trials.
Seminar Series Recording - Friday, May 20, 2022 3:00 - 6:00 pm
For questions about this event contact
Chanel Mansfield, MPH, CCRP
Program Director, Cell Therapy Operations Program (CTOP)
Office of the Vice Chancellor for Research
CTOP Mission
The mission of CTOP is to partner with CU Anschutz investigators and stakeholders to develop innovative Cellular Therapies and facilitate the regulatory and operational conduct of clinical trials.
CTOP Roles
FDA IND Submission
strategy and materials
Project Timelines Management
manufacturing and regulatory milestones
Comprehensive Sponsor Budget Development
Regulatory Submission
materials for scientific and ethical review (PRMS, IBC, IRB)
Pharmacovigilance Oversight Plans