Developing and maintaining trial protocols

The Central Protocol Operations Program (CPOP) oversees the development, maintenance, and distribution of study protocols generated by Alliance scientific committees, including the Study Concept and Review Committee.

CPOP coordinates the process from study concept through protocol development and activation, including scientific team coordination, concept review and prioritization, collaboration with the Translational Research Program, NCI submission, protocol development, budgeting, and study-specific logistics such as biomarker funding, pharmaceutical and regulatory affairs, safety requirements, and accrual management.

The program represents the Alliance in study-specific negotiations with the NCI, pharmaceutical partners, other research networks, international collaborators, and other stakeholders, while monitoring activities against NCI NCTN Operational Efficiency Working Group (OEWG) and NCORP efficiency timelines..

CPOP also maintains the official protocol documents and related study materials and posts them on the Cancer Trials Support Unit (CTSU) website for participating sites. CTSU also serves as a central communication platform for Alliance study chairs and investigators throughout the protocol development and maintenance process.

Principal Investigator and Director
Alliance Central Protocol Operations Program
Olwen Hahn, MD
Associate Professor of Medicine, Section of Hematology and Oncology
University of Chicago Medical Center