The Central Protocol Operations Program oversees the development and maintenance of all study protocols generated by Alliance scientific committees.
Program structure
Alliance staff members manage the complex process of study protocol development, including scientific team coordination, study concept review and prioritization, which includes collaboration with the Translational Research Program (TRP) for their scientific review, NCI submission, protocol document development and maintenance, and study budgeting.
In addition, Alliance staff coordinate study-specific logistics such as biomarker study funding (including collaboration with TRP to prepare applications), pharmaceutical and regulatory affairs, other regulatory logistics and implementation of accrual management plans. This process adheres to NCI NCTN Operational Efficiency Working Group (OEWG) timelines and the NCORP Concept/Protocol Efficiency Timelines, which are carefully monitored by Protocol Operations Office staff.
The Protocol Office also posts protocols and other study-related documents on the CTSU web site
for downloading by sites and serves as focal point of communication for both study chairs and investigators throughout Alliance member institutions.
Once a protocol is activated, Alliance staff implement protocol amendments and other protocol communications, maintain all regulatory support documentation, and serve on numerous NCI committees that work to improve the cooperative group process. The Central Protocol Operations
Program represents the interests of the group in many study-specific negotiations with the NCI, pharmaceutical firms, other network groups, international collaborators, and the public.