Protocol Development Services

Overview

Siteman Cancer Center employs a team of specialists to work with investigators in the development of institutional trials within the cancer center. This Protocol Development team supports cancer research by providing writing and design assistance for investigator-initiated trials (IIT). These services are available at no cost to Siteman members.

The Protocol Development team works closely with investigators and collaborators within Siteman’s Biostatistics Shared Resource during the iterative protocol drafting process to ensure well-defined study objectives and well-crafted protocol design prior to initiation of scientific and regulatory review. All new IIT applications at Siteman are written and/or reviewed by the Protocol Development office, ensuring that every cancer-focused IIT is consistently and optimally designed.  Throughout the submission process, Protocol Development guides the collaborative review process by working seamlessly with study principal investigators, Siteman’s Biostatistics Shared Resource, the OnCore Support Team, and study data managers.

Protocol Development Services

• Develop new protocols and informed consent documents;
• Prepare new study applications to trigger reviews by the Protocol Review and Monitoring Committee (PRMC) and the Washington University Institutional Review Board;
• Manage applications for submission to other specialized committees within the university and functions as a liaison between these committees and cancer center investigators in order to incorporate appropriate changes and ensure timely review;
• Assist with the preparation and approval of amendments when changes are required to previously approved projects;
• Create electronic case report forms that capture the necessary data to meet protocol-defined endpoints;
• Prepare Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications for submission to the Food and Drug Administration (FDA);
• Register all applicable studies with the NCI’s Clinical Trials Reporting Program (CTRP); and
• Provide ongoing support for the registration, maintenance, and reporting of trial results to ClinicalTrials.gov for all SCC IITs.

Contacts

Stephanie L Myles, Associate Director – Clinical Trials
[email protected]