Federal regulations and policies establish the requirements for ClinicalTrials.gov and the Clinical Trials Reporting Program. CRS facilitates the registration and ongoing maintenance in these federal registries for Consortium partner institutions.

CRS facilitates the contract negotiation for industry trials and budget setup during study startup. During the life of the study, activities include invoicing, booking of revenue and the renegotiation of contracts, when necessary.

CRS conducts monitoring in accordance with the NCI-approved Institutional Data and Safety Monitoring Plan. Clinical research studies not monitored by another entity will be monitored by CRS. The frequency and scope of monitoring are determined by the risk level of the study. 

CRS oversees the process of granting non-employee access to clinical systems across partner organizations and facilitates the application process for Seattle Children's.

CRS facilitates meetings aligned with the NCI-approved Institutional Data and Safety Monitoring Plan, ensuring compliance and supporting the Consortium's NCI-Designated Comprehensive Cancer Center status.

The Compliance program establishes standards for clinical trial management and integrates monitoring, auditing and training through an evidence-based approach to optimize resources and data utilization.

CRS provides guidance and assistance as needed to all Consortium member investigators conducting clinical research under FDA regulations. The Regulatory Affairs program also provides hands-on support, coaching and institutional representation during FDA inspections.

The OnCore Clinical Trials Management System (CTMS) is a centralized, web-based enterprise resource supporting clinical research across the Consortium. It streamlines research operations, enables mandatory reporting to federal funding agencies and, where applicable, integrates with the medical record system to ensure accurate and timely research billing.

CRS provides training for Consortium faculty and staff involved in clinical research through eModules, recordings and workshops, offering continuing education units (CEUs) for ACRP/SOCRA-certified professionals. CRS also hosts monthly forums to support education, community-building and operational updates.

CRS streamlines study startup for industry-sponsored oncology clinical trials, providing end-to-end support for research groups.