Federal regulations and policy dictate the types of studies that must be registered on ClinicalTrials.gov and the Clinical Trials Reporting Program (CTRP). CRS facilitates registration and maintenance in these federal registries for Consortium partner institutions.

The Industry Clinical Contracts Office and Fiscal Management groups within Clinical Research Support address the contract negotiation for industry trials and budget setup on study start-up for Fred Hutch.  During the life of the study, activities include invoicing and booking of revenue, as well as the renegotiation of contracts, when necessary.

CRS conducts monitoring according to the NCI-approved Institutional Data and Safety Monitoring Plan. All clinical research studies that are not monitored by another entity will be monitored by CRS. The frequency and the scope of the monitoring are determined by the risk level of the study. Studies that support an Investigational New Drug (IND) held by a Consortium investigator or meet the NIH definition of high risk are monitored twice per year. Studies designated as medium risk are monitored every 12-24 months.

Partner Access facilitates non-employee access to clinical systems at partner organizations. In particular, CRS facilitates the application process for Seattle Children’s. 

CRS manages a range of meetings that support cancer-related interventional trials and initiatives. The focus is to arrange, conduct, and record meetings according to the NCI-approved Data and Safety Monitoring Plan and where mandated by the Center's status as a NCI-Designated Comprehensive Cancer Center.

The Compliance program exists to increase compliance with Good Clinical Practice (GCP) and establish standards for clinical trial management and conduct. It serves as a link between the existing monitoring and training programs and provides an evidence-based approach to efficient use of both resources.

Regulatory Affairs provides services related to Cancer Consortium, clinical research and manufacturing activities that are regulated by the FDA.

• Clinical Research: Regulatory Affairs provides guidance, reviews of documentation, and technical writing support for investigator-initiated clinical research studies that are submitted to the FDA.
  
• FDA Inspections: Regulatory Affairs provides support, coaching, and institutional representation during FDA inspections of Consortium investigators.
• Training: Regulatory Affairs provides tailored training addressing responsibilities of conducting investigational new drug (IND) research under FDA regulations.
• Manufacturing:  Regulatory Affairs consults with Fred Hutch research and clinical manufacturing facilities to provide guidance and technical writing support for manufacturing processes, quality systems, and submissions to the FDA.

The OnCore Clinical Trials Management System (CTMS) serves as a single, centralized, web-based enterprise resource to support clinical research studies conducted across the Consortium.

Data related to the research management of Consortium studies are gathered and reported in a real-time basis in the CTMS. This is provided not only to support the management of the daily CRS operations, but also many departments and programs within the Cancer Consortium as well as reporting to our funding agencies.

CRS manages the Clinical Research Coordinator Training which brings together both CRS and other Consortium Member resources for a multi-day training event twice per year.

CRS also helps to manage Consortium Study Coordinator meetings. These clinical and research-oriented agendas, organized for research coordinators from the Fred Hutchinson Cancer Center and UW, are based on topics of timely import. Items of ongoing interest are brought back on a regular basis.