Clinical Research Support oversees a group of resources available to investigators to support their research, simplify processes and enable regulatory compliance.
Clinical Trials Website Management
Clinical Research Support manages documents and data that drive Clinical FYI, data that is presented to the public on the Fred Hutch Clinical Trials Website and SCCA Clinical Trials website, and manages the submission of studies to both the NCI's Clinical Trials Reporting Program and ClinicalTrials.gov.
ICCO & Fiscal Management
The Industry Clinical Contracts Office (ICCO) and Fiscal Management groups within Clinical Research Support (CRS) 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 Clinical Research Support. The frequency and the scope of the monitoring are determined by the risk level of the study. All studies that support an IND held by a Consortium investigator, are Phase I studies, or meet the NIH definition of high risk are monitored twice per year. All other studies are monitored annually.
Partner Access facilitates non-employee access to clinical systems at partner organizations. In particular, Clinical Research Support facilitates the application process for Seattle Children’s.
Protocol Review Meeting Coordination
The meeting coordination team in CRS manages a range of meetings that support clinical research studies and initiatives. The focus is to arrange, conduct and record meetings with a particular focus on the Protocol Review & Monitoring System and Data and Safety Monitoring Committee mandated by the Center's status as a NCI-Designated Comprehensive Cancer Center.
The Quality Management program exists to increase compliance with GCP, establish standards for study coordination, and billing compliance. It serves as a link between the existing monitoring and training programs and will provide an evidence-based approach to efficient use of both resources.
Regulatory Affairs provides services related to clinical research and manufacturing conducted in the Cancer Consortium that is regulated by the FDA.
- Manufacturing: Consulting with manufacturing facilities at both Hutch and SCCA, Regulatory Affairs provides guidance and technical writing support for manufacturing processes, quality systems, and submissions to the FDA.
- Clinical Research: Regulatory Affairs provides advice, reviews of documentation or technical writing support for clinical research studies that are submitting to the FDA.
- Training: Regulatory Affairs provides tailored training addressing specific concerns of manufacturing or clinical teams.
Research Management Data
The OnCore 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.
Clinical Research Support 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 (CSC) meetings. These clinical and research-oriented agendas, organized for research coordinators from the Fred Hutchinson Cancer Research Center, SCCA, and UW, are based on topics of timely import. Items of ongoing interest are brought back on a regular basis.