graphic showing clinical research support
Clinical Research Support (CRS) oversees a group of resources available to investigators to support their research, simplify processes and enable regulatory compliance.

Mission

Clinical Research Support’s mission is to ensure the conduct of efficient, compliant and high quality clinical research throughout the Cancer Consortium

Key Activities

Clinical Trial Registries

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.

ICCO & Fiscal Management

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.

Monitoring

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

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

Protocol Review Meeting Coordination

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.

Compliance

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

Regulatory Affairs provides services related to clinical research and manufacturing conducted in the Cancer Consortium that is 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: Consulting with manufacturing facilities at Fred Hutch, Regulatory Affairs provides guidance and technical writing support for manufacturing processes, quality systems, and submissions to the FDA.

Research Management Data

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.

Training

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.

Study Management

We provide resources for starting, renewing, modifying and closing a study. For all study activities, Clinical Research Support is there to assist and guide study teams.

Study Start Up

Information to be used as a guide when starting a study, including contracts and fiscal management, regulatory requirements, funding and reviews.

Study Start Up Information

Study Conduct

Information to be used when conducting a study including monitoring, protocol revisions, annual renewals and data and safety monitoring plans.

Study Conduct Information

Study Closure

Information to be used as a guide on how to close a study, patient follow-up and requirements for closing a study.

Study Closure Information

Helpful Resources

Clinical Research Support has assembled a number of resources for researchers conducting studies including the Clinical Research Resources Website (CRRW), obtaining partner access, systems used and training opportunities.

Policies and Tools

Policies

The CRS has assembled policies that ensure that all the cancer trials at our center are conducted with the highest possible standards for safety and scientific integrity.

Find a Policy

Forms, Templates & Documents

Forms and templates are needed at all stages of study start up and conduct. In the sections below, forms are grouped based on the status of the study.

View Forms

Contact Clinical Research Support

Representatives from Clinical Research Support are available to provide information and answer questions.