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.


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

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Key Activities

Clinical Trial Registries

Federal regulations and policy dictate the types of studies that must be registered on 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.


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.


The Compliance program exists to increase compliance with Good Clinical Practice (GCP), applicable regulations, institutional policies, the institutional Data and Safety Monitoring Plan (DSMP), and SOPs, and establish standards for clinical trial management and conduct. It serves as a link between the monitoring, auditing, and training programs and provides an evidence-based approach to efficient use of available resources and data.

Regulatory Affairs

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, document review, and technical writing support for investigator-initiated clinical trial protocols and associated materials that are submitted to the FDA under an investigational new drug (IND) application.
  • 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 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.

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. These data support research operations across the consortium, are used for mandatory reporting to federal funding agencies, and (where appropriate) are interfaced to the medical record system to facilitate accurate and timeline research billing.

Orientation and Training

CRS provides orientation support and clinical research-related training to Consortium faculty and staff involved in the design, conduct, and/or reporting of a cancer-related, interventional, and prevention clinical trial. Training is offered in various formats such as eModules, recorded presentations, and instructor-led workshops, which help build foundational knowledge and provide continuing education units (CEUs) for those who are ACRP/SOCRA certified. CRS runs monthly forums for research managers and general study staff to foster community, support education opportunities, and provide operational updates.

Central Startup

The Central Startup Team facilitates comprehensive study startup on behalf of research groups for industry-sponsored oncology clinical trials. Comprehensive startup services include: initial intake and site minimum requirement collection; assignment to the central startup team; all required clinical trial management system submissions; internal and external regulatory submissions, budget development and negotiation; clinic implementation; site training/supply/access requests from site qualification to RG-activation.

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, auditing, 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


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.