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), 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 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.

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.

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.

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.