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 FHCRC 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.
Contracts & Fiscal Management
Contracts & Fiscal Management addresses the contract negotiation for industry trials and budget setup on study start-up for FHCRC. 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 Safety and 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 Coordination
Protocol Review Coordinators (PRCs) act as a liaison between the study team and the IRB by advising study teams regarding the preparation and submission of new studies, annual renewals, and study modifications. Their primary expertise is navigating the review system and ensuring appropriate committee reviews, but PRCs also have advanced working knowledge of regulatory requirements and the Cancer Consortium clinical research infrastructure.
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 mandated by the Center’s status as a 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 the Center 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
Research Management Data gathers and reports up-to-date information on a real-time basis related to the research management of the Consortium. 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. There are several databases utilized in Clinical Research Support:
- PIRO: Consortium protocol information as well as information required for the Clinical Research Support operations
- Patient Accrual Tracking System (PATS): patient enrollment information for Cancer Consortium institutions outside of FHCRC.
- Clinical Trials/Monitoring Database
- EPSAC/Training Database
Clinical Research Support manages the Clinical Research Coordinator Training which brings together both CRS and other Consortium Member resources for a three-day training event twice per year.
Clinical Research Support manages monthly CRS/IRO Brown Bag meetings. These meetings allow study teams to have direct access to both Clinical Research Support and Institutional Review Office staff. The open-forum meeting is used to answer questions, talk about upcoming changes, and build relationships between the IRO, CRS and study teams.
Additionally, Protocol Review Coordination offers one-on-one training with new coordinators working with a Protocol Review Coordinator.