Pages detailing various steps during the start-up process can be found on the Study Start-Up FH Oncology Map and UW Oncology Map. The map along with tools to assist with startup including protocol templates, Start Up Process FAQs, Startup Budget Development FAQs, Central Startup Checklist (FH specific), Central Startup Checklist (UW specific) and review tools can be found on the Clinical Research Resources Website.
Log in to OnCore for additional resources and recommendations for negotiating industry sponsored clinical trial budgets available in OnCore\CTMS Documents under CRS Budget and Startup Resources:
Please contact Ashley McCauley at CRSstartuprequest@fredhutch.org for more information about comprehensive startup support for industry-sponsored interventional trials.
If you do not have a HutchNet ID and would like access to the Clinical Research Resources Website, please contact Clinical Research Support.
Industry Clinical Contracts Office (ICCO) is the group within Clinical Research Support (CRS) that negotiates and facilitates the execution of agreements related to industry-sponsored clinical trials.
Executing clinical trial agreements between Fred Hutch and industry sponsors involves negotiating numerous terms including publication, confidentiality, intellectual property rights, data ownership, indemnification, and subject injury language.
ICCO negotiates these terms with the intent of protecting the rights of Fred Hutch, the investigator, and the study subjects. This process often takes several rounds of negotiations before a contract can be finalized.
Once a clinical trial agreement is fully executed, our fiscal management group, CRS Post Award facilitates project setup and provides ongoing management of the project budget from activation to closeout.
Types of agreements may include:
- Industry-sponsored clinical trial agreements
- Investigator-initiated study agreements
- Confidential disclosure/nondisclosure agreements related to clinical trials
- Clinical material transfer agreements and clinical drug transfer agreements for drugs/devices/biologics used in humans in clinical research
- Industry-funded subcontracts under a clinical or non-clinical research agreement
- Amendments to any of the above types of agreements
If you have questions on how to submit to our office or you’ve received a clinical trial-related agreement that will involve Fred Hutch and are not sure of next steps, please email the ICCO group at ICCO@fredhutch.org. We are happy to answer any questions you may have.
All submissions to ICCO should go through Forms Central. Please click on the type of Agreement below that you are submitting:
- Clinical Trial Agreement (sponsor-initiated or investigator-initiated)*
Before submitting an Industry Sponsorship Form for a CTA, please complete the REDCap New Study (Intake) Submission Form to obtain the RG number for the protocol.
- Confidential Disclosure Agreement/Nondisclosure Agreement
For agreement types other than those listed above, please reach out directly to ICCO.
Starting and managing a study conducted under an Investigational New Drug application (IND) or Investigational Device Exemption (IDE) involves greater risk, complication, and attention from the study team. The Clinical Research Support Regulatory Affairs group is ready to help all Consortium study teams navigate the regulations and processes laid out by the FDA.
- Study will be conducted under a new IND or IDE to be submitted by the PI or another individual at Fred Hutch/UW.
- Study will evaluate one or more approved drugs in a way that is not specifically described in the FDA-approved package insert (e.g., different indication, dose, schedule, combination, combining with radiation, etc.). This type of study may require an IND or determination of IND exemption.
- Note: Standard clinical use of approved products in an oncology setting does NOT always specifically reflect the approved labeling. RA should be contacted if the study use differs from labeling, even if it is based in established clinical practice.
- Study will evaluate a device, including in vitro assays.
- Study will evaluate stem cell transplant for treatment of disease other than hematologic malignancies.
- Study has IND exemption confirmed by the FDA.
- Study will be conducted under an existing IND or IDE held by the PI or another individual at Fred Hutch/UW.
- Study will be conducted under an IND held by an investigator at another institution, or held by another academic/research institution.
Protocol Review and Monitoring Systems (PRMS)
The Consortium PRMS is a two-stage review mechanism for assuring rigorous internal oversight of the scientific aspects of all cancer-related interventional trials.
- Cancer-related trials are those:
- Funded by NCI; or
- Primary site of a multi-site trial has classified the study as cancer or cancer-related; or
- The trial cohort will include both patients with a cancer diagnosis and others without a cancer diagnosis AND includes a primary or secondary analysis of the portion of the cohort with a cancer diagnosis; or
- Research of secondary conditions related to cancer treatment in patients with a cancer diagnosis who have received that treatment; or
- Cancer prevention studies that specifically include a primary outcome of cancer diagnosis.
- An interventional trial is research in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. For more information, please see the NIH Decision Tool: Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial?
In determining the impact the new study could have on the research field involved, the PRMS considers the adequacy of the plans to include women, minorities, special populations, and individuals across the lifespan as appropriate for the scientific goals of the research. Research results cannot fully be considered generalizable if the research does not include groups most greatly affected. The Office of Community Outreach and Engagement (OCOE) can help Cancer Consortium investigators in better understanding how to engage diverse populations with the goal of broadening research participation.
The PRMS has been fully approved by the NCI (status can be found here).
First stage: The Research Groups complete the initial scientific review of concepts and protocols, prioritizing trials for their patient population to reduce the number of studies that are low-accruing due to competing trials.
Second stage: The Scientific Review Committee (SRC) reviews research studies for scientific merit and integration of the research effort with regard to competing protocols and Cancer Consortium research priorities.
Radiation Safety Committee
- The Fred Hutch/Cancer Consortium IRB Website provides guidance and requirements for radiation safety review for Fred Hutch and Cancer Consortium studies along with key contact information for the radiation safety departments at each of the Cancer Consortium sites.
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.
The program provides support to Investigators and study teams throughout the study lifecycle and input on Consortium-wide initiatives.
To best support and facilitate compliance efforts, the Compliance program works closely with many departments and services throughout the Cancer Consortium, including:
- Clinical Research Support, including Regulatory Affairs, Monitoring, Training and Education, Institution-Sponsored IND (ISI) Program, Central Regulatory, NCTN;
- Institutional Review Office/Institutional Review Board;
- Patient Safety and Quality;
- Office of the General Counsel; and
- Ethics and Compliance Office
- Provide guidance to study teams regarding how to best address monitor’s and auditor’s findings.
- Work with study teams on compliant processes and workflows that aim to decrease institutional risk and ensure subject safety.
- Perform facility audits (e.g., laboratories, clinical areas engaged in research).
- Perform routine, focused, pre-inspection industry, and sponsor audits.
- Develop Consortium-wide tools and launch compliance-related initiatives.
- Assist study teams and ancillary services with Corrective and Preventive Action (CAPA) Plan development and review.
For questions, please contact CRSCompliance@fredhutch.org.
CRS manages meetings that support clinical research studies and initiatives. Learn more about the committees.
The Cancer Consortium's participation in the National Cancer Institute's (NCI) National Clinical Trials Network (NCTN), is overseen by Clinical Research Support.
Questions or Assistance
Clinical Research Support is here to assist and guide study teams. Please contact us if you need anything not found in these resources, or need clarification on how to proceed with your study.