This page provides an overview of key processes for initiating a clinical research study. Detailed startup information can be found on the Clinical Research Resources Website. These include study startup maps, protocol templates, checklists, FAQs and other review tools.
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Contracts & Fiscal Management | Regulatory Affairs | Study Funding | PRMS | Study Reviews | Compliance
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.
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.
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
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
- Subcontract
- Amendment/Modification
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.
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?
PRMS does not review non-interventional cancer studies or studies that are not studying cancer-related conditions, this includes observational studies and LTFU studies.
The Compliance program supports compliance with Good Clinical Practice (GCP), applicable regulations, institutional policies (including the institutional Data and Safety Monitoring Plan) and standard operating procedures. The program establishes standards for clinical trial management and integrates monitoring, auditing and training through an evidence-based approach to optimize resources and data utilization.
The program provides support to Investigators and study teams throughout the study lifecycle and input on Consortium-wide initiatives.
For questions, please contact CRSCompliance@fredhutch.org.
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.
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.