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Trial Innovation Network

The Clinical and Translational Science Award (CTSA) Program has established a new collaborative research network called the Trial Innovation Network. The Trial Innovation Network is comprised of more than 50 medical research institutions in 31 states funded by the CTSA Program.

The goal of the Trial Innovation Network is to execute multi-site trials better, faster, and more economically.  To achieve this, the Network features a single IRB system, master contracting agreements, quality by design approaches, and a focus on evidence-based strategies for recruitment and patient engagement. The Network will also serve as a national laboratory to study, understand, and accelerate the process of conducting clinical trials.

Investigators can engage the Trial Innovation Network through consultations and services to support multi-center clinical trials and studies. Consultations may lead to clinical protocols that can be implemented at CTSA institutions across the country.

All proposals should be reviewed and approved by the ITHS Hub Liaison Team prior to submission. Please contact us through the form below. 

Trial Innovation Network Resources

Trial Innovation Network Resources

The following types of services and initial consultations are provided by the Trial Innovation Network:

Services

  • Implementing Standard Clinical Trial Agreements for your multi-site study
  • Implementing a Central IRB for your multi-site study
  • Recommendations about study feasibility and recruitment/retention strategies
  • Evaluating and improving recruitment materials
  • Engaging diverse groups of stakeholders as part of a Community Engagement Studio
  • Leveraging the Electronic Health Record to inform study design and site selection

Initial Consultations

  • Study design (aims, methodology, statistical plan, regulatory considerations, recruitment, assessments, interventions, etc.)
  • Study budget (estimates for overall budget, site/subject budget, recruitment budget, etc.)
  • Projected timelines (funding, planning, start-up, conduct, close-out, and publication)
  • Recruitment strategies
  • Assessment of feasibility (identification of potential barriers to completing the study on-time and on-budget)

More Information

For more information on the process for requesting Trial Innovation Network services and consultations, go to https://trialinnovationnetwork.org/definition-of-services-and-initial-consults/.

All requests must be reviewed, approved, and submitted by the ITHS Hub Liaison Team, please begin by filling out the “Request an ITHS TIN consultation” form below.

ITHS Support for TIN Study Sites

ITHS Support for Local Trial Innovation Network Study Sites

If you are an investigator from one of the ITHS partner institutions or collaborating organizations, you may be selected to participate as a site on a Trial Innovation Network study.  If you decide to participate as a site, ITHS faculty and staff are here to help support local study start up.  This includes cohort identification services, access to SMART IRB, utilization of the FDP-CTSA Standard Agreement, and answers to questions about working on a CTSA Trial Innovation Network study.

The Trial Innovation Network automatically notifies ITHS when selecting local sites for participation in Network studies.  We will reach out to you to let you know we are here to help.  If you are thinking of participating in a Trial Innovation Network study and haven’t heard from us, or have general questions about this process, please feel free to contact us through the form below.

Webinars

Webinars

The Trial Innovation Network offers regular webinars.  Some webinars are CTSA-specific, but many are general clinical research-related topics.  All Network webinars are open and free to attend.

Proposal Process

Accessing Trial Innovation Network Services and Consultations

Investigators who have a full time faculty appointment at the University of Washington may submit a proposal to the Trial Innovation Network requesting a Service or Initial Consultation. Proposals must be submitted by ITHS on the investigator’s behalf.

Resources to Develop Your Proposal to the Trial Innovation Network
Streamlined IRB & Contracting

Smart IRB

Recent policy changes by the NIH and DHHS require the use of a single IRB of record for multi-site research to reduce redundant IRB review and to streamline investigator submission processes.

Central IRBs

The Trial Innovation Network has established three Central IRBs (CIRBs), which are based on the SMART IRB Authorization Agreement. This service will provide CIRB services to a funded multi-center clinical trial.

The Trial Innovation Network CIRB will also provide resources, tools, and a web-based platform (SMART IRB Exchange) to operationalize the CIRB. The goal is to ensure all site investigators understand the process for initiating the use of a CIRB at their local institution, as well how to submit and report to the CIRB from initial submission to study closeout.

Standard Agreement

The complexity of contract negotiations can be a major barrier to timely study start-up. The Trial Innovation Network can help you save time by implementing the use of the Federal Demonstration Partnership (FDP)-CTSA Standard Agreement for your multi-site study. This streamlined process accelerates site participation in clinical trials by reducing delays due to contract negotiations.

Please contact us if you’d like to receive a copy of the FDP-CTSA Standard Agreement.

More Information

The University of Washington has agreed to utilize the CTSA Smart IRB and the Accelerated Clinical Trial Agreement to facilitate single IRB reliance and standardize contracts. This is an individual agreement with each institution; for more information about contracting and IRB standard agreements, please refer to the following institutional contacts:

UW

IRB Reliance Agreements
Human Subjects Division
Adrienne Meyer / Email

Standard Contracting Agreements
Office of Sponsored Programs
Vali Gazula / Email

Fred Hutch

IRB Reliance Agreements
Institutional Review Office
Karen Hansen /  Email
– or –
Van Nguyen /  Email

Standard Contracting Agreements
Office of Sponsored Research
Cynthia Lysen / 206-667-5807

Seattle Children’s

IRB Reliance Agreements
Office of Institutional Assurances
Laurie Price / Email
– or –
Kelly Lawrence /  Email

Standard Contracting Agreements
Contact the Vice President, Research
Erik Lausund / Email / 206-884-5138

Contact Us

Contact Us

Request an ITHS TIN Consultation

Request an ITHS TIN Consultation

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Latest Trial Innovation Network News

  • The National Institutes of Health (NIH) will require most applications for multi-site studies conducting the same protocol at each site and which are received on or after January 25, 2018 to describe the use of a single Institutional Review Board (IRB). ...

Cite ITHSThe Institute is supported by grants UL1 TR002319, KL2 TR002317, and TL1 TR002318 from the NIH National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program (CTSA).

Please help us continue to support your research by citing our grant number(s) in publications we supported.