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  • Effective July 1, 2023:
    Each CTN2 Clinical Trial Agreement (CTA) will include a fair market value Sponsor Network Fee (SNF) for sponsored industry trials. The SNF is independent of the study budget fees for compensation to the Site for their costs and activities and shall not reduce of any part of the Site’s study budget.
  • Description and Rationale
    Created as a 501(c)3 subsidiary of the University of Tennessee Research Foundation, CTN2’s mission is deeply rooted in the advancement and support of research within its community of Sites in Tennessee and the region. CTN2 is uniquely structured to improve the benefit-burden balance of conducting research, bringing value to Sponsors, Sites, and patients. CTN2’s model enables our sites to focus on patient accrual and clinical trial conduct delivering rapid and high-quality results. The SNF is charged to Sponsor for the services and benefits CTN2 provides as a site management organization (SMO) to its partnering sponsors and institutions: The use of CTN2’s network and services provides sponsors access to 18+ clinical sites while minimizing Sponsor time and effort using a ‘reverse funnel’ process for activities and communications. Driving collaboration and mentorship opportunities between sites further expands the network potential to increase enrollment. Access to industry and clinical expertise from early trial development through life cycle of trial provides unique value. CTN2 routinely engages with sites to understand and support each Sites’ unique resource needs such as staffing, training, and certification that fits within the CTN2 mission. CTN2’s organizational strength provides a powerful channel for communications with high levels of engagement and approachability.
  • Network Services and Justification
    Depending on the trial requirements, services may include, but are not limited to, marketing, identification, receipt and evaluation of study opportunities, study feasibility, identifying appropriate sites, single point contracting, single point payment management, and overall project management through the life cycle of the trial. 1. FEASIBILITY ANALYSIS – Impact to Benefit-Burden Balance: Single Point of Contact; Contracting Efficiency; Access to Patient Counts in Data Warehouse; Insight to Site Feasibility & Capabilities CTN2 works with its sponsors to understand the clinical trial protocols, patient population, and timelines in order to identify the best CTN2 regions, sites, and investigators for the particular project. Service includes execution of the CDA (a single CDA for multiple sites in most cases). These services are in addition to the site-specific feasibility conducted. 2. CONTRACTING FOR TRIAL CONDUCT – Impact to Benefit-Burden Balance: Single Point of Contact; Contracting Efficiency; Insight to Site Contract Requirements CTN2 streamlines the facilitation of CTA review and execution based on acceptable language in CTN2’s Network Agreement with Sites. Contracting services includes Master CTA’s and amendments to Agreements. Service includes CTN2’s insight and updates of non-sponsor site agreements, when applicable. Based upon our experience, Feasibility Analysis and Contracting services conducted by CTN2 is estimated to include approximately 8 – 10 hours of CTN2 staff and medical director time. 3. PAYMENT MANAGEMENT AND RECONCILIATION – Impact to Benefit-Burden Balance: Single Point of Contact; Payment Efficiency CTN2 serves as the payee for all sponsor payments as a pass-thru to Sites. As the payee, CTN2 verifies all paymentsfor accuracy, including but not limited to for the correct study, site, amount and invoice, prior to sending to Site. Our process alleviates sponsor time and effort to reconcile on the back end, sometimes months after trial has ended. We have been providing this service (free of charge) since CTN2’s inception and have worked in depth with sponsors to refund or adjust numerous incorrect payments to ensure payments are in good standing in real time. Based upon our experience, Payment Management and Reconciliation services conducted by CTN2 are estimated to include approximately 8 – 10 hours of CTN2 staff time. 4. OVERALL NETWORK PROJECT MANAGEMENT – Impact to Benefit-Burden Balance: Single Point of Contact; Close Engagement with Sites CTN2’s goal is to reduce the sponsor project management resource needed to manage CTN2 sites. We do this by acting as an extension of the sponsor project management team to provide overall project management of the study tasks for the sponsor and sites. We provide a single point of contact for all study startup, administrative and payments. We cultivate a service minded culture and are always there to help. Having trouble getting in touch with or getting a response from one of our sites? Contact CTN2 and we can help! Based upon our experience, the Overall Network Project Management services conducted by CTN2 are estimated to include approximately 10 – 12 hours of CTN2 staff time. 5. ACCESS TO INDUSTRY & CLINICAL EXPERTISE – Impact to Benefit-Burden Balance: Resource for Trial Development and Feasibility As a statewide, multi-therapeutic area clinical trial network, CTN2 is able to provide our sponsors with unprecedented access to clinical trial and patient care expertise. Whether your medical team is looking for experts to review a potential clinical trial, have access to industry experts, or discuss specifics related to patient care and treatment, CTN2 provides this access. CTN2 attends and participates in industry-related functions such as a Clinical Trials Industry Advisory Committee and commercial events to stay well informed of changes and trends. Based upon our experience, Access to Industry & Clinical Expertise service conducted by CTN2 is estimated to include approximately 4 – 6 hours of CTN2 staff and medical director time.
  • CTN2 Network Fee Charge
    The Sponsor Network Fee charge and justification is located separately from the study budget in the CTA Exhibit or Schedule in the CTA and applicable upon execution of the CTA. Interventional Studies – $5,000 per site. One time, non-refundable fee payable upon execution of CTA. Non- Interventional Studies – $2,500 per site. One-time, non-refundable fee payable upon execution of CTA. Fees are reviewed annually prior to July 1st and subject to change. For questions, please contact Phil Cestaro at or Sandra Dodd at
  • Frequently Asked Questions
    What’s the difference between charges in the Site budget and the Network Fee? The SNF is charged for costs associated with Network activities, over and above Site activities. The costs and services included in the SNF are not included or duplicative to any of costs outlined in the Site Budget. As a partnering institution, CTN2’s role augments research activities already covered in the Site budget. CTN2 services are designed to enhance research and improve the benefit-burden balance. Will Sponsor Network Fee be paid if CTA not executed? No. SNF is applicable upon execution of the CTA. What language should be included in the terms of the CTA? Language will be provided. Will Sites need to amend executed CTAs or CTAs in negotiation? No. SNF is applicable to new trials in which the initial contract edits have not yet been received by sponsor. Where is the Network Fee located within the CTA? The SNF includes justification for network services in a Schedule or Exhibit to the CTA, separate from study budget fees. See the attached CTA Sample Language for CTA.
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