Cardiothoracic Surgical Trials Network (CTSN) Linked Clinical Research Centers (UM1 Clinical Trial Not Allowed )

Released Date
Expiration Date
Activity Code
UM1
Full Announcement
RFA-HL-19-009

Frequently Asked Questions for the Cardiothoracic Surgical Trials Network (CTSN) Renewal FOA RFA-HL-19-009 Linked Clinical Research Centers (UM1 Clinical Trial Not Allowed)

Q1. Section IV.2 of the Funding Opportunity Announcement, “Other Attachments” section requires documentation for “Population Available for Cardiac Surgical Clinical Trials and Studies (Required).” Should this be an individual pdf document for the primary site and a second pdf document for the affiliate site?

A1. Combine any relevant information into one pdf file for both primary and affiliate sites.

Q2. Section IV.2 of the Funding Opportunity Announcement, “Other Attachments” section requires documentation for Clinical Research History (Required).Should this be an individual pdf document for the primary site and a second pdf document for the affiliate site?

A2. Combine any relevant information into one pdf file for both primary and affiliate sites.

Q3. Section IV.2 of the Funding Opportunity Announcement, “Other Attachments” section requires documentation for “Data Integration Capabilities (Required).” Should this be an individual pdf document for the primary site and a second pdf document for the affiliate site?

A3. Combine any relevant information into one pdf file for both primary and affiliate sites.

Q4. Section IV.2 of the Funding Opportunity Announcement, “Other Attachments” section requires documentation for “Special Strengths (Required).” Should this be an individual pdf document for the primary site and a second pdf document for the affiliate site?

A4. Combine any relevant information into one pdf file for both primary and affiliate sites.

Q5. Section IV.2, of the Funding Opportunity Announcement, “Other Attachments”  section requires documentation for “Clinical Research History (Required).” Since the trials to be performed over the grant period are unknown, should this pdf include the entire history of cardiac surgery at the site (possibly including thoracic aorta procedures as well)? 

A5. This section is asking for historical data for the three years from 2015-2017.  No trials are specified, so provide whatever information you think is appropriate for the review committee to evaluate your cardiac surgical population.

Q6. Section IV.2 of the Funding Opportunity Announcement, “Other Attachments” section; Population Available for Cardiac Surgical Clinical Trials and Studies lists Single CABG as an example of a cardiac surgical procedure. This phrase is ambiguous. Does this mean a) “isolated” CABG (either primary or as a reoperation) or b) use of a single bypass graft or c) primary (first time) CABG? 

A6. The example was intentionally ambiguous. Therefore, provide any/all information you think is relevant to the application and will be helpful for reviewers to assess.

Q7. The FOA states “An LCRC affiliate site must have conducted fewer than three NHLBI-funded randomized controlled trials per year in cardiac surgery and received less than $3 million in NHLBI total grant funding to the institution in 2017.” Is this a change from the language in the previous Notice of Intent to Publish?

A7. The requirement has not changed. The FOA asks for documentation of meeting these criteria.

Q8. Section IV.2, of the Funding Opportunity Announcement, “Other Attachments” “Clinical Research History (Required)”  asks for “the primary and affiliate sites’ prior experience with multi-center collaborative clinical research in cardiac surgery and cardiovascular disease.”  Is the intention for each site to also list non-surgical cardiovascular trials, such as coronary stent trials, CV drug trials, aortic stent trials, peripheral vascular disease, etc. 

A8. Yes, the intent is for applicants to provide a summary of cardiac surgical and non-surgical cardiovascular trials for both the primary and affiliate site. 

Q9. What is the expectation or requirement in regard to implementation science in the skills core and clinical trials enterprise?  

A.9. Implementation science is being introduced into the CTSN as the next step in translating important findings where they are most needed to clinical and community settings. In Section IV. Application and Submission Information under the “Research Strategy, C. Clinical and Implementation Research Skills Program Plan,” the applicant is asked to “describe plans for fostering the next generation of clinical researchers so that they are versed in late-stage (T4-translation to populations) implementation research.”  In this same section the applicant is asked to “Detail the strategy for integration of late-stage (T4 translation to populations) implementation research skills development into the clinical research activities and outline how this effort will be targeted to impact CV disease.”  These concepts relating to Implementation Science are to be included in the Plan along with the other clinical research skills development activities. There is no specific requirement concerning implementation science in the clinical trials enterprise. However, it is anticipated that in the renewal these concepts will increasingly be integrated into data collection and future trial designs and plans for the ultimate translation and uptake of clinical findings to populations with high disease burden. 

Q10. What is the expectation or requirement for the performance of the primary site in terms of enrollment/randomization of patients into CTSN trials by the affiliate site?

A10. The primary site is tasked with mentoring the affiliate site and providing a plan related to this activity as described in Section IV. Application and Submission Information under the “Research Strategy, B. Mentoring Plan for Affiliate Site.” There is no specific requirement concerning enrollment by either the primary or the affiliate site. Milestone accrual plans will be developed for all sites participating in the Network commensurate with site patient load and other factors after the Network has launched. Affiliate sites will be expected to participate in calls, investigator meetings,  protocol development and reporting of results for the trials.

Q11. Section IV.2 of the Funding Opportunity Announcement, “Other Attachments” section requires documentation for “Clinical Research History (Required)” and specifically states that a scorecard must be provided and certified by the DCC for CTSN trials. How do we obtain a scorecard for CTSN projects?

A11. Please contact Dr. Annetine Gelijns at the current CTSN Data Coordinating Center to request a scorecard for the CTSN trials conducted at your site, which should be included in the Clinical Research History pdf document.

Q12. Can VA sites be affiliates and if so how? 

A12. Yes, VA hospitals can be affiliate sites. Please click here to read eligibility requirements for Federal Institutions. There may be restrictions related to salary reimbursement (please refer to the next question for the relevant link). 

Q13. Are there allowable and unallowable costs when collaborating with a Government Agency such as the Veteran’s Administration? 

A13. Please refer to the Grants Policy Statement where allowable and unallowable costs are discussed. Please click here to access the appropriate section.

Q14. If submitting a renewal application, is the progress report and publications list included in the 12 page limit or can this be a separate file?

A14. If submitting a Renewal application, the Progress Report for Renewal Applications falls within the Research Strategy and is therefore included in the page limits for the Research Strategy. Our advice is to include it in whichever section (A. Clinical and Clinical Research Capabilities (12 pages); B. Mentoring Plan for the Affiliate Site (12 pages); or C. Clinical Implementation Research Skills Program Plan (6 pages)) makes the most sense in the context of the story being conveyed. The Progress Report Publication List only applies to Renewal applications and is a separate attachment which is not page limited. Please see page 140 of the GENERAL INSTRUCTIONS FOR NIH AND OTHER PHS AGENCIES for additional guidance.

Q15. Since no actual clinical trials are being proposed in the application, what is expected for the sections related to Human Subjects and Clinical Trials Information and Inclusion of Women, Minorities, and Children?  

A15. Because human subjects research is anticipated within the period of award, but definite plans for this involvement cannot be described in the application, a Delayed Onset record should be provided. A delayed onset record should include a study title (note this can be changed later, so the title text is not important – can simply be “Studies – TBD” or “Studies identified post award”). The Anticipated Clinical Trial check box should not be checked since the FOA does not allow Clinical Trials. A Justification Attachment must also be provided explaining why human subjects study information is not available at the time of application (e.g., the trials will be developed and launched after the Network is awarded). Because a full study record is not needed, the Inclusion of Women, Minorities and Children attachment does not apply. We have published a Notice to resolve this issue (please see NOT-HL-18-634).

Q16. Is a DUNS number required for the affiliate site? 

A16. A DUNS number is optional for any site other than the primary site, making it optional for an affiliate site. However, if the institution has a DUNS number, it is advisable to include it.  This will make processing the application easier.

Q17. Is there a single specific aims page that has 3 aims (Clinical and clinical research capabilities, mentoring plan for affiliate site, and clinical and implementation research skills program plan) vs. a separate specific aims page for each of the 3 major components of the application? 

A17. Specific aims for the proposed project must be limited to a single page/attachment, per the SF424 (R&R) Application Package instructions.

Q18. Will there be additional ways a cardiac surgical site can participate in the Network if an LCRC award is not received?

A18. Yes, there are several ways that a cardiac surgical site can participate in the Network even if an LCRC award is not received. Two examples include the following:

  • After the new CTSN is established, a cardiac surgical site may apply to become a consortium center through a process that will be established after network is launched (Spring, 2019).
     
    • Consortium center participants will have the opportunity to serve on the Steering Committee and in leadership positions related to trial development, conduct and reporting within the network.
       
  •  Investigators may partner with the network to submit a grant application through NHLBI multi-center clinical trial funding opportunity announcements (FOAs) for trials that seek to leverage the CTSN infrastructure.

The graphic below outlines the CTSN structure and its interacting components.

CTSN structure and the its interacting components graphic chart

Q19. Is the NHBLI expectation to include a Significance, Innovation, and Approach sub-heading as well as those listed in the FOA under each section A, B, and C as specified in 424 Guidelines?

A19. All FOA instructions supersede the application guide instructions. So, in this case, where the applicant is instructed to use “Clinical and Clinical Research Capabilities”, “Mentoring Plan for Affiliate Site”, and “Clinical and Implementation Research Skills Program Plan” as sub-headings for the Research Strategy section, they are in place of the standard sub-headings of Significance, Innovation, and Approach.

Q20. Are there page limitations for the “Other Attachments” required in the application?

A20. There are no page limitations for the “Other Attachments.” However, please only provide the necessary information to respond to the five required sections.  Do not use the “Other Attachments” as a means of circumventing the page limits of the Research Strategy section with inappropriate content.

Q21.  Can the Clinical Implementation Research Skills Program (CIRSP) be located at the Affiliate Site?

A21.  Yes, the CIRSP can be located at either the Primary or Affiliate Site.  It is incumbent on the applicant to make a compelling case within the application for the CIRSP placement.

Q22.  What is the total budget and where should the CIRSP budget be shown on the grant application?

A22. The direct costs for the CIRSP are $100K, indirect (F&A) costs can be requested on this amount.  The budget can be shown as “Other Expenses” as a separate line item on page in the application.

Q23. Does the Total Direct Cost amount of $400K/year include the $100K/year allowed for the Clinical Implementation Research Skills Program?

A23. Yes, the budget of $400K total direct costs is all inclusive for both the primary site, affiliate site, and the CIRSP.

Q24. Which CTSN trials should be captured in a score card as required by the RFA (Section IV, Other Attachments, #2 Clinical Research History – “Note: A scorecard with the above information must be provided and certified by the DCC for CTSN trials.”)

A24. The CTSN DCC will provide a certified score card with all planned and actual enrollment information for the following trials from 2015 to the present: Rate Control vs. Rhythm Control for Postoperative Atrial Fibrillation (POAF), Neuroprotection for Patients Undergoing Aortic Valve Replacement (NP), Safety and Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients (LVAD MPC II), Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery (TR), and Randomized Trial of Hybrid Coronary Revascularization versus Percutaneous Coronary Intervention (Hybrid).

Q25. Can the staffing requirements, be altered if well justified?

A25.  Yes, however, for the purposes of responsiveness and meeting review criteria laid out in the Funding Opportunity Announcement (FOA), it is strongly suggested that the proposed levels of effort address the staffing needs laid out in the FOA.

Q26. In Section IV.2 “Other Attachments,” number 3 asks for “Documentation of total NIH research funding in 2017” is this correct?

A26. This is an error and should read “Documentation of total NHLBI research funding in 2017.”

Q27. Should the affiliate site indirect costs be included in the parent (primary site) direct costs?

A27. No, NIH policy excludes consortium/contractual F&A when determining if an applicant is in compliance with the direct cost limitation.  While consortium F&A costs may be requested and awarded, applicants should not consider these costs when determining if a budget exceeds a direct cost limit.

Q28. Questions have come in from CTSN core and consortium sites concerning compliance with the Clinical Research History “scorecard requirement,” in the Other Attachments section, particularly whether the scorecard they have received from the DCC fulfills the RFA requirement.

A28. The scorecards provided by the DCC supply all required information concerning CTSN trial performance in response to the intent of the RFA.  Applicants are to follow the RFA guidance for submission of non-CTSN trials.