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Restructuring the NIAID Clinical Trials Networks

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Frequently Asked Questions and Answers Related to the Clinical Trials Units Funding Opportunity Announcement


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General Questions

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1. How many Clinical Trials Units (CTUs) does NIAID intend to award?

 

2. Has NIAID pre-established the number of CTUs or CRSs that will be awarded by geographic region and research area?

 

3. Will CTU applicants know which clinical research network applicants are successful prior to submitting their CTU applications?

 

4. Can a U.S. CTU applicant identify a non-U.S. based research organization as a CRS in their application?

 

5. Are other United States Government (USG) agencies eligible to apply as a CTU?

 

6. Can a CTU participate in research under this FOA as well as in projects funded by other USG agencies? Is NIAID approval required to do so?

 

7. The CTU application aims to capture much information within limited page requirements. Is it allowable for applicants to decrease the font size to provide more information?

 

8. Can an institution submit more than one CTU application?

 

9. Should each CRS have its own community advisory board (CAB)?

 

10. In considering a possible plan to merge adult and pediatric CRSs at the same institution, I was wondering whether the physical locations where participants are seen can be in different parts of the same institution and still have it be considered a single CRS?

 

11. Can CTUs propose satellite sites in their application?

 

12. Regarding RFA-AI-12-018: I am confused. For Component 1 only CTU Research Overview limited to 30 pages or components 1-10 limited to total 30 pages?

 

13. Will the Sites that participate in the Clinical Research Network on Antibacterial Resistance count towards the maximum of eight CRSs?

 

14. The clinical trial units under this RFA are mainly set up to handle interventions at the level of the individual. But one of the research areas is 3. Integrated HIV prevention strategies. The most meaningful integration is at the population level and the unit to carry out such integration would be a health department. The University of Michigan Department of Epidemiology (an academic institution) and the Michigan Department of Community Health (The Public Health Service Unit at the State level) is establishing a collaboration that uses new methodology developed at the University of Michigan to use population patterns of deep sequences of HIV viruses along with various other streams of data to suggest and eventually to evaluate interventions focused on stopping ongoing chains of transmission that can be documented by HIV sequence relationships. Is there any chance that a CTU with a public health focus and without a clinical setting would be competitive in response to this RFA. If so, could we please arrange a meeting to discuss this? Thanks.

 

15. Can two sites at different institutions combine to form a single CRS? This would be helpful in creating a CRS with a larger cohort of subjects eligible for participation in research and enabling the CRS to more easily exceed the average of 20 subjects in clinical trials over a 12-month period. The institutions in this scenario would be part of the same CTU.

 

16. Is it acceptable to apply as an independent CTU as well as a CRS linked to another CTU concurrently?

 

17. In the previous re-competition, sites that mainly conducted pediatric and perinatal research were allowed to have the obstetrics unit be a part of the pediatric CRS. While this was done primarily to reach the "n of 20," I am not sure if the same is allowed in the current application. To be specific, our OB unit is in another institution but we provide data management, regulatory and research staff, and research laboratory capabilities. Patients can be seen at either institution. I would prefer to keep with the same CRS structure we have had in the past. Will this be "responsive"?

 

18. How many PD/PIs are allowed for CTU applications designating multiple PD/PIs?

 
 

19. What information is requested on the cover page for each component? Is it acceptable to include a table of contents and/or an abstract on that page? Does the cover page count toward the page limit for each component?

 

20. The PHS 398 instructions (Part I, Section 5.5.4) indicate that the human subjects inclusion enrollment report form is required for protocols in grant renewal applications. However, since the CTU FOA guidance specifically states that protocols are not to be proposed in the application (nor should there be any requests for protocol-funding), would this requirement apply?

 

21. Is it possible for NIAID to make the scientific agendas for the Network Leadership Group (LG) applications available to CTU applicants?

 

22. Please clarify that the maximum limit of pages for a CTU with 4 CRS (for components 1 to 10).

 

23. Can a person be named as the CTU PD/PI and at the same time be a CRS leader of the biggest CRS at the CTU?

 

24. The communication section includes the following instruction: Describe how the different components of the CTU will communicate and interface with (i) the LOC, LC, and SDMC; (ii) NIAID and other key groups including the DAIDS Office of Clinical Site Oversight (OCSO), the DAIDS Clinical Laboratory Oversight Team (DCLOT), the DAIDS Enterprise System (DAIDS-ES); (iii) the NIAID monitoring contractor; and (iv) the HIV/AIDS Network Coordination (HANC). Can you elaborate on what is meant by communicating with the DAIDS Enterprise System?

 

25. To date, HANC has served as a resource and not an entity with which we have specific required interactions. Can you elaborate on what the expectations are for interactions with HANC?

 

26. Is a letter of commitment from a Network Leadership Group (LG) a required component of a CTU application?

 

27. Do you have a standard nomenclature for how we refer to the "Network Leadership Groups" in the CTU applications? In other words, although the "Leadership award" will not have been decided by the time of the CTU grant submission, is it acceptable to call the "Leadership Group for a Clinical Research Network on Therapeutics for HIV/AIDS and HIV-associated Infections in Adults" simply the "ACTG" or would you prefer "LGCRNTHAHIA"?

 

28. The instructions in the FOA for components 7, 8, and 10 include specific descriptions of the facilities and equipment - items which would normally be included on the Resources page (following Biographical Sketches in the table of parts). This seems to create some redundancy in the grant - would the Resources page(s) serve to briefly summarize the items at each CRS and the administrative core described earlier in the grant?

 

29. Is it acceptable to name my Program Officer for the helpful guidance he provided in improving the performance at my site, in my CTU application?

 

30. Can a CRS site have a sub-agreement?

 

31. Is it possible to get an extension of the CTU application deadline, if I know that it will be difficult for me to meet the January 29, 2013, due date?

 

32. Is it appropriate to submit the PHS 398 CTU application on A4-size paper?

 

33. Should I solicit and include a letter of commitment/support from a current Network Leadership Group in my CTU application?

 

34. The RFA AI-12-018 instructions state that the submission structure must follow PHS 398 instructions except as noted. While it is clear that Component 1 must be structured into the typical Significance, Innovation, Approach layout with specific aims, it is ambiguous whether the other Components also must follow this structure. Can we get some clarity on whether the other components require specific aims, and whether they require significance, innovation, and approach?

 

35. To anticipate budget for "travel for attendance at clinical research network meetings," since it seems they will be dictated by Networks more than CTUs, can you please give an estimate of how many meetings there may be per year? Where (DC?)? How many days? How many people from each CTU are expected to attend?

 

36. The instructions on how to construct our application in response to component 1 are not clear. Can you please let me know how to organize this component?

 

37. For existing Clinical trials Units, is this considered by DAIDS to be a renewal application or is this a new application?

 

38. Regarding RFA-AI-12-018, for which personnel should we include Biosketches?  I understand that we should include Biosketches for the following Key Personnel: CTU PI(s), CTU Coordinator, CRS Leaders, CRS Coordinators, and Pharmacists of Record.  Our application will also include many Other Significant Contributors (Site Investigators, Collaborating Investigators, and Collaborating Clinicians), but it is unclear to us whether we should include Biosketches for all of these individuals as well, or only the five Key Personnel roles mentioned above.

 

39. Regarding the submission for RFA-AI-12-018: Will the paper grant submissions be photocopied or scanned before sending to reviewers? Should we assume that reviewers will only get black and white copies?

 

40. For the optional Component 11, the RFA indicates this section is limited to six pages. Does this mean six pages total for the CTU or six pages per CRS component wishing to respond to this section?

Administration and Oversight

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41. Once awarded, how will poor performing CRSs be handled?

 

42. Once awarded, how will poor performing CTUs be handled?

 

43. Is a CTU and CRS based in Argentina required to have a FWA??

 

44. The FOA states that there is one CRS leader per CRS. If an adult and pediatric CRS merge, can we propose co-leaders or do we still only propose one CRS leader?

Grants Management and Budget

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45. Can U.S. or international CRSs receive funding for alterations and renovations (A&R) under this FOA?

 

46.What is the difference between "Core" and "Protocol" funding for CTUs and CRSs?

 

47. How are CTU core funding amounts determined?

 

48. How are CTU protocol funding amounts determined?

 

49. Are CTUs allowed to rebudget core or PF between components and/or networks?

 

50. In some countries, differences may exist between U.S. and local financial management and bookkeeping standards. What can applicants do to ensure that they meet the appropriate criteria?

 

51. Can two Clinical Research Sites share a Federal Wide Assurance (FWA)?

 

52. Please explain the relationship between an FWA and the Institutional Review Board (IRB). Does each CRS need to have its own IRB?

 

53. Regarding the RFA on CTU for NIAID Clinical Trials Networks, I would like to ask whether the salary support for CRS leaders and key CRS administrative staff should be included in the CTU core fund (CF) or in the protocol fund (PF).

 

54. Please clarify the core funding as referred to under Section II Award Information - Award Budget, is it CTU core funding or CTU plus CRS core funding?

 

55. Please confirm whether network leadership applications/budgets should include the costs associated with site community staff/representatives traveling to network annual meetings or if these expenses are to be covered by CTU budgets?

 

56. The FOA states that applicants should only include CORE costs in the application, can you confirm whether applicants should include costs for the first 20 participants?

 

57. Please clarify how funding will be distributed in the case of an international CTU with a domestic CRS? Can a domestic CRS receive funding directly from NIAID?

 

58. Will applications requesting funding amounts in excess of the suggested amounts ($1.2–2.0 million for a CTU with 3–4 sites and 2–3 networks) be considered unresponsive? At the workshop in Washington in July, it seemed the consensus was that the suggested amounts were too low to maintain adequate infrastructure as required in the FOA?

59. Can CTU/CRS Core budgets be constructed to include a "cost-of-living" escalation in the out years?

 

60. The CTU FOA provides a sample range of core costs of $1.2M - $2.0M for an hypothetical CTU participating in 2–3 NIAID HIV/AIDS Networks with 3–4 CRSs. Is this an annual estimate, or for the entire project period of the grant?

Scientific Review

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61. This relates to the distinction between the CTU's "core staff" and "protocol staff"; while data managers and quality managers should be a part of the site's core staff, is there guidance on what is a reasonable amount of support they should receive from the core budget (should it be minimal, like 10 percent fte, because they won't have much work to do if they have no data from protocols)? Similarly, others deemed to be more "key" to the program, such as the CTU PI, CRS Directors, and Site Pharmacists typically have needed to commit a substantive fte (30 percent+) to a CTU grant, but if there are no protocols, is it justifiable for them to receive that much funding from their Core? In the last CTU FOA, the "N=20 ppts on study" requirement helped with this judgment, but this time it is less clear.

 

62. Will the NIAID "annual funding cycle" for the CTUs be matched with "annual funding cycle" for the "Research Network Leadership Groups"? Having them aligned would seem to be helpful for the fiscal administrators of CTUs that are receiving funds from both the NIAID and protocol funds directly from the "Leadership Groups."

 

63. Our budget in response to this FOA will exceed $500,000. Does NIAID need to give us approval prior to submitting an application for this FOA?

 

64. Is there a mechanism to request that a particular reviewer who may be in conflict be excluded from the review of a specific CTU application?

 

65. Will CTU applications be evaluated against applications received from institutions in the same country or geographic area?

 

66. A summary statement will be issued summarizing the CTU application review. Will an applicant have the opportunity to respond to the summary statement?

 

67. Will reviewers have access to CTU and CRS performance data from prior NIAID grantees?

 

68. Will the number of clinical research network affiliations proposed influence the overall score of the CTU application?

 

69. Will the number of CRSs proposed influence the overall score of the application?

 

70. If two applications are submitted from the same institution, will the determination regarding whether or not they are "scientifically distinct" be made through the peer review process, or through pre-review evaluation by the CSR? If the latter, and the CSR determines the applications are not sufficiently scientifically distinct, will both applications be considered non-responsive and returned without review?

Last Updated January 18, 2013

Last Reviewed January 18, 2013