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Restructuring the NIAID Clinical Trials Networks

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Frequently Asked Questions and Answers Related to the Antibacterial Resistance Funding Opportunity Announcement


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General Questions

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1. What is the UM1 NIH grant activity code?

 

2. As a foreign investigator, am I permitted to participate in the new Leadership Group for a Clinical Research Network on Antibacterial Resistance?

 

3. Can the LG accept independent bids from industry?

 

4. I assume that the page limitations for the components of the research plan for the Leadership Group for a Clinical Research Network on Antibacterial Resistance (UM1) FOA (i.e., research overview-30 pages; Leadership and Operations Center (LOC)-30 pages; Laboratory Center (LC)-12 pages, Statistics and Data Management Center (SDMC)-12 pages) replaces the Research Strategy section in the research plan instructions of the PHS 398? Is that correct?

 

5. In addition, the following sections must also be addressed in an application for the AR Leadership Group FOA, which DO NOT have page limits, correct?

5. Bibliography and References Cited/Progress Report Publication List
6. Protection of Human Subjects
7. Inclusion of Women and Minorities
8. Targeted/Planned Enrollment Table
9. Inclusion of Children
10. Vertebrate Animals
11. Select Agent Research
12. Multiple PD/PI Leadership Plan
13. Consortium/Contractual Arrangements
14. Letters of Support (e.g., Consultants)
15. Resource Sharing Plan(s)

 

6. Should there be a Preliminary Studies section, and do the references cited for that section fall within the page limits of the Research Plan?

 

7. Are there page limitations for personal bibliographies of key investigators?

 

8. I understand there was a webinar for the Leadership Group for a Clinical Research Network on Antibacterial Resistance funding opportunity in March but I missed it. Is it still possible to view the webinar?

 

9. Would an application focused on TB be responsive to the NIAID antibacterial resistance Leadership Group funding opportunity?

 

10. I am confused about how the antibacterial resistance trials network is to be incorporated into the NIAID Clinical Trials Network. Is response to RFA-AI-12-018 and subsequent participation as a CTU in the HIV-associated networks the only opportunity to participate as a CRS/CTU in the antibacterial trials network? Will there be an additional RFA coming out for sites that wish to participate only in the antibacterial trials network?


Administration and Budget

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11. The budget table is requested in terms of direct costs and total direct costs (pg. 12), but in other areas it refers to $10M/yr. as “total costs,” which implies direct plus indirect. We have been assuming that the $10M would include indirect costs but wanted to confirm.

 

12. The budget table (pg. 12) requests costs for the “functional components” LOC, LC, SDMC only. In other areas (pg. 5) it describes the performance sites who will implement the agenda as "separately awarded NIAID-supported clinical research sites," and pg. 28 reads that NIAID will "lead the negotiation of Clinical Trials Agreements" with network investigators. This implies that NIAID will support the sites outside of the $10M/year network funds. Is this correct?

 

13. If NIAID will support the sites outside of the $10M/year network funds, does this support cover all costs for implementation of the proposed studies at the sites and the $10M/year is to be used only for running the network infrastructure (protocol development, network oversight, data/stats/monitoring for low resource studies, lab, QC, etc.)?

 

14. If it is true that NIAID supports the sites beyond the $10M/year, do the sites have to either be in an existing network (e.g., VTEUs), win one of the upcoming CTU awards or can we request that NIAID contract with some “fee for service” type sites that specialize in only one area, rather than being an integral part of a related network?

 

15. Is this proposal supposed to provide a scientific agenda or the capacity to support a clinical network, or both?


High Resource/Low Resource Questions

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16. We have questions about the level of support and options for the high resource studies. We assume EMMES is the group that will be providing NIAID-funded activities for data/monitoring/stats for the high resource studies. Any flexibility there? It is stated that NIAID will ultimately determine which studies are high and low resource but that will obviously have a large impact on the budget and number of studies we can propose. Do you have any idea how this process will work?

 

17. For high-resource projects, who pays the effort on the key personnel who are PIs on the trial but who also happen to be supported members of the Leadership Group? In other words, DMID provides data management, site auditing, CRF design, etc., but who pays personnel costs on the high-resource project: Leadership Group or DMID?

Last Updated February 24, 2012

Last Reviewed February 03, 2012