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1. How many Clinical Trials Units (CTUs) does NIAID intend to award?
It is anticipated that NIAID will award at least 25 CTUs through this Funding Opportunity Announcement (FOA). However, we will fund the number of CTUs necessary to ensure that each of the NIAID HIV/AIDS clinical research networks has the clinical research sites needed to accomplish its scientific agenda.
NIAID will consider the scientific and technical merit of the proposed applications as determined by scientific peer review, availability of funds, programmatic priorities, and geographic distribution of the proposed Clinical Research Sites (CRSs) to determine awardees. NIAID reserves the right to fund partial components, as defined by the FOA, of an application.
2. Has NIAID pre-established the number of CTUs or CRSs that will be awarded by geographic region and research area?
No. Quotas have not been established for CTUs or CRSs by geographic location or research area. NIAID reserves the right to limit the number and types of CTUs and CRSs that are appropriate to support the NIAID clinical research networks.
3. Will CTU applicants know which clinical research network applicants are successful prior to submitting their CTU applications?
No, NIAID clinical research network grant awardees will not be known by CTU applicants prior to the CTU application deadline. CTU applicants should propose CRSs and affiliation with the clinical research areas as posted in the Network Leadership Group FOAs.
4. Can a U.S. CTU applicant identify a non-U.S. based research organization as a CRS in their application?
Yes. Eligible domestic (U.S.) or international organizations can be
5. Are other United States Government (USG) agencies eligible to apply as a CTU?
Yes. All applicants, including USG agencies interested in applying for CTUs, will be expected to compete through this FOA. We expect the only difference between successful USG and non-USG agency applications to be the mechanism of funding.
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?
Awardees under this FOA are eligible to work on projects funded by other USG agencies and do not require NIAID permission to do so. Applicants currently participating in such projects (e.g., PEPFAR) should indicate relevant activities when describing their experience in the application. Successful applicants must indicate if any scientific or budgetary overlap among projects exists at the time of award and must work with NIAID to negotiate how to eliminate this overlap.
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?
No. Applications must follow the formatting guidelines set forth in the PHS 398 instructions. Applications that do not conform to these specifications will be returned without review.
8. Can an institution submit more than one CTU application?
There can be more than one CTU application from a single organization/institution, provided that each application is scientifically distinct. CTU applicants should provide adequate scientific justification for proposing more than one CTU from a single institution in each of the applications proposed. NIAID reserves the right to combine components submitted in multiple applications from a single institution into a one award.
9. Should each CRS have its own community advisory board (CAB)?
The number of CABs within a given CTU is a decision best made by the CTU applicant. This decision should take into account the role of the CAB in representing the local community participating in the clinical research and the geographic and cultural diversity of the CRSs.
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?
Yes, participants can be seen in different parts of the same institution and still be considered part of the same CRS. We encourage a model of "self-assembly" based on your organizational circumstances, as there are many nuances to what constitutes one discrete CRS from another. Please refer to the CRS definition in the FOA document for details; however, the goal is to encourage consolidation, where possible and practical, so that efficiencies can be recognized. Factors to consider in determining whether a CRS should be a discrete entity include: institutional affiliation, extent of resources shared (staff, clinic, pharmacy, lab, regulatory), geographic location, leadership of the CRS, and scope of IRB authority. If resources can be coordinated efficiently and shared across two or more locations within the same institution without compromising study conduct and performance, then consolidation into one CRS is highly encouraged.
11. Can CTUs propose satellite sites in their application?
Satellite sites should not be discussed in this application. Satellite sites (like protocol-specific sites) will be identified after award as necessary, based on identified protocol-specific clinical research network needs.
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?
The applicant’s response to Component 1 (CTU Research Overview) is limited to 30 pages. Responses to each of the other components (2 through 11) are limited to an additional number of pages as specified in the FOA for those individual components. For example in response to Component 1, an applicant can write up to 30 pages; in response to Component 2, the applicant can write up to 12 pages; and in response to Component 10 (assuming the applicant proposes 3 CRS), the applicant can write up to 36 pages (12 pages for each CRS proposed).
13. Will the Sites that participate in the Clinical Research Network on Antibacterial Resistance count towards the maximum of eight CRSs?
No, the response as to capability to participate in the Clinical Research Network on Antibacterial Resistance is a stand-alone item in the application. Applicants’ discussions of their interest and capacity to participate in the Clinical Research Network on Antibacterial Resistance should be limited to component 11 (Clinical Research Network on Antibacterial Resistance) of the FOA. Applicants are not expected to include their proposal to work in this network in the table and/or discussions in component 1 (CTU Research overview) or in the descriptions of each CRS (maximum of eight) in component 10 (Clinical Research Sites).
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.
No, a CTU as proposed will not be competitive. Responsive CTUs to this FOA will be robust, integrated research units comprised of one to eight CRSs and must participate in a minimum of two HIV/AIDS Clinical Research Networks. CTUs which propose to affiliate with the Network on Integrated Strategies to Prevent HIV Infection must have the capacity to contribute to a broad range of activities within the scientific priority areas described in the FOA (RFA-AI-12-011), many of which will require a clinical setting to conduct the research. These scientific priority areas include the following two areas:
After the successful CTU applicants have been identified, if the capacity and population for a specific study does not exist within the funded portfolio of NIAID CTUs/CRSs, there is a mechanism for limited expansion of sites to meet the needs of a specific protocol. This mechanism is described in Part 2, Section 3 ("CTU Structure and Function") of the CTU FOA.
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.
Two sites from different institutions cannot combine to make up one CRS simply to satisfy the enrollment or other performance requirements established by NIAID and/or the Clinical research networks. Please refer to the CRS definition in the FOA document for details. Although applicants are encouraged to consolidate where possible and practical, the benefits of the proposed configuration as well as the efficiencies recognized should be evident in the application. Factors to consider in determining whether multiple components constitute a single CRS entity include: institutional affiliation, extent of resources shared (staff, clinic, pharmacy, lab, regulatory), geographic location, organizational structure, leadership of the CRS and scope of IRB authority.
After successful awards have been made in response to this solicitation, protocol specific needs may arise which cannot be met by the existing CRSs, thus presenting a limited opportunity to engage additional site locations and to meet the specific protocol required need. Such additional site locations will be expected to close at the conclusion of the protocol.
16. Is it acceptable to apply as an independent CTU as well as a CRS linked to another CTU concurrently?
The CTU is an organization/institution responsible for coordination and oversight of clinical trials in accordance with the clinical research network, NIAID and other applicable policies and as such it is not interchangeable with a CRS and cannot be proposed as part of another CTU. The CTU is comprised of distinct, physical components such as pharmacy, laboratory, and clinical research sites (CRS). As noted in the FOA, an individual CRS and/or CRS Leader may be proposed in only one CTU application.
Although an institution/organization may propose more than one CTU application, each application must contain justification for such needs. CRSs within an institution/organization that are aligned with different institutions/organizations other than theirs must provide evidence of the practical efficiencies that will be recognized by this alignment.
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"?
After successful awards have been made in response to this solicitation, protocol specific needs may arise which cannot be met by the existing CRSs, thus presenting a limited opportunity to engage additional site locations and to meet the specific protocol required need.
There are several questions and answers within this Q&A that pertain to the definition and composition of a Clinical Research Site (CRS) that may be helpful to you.
18. How many PD/PIs are allowed for CTU applications designating multiple PD/PIs?
Although there is no upper limit to the number of Principal Investigators/Program Directors (PIs/PDs) that can be named in an application, applicants should carefully consider alignment of roles, responsibilities and scope of authority of individuals named as PD/PIs. Applicants must provide a Leadership Plan if they propose multiple PIs/PDs, and the plan must clearly define how authorities and accountabilities are aligned, plans for decision-making, and communication across the multiple PIs/PDs, in addition to other requirements outlined in NIH Grants Policy (see link below). Each PD/PI named in a multi-PI/PD application is responsible for the proper conduct and management of the entire CTU, and must be able to run the operations of the entire CTU. The number of PD/PIs should be well justified and not exceed the number required for efficient management of the CTU.
Additional information on multiple PD/PIs is available at: Frequently Asked Questions: Multiple Principal Investigators
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?
We expect applicants to provide a cover page as an "administrative separator" between each of the components. This cover page will not count towards the page limits. Something as simple as "Component 5 – Evaluation" is all we expect to see.
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?
The protocol inclusion enrollment report form is not a requirement for applications responsive to the CTU FOA because the applicants are proposing infrastructure for the NIAID Clinical Research Network Leadership grants, and are not requesting funding for any specific clinical trials as part of the CTU FOA application. Applicants are expected to mention past or current clinical research work in support of the past performance and capacity criteria; however, inclusion enrollment reports for any trial(s) referenced in the application is not a requirement.
21. Is it possible for NIAID to make the scientific agendas for the Network Leadership Group (LG) applications available to CTU applicants?
NIH policy prohibits NIH institutes from sharing applicant information. NIAID will not be providing public access to the content of the LG applications. CTU applicants are encouraged to review the research priority areas for each of the LG FOAs as they develop their applications. Each of the six LG FOAs can be accessed by visiting Restructuring the NIAID Clinical Trials Networks
22. Please clarify that the maximum limit of pages for a CTU with 4 CRS (for components 1 to 10).
The maximum number of pages for a CTU with 4CRSs is 156 broken down as follows:
Component 1 30 pages
Component 2 12 pages
Component 3 6 pages
Component 4 6 pages
Component 5 6 pages
Component 6 12 pages
Component 7 12 pages
Component 8 12 pages
Component 9 12 pages
Component 10 96 pages (up to 12 pages each per up to 8 CRS)
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?
The determination of whether or not the CTU PD/PI can also be designated as a CRS Leader for any given CTU will depend on the size and scope of the CTU. An individual is not specifically prohibited from serving simultaneously in both roles however, the experience, qualifications and extent to which the PD/PI and /or CRS Leader is committed to other activities should determine the appropriateness of that decision.
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?
Please refer to the glossary of acronyms and terms for a full description of the DAIDS Enterprise System (DAIDS-ES). The DAIDS- ES includes multiple modules with which the DAIDS clinical trials networks (including CTUs) are required to interact. These modules include, but are not limited to: Adverse Experience Reporting and Processing System, Clinical Site Monitoring, and Protocol Registration. Applicants should outline their overarching strategies for interacting with one or more of these modules across the multiple components of their CTU. For example, describe how resources will be aligned to interact with these modules to support timely and efficient communication.
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?
Please refer to the glossary of acronyms and terms for the full description of HANC. HANC provides coordination for many network wide initiatives and the clinical research networks (including CTUs) are integral to the success of the collaborative efforts of HANC. Applicants are encouraged to explain their plans for communicating and collaborating with HANC including willingness to participate in working groups, method by which they will consider the HANC outputs, and other constructive plans for providing input to these and other network-wide initiatives.
26. Is a letter of commitment from a Network Leadership Group (LG) a required component of a CTU application?
Although letters of commitment/support are not required, applicants may consider providing them to demonstrate the support of consortium participants and collaborators such as Senior/Key Personnel and Other Significant Contributors included in the grant application. When considering who submits letters of commitment/support, applicants should remember that superfluous materials reduce the time reviewers can invest in evaluating the application and can decrease the potential pool of qualified reviewers due to conflicts of interest. Do not place letters of commitment/support in the Appendix section of the application. Letters of commitment/support are to be attached as PDFs to Section 14 of the Research Plan section of the PHS 398 and do not count to the page limits of the components in the 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"?
These examples or some other designation are appropriate as long as each designation is clearly defined and consistently applied, so that reviewers can easily identify what each designation refers to.
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?
For each of the components, applicants must respond to all FOA instructions; therefore, all relevant equipment to support the CTU’s capacity should be listed in the appropriate component section(s) even if this is redundant with the Resources page. In addition, the PHS 398 Resources page should include a listing of relevant resources available to the grantee at all of the CTU components. It is appropriate for the Resources page to reference additional details for a piece of equipment in the component sections (provide component and page number) to assist the Reviewers in finding the complete information, but it is expected that the Resources page will include a list of all Resources that the applicant would like to highlight in their application.
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?
Some NIAID, NIH staff work closely with grantees as part of their routine grant oversight responsibilities, and it is not necessary to specifically identify those staff in an application. Naming specific NIAID, NIH staff in an application should be reserved for identifying associations that extend beyond regular research grant management/oversight activities. If such associations exist, they should be explained, and the NIAID, NIH staff should be identified in the application. The associations may constitute a conflict that will be managed, pre- and/or post-review, according to NIH/NIAID policy.
30. Can a CRS site have a sub-agreement?
Although it is expected that the grantee organization will enter into a written agreement with CRS organizations involved in the science of the project (i.e., performing requirements of an approved protocol), this does not preclude a CRS from entering into other arrangements with individuals who are outside their organization. For example they may need to support consultants to meet the specific need of a protocol. Please refer to the NIH Grants Policy Statement (Section 15: Consortium Agreements) for further information.
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?
The NIH expects that grant applications will be submitted on time. For CTU applications, receipt of the application by the Center for Scientific Review, by January 29, 2013, as noted on the funding announcement is considered on time submission. NIH will not provide permission for a late submission in advance. Refer to NIH Guide Notice NOT-OD-11-035 for further information.
32. Is it appropriate to submit the PHS 398 CTU application on A4-size paper?
Part I, Section 2.6 of the PHS 398 instructions state that the applications must use standard size (8 ½" x 11") sheets of paper and provide at least one-half inch margins (top, bottom, left, and right) for all pages, including continuation pages. A4 paper is 8.27 x 11.69 inches. Although, applications submitted on A4 paper will not be returned, applicants must ensure margin guidelines as described in PHS 398 are followed in order to facilitate scanning of the application into the system.
33. Should I solicit and include a letter of commitment/support from a current Network Leadership Group in my CTU application?
No. Since the final determination of successful NLG applicants is still unknown, general letters of support/commitment from current Network Leadership Group awardees are not encouraged.
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?
Since Component 1 "CTU Research overview" is intended to capture the essence of the entire application and is the only component that will be scored individually, it is also the only component that requires this specific PHS 398 mandated review criteria (Significance, Investigator, Innovation, Approach, and Environment). Each of these review criteria will be considered and contribute to the overall score for component 1. Please note that these criteria do not necessarily have to be ordered in the same sequence as described in the FOA, as long as the required elements are easily identified by the reviewers within component 1.
Components 2 through 11 do not include these five specific review criteria. CTU applications should include specific responses to the guidance listed in Section IV as well as the review criteria noted in Section V of the FOA for each component.
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?
The Clinical Research Network Leadership grants for the next cycle will not be awarded by the time the CTU applications are due; therefore, it is unclear how each Network will manage their annual meetings. For planning purposes in the CTU application, it would be appropriate to anticipate that there will be at least one annual network meeting in the Washington, DC, metropolitan area as is the current practice. Network meetings currently range from one to two meetings in the DC metropolitan area, and the meetings usually run for about 4 to 6 days.
There is no minimum requirement for attendance from a CTU, but CTU staff is expected to be fully integrated into the networks with which they participate and the annual meeting is an important forum for network wide discussions, trainings, and other engagements.
Traditionally we have had the CTU PI, CRS Leader, CRS Coordinator, CAB representative, Pharmacist of Record and one or two other individuals from a CRS attend the meeting. Additional staff from the CTU may be required at these and other meetings based on the agenda of issues and/or training sessions planned.
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?
Some flexibility, based on applicant experience and plans, is possible in Component 1. However, since the CTU applications are responding to an RFA, applicants must first adhere to the specific guidance in the CTU FOA. The PHS 398 instructions are to be followed when the CTU FOA guidance refers to them.
Therefore, organize Component 1, "Research Strategy," in no more than 30 pages according to the CTU FOA guidance.
To facilitate its evaluation, Component 1 also should be developed with attention to its Review Criteria, specifically, Significance, Innovation, Approach, Investigator, and Environment (see CTU FOA Section V. Application Review Information, Scored Review Criteria – Component 1). Areas within Component 1 that address these review criteria should be identified using the appropriate subheading.
However, all the issues called for in Component 1 need not be categorized only into these five areas; additional subheadings are acceptable.
37. For existing Clinical trials Units, is this considered by DAIDS to be a renewal application or is this a new application?
A CTU application is considered a renewal as long as it is being submitted by a currently funded CTU grantee institution which proposes to conduct HIV/AIDS Clinical Research Network activities, even though the composition of the CTU and proposed Network affiliations may be different from the current configuration. Please note that the CTU application title may change and still be considered a renewal, as long as the grantee institution remains the same.
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.
As outlined in Part I, Section 4.6 (Biographical Sketch) of the PHS 398 guidelines, this section must contain the biographical sketches of all individuals listed as Senior/key Personnel and Other Significant Contributors. Therefore, in addition to the CTU FOA identified Key personnel, biosketches are also required for Other Significant Contributors.
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?
The Center for Scientific Review (CSR) will perform black and white (B&W) scans of the applications. However, if some pages with color material are not resolvable in B&W, the Scientific Review Program provides reviewers color versions of those pages.
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?
The six-page limit for component 11 is the total maximum page limit for all CRSs proposing to affiliate w/the Antibacterial Resistance Network.
41. Once awarded, how will poor performing CRSs be handled?
In addition to the clinical research network evaluation of CRSs, CTUs are expected to be continuously evaluating their component parts and as such, CTU applications must include a description of the process for assessing and improving performance and capacity of all components of the CTU, as well as reporting relevant information to NIAID and the clinical research network leadership group (LG). The CTU evaluation of its components is not expected to replace the clinical research network performance evaluation but rather include it as part of the overall internal CTU evaluation process. In addition, close-out procedures for poorly performing CTU components must also be included in the application. It is expected that the CTU PDs/PIs will work closely with the clinical research network LG and NIAID to provide an opportunity to improve performance for poorly performing components.
42. Once awarded, how will poor performing CTUs be handled?
All NIH grants are subject to adherence of the terms and conditions of award, as provided in the Notice of Award (NOA). In addition, a CTU that is not performing in accordance with NIAID standards may have their funds discontinued.
43. Is a CTU and CRS based in Argentina required to have a FWA??
An institution must have a valid Federal Wide Assurance (FWA) in order to receive U.S. Department of Health and Human Services support for research involving human subjects. Each FWA must designate at least one IRB registered with OHRP. If the applicant organization does not have an approved FWA on file with OHRP at the time of the application, the signature on the Face Page of the PHS 398 application is a declaration that the applicant organization will comply with 45 CFR Part 46 and proceed to obtain an FWA. NIH funding will not be provided to a CTU applicant without a valid FWA for the institution.
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?
We encourage applicants to seek opportunities for consolidation of activities within the clinical trials unit. The CTU FOA emphasizes coordination of activities, to achieve efficiencies and avoid redundancies, to the extent possible and practical.
When considering CRS disposition within a unit, applicants should consider several factors including CRS Leadership, extent of resources shared, geographic location, institutional affiliation, and scope of IRB authority. It is understandable that some specific activities within a given CRS may be discrete; however, the overall goal should tend towards coordination within a CRS.
Although we do not necessarily expect the CRS Leader to have the breadth of scientific expertise to actively conduct research within the entire spectrum of Network affiliations proposed, it is expected that the overall CRS management will fall under the leadership of a single CRS Leader, and if necessary, some components of the scientific leadership may be delegated to other qualified individuals within the CRS.
45. Can U.S. or international CRSs receive funding for alterations and renovations (A&R) under this FOA?
The CRSs proposed in applications are expected to have an appropriate infrastructure in place and be capable of initiating participant enrollment upon award. In rare cases, minimal costs may be requested for "minor" alterations, renovations or repairs with adequate justification.
46.What is the difference between "Core" and "Protocol" funding for CTUs and CRSs?
Core funds provide financial support to maintain minimal infrastructure and staff at the CTU irrespective of protocol activity. Core funds do not include expenses directly attributable to the development, approval, or conduct of specific clinical trials. Core funds may include (but are not limited to)
Protocol funds (PF) provide additional support to the CTU to cover protocol-related expenses attributable to protocol development, implementation, or close-out of a clinical trial. Protocol funds include, but are not limited to
47. How are CTU core funding amounts determined?
Core funding amounts are determined by NIAID based on the size and scope of the CTU.
48. How are CTU protocol funding amounts determined?
Protocol funding amounts are recommended by the NIAID clinical research network Leadership Groups based on specific study requirements.
49. Are CTUs allowed to rebudget core or PF between components and/or networks?
An awardee is expected to rebudget existing funds to meet legitimate needs. However, in rare circumstances, PF may be restricted in a Notice of Award (NOA) to be used only for the purpose stated in the restriction.
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?
NIH expects our grantees to follow existing U.S. policies and regulations concerning management and accounting. The NIH Grants Policy Statement (http://grants1.nih.gov/grants/policy/nihgps_2010/index.htm) is an excellent resource for all NIH policies and regulations for recipients of NIH grant awards.
51. Can two Clinical Research Sites share a Federal Wide Assurance (FWA)?
Each institution where a CRS is located is required to have an FWA. Therefore, two CRSs affiliated with the same institution can share one FWA. Further information on FWA policies can be found at the Office of Human Research Protection website: http://www.hhs.gov/ohrp/.
52. Please explain the relationship between an FWA and the Institutional Review Board (IRB). Does each CRS need to have its own IRB?
Each institution where a CRS is located is required to have an FWA. It is also required to designate an IRB, whose role is to approve and periodically review the research being conducted at that CRS to ensure the adequate protection of human subjects. This IRB must be named in the FWA of the institution where the research will be performed. Multiple CRSs located at the same institution may function under the same FWA. They may or may not have the same IRB. Please see the Office of Human Research Protections for more information.
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).
Although the level of support will depend on the CTU structure, salary support for CRS Leaders and other key CRS administrative personnel will appear primarily in the Core budget (which should be provided in response to the CTU FOA) to support a baseline level of CTU activities. However, some of these individuals may also appear on the PF budget (which should not be provided in response to the CTU FOA), to support expanded commitment of core activities or protocol related activities.
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?
NIAID will provide core funds to CTUs on an annual basis for the support of CTU administrative and CRS core activities. In FY 2014, approximately $70M is the total anticipated CTU and CRS core funding for all awards that will be made pursuant to RFA-AI-12-018. The exact amount of the core funds awarded to each CTU will depend on the continued availability of funds, the total number of CTUs funded, and the size and scope of the specific CTU.
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?
Costs associated with site community staff/representatives traveling to network annual meetings may be included in either the network leadership group or CTU application budgets, but not both, as appropriate for each network and participating CTU.
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?
CTU grant applications should not include any costs for protocol-specific expenses in their budgets.
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?
All CTU-related funding provided directly from NIAID, regardless of where the activities occur, will be provided to the CTU grantee institution (domestic or international) for further distribution by the grantee to the appropriate component. No funds will be provided directly from NIAID to the CRSs (domestic or international).
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?
Although CTUs will not be considered unresponsive for exceeding the suggested amounts, excessive deviations from this guide would be unrealistic and may be suggestive of a CTU that is not cost effective. Cost containment is an area of emphasis in this competitive cycle and therefore appearances of excessive estimates may reduce the enthusiasm for the application. Based on current funding levels and the corresponding anticipated portfolio of CTUs, the funding amounts in the example are representative of what NIAID expects to provide to CTUs of that size and scope.
59. Can CTU/CRS Core budgets be constructed to include a "cost-of-living" escalation in the out years?
It is allowable to include additional "cost of living escalations" on the budget form page 5 for years 2–7 of the core budgets in the CTU application. In addition, please Identify with an asterisk (*), and justify any significant increases or decreases from the initial year budget. See Part 1, Section 4.5 (Budget for Entire Proposed Period of Support) in the PHS 398 Instructions for further information.
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?
The sample core range provided in the CTU FOA is an annual estimate.
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.
For the purposes of constructing the CTU and CRS core budgets, while there is no pre-defined minimum number of staff or level of effort provided as a guide, it is appropriate to identify personnel and level of effort required to maintain a baseline level of CTU activity, irrespective of the level of protocol activity. On the other hand, those individuals whose activities are more closely aligned to specific protocol activities will be expected to appear with minimal effort on these core budgets since they will be covered by protocol funds, post award. The proposed staff and level of effort for individuals included on the budgets must be adequately justified.
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."
The Network Leadership Group and CTU award dates are being realigned so that they are awarded within the same fiscal year.
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?
Permission to submit a grant proposal with a budget exceeding $500,000 per year in direct costs is not required for this FOA (RFA-AI-12-018). Interested applicants may submit applications by January 29, 2013, following the instructions contained in the 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?
NIAID has taken great care to establish mechanisms to avoid real or potential conflicts of interest during the review of applications. However, in exceptional circumstances applicants may contact the scientific review program staff at NIAID if they are concerned that a specific potential conflict may not be identified.
65. Will CTU applications be evaluated against applications received from institutions in the same country or geographic area?
CTU applications will be evaluated independently according to the review criteria delineated in the FOA. Applications will not be evaluated "against" each other, and the review is based solely on the information provided in the application.
66. A summary statement will be issued summarizing the CTU application review. Will an applicant have the opportunity to respond to the summary statement?
No, there is no opportunity for an applicant to respond to the summary statement.
67. Will reviewers have access to CTU and CRS performance data from prior NIAID grantees?
Reviewers will base their review on the information contained in the application. However, NIAID may consider past performance data from previous grant cycles (if available) in making funding decisions.
68. Will the number of clinical research network affiliations proposed influence the overall score of the CTU application?
Applicants are encouraged to propose the most competitive CTU structure including at least two HIV/AIDS clinical research networks. Proposing the maximum number of network affiliations may not necessarily be the optimal configuration for every CTU. Successful applicants will adequately justify the number of network affiliations reflected in their CTU.
69. Will the number of CRSs proposed influence the overall score of the application?
Applicants are encouraged to propose the most competitive CTU structure including at least one, but no more than eight, CRSs. Proposing the maximum number of CRSs may not necessarily be the optimal configuration for every CTU. Successful applicants will adequately justify the number of CRSs reflected in their CTU.
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?
Consolidation is encouraged to achieve operational efficiencies where possible and practical. To this end, it is expected that each institution will consider opportunities for recognizing such efficiencies prior to submission of their applications. Determination of scientific overlap and related funding decisions will be made by NIAID post-review of applications.
Last Updated January 18, 2013
Last Reviewed January 18, 2013