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1. Will there be a separate progress report section required in the research plan (other than the publication list), or will the sections in the various Components serve this purpose?
Renewal applications are not to include a separate Progress Report in the Research Plan as described in the PHS 398. Instead, renewal applications are to follow FOA directions and address progress as requested in the “Performance and Applicant Experience” sections of the Components.
Specifically:
- For the Leadership Group (LG), the description of progress belongs in the "Performance and Applicant Experience" of Component 1: Leadership Group Overview.
- For the separate Leadership and Operations Center (LOC), Laboratory Center (LC), and Statistics and Data Management Center (SDMC) submissions, progress is to be addressed as requested in the “Performance and Applicant Experience” section of Component 2 of the individual applications.
2. What is the UM1 NIH grant activity code?
The UM1 activity code is a research project Cooperative Agreement to support large-scale complex clinical trials with multiple components, e.g., clinical networks. The components represent a variety of supporting functions and are not independent of the research projects. Substantial Federal programmatic staff involvement is intended to assist investigators during performance of the research activities, as defined in the terms and conditions of an award.
3. How many HIV/AIDS Leadership Group (LG) applications does NIAID intend to fund?
The number of awards is contingent upon NIH appropriations, availability of funds in Fiscal Year (FY) 2014 and the submission of meritorious applications. For each LG FOA, NIAID anticipates funding one award each to the Leadership and Operations Center (LOC), Laboratory Center (LC) and Statistical and Data Management Center (SDMC) comprising a Leadership Group.
4. I would like to have the program for NIAID’s grantsmanship workshop on July 28-29, 2012 in Washington, D.C., for clinical trials units for the re-competed clinical research networks. Can you please send me the program?
5. NIDCR, NIMH, NINDS and NIDA are listed as participating I/Cs in this FOA, RFA-AI-12-004. Is their contribution included in the $36.93 million for this FOA? If so, is there a specific amount these I/Cs are contributing? If not, what guidance can you provide to the applicants as to the appropriate amount of the networks scientific agenda that should be apportioned to the interests of these collaborating I/Cs?
All applications should address the Scientific Agenda outlined in the FOA in Research Priority Areas Part 2, Section 1, #3. The financial commitment of other participating NIH Institutes/Centers is reflected in the total published amount of $36.93M, but as always is contingent on the availability of funds and Programmatic priorities. This applies to all five of the HIV/AIDS Leadership Group FOAs.
6. When preparing the inclusion enrollment tables for a renewal application, should we provide data for all trials to date, or only those that have opened or had changes in enrollment since the last competitive application was submitted?
The Inclusion Enrollment Report should provide data for each current trial with cumulative total accrual of subjects to date. If there is more than one study/protocol, provide a separate Inclusion Enrollment Report for each.
7. What is the primary driver for the CDISC adoption (SDMC harmonization, submission to FDA, interchange with DAIDS, etc...)?
The primary reasons for CDISC adoption include the potential requirement by FDA for SDTM- formatted data submissions in the near future, and to improve our ability to effectively conduct pharmacovigilance and meta-analyses across clinical datasets.
8. What is meant by “data collection”? Do we need to collect in CDASH standards or can we map CRF/lab data to SDTM?
The use of standardized data collection with CDASH is encouraged but not required. If you plan to collect data in one format and convert to SDTM when needed, your application should characterize how your proposed process will impact the speed of data availability, costs to the grant, and accuracy of the converted data.
9. If CDASH standards are not required for data collection, at what point do we need to map to CDISC standards within a study? At first analysis? At study close-out?
Our requirement is that any data that may need to be analyzed or submitted to a regulatory authority be available in SDTM format at any point during or following the trial.
10. Do we need to standardize lab assay data (and other data that currently does not have defined data structures, e.g. behavioral data, ePRO/PRO data) across data centers? Will there be any assistance provided to the SDMCs to coordinate this?
The SDMCs will be expected to coordinate a standardized approach for any data providing additional assistance for coordination beyond the Leadership grant award itself.
11. Are there any exceptions for any data types or studies, e.g. Household-level data collected in a community randomized trial?
Our intent is for data to be readily available in SDTM format for analysis and submission to regulatory authorities. However, you may wish to propose any exceptions that you believe would be appropriate.
12. Do we need to produce ADaM datasets?
There is no requirement to produce ADaM datasets.
13. Do we need to provide technical documentation? If so, is there a required format, e.g. eCTD, or are there specifications on what should be included?
The Leadership Group RFAs request a plan on how the SDMC will collect, store and transfer data in accordance with CDISC and any documentation supporting these capabilities may be beneficial, but not essential.
14. What are the requirements for historical data and data from studies ongoing at initiation of new grant? Do we need to map to CDISC standards for PUDS releases?
We do not anticipate converting data from ongoing studies to CDISC format. If a determination is made to convert existing data or data from trials that are ongoing at the time of the awards, a separate funding mechanism will be used.
15. In the section "5. Leadership and Operations Center, Laboratory Center and Statistical and Data Management Center Specific Responsibilities", one of the evaluation criteria is stated as follows: “Are the plans to assure compliance with regulatory requirements for data management, including compliance with CDISC, adequate?” What regulatory requirements mandate CDISC?
No current regulatory requirements mandate use of CDISC. This statement refers to assuring compliance with a likely future regulatory requirement for use of CDISC.
16. In the "SDMC Component 2" section, the first data management requirement is that “The SDMC will also be expected to collaborate with other NIAID/DAIDS-affiliated SDMCs in the development of data elements that do not yet exist within CDISC.” Since the formal definition of new CDISC elements and, where necessary, new CDISC domains to accommodate them may require substantial medical expertise and input, what plans does NIAID/DAIDS have to provide the resources necessary to accomplish this?
The Leadership Award itself is the resource that will be provided to SDMCs to accomplish the tasks set forth in the Leadership FOAs. We do not anticipate making other specific resources available.
17. What is the NIAID/DAIDS’ backup strategy for CDISC standardization if the CDISC consortium ceases to operate?
While we consider it unlikely that the CDISC consortium will cease to operate during the 7-year period of the Leadership Awards, applicants may wish to provide their proposed plans to address such a contingency.
18. For an incumbent, would an application in response to clinical trials network RFA be considered a renewal or a new application?
A current awardee of a HIV/AIDS clinical trial network has a UM-1 award with a grant number. An application in response to these RFAs, from the current PI and/or institution, would be a renewal.
19. How will NIH collaborate with the clinical research networks?
Each HIV/AIDS Leadership Group will be assigned a NIAID Division of AIDS (DAIDS) Program Official(s) and Project Scientist(s). Additional NIH staff involvement will be provided to facilitate coordination of resources and activities across the Leadership Groups. External advisory groups convened by NIAID in conjunction with the LG will provide evaluation, advice and recommendations concerning ongoing and planned research activities of the network.
20. Do applicants need NIAID’s prior approval to submit an application requesting $500,000 or more direct costs per year?
No. Applications in response to this FOA do not require prior approval to submit a request for $500,000 or more direct costs per year.
21. What are CORE Funds?
Core funds cover the expenses needed for the Leadership Group to carry out its clinical research agenda. NIAID will provide core funds to the Leadership and Operations Center (LOC), Laboratory Center (LC), and the Statistical and Data Management Center (SDMC). LG application budgets should ONLY request core funds for the LOC, LC and the SDMC. Examples include salary (including fringe benefits) for senior/key personnel and critical contributors, consultant costs, supplies, travel, equipment and consortium costs. Core funds do not include expenses directly attributable to the development, approval or conduct of specific clinical trials.
22. What are Protocol Funds (PF)?
Protocol Funds provide additional support to the CTU to cover protocol-related expenses attributable to protocol development, implementation or close-out of a clinical trial. For example, salary for a statistician needed to participate in protocol development is a core cost; an unanticipated increase in statistician time and effort to meet the needs of a protocol would be considered PF. Post-award, if additional funding is needed to implement and support clinical trials and/or the network’s agenda these needs are to be determined in collaboration with NIAID. Protocol Funds are NOT to be included in the LG application budgets.
23. What costs should be considered LC PIF rather than LC Core? (i.e. assay supply costs, technician salary/benefits, assay specimen management, protocol peptide validation - some or all of these?)
The LC application budget needs to comprise Core costs only. It should cover senior/key personnel and other significant contributors/fringe benefits, supplies, travel, equipment, consortium costs plus related indirect and consultant costs. Further instructions and examples can be found in the PHS398 application instructions.
24. When should we expect to receive instructions on requesting LC PIF funds? How will these LC PIF funds be requested and managed? Will the LC request direction from NIH/NIAID/DAIDS?
All PIF calculations for the LG (LC/SCDMC/LOC) and CTU/CRS will occur post-award and will be dependent on clinical protocol initiation. Each year, NIAID will solicit a request for PF funding and negotiations between the LG, CTU leadership, and NIAID will determine the final amount.
25. How will LC PIF costs be funded should there be a gap between the current LC award and the new PIF CORE award?
If there is a time difference between the end of current awards and the new Notice of Award, NIAID will have the ability to use a no-cost extension of current awards to ensure continuation of current studies and an orderly close-out of the appropriate activities.
26. Over the last several years the ACTG has moved toward a hybrid system of direct Protocol Funds (PF) support to the clinical research sites (awarded by NIAID to the CTUs) and additional PF in the form of sub contracts distributed by the network. The FOA states that applicants must propose one system or the other, and that a combination approach is not permitted. Is there flexibility on this point? If PF is channeled through the network, what proportion of a site’s PF allocation can be provided by the network at the time subcontracts are established each year? Such advance funding will be vital to maintaining a stable personnel infrastructure at the sites.
As stated in the FOA, a proposed leadership group will need to decide on which method they will utilize for their disbursement of PF, and a combination of methods will not be permitted. This designation is limited to the annual PF distribution to the CTU and does not affect any minimal subcontract funding that a LG may negotiate with a CTU for protocol activities. More information about the structure and function of the CTUs/CRSs will be available when the CTU FOA is published in the second quarter of 2012.
27. Maximum efficiency in fiscal management of the grant is achieved when the Leadership and Operations Center (LOC) and the Laboratory Center (LC) components are awarded to the same institution (management of both grants can be centralized). If the intended LC PI is at a different institution than the LOC PI, the only way to make this work is for the LOC PI to be a co-PI on the LC component, which requires the a minimum effort of 30%. But, the LOC PI may already be devoting 50% effort.
Applications for the Leadership Group (LG) must be comprised of three separate linked UM1 applications: a Leadership and Operations Center (LOC), a Laboratory Center (LC) and a Statistical and Data Management Center (SDMC). Each of the three applications, if successful, will receive a separate grant award. Each LG segment (LOC, LC and SDMC), or grantee institution, is the funding recipient, administers the award, and is responsible for assuring compliance NIH requirements and all applicable policies, certifications and assurances.
Co-PI is not a term that is recognized by NIH even though it is recognized by our fellow agencies. Applicants may consider either a single Program Director/Principal Investigator (PD/PI) with a co-investigator(s) or a multiple-PD/PI application if that is most appropriate. When a single PD/PI is proposed in any of the three LG applications, the PD/PI will be required to devote at least 6 person months (50%) effort to the project. Applications proposing Multiple PD(s)/PI(s) are permitted, but the roles and responsibilities should be clearly delineated and justified. If two or more PD(s)/PI(s) are named in any application, each PD/PI must devote at least 3.6 person months (30%) effort to the project.
28. Which assays should be included in PIF - primary immunogenicity, secondary immunogenicity, diagnostics (HIV, others not included in clinic costs), HLA typing, exploratory (in protocol)?
The assays associated with approved clinical protocols will be funded with PIF funding.
29. The HIV Clinical Trial network RFAs list specific dollar funding amounts for each RFA. Do these funding amounts represent a maximum as to what to budget or are they a guideline? If an application budgets in excess of the funding listed for the RFA, will it be viewed as non-responsive?
An application with a budget amount in excess of those stated in each FOA will not be returned as non-responsive. Each application’s budget will be peer-reviewed and should appropriately reflect and support the science being proposed in the application. The advice of the review panel in consultation with NIAID officials will be used to determine the actual award amount. As always, the award amount contained in the notice of award is contingent upon the availability of funds and programmatic priorities.
30. Will consortium F&A costs be counted toward the total cost limit specified in the RFAs?
Consortium F&A costs are included in the direct cost of the application and, therefore, contribute to the overall total cost, which cannot exceed the amount specified in the RFA.
