Frequently Asked Questions (FAQs) for RFA-DE-19-001 and RFA-DE-19-002

Administrative and Resource Center (U19 Clinical Trial Required) RFA-DE-19-001

Coordinating Center (U01 Clinical Trial Required) RFA-DE-19-002

This webpage for FAQs pertaining to RFA-DE-19-001 and RFA-DE-19-002 will be updated periodically. Potential applicants are encouraged to check this website for up-to-date information. If you have a question that is not addressed here, please email it to DentalPBRN@nidcr.nih.gov.

Updated 6/22/2018

  1. Question: The U19 RFA states: “…the Node Directors meetings, Practitioner Executive Committee, and Steering Committee meetings of all key Node and Coordinating Center administrative personnel.”  Is there a defined difference in roles between the Node Directors meetings and the Steering Committee regarding strategic oversight and administrative detail?
  2. Answer:  RFA-DE-19-001 does not define a difference in roles between the Node Director meetings/responsibilities and the Steering Committee regarding strategic oversight and administrative detail.

    The RFA states that, “Each Node will have a Node Director who will manage a Node Organizational Structure and will provide direction and oversight of the Node to support its research and administrative functions. . . Working with the Coordinating Center, the National Network Director and Node Directors will work collaboratively to provide scientific leadership, infrastructure support, and coordination of the DPBRN activities and resources.”

    Applicants may propose the centralized leadership oversight committee composition/roles/responsibilities that will meet the leadership objectives described in the RFA and quoted above.

Updated 6/18/2018

  1. Question:The FOA states that "The NIDCR will fund one national DPBRN Administrative and Resource Center led by a National Network Director(s)". We checked http://www.nationaldentalpbrn.org/, there is only one National Network Director listed there. We wonder if there are other National Network Directors.

    Answer:The NIDCR-supported National Dental Practice-Based Research Network (PBRN) was funded in response to RFA-DE-12-002. For this dental PBRN, there is one National Network Director, and there are also six Regional Directors

Updated 6/7/2018

  1. Question: The FOA explains that a budget is not required for each of the 4 Elements. The NIH ASSIST SF424 system requires that a budget form be included in the Elements section. If all Elements are budgeted within the Administrative Core budget, should a budget form with $0 be included in the Elements section?  And should the Budget Justification narrative in the Elements section explain why the budget form states $0?

     Answer: If all 4 Elements within the DPBRN Elements Core are budgeted within the Administrative Core budget, a budget form with $0 should be included in the DPBRN Elements Core section. The Budget Justification narrative in the DPBRN Elements Core section should explain why the budget form states $0 and why all 4 Elements are budgeted within the Administrative Core budget.

Updated 5/15/2018

  1. Question: Does NIDCR have in mind a certain number of investigator-initiated clinical observational studies or clinical trials that they expect the coordinating center to support within the U01 coordinating center budget? And/or would certain categories of expenses be categorically included in the budgets for investigator-initiated studies?Answer: The exact number of studies supported will depend on the number and nature of the investigations proposed, the availability of funds, and the capacity of the network. Study-specific activities that are not part of the functions described in RFA-DE-19-001 or RFA-DE-19-002 as responsibilities of the Administrative and Resource Center or Coordinating Center could be included in budgets for investigator-initiated studies. Refer to Question 3 posted on 4/16/2018 for additional information.   
  2. Question: If studies funded through the investigator-initiated FOA exceed the number of studies that can be supported by the U01 coordinating center budget, will additional funds for the coordinating center be allocated? Answer: This information is not available at this time.
  3. Question: If studies funded through the future FOA for investigator-initiated studies justified the need for additional salary support for study managers, programmers or other personnel to conduct study-specific activities that are not part of the functions described in the RFAs as role/responsibilities of the Administrative and Resource Center or Coordinating Center, could that support come through the FOA for investigator-initiated studies?
    Answer: Additional support for study-specific activities that are not part of the functions described in the RFAs as roles/responsibilities of the Administrative and Resource Center or Coordinating Center could be included in budgets for investigator-initiated studies.  
  4. Question: Do you anticipate that the coordinating center will have a subcontract relationship with the prime site for each award made under the future investigator-initiated FOA?
    Answer: This information is not available at this time. The NIDCR intends to fund one national DPBRN Coordinating Center and one national DPBRN Administrative and Resource Center, as companion awards, to support the infrastructure for and implementation of multiple observational studies and clinical trials.

  5. Question: Given the new NIH requirement for SingleIRB, what will be the appropriate pathway for approval for individual practitioners participating in the DPBRN? What role will local IRBs of the regional nodes have in this process?
    Answer: The applicant should propose a single IRB plan that would best meet the projected needs of the DPBRN.

  6. Question: Which RFA is responsible for allowable costs associated with the administrative tasks of supporting a Single IRB- the U01 or U19?
    Answer: RFA-DE-19-001 states that utilization of a single IRB is one of the centralized DPBRN functions. Consequently, applications to RFA-DE-19-001 would be responsible for allowable costs associated with the administrative tasks of supporting a single IRB.

  7. Question: Which RFA incurs costs associated with and the responsibility of training and certifying practitioners (GCP, Responsible Conduct of Research, CITI)?
    Answer: Applications to RFA-DE-19-001 would incur costs associated with training practitioners on human subjects protections and conduct of clinical research. RFA-DE-19-001 addresses the infrastructure to support four required components of the DPBRN: a) Practitioner Recruitment and Engagement, b) Practitioner Training, c) Practitioner and Patient Compensation, and d) Communication and Dissemination. The Practitioner Training Component (PTC) “will provide the oversight for practitioner training on general research principles, Good Clinical Practice, the protection of human subjects, data management and security, and other areas deemed essential for compliance with federal and other guidelines pertaining to the conduct of clinical research. The PTC will be responsible for development of processes to ensure that practitioners and other office staff receive study-specific training.”

  8. Question: Is there a transition plan between the current PBRN cycle and the new cycle? For example, will there be studies from the current round that need to be carried over?
    Answer: NIDCR will facilitate a smooth transition between the current PBRN and a future DPBRN. There will be no studies from the current dental PBRN that need to be carried over.  

  9. Question: One of the activities to be budgeted in the U01 includes “Developing and maintaining a practitioner membership database.” Will the awardee of the U01 be provided with access the current member database?Answer: The current member database includes practitioners’ personal information. Consequently, it should be assumed that practitioners would re-enroll in the future DPBRN or would consent to sharing their information with the national DPBRN Coordinating Center awardee.

  10. Question: Management of the PBRN website does not appear to be a responsibility in either the U01 or U1 Whose responsibility is this?
    Answer:   RFA-DE-19-001 addresses the infrastructure to support four required components of the DPBRN: a) Practitioner Recruitment and Engagement, b) Practitioner Training, c) Practitioner and Patient Compensation, and d) Communication and Dissemination. The Communication and Dissemination Component will provide internal and external communications to ensure that knowledge gained through the network is shared quickly with the public and practitioners who can use the knowledge to inform decisions about oral health care.

  11. Question: Is it possible to be provided access to the National Dental PBRN Central IRB Process Handbook? This would assist in costing out secondary activities as direct costs for the awardee institution.
    Answer: Please visit the National Dental PBRN  website to view and access all publicly-accessible resources.

Updated 5/1/2018

  1. Question: As a follow-up to Question 20, will applications submitted to the future FOA for investigator-initiated studies have an un-specified submission due dates, or will the dates be specified (e.g., standard NIH submission dates apply). Also, if the application is submitted but not funded, will a revised application be allowed, similar to other R-series grant applications?
    Answer: Information about due dates for applications and the potential for revised applications submitted to a future FOA is not available at this time.
  2. Question: The U19 application requires 3 main sections (Overall; Admin Core; Elements Core).In an effort to help reviewers, is it permissible to have a Cover Page with the title of the upcoming section? If so, is it permissible to include on that cover page a list of abbreviations used in that section?
    Answer: It is not permissible to include a Cover Page prior to each application section, as the system cannot accommodate the addition. It is also not permissible to include a list of abbreviations used within each section.

    You may view an example of how your application will be automatically assembled for review and funding consideration after submission here. Information regarding guidance and formatting on application attachments can be found here and is part of the How to Apply Application Guide.  In the Grantsmanship section, the guidance regarding the usage of acronyms states: Spell out acronyms the first time they are used in each application section/attachment and note the appropriate abbreviation in parentheses. The abbreviation may be used in the section/attachment thereafter.

Updated 4/16/2018

  1. Question/Answer: A Notice of correction (NOT-DE-18-017) was recently published to RFA-DE-19-001.
  2. Question/Answer: A Notice of correction (NOT-DE-18-018) was recently published to RFA-DE-19-002.
  3. Question: As a follow-up to Question 19 (posted 3/22/2018), if studies funded through the future FOA for investigator-initiated studies justified the need for additional salary support for Node Coordinators (study-specific activities that are not part of the functions described in the RFAs as role/responsibilities of the Administrative and Resource Center or Coordinating Center), could that support come through the FOA for investigator-initiated studies?
    Answer: Yes, additional salary support for Node Coordinators could come through a FOA for investigator-initiated studies, provided that the activities are not part of the functions described in RFA-DE-19-001 or RFA-DE-19-002.

Updated 4/04/2018

  1. Question: Can ARC or DCC pay for licenses needed to enable efficient and HIPAA compliant communication software/tools?
    Answer: Yes, however justification should be provided for the purchase.
  2. Question: There appears to be a broken link in both RFAs: https://www.nidcr.nih.gov/GrantsAndFunding/PoliciesandGuidance/ClinicalResearch/NIDCRClinicalTermsofAward.
    Answer: Thank you for bringing this to our attention. The link has been fixed.
  3. Question: Are letters of support from the regional directors expected or required for the applications?
    Answer: Letters of support from Node Directors are not expected or required for the applications. As stated in RFA-DE-19-001Section IV. Application and Submission Information, 2. Content and Form of Application Submission, Administrative Core, Budget (Administrative Core), Node (Consortium) PD(s)/PI(s) must be identified as Key Personnel.
  4. Question: Is a letter of support from the current PBRN national director expected or required for the coordinating center application? Is a letter of support from the current coordinating center expected or required for the administrative and resource center application?
    Answer: No, a letter of support from the PBRN National Director is not expected or required for the Coordinating Center application, and a letter of support from the Coordinating Center is not expected or required for the Administrative and Resource Center application. Further, as stated in RFA-DE-19-001, a Collaboration Plan must be included as an Other Attachment in the Overall component of the U19 application. The Collaboration Plan must not name any proposed national DPBRN Coordinating Center institution/entity or personnel to prevent the potential for bias during peer review. As stated in RFA-DE-19-002, a Collaboration Plan must be included as an Other Attachment in the U01 application. The Collaboration Plan must not name any proposed national DPBRN Administrative and Resource Center institution/entity or personnel to prevent the potential for bias during peer review.

Updated 3/28/2018

  1. Question: The FAQs page regarding the RFA clarifies that the funding amounts
    ($3.2 million for the Administrative and Resource Center (ARC) and $2.2 million for the Coordinating Center (CC)) for FY 2019 are total amounts (rather than direct amount). It further states that application budgets are limited to the said amounts in total costs per year and that they must reflect the actual needs of the project. Is it correct to interpret these sentences to mean that the institute has not committed funds yet for years 2 through 7, but that the stated total budgets ($3.2 million for the ARC and $2.2 million for CC as maximum amounts per year) are guidelines for how budgets should be handled for years 2 through 7 in the application (while keeping in mind that they must reflect the actual needs of the project)? Or are there other guidelines for how years 2-7 should be handled in the application budget, budget justification etc.?
    Answer: Yes, the institute has not yet committed funds for years 2 through 7, but the stated total budgets are guidelines for how budgets should be handled for years 2 through 7 in the application. There are no other guidelines for how years 2-7 should be handled in the application budget, budget justification, etc.
  2. Question: Funding is indicated to be for FY2019, but the earliest funding date is April 1, 2019. Does that mean that the first year is from April 1, 2019 to Dec 31, 2019 or from April 1, 2019 to March 31, 2020?
    Answer: The first year is from April 1, 2019 to March 31, 2020.
  3. Question: The RFA states "Prior to initiating the Development and Implementation Phases of approved network studies, a project work scope and timeline will be finalized. ..." In this context, does "approved" mean approved after peer review, or approved by the network to be developed into an application?
    Answer: For research study funds available through the U19 award, “approved” means approved by NIDCR after having been recommended by the Executive Committee and then submitted to the NIDCR for evaluation. For investigator-initiated clinical research studies to be solicited through a future national DPBRN-specific funding opportunity announcement, “approved” means grants awarded by NIDCR after having undergone peer review. Specifically, RFA-DE-19-001 and RFA-DE-19-002 state the following: “During the Conceptual Phase of each potential new network study, the National DPBRN Administrative and Resource Center in collaboration with the National Coordinating Center will be responsible for… Providing information necessary to the potential applicants as they apply for NIDCR funding (e.g., review study concept and schedule of activities, create project work scope and timeline, ensure the feasibility of the proposed research to be implemented in the network, assess availability and extent of network resources required to implement the research study).”
  4. Question: Can ARC or DCC pay for software for practitioners and/or patients?
    Answer: It is unclear what is meant by software, but justification should be provided for the purchase.

Posted 3/22/2018

  1. Question: May a potential applicant arrange a meeting or phone call with an NIDCR Program Official to discuss the RFAs and obtain clarification of instructions?
    Answer: To ensure that all potential applicants have access to the same information, queries about the RFAs must be directed to DentalPBRN@nidcr.nih.gov. All questions received by NIDCR will be answered on this FAQ webpage.
  2. Question: RFA-DE-19-001 (U19) cites an annual award amount of $3.2 million. Is this a total cost amount or direct cost amount?
    Answer: The NIDCR intends to commit up to approximately $3,200,000 in total costs in FY2019 to fund one U19 award. Application budgets are limited to $3,200,000 in total costs per year and must reflect the actual needs of the project.
  3. Question: RFA-DE-19-002 (U01) cites an annual award amount of $2.2 million. Is this a total cost amount or direct cost amount?
    Answer: The NIDCR intends to commit up to approximately $2,200,000 in total costs in FY2019 to fund one U01 award. It is expected that application budgets will be limited to $2,200,000 in total costs per year and will reflect the actual needs of the project.
  4. Question: For applications in response to RFA-DE-19-001 (U19), may an institution submit more than one application?
    Answer: Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. Refer to Part I. Overview Information and Section III.3 for additional information.
  5. Question: For applications in response to RFA-DE-19-002 (U01), may an institution submit more than one application to one of the RFAs?
    Answer: Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. Refer to Part I. Overview Information for additional information.
  6. Question: Must an applicant responding to either RFA have current or previous involvement with NIDCR-supported Practice-Based Research Networks?
    Answer: No, this is an open competition. It is not limited to applicants with prior experience in the NIDCR-supported Practice-Based Research Networks.
  7. Question: Can a Program Director/Principal Investigator (PD/PI) for an application in response to one of the RFAs be a co-investigator or subcontract (Consortium) PD/PI for an application in response to the other RFA?
    Answer: Both RFAs state that a PD/PI for an application in response to one RFA may not be a PD/PI for an application in response to the companion RFA. There are no restrictions for co-investigators or subcontract (Consortium) PDs/PIs.
  8. Question: Can an applicant organization submit an application for both RFA-DE-19-001 and RFA-DE-19-002?
    Answer: Yes, an applicant organization may submit separate applications in response to each of the RFAs. Note that there is no requirement that applicant organizations submit applications for both RFAs.
  9. Question: Is a Letter of Intent required for either RFA?
    Answer: For either RFA, a Letter of Intent is not required, is not binding and does not enter into the review of a subsequent application. The information that a Letter of Intent contains assists staff in estimating the potential review workload and is requested to be submitted by June 17, 2018. Refer to Section IV.2 for additional information.
  10. Question: What is a companion award and how will it work?
    Answer: NIH defines companion Funding Opportunity Announcements (FOAs) as a set of FOAs that share a unified theme or initiative. These FOAs may use different activity codes. They are typically (but not always) published concurrently. To ensure success of the dental practice-based research network (DPBRN), there must be strong communication and collaboration between the DPBRN Administrative and Resource Center and the DPBRN Coordinating Center.
  11. Question: For applications in response to RFA-DE-19-001 (U19), what must be included in the Collaboration Plan? How can detail be provided if we cannot identify who the collaborators may be?
    Answer: A Collaboration Plan must be included as an Other Attachment in the Overall component of the U19 application. The Collaboration Plan must describe communication and collaboration interactions between the national DPBRN Administrative and Resource Center and the national DPBRN Coordinating Center. Further, the Collaboration Plan must describe the distribution of activities and division of tasks and responsibilities pertaining to management of the DPBRN infrastructure and research studies conducted through the DPBRN and must include a conflict resolution plan. The page limit for the Collaboration Plan is 4 pages.
    The Collaboration Plan must not name any proposed national DPBRN Coordinating Center institution/entity or personnel to prevent the potential for bias during peer review.
  12. Question: For applications in response to RFA-DE-19-002 (U01), what must be included in the Collaboration Plan? How can detail be provided if we cannot identify who the collaborators may be?
    Answer: A Collaboration Plan must be included as an Other Attachment in the U01 application. The Collaboration Plan must describe communication and collaboration interactions between the national DPBRN Administrative and Resource Center and the national DPBRN Coordinating Center. Further, the Collaboration Plan must describe the distribution of activities and division of tasks and responsibilities pertaining to management of the DPBRN infrastructure and research studies conducted through the DPBRN and must include a conflict resolution plan. The page limit for the Collaboration Plan is 4 pages.
    The Collaboration Plan must not name any proposed national DPBRN Administrative and Resource Center institution/entity or personnel to prevent the potential for bias during peer review.
  13. Question: Must the PD/PI for an application in response to one RFA illustrate previous collaboration with the PD/PI of the companion application?
    Answer: No, previous collaboration is not required. Applications must describe the vision for a future collaboration between the DPBRN Administrative and Resource Center and the DPBRN Coordinating Center, including a plan for communication between the entities and the distribution and division of tasks related to management of administrative and research activities.
  14. Question: For applications in response to RFA-DE-19-001 (U19), what is the page limit for the Research Strategy section of the application?
    Answer: In the U19 application, there are 3 required sections or “components,” each of which includes a Research Strategy section. The page limit for the Research Strategy section in the Overall component is 12 pages. The page limit for the Research Strategy section in Administrative Core (Node Organizational Structure) is 12 pages. The page limit for the Research Strategy section in DPBRN Elements Core (required DPBRN components) is 6 pages. All 3 components must be included in the grant application.
  15. Question: For applications in response to RFA-DE-19-002 (U01), what is the page limit for the Research Strategy section of the application?
    Answer: The RFA states that all page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. The page limit for the Research Strategy section of a U01 application is 12 pages.
  16. Question: For either RFA, what information may be included in the Appendix?
    Answer: The Appendix Policy specifies the only allowable Appendix materials, and applications submitted with Appendix materials not specified in the Appendix Policy will be withdrawn as noncompliant. It is recommended not to include any appendix materials in applications submitted to either RFA since the allowable materials are research study-specific, and applications submitted to these RFAs do not request study-specific details.
  17. Question: For applications in response to RFA-DE-19-001 (U19), why am I instructed to respond “yes” to the 4 questions in the Clinical Trials Questionnaire if I am not proposing a clinical trial in the grant application?
    Answer: The grant application must demonstrate that the proposed network has the capacity to develop and implement clinical trials. A Study Record must be entered as an example of how a clinical trial would be implemented in the network. Some of the information needed to demonstrate capacity is located in the FORMS-E Study Record: PHS Human Subjects and Clinical Trials Information form. To access the required data entry fields in the Study Record, the applicant must do the following:

    In the Overall component

    1. In SF424 (R&R) Other Project Information (Overall), indicate “Yes” to the question “Are Human Subjects Involved?”
    2. Add an attachment to Other Requested Information to cross-reference Study Record information across components. This attachment should indicate that all components (Overall component, Administrative Core, and DPBRN Elements Core) will contribute towards development and implementation of clinical trials in the network.
    3. Complete a Study Record: PHS Human Subjects and Clinical Trials Information form. Indicate “Yes” to the 4 questions of the Clinical Trials Questionnaire (Section 1.4), which will allow access to certain data entry fields needed to demonstrate the network’s capacity to develop and implement clinical trials. (As indicated in the RFA instructions, complete the following fields only: 1.1, 1.2, 1.3, 1.4, 2.1, 2.4, 2.5, 3.1, 3.2, 3.3, 4.7.)
    4. Do not enter a Delayed Onset Study Record in the Overall component.

    In the Administrative Core

    1. In SF424 (R&R) Other Project Information (Administrative Core), indicate “Yes” to the question “Are Human Subjects Involved?”
    2. Add an attachment to Other Requested Information to cross-reference Study Record information across components. This attachment must indicate that the Study Record details, which demonstrate the network’s capacity to develop and implement clinical trials, are included in the Overall component.
    3. Do not enter a Study Record in the Administrative Core.
    4. Enter a Delayed Onset Study Record in the Administrative Core. Note the following additional instructions, which were inadvertently omitted from RFA-DE-19-001 (A Notice to clarify the omission will be published):
      The grant application must include one or more developmental/exploratory, pilot (feasibility), and/or survey delayed onset studies to be funded through this award. The delayed onset study(ies) represent future studies funded through the U19 grant to be conducted through the national DPBRN and should not provide specific details about the proposed clinical studies. Enter the delayed onset study(ies) in the Administrative Core only. Per the instructions, multiple delayed onset studies can be grouped in a single record, and the justification attachment can represent all delayed onset studies grouped in a single record. The justification should indicate that the delayed onset clinical studies will be submitted to the NIDCR as study concepts, which will undergo evaluation and future implementation in the DPBRN.

    In the DPBRN Elements Core

    1. In SF424 (R&R) Other Project Information (DPBRN Elements Core), indicate “Yes” to the question “Are Human Subjects Involved?”
    2. Add an attachment to Other Requested Information to cross-reference Study Record information across components. This attachment must indicate that the Study Record details, which demonstrate the network’s capacity to develop and implement clinical trials, are included in the Overall component.
    3. Do not enter a Study Record in the DPBRN Elements Core.
    4. Do not enter a Delayed Onset Study Record in the DPBRN Elements Core.
  18. Question: For applications in response to RFA-DE-19-002 (U01), why am I instructed to respond “yes” to the 4 questions in the Clinical Trials Questionnaire if I am not proposing a clinical trial in the grant application?
    Answer: The grant application must demonstrate that the proposed Coordinating Center has the capacity to support clinical studies to be conducted within the DPBRN. A Study Record must be entered as an example of how a clinical trial would be supported. Some of the information needed to demonstrate capacity is located in the FORMS-E Study Record: PHS Human Subjects and Clinical Trials Information form. To access the required data entry fields in the Study Record, the applicant must do the following:
    1. In SF424 (R&R) Other Project Information, indicate “Yes” to the question “Are Human Subjects Involved?”
    2. Complete a Study Record: PHS Human Subjects and Clinical Trials Information form. Indicate “Yes” to the 4 questions of the Clinical Trials Questionnaire (Section 1.4), which will allow access to certain data entry fields needed to demonstrate the Coordinating Center’s capacity to support clinical trials. (As indicated in the RFA instructions, complete the following fields only: 1.1, 1.2, 1.3, 1.4, 2.1, 2.4, 3.1, 3.2, 3.3, 3.5, 4.7.)
    3. Do not enter a Delayed Onset Study Record.
  19. Question: The RFAs mention a funding opportunity announcement (FOA) planned for later that will fund investigator-initiated studies. Can you tell U19/U01 applicants what budget items that FOA will fund? For example, would the investigator-initiated RFA fund salary support for the Study PI and Investigator(s), practitioner payments, and patient payments? Will that FOA fund other items, such as investigator travel costs, node coordinator travel costs, study-specific publication costs, consultant costs, and any other items? This would help applicants draw the line where study-specific budgets end and infrastructure budgets begin.
    Answer: Since a future FOA will solicit applications for research studies to be conducted in the dental practice-based research network, expenditures that are necessary and reasonable to develop and implement future studies would be included in applications responding to a future FOA. The U19/U01 applications should budget for study-specific expenditures described as roles/responsibilities/functions of the Administrative and Resource Center or Coordinating Center stated in the RFAs. For example, in RFA-DE-19-001 (U19), personnel within the Node Organizational Structure are responsible for functions such as “engaging practitioners in study participation,” “participating on study teams to provide oversight of network resources and advising study teams about network operations,” “working collaboratively with study teams to develop clinical research training procedures and materials for practitioners,” “assuring that practitioners are appropriately trained,” etc. Similarly, in RFA-DE-19-002 (U01), functions of the Coordinating Center include “providing biostatistical support to study teams for study design and protocol development…,” “assisting study teams in the preparation of study protocols, case report forms, and other study-related documents,” “establishing and maintaining a data management system needed for study data collection and storage…,” etc. In RFA-DE-19-002 (U01), see Section IV. 2 R&R or Modular Budget for additional information about activities to be budgeted.
  20. Question: When will a future funding opportunity announcement be published that will solicit applications for research studies to be conducted in the dental practice-based research network? Would this be possibly in a few months, or only after the U19/U01 awards have been made? This is relevant to planning how U19 and U01 budgets might be affected by the timing of large-scale study launches.
    Answer: Information about timing of a future FOA is not available at this time. Applicants should propose budgets and network activity timelines based upon when it is expected that the network will have the capacity to launch large-scale clinical studies.
Last Reviewed
June 2018