Patient-Centered Outcomes Research (PCOR) for Treatment Options in Uterine Fibroids: Developing a Prospective Multi-Center Practice-based Clinical Registry (P50)

Frequently Asked Questions


The following questions are derived from individual questions submitted to UFRegistryFOA@ahrq.hhs.gov about the Request for Applications (RFA) HS-14-006: Patient-Centered Outcomes Research (PCOR) for Treatment Options in Uterine Fibroids: Developing a Prospective Multi-Center Practice-based Clinical Registry (P50) and are shared here for all potential applicants. We encourage applicants to review all replies and to monitor this site for newly added questions and answers.


  Contents

A. Determining Suitability of the Theme, Projects, or Research Ideas for Submission
B. Investigator Qualifications, Titles, and Other Designations
C. Budget

A. Determining Suitability of the Theme, Projects, or Research Ideas for Submission

Question A1: Does “clinical center” refer to a single provider site, or can it be a network of providers?

Answer A1: The clinical center, as defined in the context of this Funding Opportunity Announcement (FOA), may be a single large tertiary medical center, a medical center with a number of existing affiliated hospitals within a defined geographic region, or an integrated delivery system that comprises a consortium of community-based hospitals and provider networks. Applicants should provide a detailed description of the composition and configuration of the clinical center and explain why the proposed composition is the most appropriate in establishing the clinical registry and addressing the research studies as proposed. The FOA requires that the proposed clinical center be geographically diverse and able to represent and reflect diverse practices and patient population groups, as well as socioeconomic and demographic characteristics. As stated in the FOA, each clinical center should have sufficient patient volume in the practice to support the proposed studies and the requisite data collection/management capabilities.

Question A2: How can applicants determine if their planned approach is a good fit for this FOA?

Answer A2: Applicants are strongly encouraged to read the FOA closely, including its explicitly stated objectives and review criteria; this is the best available guidance to potential applicants about the responsiveness of their planned research. Applicants should be aware that the determination of suitability and responsiveness of applications is within the purview and authority of the Special Emphasis Panel, not AHRQ.

Question A3: Can applicants discuss the scientific and research aspects of their proposals with AHRQ staff?

Answer A3: AHRQ appreciates all expressions of interest from prospective applicants. Applicants should read the FOA closely, including its review criteria; this is the best available guidance to potential applicants about the responsiveness of their planned research.

Applicants who have specific questions after reviewing the FOA can Email their questions to UFRegistryFOA@ahrq.hhs.gov. For reasons of equity and consistency, AHRQ scientific staff responds in writing to all inquiries. Wherever it is possible and appropriate, AHRQ staff will clarify common areas of uncertainty in a written and generalized format that is applicable for dissemination to other potential applicants, such as frequently asked questions. Telephone counseling on potential study ideas is discouraged in order to be equitable and avoid potential misdirection of applicants.

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B. Investigator Qualifications, Titles, and Other Designations

Question B1: Can the Principal Investigator (PI) of a clinical center (CC) also serve as a Co-Investigator for the Research and Data Coordinating Center (RDCC)?

Answer B1: As stated in the FOA, “The applicant institution that serves as the RDCC can also itself serve as a CC, with the following provisos: 1) The CC must be functionally separate and independent from the RDCC; 2) The CC should have its own co-investigator (distinct from the PD/PI) and team members.” The roles and responsibilities of the RDCC and CC are distinct, and the intent of the FOA is to preserve the independent and separate functioning of the RDCC and equal relationship across all CCs. As such, the FOA calls for the CC to have its own team members. Applications that propose any deviation from this FOA guidance should provide a strong justification and rationale for the proposed approach.

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C. Budget

Question C1: The FOA states, “Detailed budget is required not only for the initial budget period but the entire requested period of support as well.” Does this mean applicants must provide a detailed budget for every year of support requested, or just a composite budget for future years, as shown in the PHS 398 Application Guide?

Answer C1: Applicants are required to submit complete detailed budgets and budget justifications for all components of the project (Core Registry Functions, each individual Research Project) for each year of support requested and include a composite budget for each year of support. Detailed future year budgets for consortia (if applicable) must also be included.

Question C2: Are consortium institution direct and indirect costs counted as direct costs on the parent institution's budget?

Answer C2: Yes. All consortium costs (direct and indirect) count as direct costs on the parent institution's budget.

Question C3: Where in the budget should applicants include research participation costs?

Answer C3: Research participation costs, if proposed and included, should be centrally allocated as part of the RDCC budget, not that of the individual CC. The RDCC can set a cost level per recruited patient as appropriate.

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Current as of November 2013
Internet Citation: Patient-Centered Outcomes Research (PCOR) for Treatment Options in Uterine Fibroids: Developing a Prospective Multi-Center Practice-based Clinical Registry (P50): Frequently Asked Questions. November 2013. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/funding/fund-opps/rfahs14006faq.html