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Prepare a Proposal

Preparing a proposal can be a daunting task. There are a lot of sponsor and CNE requirements. On this page, you’ll find information to make the process a little easier, from grantsmanship tips to the nuts and bolts of developing a budget and proposal.

Gift vs Grant

Funding from voluntary health organizations or associations, such as the American Cancer Society or American Heart Association, is usually treated as a grant and not a gift. 

Please reach out to ospraward@carene.org for guidance if you are unsure whether your project qualifies as a grant or a gift.


A gift is the voluntary, non-reciprocal transfer of money or property from a donor to an institution. The donor may be an individual, a corporation or a non-profit organization. The donor does not expect anything of value in return other than recognition and does not have control over expenditure of the funds. A gift may meet the interests of the donor and can be restricted or unrestricted. A restricted gift is a contribution designated for a specific purpose, program, or project. If the donor does not specify any restrictions, the gift is unrestricted and the institution allocates the funds at its own discretion.


A grant (aka, sponsored program/project funding, award) is the transfer of money or property from a sponsor to an institution that may require performance of specific duties such as research, budget reports, progress reports, and return of unused funds. 

Any funding provided by U.S. Government agencies, at the federal, state, or local level, in support of CNE activities should be treated as a grant. Government funds are not treated as gifts. 

Create a Proposal

A proposal is a detailed request for funding submitted to a sponsor (federal, governmental, foundation, industry, etc) following their format and specifications. Although the scientific content within the proposal is up to the PI/PDs, your SPRA pre-award team is available to help. Each proposal must comply with CNE policies, and if accepted for funding, the proposal forms the basis for the award terms and conditions.

It may be helpful to have an awareness of currently funded research and review previously submitted proposals here at NIH Reporter.

Open Grants

Public access repository of grant proposals submitted to a variety of funding agencies.

Learn More


Helpful Hints: *Remember to read the funding announcement (FOA) or request for proposal (RFP) carefully to ensure you have followed all sponsor instructions and formatting requirements. Each one is different even if they come from the same funding agency. 

Things to Remember: *Remember to leave adequate time to collect the document from outgoing sub-awards (if applicable) and for review by SPRA before the sponsor deadline and to prevent a system error from delaying final submission.

Institutional Information

Institutional information: Butler, Women & Infants, The Providence Center and Kent institutional facts and data needed to fill out applications and provide information to sub-institutions can be found here on the Federal Demonstration Partnership Clearinghouse.


A biosketch serves as a streamlined version of an individual’s CV and documents their qualifications and experience for a specific role in a project. NIH and NSF use standard biosketch templates. Other sponsors and funders might have different requirements for CVs/biosketches.


NIH Biosketch Page: https://grants.nih.gov/grants/forms/biosketch.htm

Instructions for Biosketch: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-g/general/g.240-r&r-seniorkey-person-profile-(expanded)-form.htm#Instructions

NIH Disclosure Table: Biosketch vs Other Support: https://grants.nih.gov/grants/forms/NIH-Disclosures-Table.pdf

FAQs: https://grants.nih.gov/faqs#/biosketches.htm

The Science Experts Network Curriculum Vitae (SciENcv)

https://www.ncbi.nlm.nih.gov/sciencv/ utility is a cooperative project requested by the Federal Demonstration Partnership (FDP), which is an association of academic research institutions and federal agencies. It is being built by the National Center for Biotechnology Information (NCBI) at the National Institutes of Health.

This new electronic system helps researchers assemble the professional information needed for participation in federally funded research. SciENcv gathers and compiles information on expertise, employment, education and professional accomplishments. Researchers can use SciENcv to create and maintain biosketches that are submitted with grant applications and annual reports. Templates for other support documents are being built and will soon be available as well. 

What SciENcv does:

  • Eliminates the need to repeatedly enter biosketch (and soon other support) information
  • Reduces the administrative burden associated with federal grant submission and reporting requirements
  • Provides access to a researcher-claimed data repository with information on expertise, employment, education, and professional accomplishments
  • Allow researchers to describe their scientific contributions in their own language
  • Leverages data from existing systems (eRA Commons, myNCBI)

Registration and login information: https://www.ncbi.nlm.nih.gov/sciencv/

Step by step instructions for using SciENcv: https://www.ncbi.nlm.nih.gov/books/NBK154494/

NIH Data Management and Sharing Plan (DMSP)

NIH has issued the Data Management and Sharing (DMS) policy (effective January 25, 2023) to promote the sharing of scientific data. Under the DMS policy, NIH expects that investigators and institutions:

  • Plan and budget for the managing and sharing of data
  • Submit a DMS plan for review when applying for funding
  • Comply with the approved DMS plan

More information on creating a DMS Plan, budgeting for data management, and resources related to the new policy are available here.

Create a Budget (Federal, State, Foundation)

A budget is a line item financial representation of your proposal's scope of work. Costs should be carefully considered to reflect the needs of the project and adhere to the cost principles as defined by the Office of Budget Management’s Uniform Guidance (Grants and Co-Ops) or clauses in the Federal Acquisition Regulation (Contracts).  More detail on creating budgets for grants, co-ops, and contracts can be found here. Each line item should be justifiable to meet the aims of the proposed project. 

Be sure to read the solicitation notice carefully as sponsor requirements for budget proposals vary. Many require a detailed, line item budget and justification while some, such as the NIH Modular budget require very little detail. 

A detailed budget should be prepared by you or your team and forwarded for review to your SPRA pre-award team. This is true for all proposals, regardless of sponsor submission requirements. You should contact the SPRA pre-award team as soon as you decide to submit a proposal, even if it’s well in advance of the sponsor deadline. For projects with pass-through funding, sub-recipient institutions have their own routing processes and internal deadlines which may be far in advance of the sponsor deadline.

*The following is specific to Industry Sponsored Proposals

Review A Budget

Preliminary budget negotiations are encouraged. However, the PI should not negotiate changes to fringe or facilities and administrative rates that differ from the federally negotiated rates established at each OU. Formal negotiations with the sponsor, including those related to F&A rates should be conducted by SPRA.   

More detailed information on the creation of budgets for grants and contracts, allowable costs, and budget review and negotiation for industry-sponsored projects is available here.


In most cases, the sponsor will provide a draft budget that includes all reimbursable procedures, services, and personnel along with the proposed reimbursement. Each line item within the proposed budget needs to be carefully reviewed to determine if it is feasible from an operations perspective and also to assess our organization’s actual cost as compared to what the sponsor proposed.

More detailed information on the industry-sponsored budget review, including requesting research pricing is available here.

Pass-through Funding

Contact OSPRAward@carene.org for information on required documents and due dates. The need for pass-through funding on a project is usually determined at the proposal stage and documentation for the sub-award recipients is included with the funding application.

Incoming Sub-award

An incoming sub-award is an agreement between a prime site, where grant funds were awarded, and a CNE OU. Funds come from the prime site to the CNE OU to fund your effort and research expenses related to work on the grant awarded at the prime site.

Outgoing Sub-award

An outgoing sub-award is an agreement between a CNE OU and another institution. In this instance, the CNE OU is the prime site receiving the grant funding and is sending sub-award funding to another institution.


As a postdoc, how do I submit an application for a K award or other low overhead award?

The K award process varies by OU. 

At Butler Hospital the first step to submitting a low overhead application is filling out a RSPC (low overhead) application for approval internally. A copy of the application can be obtained from Michele Hutchinson. Completed applications should be returned to Michele. Allow sufficient time for that application to be processed prior to the sponsor deadline. Once the RSPC application is approved, you should follow the sponsor's directions to complete your application, working with your mentor. Be mindful of specific requirements outlined in the FOA. Standard deadlines for internal budget and application review apply. 

At Women & Infants Hospital and Kent Hospital prospective K applicants should initiate a conversation with their department chair or chief prior to preparing an application. For industry-sponsored research, formal indirect negotiations should be conducted by SPRA.

What’s the difference between a PI/PD, MPI, Co-I?

PI/PD: an individual responsible for the conduct of a research project.

Multiple PI (NIH) or Co-PI (NSF): A team science approach where the conduct of the research project is shared between individuals. Each MPI has equal responsibility and authority for the overall project.

Co-Investigator: a significant contributor to the scientific goals of a project but does not have overall responsibility for the project.
My industry sponsor has indicated they won’t pay our full, federally negotiated indirect rate. Should I offer them a lower rate?

No. A PI should not suggest or promise a lower indirect rate to a sponsor. In the event a sponsor indicates to the Principal Investigator that it does not wish to pay these costs in full, SPRA should be contacted in order that this office may contact the sponsor for further negotiation regarding this issue.

Is there a glossary of terms I can consult?
The NIH glossary of terms can be found here
How do I get a username and password to eRA Commons, grants.gov, or other electronic submission platform?
A request should be made to OSPRaward@carene.org indicating what role you are requesting.

NIH Extramural Nexus

https://nexus.od.nih.gov/all NIH Extramural Nexus Wed, 02 Nov 2022 16:02:42 +0000 en-US hourly 1 https://wordpress.org/?v=6.0.3 112833137 https://nexus.od.nih.gov/all/2022/11/02/if-you-see-something-amiss-say-something/ https://nexus.od.nih.gov/all/2022/11/02/if-you-see-something-amiss-say-something/#respond Wed, 02 Nov 2022 16:02:42 +0000 https://nexus.od.nih.gov/all/?p=23722 If you ever come across misconduct, whether it be harassment, fraud, grant scams, research misconduct, peer review violations, or foreign interference, please report it.


You can find the appropriate contacts for various types of concerns on our new Report a Concern page. (Or just click on this button screenshot of report button located on various pages of the NIH Grants and Funding website.)

screenshot of report a concern page

If you’re looking for other contacts at NIH, check out the Need Help page.

https://nexus.od.nih.gov/all/2022/11/02/if-you-see-something-amiss-say-something/feed/ 0 23722 https://nexus.od.nih.gov/all/2022/10/31/forms-h-instructions-forms-and-a-handy-checklist/ https://nexus.od.nih.gov/all/2022/10/31/forms-h-instructions-forms-and-a-handy-checklist/#respond Mon, 31 Oct 2022 18:15:28 +0000 https://nexus.od.nih.gov/all/?p=23718 Hopefully, you’ve seen our notices (NOT-OD-22-195, NOT-OD-23-012), tweets, and previous Nexus posts (FORMS-H Coming for January 2023 Due Dates, Gearing Up for Transition to FORMS-H Application Forms, data sharing posts, genomic data sharing posts) regarding our pending transition to an updated set of grant application forms we refer to as FORMS-H and the implementation of new Data Management and Sharing (DMS) requirements. If so, you already know that you must use FORMS-H forms for grant application due dates on or after January 25, 2023 and that our forms and instructions have been updated to support the new sharing requirements.

The FORMS-H application instructions are posted, FORMS-H application packages are starting to show up on active opportunities, and it’s time to get to work on your applications.

This checklist will help you navigate the changes.

FORMS-H Checklist

  • Use an application form package with a Competition ID that includes “FORMS-H”.
    • Not sure how to identify the correct form version? See Do I Have the Right Forms for My Application?
    • If you find you have started your application on the wrong form set, take advantage of copy features available in ASSIST, Grants.gov Workspace, and many institution system-to-system solutions.
  • Determine if your proposed research is subject to the DMS policy.
    • The policy applies to all research that generates scientific data (e.g., single and multi-project research projects and centers), but not to some other activities (e.g., training, fellowship, construction, conference grants, resources).
  • Develop a Plan for managing and sharing scientific data and submit this Plan within the funding application or proposal.
    • Submit a single Plan per application using the new “Other Plan(s)” item on the PHS 398 Research Plan or PHS 398 Career Development Award Supplemental form. For applications also subject to the Genomic Data Sharing (GDS) Policy, address genomic data sharing considerations in your DMS Plan.
      • Multi-project applications: include the DMS Plan in the Overall component only.
  • Estimate and request funds for data management and sharing activities if not already covered by the institution or other sources.
    • Request “Data Management and Sharing costs”
      • Modular budgets: use the Additional Narrative Justification attachment of the PHS 398 Modular Budget Form.
      • Detailed budgets: include “Data Management and Sharing Costs” line item under F. Other Direct Costs “8-17 Other” on the R&R Budget Form.
      • Multi-project applications: at least one component must include a “Data Management and Sharing Costs” line item with either all DMS costs incurred, including personnel costs (e.g., personnel who will be curating data for the project) or 0 if no cost is incurred.
    • Justify DMS costs and provide a brief (half page or less) summary of the DMS Plan within section L. Budget Justification in a section titled “Data Management and Sharing Justification”.
      • Modular budgets: use the Additional Narrative Justification attachment of the PHS 398 Modular Budget Form
      • Detailed budgets: use the Budget Justification attachment of the R&R Budget Form.
      • Multi-project applications: include a justification within any component that includes the “Data Management and Sharing Costs” line item
  • Upon submission check all applicable application files in eRA Commons (e-Application; Data Management and Sharing (DMS) Plan; eSubmission-PHS Assignment Request Form; cover letter)
    • Note: Unless indicated in the funding announcement, the Data Management and Sharing Plan is not evaluated at time of peer review but is evaluated prior to award. Although part of the official submission, when not considered during peer review the attachment is maintained as a separate “Data Management and Sharing (DMS) Plan” document in the grant folder viewable via the Status Information screen in eRA Commons. This document is viewable by authorized users and is not part of the assembled e-Application.

Additional Resources

https://nexus.od.nih.gov/all/2022/10/31/forms-h-instructions-forms-and-a-handy-checklist/feed/ 0 23718 https://nexus.od.nih.gov/all/2022/10/31/human-subjects-research-policies-clinical-trials-inclusion-on-december-6-7/ https://nexus.od.nih.gov/all/2022/10/31/human-subjects-research-policies-clinical-trials-inclusion-on-december-6-7/#respond Mon, 31 Oct 2022 17:00:57 +0000 https://nexus.od.nih.gov/all/?p=23715 Are you working with human subjects in your research and wondering about how HHS regulations and NIH policies apply, how to prepare a research proposal, or how to develop inclusion plans? Join experts from the NIH Division of Human Subjects Research and HHS Office of Human Research Protections (OHRP) for answers to these questions and more at the Human Subjects Research: Policies, Clinical Trials, & Inclusion event on December 6 and 7, 2022. During this 2-day virtual event, these NIH and HHS experts will share policies, resources, guidance, and case studies in this informative and engaging, live event. Check out the full agenda on this page for a detailed list of topics covered.

Registration is free and is included in your personal “All Access Pass” to the virtual NIH Grants Conference 2022-2023 season. The Conference begins with monthly PreCon Events, such as this one on International Collaborations, which are designed to dive deeper into select grant-related topics. These events culminate with the 2-day NIH Grants Conference, Feb 1-2, 2023, which includes over 25 different topics on funding, policies, and processes shared by NIH and HHS experts. You only need to register once for the NIH Grants Conference Center. Once registration is complete, just log into the site and save upcoming events to your calendar, gather resources from over 45 NIH Institute, Center, and Office booths in the virtual Exhibit Hall, and come back to visit any time during the conference season.

Be sure to view all of the upcoming pre-conference events on the NIH Grants Conference website to see what may be of interest. Next up:

Interested? Register today and share information about the conference events with colleagues, students, trainees, those newer to NIH grants, and others who may not normally receive these invitations. Presentation materials are provided in advance in the conference center and (just in case you missed one) recordings are posted 5-7 business days after the event. We hope to see you there! #NIHGrantsConf

https://nexus.od.nih.gov/all/2022/10/31/human-subjects-research-policies-clinical-trials-inclusion-on-december-6-7/feed/ 0 23715 https://nexus.od.nih.gov/all/2022/10/28/november-11-friday-2022-nih-closed-for-the-federal-holiday/ https://nexus.od.nih.gov/all/2022/10/28/november-11-friday-2022-nih-closed-for-the-federal-holiday/#respond Fri, 28 Oct 2022 19:09:11 +0000 https://nexus.od.nih.gov/all/?p=23713 NIH (including help desks) will be closed on Friday, November 11, 2022 for the federal holiday (Veterans Day). If a grant application due date falls on a federal holiday, the application deadline is automatically extended to the next business day.

https://nexus.od.nih.gov/all/2022/10/28/november-11-friday-2022-nih-closed-for-the-federal-holiday/feed/ 0 23713 https://nexus.od.nih.gov/all/2022/10/28/feedback-sought-on-strengthening-capacity-for-emergency-clinical-trials/ https://nexus.od.nih.gov/all/2022/10/28/feedback-sought-on-strengthening-capacity-for-emergency-clinical-trials/#respond Fri, 28 Oct 2022 13:05:24 +0000 https://nexus.od.nih.gov/all/?p=23706 The White House Office of Science and Technology Policy (OSTP) and National Security council recently released a Request for Information seeking ideas on strengthening the national capacity of clinical trial infrastructure and emergency clinical trials. An OSTP blog discusses the importance of having a robust clinical trial infrastructure prepared for an emergency as well as the importance of inclusive and well-designed studies.

Echoing the OSTP post, it is a good time to look back on our clinical trial efforts as the public health emergency moves into a new phase. What worked? What did not? How can we apply lessons learned moving forward? In my earlier reflections on whether NIH made fast and meaningful contributions to respond to the pandemic, I noted, for instance, the importance of (a) working closely with all partners to leverage existing infrastructure, (b) leveraging newly available funding to pivot rapidly in response to the pandemic, and (c) thinking about more than just awards and dollars but rather the generation meaningful results within a remarkably short time. More on our response during the pandemic may be found in these NIH Extramural Nexus posts.

What are your thoughts? Some areas OSTP is interested in include (from their post):

  • What do institutions and scientists need to keep the research base warm and ready for action?
  • How can we get the enterprise rowing in the same direction from day one, asking the right scientific questions, and efficiently coordinating resources?
  • How do we ensure that all Americans and all communities have the opportunity to participate in high-quality, impactful clinical research studies?
  • How can we make sure this is organized and governed appropriately, across public and private sectors?
  • Are there opportunities to make advance agreements to streamline the research response in real time?

You are welcome to send ideas in response to the Request for Information via email to emergencyclinicaltrials@ostp.eop.gov (please include “Emergency Clinical Trials RFI” in the subject line).

https://nexus.od.nih.gov/all/2022/10/28/feedback-sought-on-strengthening-capacity-for-emergency-clinical-trials/feed/ 0 23706 https://nexus.od.nih.gov/all/2022/10/28/where-should-my-data-management-and-sharing-plan-be-included-in-my-application-for-funding/ https://nexus.od.nih.gov/all/2022/10/28/where-should-my-data-management-and-sharing-plan-be-included-in-my-application-for-funding/#respond Fri, 28 Oct 2022 12:28:28 +0000 https://nexus.od.nih.gov/all/?p=23704 For applications being developed for due dates on/after January 25, 2023, Data Management and Sharing (DMS) Plans will be collected in a NEW field called “Other Plans” on the PHS 398 Research Plan and Career Development Award forms. See Writing a DMS Plan for the details on what to include in a Plan.

Note that any costs to support data management and sharing should be accounted for in either the R&R Detailed Budget Form or the PHS 398 Modular Budget Form along with a brief justification of those costs. See Budgeting for DMS and the Application Instructions for details.

https://nexus.od.nih.gov/all/2022/10/28/where-should-my-data-management-and-sharing-plan-be-included-in-my-application-for-funding/feed/ 0 23704 https://nexus.od.nih.gov/all/2022/10/27/navigating-new-status-screens-in-era-commons/ https://nexus.od.nih.gov/all/2022/10/27/navigating-new-status-screens-in-era-commons/#comments Thu, 27 Oct 2022 21:50:20 +0000 https://nexus.od.nih.gov/all/?p=23692 Several Status screens in eRA Commons moved to a new visual appearance on October 27 [see Oct. 25 eRA News (screens for signing officials) and Oct. 3 eRA News (screens for both SOs and principal investigators)]. Note that this means that there are new ways to navigate to the information you need and new methods to quickly find what you are looking for in Status.

Here is a primer:

  • Looking for action items? Click the three-dot ellipsis next to a grant number to see a drop-down menu of action items.
    screenshot of three dots next to grant number showing action items
  • Aiming to navigate to another module? Click the apps menu, located in the upper left of the blue header to see a dropdown of other modules you are authorized to see.
    screenshot of apps menu
  • Needing info quickly? Use the table filter to type a PD/PI name, a grant number, etc. and quickly locate the information.
    screenshot of status result - general search

The new Search screen has nine Search Type options presented in a dropdown menu instead of listing them at the left side of the screen. When an SO selects a particular search, the screen dynamically changes or redirects the SO to a new screen that reflects the search.

To help SOs become familiar with the new navigation and design, a new video, a Signing Official: Finding Information (SO Only) tutorial can be found on the eRA Videos page.

For additional details with screen shots, see Navigating and Using the User Interface in eRA Modules (or you can always view Status Module online help from within the module by clicking the question mark icon next to the screen header).
screenshot of closeout status with question mark icon

https://nexus.od.nih.gov/all/2022/10/27/navigating-new-status-screens-in-era-commons/feed/ 1 23692 https://nexus.od.nih.gov/all/2022/10/27/signing-officials-can-choose-to-bypass-2-day-viewing-window-for-administrative-supplements/ https://nexus.od.nih.gov/all/2022/10/27/signing-officials-can-choose-to-bypass-2-day-viewing-window-for-administrative-supplements/#respond Thu, 27 Oct 2022 20:43:14 +0000 https://nexus.od.nih.gov/all/?p=23695 To speed up the system processing of electronic administrative supplements, signing officials (SOs) have the option to bypass the 2-day application viewing window and allow the application to go straight to staff for processing (see NOT-OD-23-011).

The SO will use the Status module in eRA Commons to search for Recent/Pending eSubmissions, locate the administrative supplement application(s) within the 2-day window period and click the ‘Verify’ link in the Action column. Once the SO confirms the choice, the application will be immediately released for agency processing.

Note that once this bypass option is exercised, the SO cannot reject or make further changes to the application. Organizations must carefully review their applications prior to using the Verify action to avoid the need for resubmissions.

As always, applicants are encouraged to discuss administrative supplement requests with the awarding agency prior to submission.

Resources: 2-Day Window Skip topic in the eRA Commons online help; eRA News item.

https://nexus.od.nih.gov/all/2022/10/27/signing-officials-can-choose-to-bypass-2-day-viewing-window-for-administrative-supplements/feed/ 0 23695 https://nexus.od.nih.gov/all/2022/10/25/you-do-the-research-nih-repays-your-student-loans-apply-by-november-17/ https://nexus.od.nih.gov/all/2022/10/25/you-do-the-research-nih-repays-your-student-loans-apply-by-november-17/#comments Tue, 25 Oct 2022 19:33:26 +0000 https://nexus.od.nih.gov/all/?p=23688 If you’re going to be conducting research for the next two years, why not have your student debt taken care of while you work? In exchange for a commitment to conduct biomedical or behavioral research, the National Institutes of Health (NIH) will repay up to $100,000 of student loan debt with a two-year contract through the NIH Loan Repayment Programs (LRPs). NIH wants to keep highly qualified biomedical and behavioral scientists like you in the lab, so we’re here to pick up the tab on your student debt. Check if you’re eligible for an LRP award today and apply by November 17, 2022.

“It does not feel hyperbolic to say the NIH LRP was life changing for me, and I hope it will be for some of you too!”, said Dr. Emily Willroth, Assistant Professor of Psychological and Brain Sciences, Washington University in St. Louis.

Not funded the first time? Try, try again! On average, nearly 50% of all new LRP applications are funded. The LRPs are unique programs, with tremendous benefit to early-stage researchers, so we strongly encourage researchers that were not successful in getting their applications funded to apply again.

Changing institutions? LRP Awards are portable! Awardees get to bring their LRP awards with them when they move to a different research institution. LRP awards can also be renewed for one-or two-year periods until all educational debt is paid in full.

Ready to apply for an LRP award? The application cycle is now open until November 17, 2022.

Here’s a few helpful resources to get you started:

https://nexus.od.nih.gov/all/2022/10/25/you-do-the-research-nih-repays-your-student-loans-apply-by-november-17/feed/ 1 23688 https://nexus.od.nih.gov/all/2022/10/24/what-should-i-include-in-the-project-outcomes-section-of-my-progress-report/ https://nexus.od.nih.gov/all/2022/10/24/what-should-i-include-in-the-project-outcomes-section-of-my-progress-report/#respond Mon, 24 Oct 2022 19:26:52 +0000 https://nexus.od.nih.gov/all/?p=23685 The Project Outcomes section of the Research Performance Progress Report (RPPR) provides information about the cumulative outcomes or findings of the project. This information is made available to the public through NIH RePORTER, so take that into account when completing this section!

As noted in the RPPR Instruction Guide, Project Outcome summaries should not exceed half a page and must be written according to the following guidelines:

  • Is written for the general public in clear, concise, and comprehensible language
  • Is suitable for dissemination to the general public, as the information may be available electronically
  • Does not include proprietary, confidential information or trade secrets

Importantly, recipients conducting NIH-defined Phase III Clinical Trials must also include results of valid analyses by sex/gender, race, and ethnicity in the Project Outcome Summary. For more information on valid analysis, see the Analyses by Sex or Gender, Race and Ethnicity for NIH-defined Phase III Clinical Trials (Valid Analysis) page.

Looking for an example to use as a reference? Check out our Sample Project Outcomes page for examples, including one that addresses the results of valid analysis by sex/gender, race, and ethnicity.

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