NEI Collaborative Clinical Vision Research Project: Chair's Grant (UG1 Clinical Trial Required)

NEI Collaborative Clinical Vision Research Project: Chair's Grant (UG1 Clinical Trial Required) is sponsored by National Eye Institute (NEI), National Institutes of Health. This cooperative agreement supports investigator-initiated large-scale clinical trials, human gene-transfer, stem cell therapy trials, and other complex or high resource- or safety-risk clinical trials related to vision disorders.

Expired PAR-23-209: NEI Collaborative Clinical Vision Research: Chair's Grant (UG1-Clinical Trial Required) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Eye Institute ( NEI ) Funding Opportunity Title NEI Collaborative Clinical Vision Research: Chair's Grant (UG1-Clinical Trial Required) UG1 Clinical Research Cooperative Agreements - Single Project Notices of Special Interest associated with this funding opportunity February 10, 2026 - Notice of Change to Key Dates for PAR-23-209, PAR-23-204, PAR-23-201 NEI Collaborative Clinical Vision Research Grants (UG1 Clinical Trial Required).

See Notice NOT-EY-26-001 January 28, 2026 - NIH Removing AIDS Application Due Dates from NOFOs. See Notice NOT-OD-26-029 March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023 - See Notice NOT-OD-22-198 .

August 8, 2022 - New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023 - See Notice NOT-OD-22-195. August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy - see Notice NOT-OD-22-189 . Notice of Funding Opportunity (NOFO) Number Companion Funding Opportunity See Section III.

3. Additional Information on Eligibility. Assistance Listing Number(s) Funding Opportunity Purpose The NEI uses UG1 cooperative agreement awards to support investigator-initiated large-scale clinical trials, human gene-transfer, stem cell therapy trials, and other complex or high resource- or safety-risk clinical trials.

These projects are multifaceted and of high public health significance requiring clear delineation of study organization including roles and responsibilities and require careful performance oversight and monitoring.

For purposes of this Notice of Funding Opportunity (NOFO), the proposed study must be intended to evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders, or to compare the effectiveness of two or more established interventions.

The NEI UG1-supported studies are typically funded as a group of single-component companion grant awards including the Chair’s Grant, the Coordinating Center, and Resource Centers, when appropriate. Specifically, this NOFO encourages applications for the Chair's grant, which includes the scientific rationale, study aims and significance of the research project.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The following table includes NIH standard due dates marked with an asterisk.

Dates in bold and italics reflect changes per NOT-EY-26-001 Application Due Dates Review and Award Cycles New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date July 13, 2023 July 13, 2023 September 07, 2023 * November 2023 January 2024 April 2024 September 25, 2023 * September 25, 2023 * January 07, 2024 * March 2024 May 2024 July 2024 January 25, 2024 * January 25, 2024 * May 07, 2024 * July 2024 October 2024 December 2024 May 25, 2024 * May 25, 2024 * September 07, 2024 * November 2024 January 2025 April 2025 September 25, 2024 * September 25, 2024 * January 07, 2025 * March 2025 May 2025 July 2025 January 25, 2025 * January 25, 2025 * May 07, 2025 * July 2025 October 2025 December 2025 May 25, 2025 * May 25, 2025 * September 07, 2025 * November 2025 January 2026 April 2026 September 25, 2025 * September 25, 2025 * January 07, 2026 * March 2026 May 2026 July 2026 January 25, 2026 * January 25, 2026 * May 07, 2026 * July 2026 October 2026 December 2026 May 25, 2026 * May 25, 2026 * Not Applicable November 2026 January 2027 April 2027 All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description The purpose of this Notice of Funding Opportunity (NOFO) is to provide a framework for applicants seeking a Chair's Grant. The Chair's Center provides clinical, scientific, and technical leadership in protocol development and implementation for a multicenter or other complex or high resource- or safety-risk clinical trial.

The application provides details regarding the protocol, research design, patient population and procedures and methods proposed for accomplishing study goals. The NEI UG1-supported studies are typically funded as a group of companion grant awards including the Chair’s Grant, the Coordinating Center, and the Resource Centers, as appropriate.

Separate applications may be submitted for Coordinating Centers or Resource Centers under the following respective UG1 companion NOFOs: PAR-23-204, NEI Collaborative Clinical Vision Research Project: Coordinating Center Grant.

(The Coordinating Center proposes a role of statistical and methodologic leadership, logistical coordination and trial support, and safety monitoring including support of the Data and Safety Monitoring Committee) PAR-23-201, NEI Collaborative Clinical Vision Research Project: Resource Center Grant.

(The Resource Center provides the expertise and infrastructure for imaging, laboratory, or other requisite services) Scope of this Notice of Funding Opportunity: The scope of this NOFO is to encourage grant applications for investigator-initiated clinical trials to establish the efficacy or compare the effectiveness of screening, diagnostic, preventative or therapeutic interventions.

Renewal applications that request additional years or funds to complete the original aims of a clinical trial will be accepted under this NOFO. Renewal applications may also be submitted to request support to extend follow-up of clinical trial cohorts after completion of the primary study goals to gather information on longer-term outcomes.

As applicable, this NOFO may support laboratory work associated with study product manufacture, repackaging, and distribution; quality assurance (i.e., identity, potency, or other aspects of product integrity); and participants safety.

Applications Not Responsive to this NOFO: The following types of activities remain outside of the scope of this NOFO, and applications proposing such activities will be considered non-responsive to this NOFO and will be withdrawn without review: Applications involving a clinical experiment that is not directly intended to evaluate a screening, diagnostic, preventative, or therapeutic intervention, or compare the effectiveness of established interventions, are not suitable for this NOFO.

Applications that are not complex or of high resource-or safety-risk are not suitable for this NOFO. Preclinical, developmental, or preparatory studies for gene transfer and stem cell therapy are not supported under this NOFO. NIH-defined clinical trial applications proposing basic experimental studies with humans (BESH) and/or minimal risk studies are not supported under this NOFO.

Applicants are strongly encouraged to contact Scientific/Research staff as plans for an application are being developed (see Section VII, Agency Contacts), and no later than 12 weeks prior to the anticipated application submission date. See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II. Award Information Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement.

Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI. 2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Required: Only accepting applications that propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited but need to reflect the actual needs of the proposed project.

The scope of the proposed project should determine the project period. The maximum period is five years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registration; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement. 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2. 3.

7. 4 Submission of Resubmission Application . This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another application pending appeal of initial peer review (see 2. 3.

9. 4 Similar, Essentially Identical, or Identical Applications ) Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed.

The following must be included as an attachment, if applicable Clinical Protocol (required) – a full clinical protocol must be included. The FDA and NIH developed a Clinical Trial Protocol Template (See http://osp. od.

nih. gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials ) which can be modified for any type of clinical trial. The filename "ClinicalProtocol.

pdf" should be used and will be reflected in the final image bookmarking for easy access to reviewers. Milestone Plan (required) – Applicants are required to provide detailed project performance and timeline objectives.

The proposed milestones must include achievable goals for the project as follows: Completion of start-up activities as applicable (finalization of protocol, completion of any final regulatory approvals, contracting of sites, registration in ClinicalTrials.

gov, etc.) Enrollment of 25%, 50%, 75% and 100% of the projected recruitment Completion of data collection Completion of primary and major secondary endpoint analyses Publication of primary outcome manuscript(s) Preparation of final dataset for public use and data sharing Reporting of results in ClinicalTrials. gov The filename " MilestonePlan.

pdf " should be used and will be reflected in the final image bookmarking for easy access to reviewers.

Overall Study Organization, Administration, and Procedures (required) – Without repeating information on the PHS Human Subjects and Clinical Trials Information form basic elements regarding study organization, administration, and procedures include but are not limited to: Collaborative arrangements, duties and responsibilities of the Study Chair, Coordinating Center, Resource Centers and clinical sites as applicable; Lines of communication among study components; Administrative arrangements for IRB, FDA, and clinicaltrials.

gov submissions and adverse event reporting as applicable; Plans and preliminary schedule for preparation, distribution, and review of trial safety monitoring reports; and, provisions for formal documentation of all safety reviews and tracking of safety recommendations and/or action items through implementation. The filename " StudyOrganization.

pdf " should be used and will be reflected in the final image bookmarking for easy access to reviewers.

Manual of Procedures (MOP) (required) – Basic elements in the MOP may include, but are not limited to: visit schedule; examination and testing procedures; expected adverse events; study publication policies, draft Informed consent forms (ICFs) and, if applicable, assent form(s); sample data collection forms; data capture, management, quality assurance and analytical procedures; and applicable clinical center and resource center information.

The filename "MOP. pdf" should be used and will be reflected in the final image bookmarking for easy access to reviewers. Interventional Agent(s) or Device(s) Availability (if applicable) – Documentation should be provided on the availability of interventional agent(s) or device(s) as well as plans and support for acquisition and distribution of interventional agent(s) or device(s).

The filename " InterventionAvailability. pdf " should be used and will be reflected in the final image bookmarking for easy access to reviewers. Statistical Analysis Plan (SAP) (optional) – Applicants may attach an SAP as Other Attachment only if this Chair UG1 application is not accompanied by a companion Coordinating Center UG1 application.

The SAP must describe study outcome measures and include estimates of treatment effect, power, and sample size. The plan should justify the proposed sample size based on appropriate study assumptions, expected loss to follow-up, and power calculations. The calculations must be linked to the study endpoints and to the hypothesis(es) being tested.

The plan should also include a description of the methods to be used in the analysis of the primary outcome data. The SAP should include plans for interim analyses for safety, efficacy and futility, and final analyses; methods of bias control; and methods for handling missing data (as applicable). This is distinct from the Human Subjects and Clinical Trials information form.

The filename "Statistical Analysis Plan. pdf" should be used and will be reflected in the final image bookmarking for easy access to reviewers. Clinical Center Table (if applicable) - Applicant must submit an Organizational Table if they are the entity issuing clinical enrollment center subcontracts.

Provide a list of institutions and enrollment center PIs involved in the enrollment of participants for the proposed clinical trial and include Federal Wide Assurance (FWA) numbers. Group organizations under the organization to which they report. The filename " ClinicalCenterTable.

pdf " should be used and will be reflected in the final image bookmarking for easy access to reviewers. Applications that lack appropriate attachments are incomplete, will not be reviewed, and will be withdrawn. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Specific Aims: This section should include an overview of the proposed trial highlighting its public health relevance and significance with regard to the ability to move vision science forward, and a plan for how the Chair will provide overall leadership.

Provide a detailed description of the study including the scientific background, preliminary data and rationale for the proposed investigation.

Provide a description of the study administration including, but not limited to: Scientific, clinical and administrative experience and qualifications of the PD(s)/PI(s) and other study personnel; leadership's past track record and/or future performance potential in clinical research (NEI-sponsored or otherwise); Plans for carrying out the leadership's roles and responsibilities on a day-to-day basis, including coordination of and communication amongst multiple research activities and study entities; Plans for identifying and engaging qualified investigators to participate in the study; Plans for assuring study integrity, protocol fidelity and completion; Plans for manuscript preparation and results dissemination; Organization of, and the leadership's involvement in study committees (e.g., Executive, Steering, Operations, Publications, Data and Safety Monitoring).

Letters of Support: Letters of support from institutions with a key role in the study must be provided. Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R& R ) Application Guide.

With the following modification: Describe plans for supporting timely publication and dissemination of study findings Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement , and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 1.

Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4.

Submission Dates and Times Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day. Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies).

Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants. gov systems check the application against many of the application instructions upon submission.

Errors must be corrected and a changed/corrected application must be submitted to Grants. gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission. Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E. O.

12372) This initiative is not subject to intergovernmental review. All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement .

7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII .

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide. See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the National Eye Institute, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Requests of $500,000 or more for direct costs in any year Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy In addition, for this PAR, applicants may submit—up to 30 days prior to the review meeting—a 1–2-page status update document as post-submission material.

This update may include information on clinical sites recruited, recruitment of key personnel, obtaining the drug, access to the device, regulatory and/or IRB approvals. Section V. Application Review Information Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system. For this particular announcement, note the following: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs.

Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?

How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?

For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project? With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet