Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required)

Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required) is sponsored by National Cancer Institute (NCI), NIH. Supports investigator‑initiated clinical trials aimed at reducing cancer burden via improvements in early detection, screening, prevention, interception, healthcare delivery, quality of life, and survivorship, with potential to improve clinical practice and/or public health.

PAR-25-167: Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required) 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. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Cancer Institute ( NCI ) Funding Opportunity Title Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required) R01 Research Project Grant Notices of Special Interest associated with this funding opportunity 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 4, 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 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 .

Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose Through this notice of funding opportunity (NOFO), the National Cancer Institute (NCI) invites applications for support of investigator-initiated clinical trials related to the programmatic interests of the NCI Division of Cancer Prevention and/or the NCI Division of Cancer Control and Population Sciences that have the potential to reduce the burden of cancer through improvements in early detection, screening, prevention and interception, healthcare delivery, quality of life, and/or survivorship related to cancer; with such attributes, the proposed studies should also have the potential to improve clinical practice and/or public health.

Applications submitted to this NOFO must include studies that meet the National Institutes of Health (NIH) definition of a clinical trial (see NOT-OD-15-015 for details) and provide specific clinical trial information as described in this NOFO and the application instructions. This NOFO does not and will not support clinical trials for studies of cancer diagnosis and/or oncologic therapy in patients.

Funding Opportunity Goal(s) The goals of this NOFO include providing support of investigator-initiated clinical trials related to the reduction of the burden of cancer through improvements in early detection, screening, prevention and interception, healthcare delivery, quality of life, and/or survivorship related to cancer. Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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 How to Apply - 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.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. 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 Through this notice of funding opportunity (NOFO), the National Cancer Institute (NCI) invites applications for support of investigator-initiated clinical trials related to the programmatic interests of the NCI Division of Cancer Prevention and/or the NCI Division of Cancer Control and Population Sciences that have the potential to reduce the burden of cancer through improvements in early detection, screening, prevention and interception, healthcare delivery, quality of life, and/or survivorship related to cancer; with such attributes, the proposed studies should also have the potential to improve clinical practice and/or public health.

Applications submitted to this NOFO must include studies that meet the National Institutes of Health (NIH) definition of a clinical trial (see NOT-OD-15-015 for details) and provide specific clinical trial information as described in this NOFO and the application instructions. This NOFO does not and will not support clinical trials for studies of cancer diagnosis and/or oncologic therapy in patients.

Due to the introduction of a National Institutes of Health (NIH) policy, set forth in NOT-OD-16-147 , to create notices of funding opportunity announcements (NOFOs) that are specifically designed for applications that involve clinical trials, the National Cancer Institute (NCI) has established two R01 investigator-initiated clinical trials required program announcements.

This NOFO is to support Phase 0-IV clinical trials with the potential to reduce the burden of cancer for patients and other affected persons through improvements in early detection, prevention, healthcare delivery, quality of life, and/or survivorship related to cancer, all of which are program areas identified by NCI's Division of Cancer Prevention (DCP; https://dcp. cancer.

gov ) and/or NCI's Division of Cancer Control and Population Sciences (DCCPS; https://dccps. cancer. gov ).

This NOFO does not and will not support clinical trials to study cancer diagnoses and/or medical interventions (oncologic treatments) in cancer patients; such research will be supported through another NOFO, PAR-25-081, which is relevant to phase 0, I, and II interventional clinical trials supported by NCI through its Division of Cancer Treatment and Diagnosis (DCTD).

An application to be supported by this NOFO must propose a Phase 0-IV clinical trial involving investigations in cancer prevention or control that should contribute to the advancement of evidence–based medicine and the practice that supports it.

NIH defines a clinical trial as "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes" ( NOT-OD-15-015) .

Applications submitted to this NOFO must meet the NIH definition of a clinical trial and provide specific clinical trial information as described in this NOFO and the NIH application FORM H guidelines ( NOT-OD-22-195 ). Furthermore, investigators who are involved in clinical trials supported through this NOFO are expected to follow the NIH Policy on Good Clinical Practice (see NOT-OD-16-148 ).

This NOFO is applicable to a broad range of research supported through the NCI's Division of Cancer Prevention (DCP) and the NCI's Division of Cancer Control and Population Sciences (DCCPS) .

Examples of relevant areas of research include but are not limited to : Cancer prevention and interception : development and testing of interventions (including diet, nutritional compounds, drugs, small molecules, vaccine and biologics) and approaches (including physical activity, medical devices, cancer preventive surgery, risk-reducing surgery, and non-surgical ablative techniques) to block, reverse, or delay the early stages of cancer (including treatment of preneoplastic lesions and presurgical trials in early stage cancer with the intent of developing an agent/intervention for cancer prevention).

This also includes studies examining mechanism and surrogate biomarkers of efficacy; Cancer screening : studies of operating characteristics and clinical impact (harms as well as benefits) of cancer early detection technologies and practices, such as imaging and molecular biomarker approaches; Early detection : studies for identification, development, and validation of biological markers for early cancer detection and cancer risk assessment; Behavioral research in cancer prevention and control : development and testing of interventions addressing risk behaviors such as: tobacco use, energy balance, alcohol use, or sun exposure; vaccine uptake; immune function; screening behavior; treatment adherence; biopsychosocial processes of cancer-related behavior; communication, decision science, environmental modifications and policy changes aimed at altering cancer-related health behaviors and/or preventing or improving cancer-related risks and outcomes; Susceptibility to cancer and cancer-related outcomes : strategies to translate clinical, environmental and genomic/genetic determinants of cancer occurrence and outcomes into evidence-based interventions for clinical and public health practice; Implementation science : strategies to promote the adoption, implementation, and sustainability of evidence-based intervention into routine healthcare and public health settings or the deimplementation of ineffective interventions; Healthcare delivery : single and multi-level interventions addressing the organization and/or delivery of cancer care (e.g., team-based care; novel use of electronic health records; new organizational mechanisms/staffing such as patient navigation; new models of specialized services such as palliative care or survivorship programs); Cancer survivorship : interventions addressing the physical, psychological, social, and financial burden of cancer and its treatment among survivors of cancer and their families (e.g., mental health, social functioning, caregiver well-being and adaptation); Supportive and palliative care : development and testing of interventions (including diet, nutritional compounds, drugs, small molecules, vaccine and biologics) and approaches for the prevention or treatment of acute and chronic symptoms and morbidities related to cancer and its treatment including those experienced by patients with metastatic cancer; and/or Quality of Life (QOL) : studies to improve the QOL of patients.

Scope of Work and Additional Guidance Applicants proposing to conduct behavioral intervention research are encouraged to use an existing framework, such as the ORBIT model for developing behavioral treatments ( http://dx. doi. org/10.

1037/hea0000161 ), to determine the clinical trial phase being proposed and for guidance on study designs and methods appropriate for early-phase (Phase 0, I, and II) translational behavioral research. Applicants may also wish to reference other frameworks in their application, such as the experimental medicine approach ( https://www. ncbi.

nlm. nih. gov/pmc/articles/PMC4656226/ ) as defined by the Science of Behavior Change Common Fund initiative when proposing basic, mechanistic, and early-phase translational behavioral studies (see doi: 10.

1037/hea0001095. PMID: 34990185 for examples of behavioral translational frameworks). Applicants may propose to conduct a clinical trial or trials, or in combination with other research aims as appropriate.

This NOFO is not intended for observational studies, which may be submitted as R01 applications to the NIH "Parent" R01 NOFO, PA-20-185 or its future reissuance, or other relevant NIH NOFOs. Other types of human subject research that do not fit the NIH definition of a clinical trial may also be submitted to the NIH Parent R01 NOFO.

With regard to support for Phase III clinical trials, this NOFO will only support applications proposing Phase III clinical trials that are limited to public health interventions, healthcare delivery research (e.g., supportive care, palliative care, and symptom management), and other psychosocial, behavioral, environmental, policy, health system, or implementation strategies, and related interventions to address cancer prevention and control, provided they can be completed entirely within the grant cycle.

This NOFO is not intended to support Phase III clinical trials to test the efficacy of cancer-related medical (oncologic) interventions or Phase III clinical trials of cancer imaging (or other diagnostic) modalities. Large trials may be subject to negotiated milestone plans.

Applications that propose clinical trials sought by and to be supported through this NOFO can include studies planned to be conducted through special NCI programs and networks such as, the Specialized Programs of Research Excellence (SPOREs), Cancer Centers, and/or the NCI Community Oncology Research Program (NCORP). The studies may include correlative laboratory, imaging studies, and/or other trial-related study endpoints.

Investigators conducting studies in the NCORP should contact the NCI NCORP Research Base Program Officer prior to submission of the application. Budget requests for projects to be conducted through otherwise supported NCI clinical trials infrastructure cannot include support (i.e., funds) that would duplicate that already supported infrastructure.

Non-responsive Applications The following types of clinical trials are not responsive to this NOFO and applications proposing such activities will be deemed non-responsive and will not be reviewed: Phase III clinical trials to test the efficacy of cancer-related medical (oncologic) interventions; Phase III clinical trials of cancer imaging (or other diagnostic) modalities; Phase 0, I, and II medical imaging and oncologic interventional clinical trial covered by PAR-25-081.

Clinical trial applications requesting to utilize the NCTN and/or NCORP infrastructure and/or resources that do not have NCI prior approval.

NOTE: Applicants to this NOFO are strongly encouraged to contact NCI staff as soon as possible in the development of the application (preferably no later than 12 weeks prior to the application due date) to discuss the details of their proposed clinical trial, so that NCI staff can help the applicant understand whether the proposed clinical trial is within the goals and mission of the NCI and is appropriate for this NOFO.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply 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 maximum project period is 5 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 Organizations). Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 How to Apply-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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications .

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 How to Apply- Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 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 How to Apply - 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 How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

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

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

All instructions in the How to Apply-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. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- 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-definedclinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- 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 How to Apply- Application Guide must be followed.

If the study is an ancillary project to a Parent Clinical Trial, the study record should relate to the ancillary project and not the Parent Clinical Trial. Section 2 - Study Population Characteristics Section 2.

5 Recruitment and Retention Plan Recruitment and referral sources: include the number of potentially available participants per proposed site annually; Enrollment rate (e.g., number of participants meeting eligibility criteria for enrollment per month); Discussion of potential recruitment delays or challenges and alternative strategies that can be implemented if there are enrollment delays or shortfalls; Procedures to monitor enrollment and track/retain participants for follow-up assessments; Evidence to support the feasibility of enrollment, including prior experience and yield from research efforts using similar referral sources and/or strategies; Strategies to ensure the study population has scientifically appropriate complexity and representativeness; Decision points for terminating the trial.

The study timeline should describe key milestones throughout the project and trial that need to be met to achieve the goals of the study. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a project stage or activity. Applicants are required to provide detailed project performance and timeline objectives as outlined below.

Investigators must indicate where within the Plan the clinical trial or trials are scheduled and when the required documents will be available if not included at the time of submission. Program staff will review the milestones and timelines which can be negotiated, as needed, at the time of the award.

This section should include an estimated timeline for the following general milestones, as applicable: Complete finalized Clinical Trial Protocol for submission to NCI; Registration of clinical trial in ClinicalTrials.

gov; Completion of regulatory approvals; Enrollment of the first subject; Enrollment of 25%, 50%, 75%, and 100% of the projected recruitment for all study participants including women, minorities, and individuals across the lifespan (as appropriate); Completion of data collection time period; Completion of primary endpoint and secondary endpoint data analyses; Completion of final report of the primary outcome; Reporting of results in ClinicalTrials.

gov; Status of the FDA-regulated product requiring IND or IDE if applicable. In addition to meeting the above recruitment and other targets, applicants should give contingency plans if they do not meet the milestones and address other implementation activities necessary such as start-up tasks to achieve trial completion. Future year support is contingent on satisfactory achievement of performance milestones.

If milestones are not achieved fully, NCI may request development of a remedial plan and more frequent monitoring of progress, and/or take other remedial actions. Section 3 - Protection and Monitoring Plans Section 3. 3 Data and Safety Monitoring Plan In addition to the description of safety monitoring, address plans to monitor trial performance, including plans to assure fidelity to the protocol and integrity of the data.

Information about Data and Safety Monitoring Plans are available at https://humansubjects. nih. gov/data_safety .

Section 3. 5 Overall Structure of the Study Team In addition to the standard requirements for this item, provide a description of methods to identify additional collaborators, including enrollment/participation sites, if applicable.

Investigators who are new to the conduct of clinical trials should identify an appropriate mentor and establish the right composition for the clinical trial team (e.g., trial manager, statistician, data manager, study coordinator(s), research assistants, institutional review board [IRB] and ethics coordinator, etc.). In this situation, only the names and titles of key team members should be listed in a table.

Section 4 - Protocol Synopsis Section 4. 1. a Detailed Description It should summarize the necessary elements of the trial and supplements the Research Strategy, which includes an overview of the state-of-science and relevance of the trial and is meant to justify the need, its potential impact, and provide supporting preclinical and/or clinical evidence to justify the proposed trial, its design, and likelihood of successful completion.

Applications submitted without the Clinical Protocol Synopsis are considered incomplete and will not be reviewed. Please include the dose and intensity of the intervention in the description, if applicable. Applicants proposing behavioral intervention research are encouraged to use an existing framework, such as the ORBIT model for developing behavioral treatments ( http://dx.

doi. org/10. 1037/hea0000161 ), to determine the clinical trial phase being proposed and for guidance on study designs and methods appropriate for early-phase (Phase I and II) translational behavioral research.

4. 3 Statistical Design and Power The sample size and statistical power calculations should contain enough detail, including sufficient information on the assumptions made, so that a reviewer can readily duplicate the projected sample size for primary and secondary endpoints.

The power analysis should include a discussion of non-compliance, potential cross-over (if applicable), account for rates of follow-up (i.e., drop out/lost to follow up) during key outcome collection contacts. A discussion of how missing data will be handled should be included. Planned interim analyses for safety, efficacy, and/or futility should be described, if applicable.

For single-case design and other small-N study designs where traditional power analyses may not be applicable, provide a detailed description of the approach to sample size and analysis being used. Section 5 - Other Clinical Trials-Related Attachments 5.

1 Other Clinical Trials-related Attachments For applications that have the complete Clinical Trial Protocol available, submit the Clinical Trial Protocol as a single PDF that combines all clinical documents. Applicants should provide a list of clinical trials that demonstrate their experiences in trial coordination over the last 5 years, without duplicating information in biosketches.

The table should be provided as an attachment using the filename “Clinical Trial Experience." The table should also include the following for each trial listed: start and completion date; percent of target accrued; whether the trials reached completion; and, if applicable, the date of first publication. 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 How to Apply-Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply-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 How to Apply-Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. 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 Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications .

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 How to Apply- 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