National Institute of Allergy and Infectious Diseases (NIAID) Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

National Institute of Allergy and Infectious Diseases (NIAID) Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) is sponsored by U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID). This funding opportunity supports investigator-initiated clinical trials requiring enhanced oversight, with durations up to 7 years, relevant to infectious diseases including virology.

Expired PAR-24-100: NIAID Clinical Trial Implementation Cooperative Agreement (U01 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 Institute of Allergy and Infectious Diseases ( NIAID ) Funding Opportunity Title NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) U01 Research Project – Cooperative Agreements Notices of Special Interest associated with this funding opportunity May 9, 2025 - Notice to Applicants That the Simplified Review Framework Will be Applied to All Relevant Applications for August/October 2025 Councils.

See Notice NOT-OD-25-116 . 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 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 Small Business Innovation Research (SBIR) Cooperative Agreements - Phase II See Section III.

3. Additional Information on Eligibility. Assistance Listing Number(s) Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) encourages cooperative agreement applications for implementation of investigator-initiated, high-risk clinical trials and mechanistic studies associated with high-risk clinical trials.

Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities. Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID ( https://www. niaid.

nih. gov/research/role ). Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date 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.

New Date May 24, 2025 per NOT-OD-25-113 (Originally January 14, 2027) 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. 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 This Notice of Funding Opportunity (NOFO) encourages cooperative agreement applications for implementation of investigator-initiated, milestone driven, high-risk clinical trials including mechanistic studies within clinical trials.

Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities. The proposed trial must be hypothesis-driven, related to the research mission of NIAID, and address a research area considered a high priority by the Institute.

For HIV-related clinical trials, NIAID encourages projects that integrate biomedical and behavioral interventions; studies that explore pathogenesis of HIV infection within the trial are also encouraged. NIAID Supported Clinical Trials and Infrastructure Historically, NIAID supports both infrastructure and networks through a variety of funding mechanisms. These resources focus on high-priority disease research areas.

Examples include the HIV/AIDS Clinical Trial Networks supported by the Division of AIDS (DAIDS), the Division of Microbiology and Infectious Diseases’ (DMID) Infectious Diseases Clinical Research Consortium , and the Immune Tolerance Network supported by the Division of Allergy, Immunology and Transplantation (DAIT).

NIAID's clinical research infrastructure includes coordinating centers, statistical units, data centers, central laboratories, clinical centers, and other specialized resources. For additional information on DAIDS supported clinical trials refer to the Division of AIDS (DAIDS) Clinical Research Policies and Standard Procedures Documents . For additional information on DAIT Clinical Research Policies and Documents see: https://www.

niaid. nih. gov/research/dait-clinical-research-policies-and-standards .

Investigator-Initiated Clinical Trials Although existing clinical trial programs and infrastructure are crucial to furthering the Institute's research, NIAID recognizes that additional models of clinical research may be important to advancing its research mission; therefore, NIAID has established the investigator-initiated clinical trial program for clinical trials that cannot or will not be conducted through existing NIAID-supported clinical trial networks or infrastructure.

This program consists of support for the NIAID Clinical Trial Planning (R34) Grant and the NIAID Clinical Trial Implementation (U01) Cooperative Agreement. The NIAID Clinical Trial Implementation (U01) Cooperative Agreement is designed to support high-risk clinical trials, as defined by NIAID below and in the associated policy statement (see NOT-AI-21-037 ).

For non-high-risk trials, NIAID invites applications for two NIH Clinical Trial NOFOs, NIH Research Project Grant (Parent R01 Clinical Trials Required) PA-20-183 and NIH Research Project Grant (Parent R21 Clinical Trial Required) PA-20-194 . The NIAID Clinical Trial Planning Grant (R34) is available to support planning activities associated with either high- or non-high-risk clinical trials.

However, the NIAID Clinical Trial Planning (R34) Grant ( PAR-23-206 ) is not a prerequisite for either NIAID implementation award. If a clinical trial is ready for implementation, and readiness is adequately supported by appropriate documentation, the U01 application may be submitted to the appropriate NOFO. For additional information about NIAID's investigator-initiated clinical trial program, see https://www.

niaid. nih. gov/grants-contracts/investigator-initiated-clinical-trial-resources .

The NIAID Clinical Trial Implementation Cooperative Agreement supports implementation of high-risk clinical trials that address high-priority research areas that are well-matched with the mission and goals of NIAID.

A clinical trial is defined by NIH 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." See more at: https://grants. nih.

gov/grants/guide/notice-files/NOT-OD-15-015.

html A clinical trial is defined as high-risk by the NIAID when the trial has one or more of the following attributes: provision of a non-routine intervention, that is, an intervention or non-routine use of an intervention that would not otherwise be provided for the condition under study in the local facility where the study is being conducted; administration of an unlicensed product; or administration of a licensed product for an unapproved indication.

Any research trial that will require a regulatory oversight (such as Investigational New Drug [IND] or Investigational Device Exemption [IDE]) would be considered high risk. A non-high-risk trial would not have any of the attributes listed above; for example, it would involve provision of a routine intervention and administration of a licensed product for an approved indication.

Applicants are strongly encouraged to contact NIAID staff listed in Section VII. Agency Contacts for questions concerning the classification of the proposed clinical trial. Activities and communications regarding all clinical laboratory testing for study participants must comply with US federal regulations [see 42 CFR part 493.

2 and 493. 3(b)(2)].

This NOFO will support the conduct, completion, and analysis of the clinical trial, including activities related to the conduct of the clinical trial, which include but are not limited to the following: training of study personnel; enrollment and recruitment of study subjects; data collection, management, and quality control; investigational product costs; laboratory work and data analyses; study management and oversight; establishment of committees to manage the complexity of the trial; preparation of the final study report; and other related post-trial activities; regulatory activities and site monitoring; mechanistic studies, if applicable.

Each NIAID Clinical Trial Implementation award will support a single clinical trial that may include more than one intervention. Applications that include more than one clinical trial will not be supported by this NOFO. A single platform trial that allows for simultaneous comparison of multiple intervention groups against a single control group or a trial that includes more than one sequential stage are permitted.

All clinical trial planning activities must be completed prior to the time of application submission and investigators must be ready to implement the proposed trial at the time of award.

NIAID reserves the right to specify: 1) whether an IND/IDE application should be submitted to an appropriate regulatory agency; 2) the entity (NIAID, primary awardee, etc.) who will hold the IND/IDE; 3) the requirements for the establishment of a DSMB (Data Safety Monitoring Board)/SMC (Safety Monitoring Committee) or the use of an NIAID sponsored DSMB/SMC; and 4) the use of other NIAID clinical resources such as a Statistical and Clinical Coordinating Center.

Applicants are encouraged to discuss those decisions and requirements with NIAID prior to submission of the application. Mechanistic studies will be supported as part of all clinical trials in this NOFO. Any clinical trials supported by DAIT must include mechanistic studies.

Investigators are referred to the Division-specific research policies and standard procedures for protocol templates, guidance, and requirements for clinical trials.

See Division of AIDS (DAIDS) Clinical Research Policies and Standard Procedure Documents ; Division of Microbiology and Infectious Diseases (DMID) Office of Clinical Research Affairs ; Division of Allergy, Immunology, and Transplantation (DAIT) Clinical Research Policies and Standards . Investigators are also referred to NIAID's Clinical Research Toolkit website .

Prior to initiation, protocols and consent forms may be subject to review by the NIAID Division. Investigators are strongly encouraged to contact NIAID's program contacts provided below in Section VII for more information regarding division-specific clinical research policies and procedures. Delineation of milestones is a key characteristic of the NIAID Clinical Trial Implementation Cooperative Agreement.

A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity. Applications Not Responsive to This NOFO Applications proposing the following will be considered non-responsive and will not be reviewed: Applications proposing the following clinical trial planning tasks.

Investigators seeking support for the planning and design of clinical trials should refer to the NIAID Clinical Trial Planning (R34) Grant NOFO ( PAR-23-206 ).

Development of study design Identification of collaborators and enrollment sites Development of the clinical protocol and informed consent Development of the statistical analysis plan Development of the data management plan Development of the Investigator's brochure or equivalent The Division of Allergy Immunology and Transplantation (DAIT) will not support applications without the inclusion of mechanistic studies.

Applications that propose clinical trials that fall outside the mission and high-priority research areas of the NIAID. Applications that propose clinical trials that will utilize dedicated resources that are part of an existing NIAID-supported clinical trial network without prior program approval; or Applications that propose more than one clinical trial in a single application.

For more information, please see the Investigator-Initiated Clinical Trial Questions and Answers at: https://www. niaid. nih.

gov/grants-contracts/investigator-initiated-clinical-trials-faqs . 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 financial assistance 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 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 scope of the proposed project should determine the project period. 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 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information 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 registrations; 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 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. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: 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 Ho to Apply Application Guide must be followed.

If mechanistic studies are proposed, describe the appropriate expertise within the biosketch of the individual who will have the general responsibility for the scientific and the technical/laboratory aspects of the proposed work. This person may be the application's PD/PI or a single PD/PI in a multi-PD/PI application.

If a platform trial is proposed, describe the appropriate expertise in statistical design and analysis within the biosketch of the individual that will be responsible for the design of the platform trial. All instructions in the How to Apply Application Guide must be followed.

Because all applications must include detailed scientific and operational plans, funding needs for the entire trial and data analysis period must also be included. In addition to funds required to support clinical trial conduct, the budget should reflect sufficient funds to support independent study monitoring, medical and data monitoring, regulatory submissions, quality management, safety oversight activities.

Costs of study drug/product, labeling, distribution should also be delineated, if applicable. If parts of the costs of the trial are to be borne by sources other than NIH, these contributions must be presented in detail. These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding.

NIAID reserves the right to independently procure drug for the study if that offers cost or other advantages to the clinical trial. Further information concerning budget preparation may be obtained from the Financial/Grants Management Contact(s) listed in Section VII. Agency Contacts.

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: Specific Aims: State the goals of the clinical trial and the expected outcome(s).

Clearly and concisely present the specific objectives of the trial, as well as a specification of the primary and major secondary endpoints to be measured. Provide a clear explanation of the importance of various endpoints.

Research Strategy: Within the Research Strategy describe the following: An overview of the state of the science, a discussion of the significance of the clinical and mechanistic (if applicable) problem(s) being studied, the need for the trial, and the potential impact of the results of the trial, discussion of how the trial will test the hypothesis(es) proposed; A discussion of studies that led to the proposed clinical trial and information or data from preliminary studies which address the need for and the feasibility of the trial; A discussion of potential biases or challenges in the protocol and how they will be addressed; A description of the plans to implement and monitor Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), as appropriate; Plans for appropriate oversight over the conduct of the trial, including at a minimum the appropriate clinical monitoring independent of the study team, safety monitoring, regulatory submissions and compliance and quality management (this is in addition to what is in the Data Safety Monitoring Plan); Plans for acquisition and handling of study agent(s), if applicable; Demonstrated consideration of ethical issues involving the disease/condition under study; In addition, discuss activities related to the conduct, completion, and analysis of the clinical trial; Any anticipated impediments that could require a revision in the timeline must be identified and accompanied by a discussion of alternative approaches; Applications proposing a platform trial must include details about the interventions to be included and contain sufficient detail to assess the totality of planned interventions.

Letters of Support: Provide letters of support to document access to or commitment of critical resources, including consortium/site participants, cores, laboratories, pharmacies, data management resources, or other collaborators, including cost-sharing by NIH resources, in the case of intramural collaborators. Investigators are referred to https://www. niaid.

nih. gov/research/intramural-collaboration-extramural-funded for additional guidance on Intramural Scientist Collaboration on Extramural Funded Grants. If co-funding or in-kind support is planned from any source (non-NIH sources or NIH sources), letter(s) of commitment (e.g., type, amount, and source of support), signed by a business official, on organization letterhead, must be included in the Letters of Support section.

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. Other Plan(s): 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 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.

The following modifications apply: Include the informed consent form(s) and, if applicable, assent form(s). Complete Clinical Protocol: Applicants must include a complete Protocol as part of the Appendix. Investigators should use the NIAID Division-specific Protocol Templates when preparing the complete clinical protocol, and are urged to be succinct.

Investigators are also referred to the Trans-NIAID Clinical Research Toolkit website for clinical protocol guidance and templates. Applications that lack the Complete Clinical Protocol are incomplete and will not be reviewed.

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 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.

Other Human Subject instructions: Section 2 - Study Population Characteristics Completion of data collection time period; Completion of primary endpoint and secondary endpoint data analyses time period; Completion of final study report. Include a series of milestones for completion of the clinical trial and provide contingency plans should there be delays in attaining them.

This section must include: A timeline for the following general milestones, as applicable; Completion of regulatory approvals; Enrollment of 25%, 50%, 75% and 100% of the projected recruitment time period for all study subjects, including a plan for initial site activation and expected timing of screening/enrollment of first participant; Detailed protocol-specific performance milestones; these milestones will be negotiated at the time of the award, if appropriate; Discuss the feasibility and appropriateness of achieving and completing each milestone on-time, including alternate approaches and contingencies for dealing with potential problems and impediments.

Section 3 - Protection and Monitoring Plans 3. 3 Data and Safety Monitoring Plan The DSM Plan must address the following areas: Where the monitoring will occur; How site(s)/center(s), and participating facilities (labs, pharmacies) will be monitored.

Also address the appropriate oversight over the conduct of the trial, including at a minimum the appropriate clinical monitoring independent of the study team, safety monitoring, regulatory submissions and compliance and quality management.

Provide a data management plan addressing the following areas: (1) database system to be employed, (2) compliance with federal regulations, (3) security and emergency back-up, and (4) quality control of data from clinical sites and laboratories, as appropriate. Applications that lack the DSM Plan are incomplete and will not be peer reviewed. 3.

5 Overall Structure of the Study Team This section must include: A description of the study organization and administration, including, but not limited to: a description of committee structures needed to manage the complexity of the trial; the role of any internal or external advisory committees; the oversight, responsibilities, and coordination of any sites or cores proposed; and the role of any subcontractors or service providers for personnel or facilities.

Note: Do not contact potential members of an external advisory committee and do not propose their names in the application. Section 5 - Other Clinical Trial-related Attachments 5.

1 Other Clinical Trial-related Attachments The following additional documents should be included as attachments: Identification and qualifications of clinical trial site(s), pharmacies, and laboratories Copies of data collection forms, questionnaires, or other relevant materials The Investigator's Brochure or equivalent for the study products(s) The Table of Contents of the Manual of Operations (MOPs) A comprehensive Laboratory Plan Plans and support for acquisition and administration of study agent(s) Documentation of co-funding of clinical trials from partners, if applicable Documentation of any communications with regulatory authorities, if applicable 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.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations 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.

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