NIAID Clinical Trial Implementation (R01) Grant

NIAID Clinical Trial Implementation (R01) Grant is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). This grant supports investigator-initiated, non-high-risk clinical trials that are hypothesis-driven, related to the research mission of NIAID, and considered a high priority by the Institute, which includes neglected tropical diseases.

Expired PAR-13-149: NIAID Clinical Trial Implementation Grant (R01) This notice has expired. Check the NIH Guide for active opportunities and notices. of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Institute of Allergy and Infectious Diseases ( NIAID ) Funding Opportunity Title NIAID Clinical Trial Implementation Grant R01 Research Project Grant May 18, 2016 - This PA has been reissued as PAR-16-269 . December 11, 2015 - Notice of Change in Key Dates for PAR-13-149. See Notice NOT-AI-16-014 .

June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III. 3 regarding applications that are essentially the same. August 21, 2013: Removed reference to ASSIST in section IV.

3, since ASSIST is currently only available for multi-project applications. May 30, 2013 ( NOT-OD-13-074 ) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity PAR-13-151 , U01 Research Project Cooperative Agreements PAR-13-150 , R34 Clinical Trial Planning Grant Program Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) issued by the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for implementation of investigator-initiated, non-high-risk clinical trials. The trials must be hypothesis-driven, related to the research mission of the NIAID and considered a high priority by the Institute.

Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID ( http://www3. niaid. nih.

gov/about/whoWeAre/planningPriorities/ ). Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation (R01) Grant application.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days before the application due date June 4, 2013; September 11, 2013; January 13, 2014; May 13, 2014; September 11, 2014; January 13, 2015; May 13, 2015; September 11, 2015; January 13, 2016, and May 13, 2016 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. AIDS Application Due Date(s) June 4, 2013; September 11, 2013; January 13, 2014; May 13, 2014; September 11, 2014; January 13, 2015; May 13, 2015; September 11, 2015; January 13, 2016, and May 13, 2016 by 5:00 PM local time of applicant organization.

September 2013; January 2014; May 2014; September 2014; January 2015; May 2015; September 2015; January 2016; May 2016; and September 2016 October, 2013, January 2014; May 2014; October 2014; January 2015; May 2015; October 2015; January 2016; May 2016; and October 2016 March 2014; August 2014; December 2014; March 2015; July 2015; December 2015; March 2016; July 2016; December 2016; and March 2017 New Date May 14, 2016 per issuance of NOT-AI-16-014 .

(Original Expiration Date: January 14, 2016 ) Required Application Instructions It is critical that applicants follow the instructions in (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) 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 the Announcement Section I.

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

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

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

Funding Opportunity Description This Funding Opportunity Announcement (FOA) issued by the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for implementation of investigator-initiated, non-high-risk A clinical trial is defined by NIH as: A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).

Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and The proposed trial must be hypothesis-driven, related to the research mission of the NIAID and address a research area considered a high priority by the Institute.

For AIDS-related clinical trials, the Institute encourages investigator-initiated studies that include but are not limited to biobehavioral trials and equally as important, trials and studies that also explore disease pathogenesis.

This FOA will utilize the NIAID Clinical Trial Implementation (R01) Grants, which support implementation of investigator-initiated, non-high-risk clinical trials, and will run in parallel with two related FOAs, PAR-13-151 and PAR-13-150 , that invite applications for NIAID Clinical Trial Planning (R34) Grants, which support planning activities for investigator-initiated clinical trials, and the NIAID Clinical Trial Cooperative Agreement (U01) award mechanism, which support implementation of high-risk clinical trials, respectively.

Over the past three years, NIAID committed over $2 billion to clinical research, of which $1. 5 billion was devoted to clinical trials. Clinical trials are one research strategy NIAID uses to improve the understanding of the clinical mechanisms of infectious, immunologic, and allergic diseases or to improve prevention, diagnosis, and treatment.

For additional NIAID, applicants are encouraged to consult the NIAID web site http://www3. niaid. nih.

gov/about/whoWeAre/planningPriorities/ . Clinical Trial Infrastructure Historically, NIAID has supported a wide variety of clinical research activities through a clinical trial infrastructure funded through cooperative agreements, solicited under NIAID Funding Opportunity Announcements (FOAs), and contracts, solicited under NIAID Requests for Proposals (RFPs). This infrastructure focuses on high-priority disease research areas.

Examples include the HIV/AIDS Clinical Trial Networks supported by the Division of AIDS ( http://www. niaid. nih.

gov/about/organization/daids/Networks/Pages/daidsnetworks. aspx ), the Division of Microbiology and Infectious Diseases Clinical Trials Programs and Networks ( http://www3. niaid.

nih. gov/about/organization/dmid/programs. htm ), and the Immune Tolerance Network supported by the Division of Allergy, Immunology and Transplantation ( http://www.

immunetolerance. org/ ). NIAID’s clinical research infrastructure includes coordinating centers, statistical units, data centers, central laboratories, clinical centers, and other specialized resources.

For additional information on DMID supported clinical trials refer to the DMID Good Clinical Practice Resource Guide http://www. niaid. nih.

gov/labsandresources/resources/dmidclinrsrch/Pages/clinhandbook.

aspx Investigator-Initiated Clinical Trials Although clinical research infrastructure is 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 infrastructure.

This program consists of support for the NIAID Clinical Trial Planning (R34) Grant, the NIAID Clinical Trial Implementation (R01) Grant and the NIAID Clinical Trial Implementation (U01) Cooperative Agreement.

The NIAID Clinical Trial Implementation (R01) FOA is designed to support non-high-risk clinical trials, while the NIAID Clinical Trial Implementation (U01) Cooperative Agreement ( PAR-13-151 ) FOA is designed to support high-risk clinical trials, as defined by NIAID below and in the associated policy statement (see NOT-AI-10-024 ).

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-13-150 ) FOA 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 R01 or U01 application may be submitted to the For additional information about NIAID s investigator-initiated clinical trial program, see http://www. niaid. nih.

gov/researchfunding/sci/human/pages/iict. aspx The NIAID Clinical Trial Implementation (R01) Grant supports implementation of non-high-risk clinical trials that address research areas that are well matched with the mission and goals of NIAID.

A high-risk clinical trial is defined by the NIAID as having 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 administration of an unlicensed product; or administration of a licensed product for an unapproved 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.

For the purposes of this FOA, implementation support is defined as support for activities related to the conduct of the clinical trial, including, but not limited to: training of study personnel; enrollment and recruitment of study subjects; data collection, management and quality control; laboratory work and data analyses; study management and oversight; establishment of committees to manage the complexity of the preparation of the final study report; and other related post-enrollment activities.

Each NIAID Clinical Trial Implementation (R01) award will support the implementation of a single clinical trial; applications that include more than one clinical trial will not be reviewed. An overview of the state of the science, current status and relevance of the trial, and discussion of the clinical protocol must be presented in the application.

Applicants must propose a time-sensitive, milestone-driven clinical trial and describe the clinical trial stages, criteria for completion of the stages and contingency plans for each stage. Any anticipated impediments that could require a revision in the timeline must be identified and accompanied by a discussion of alternative approaches. The trial must be hypothesis-driven, and have clear primary and secondary endpoints.

A description of the study population, why it is an appropriate group to study the research question(s) posed, subject eligibility, inclusion and exclusion criteria, and a feasible recruitment and enrollment plan must also be included. Statistical methods appropriate for the study design, and adequate plans for data monitoring and safety are required.

All clinical trial planning activities must be completed by 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 (Investigational New Drug)/IDE (Investigational Device Exemption) application should be submitted to an appropriate regulatory agency; 2) the entity (NIAID, primary awardee, etc.) who will hold the IND/IDE; and 3) the requirements for the establishment of a DSMB(Data Safety Monitoring Board)/SMC (Safety Monitoring Investigators are referred to NIAID’s Clinical Research Toolkit website ( http://www.

niaid. nih. gov/labsandresources/resources/toolkit/pages/default.

aspx ) for protocol templates and guidance, clinical research resources, and links to program divisions. Investigators are strongly encouraged to contact NIAID s program divisions (Agency Contacts) for information regarding division-specific clinical research policies and procedures. Delineation of milestones is a key characteristic of the NIAID Clinical Trial Implementation (R01) Grant.

A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity. Applications must include a series of milestones for completion of the clinical trial and provide contingency plans should there be delays in attaining them. The milestones will undergo peer review and will be incorporated into the terms of award.

NIAID R01 clinical trial implementation grants will NOT support clinical trial planning tasks such as: 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 Applications that propose to conduct planning activities are not responsive to this FOA and will not be reviewed.

Investigators seeking support for the planning and design of clinical trials should refer to the NIAID Clinical Trial Planning (R34) Grant FOA ( PAR-13-150 ). NIAID R01 clinical trial implementation grants will NOT support high-risk clinical trials. Investigators seeking support for high-risk clinical trials should refer to the NIAID Clinical Trial Implementation Cooperative Agreement (U01) Grant FOA ( PAR-13-151 ).

NIAID R01 clinical trial research project grants will NOT provide support for clinical trials that fall outside the mission and high-priority research areas of the NIAID and will not support more than one clinical trial Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on 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 actual needs of the proposed project. The scope of the proposed project should determine the project period.

The maximum period is 5 years. Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Black Colleges and Universities (HBCUs) Controlled Colleges and Universities (TCCUs) Native and Native Hawaiian Serving Institutions American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions 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 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 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 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 Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) (formerly CCR) 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. Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration.

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 must have an active DUNS number and SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account.

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 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 his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 FOA 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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described Grants Policy Statement ), except for submission: To an RFA of an application that was submitted previously as an investigator-initiated application but not paid; Of an investigator-initiated application that was originally submitted to an RFA but not paid; or Of an application with a changed grant activity code.

Section IV. Application and Submission Information Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants. gov .

2. Content and Form of Application Submission It is critical that applicants follow the instructions in (R&R) Application Guide , except where instructed in this funding opportunity announcement 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 For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant 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 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: Priti Mehrotra, M. Sc, Ph. D.

Division of Extramural Activities National Institute of Allergy and Infectious Diseases (NIAID) (For Express Couriers: 20852-9823) All page limitations described in the SF424 Application Page Limits must be followed. Required and Optional Components The forms package associated with this FOA includes all applicable components, required and optional.

Please note that some components marked optional in the application package are required for submission of applications for this FOA.

Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional All instructions in the SF424 (R&R) Application Guide SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Attachments : Provide the following information: 1.

Clinical Protocol Synopsis The filename "Clinical Protocol Synopsis.

pdf" should be used and will be reflected in the final image bookmarking for easy The clinical protocol synopsis must include the following A description of the study population, including subject eligibility and inclusion/exclusion criteria; Sampling, recruitment and enrollment plans, including a discussion of the availability of subjects for the proposed study and the ability of enrollment center(s) to recruit and retain the proposed number of The process to be used for obtaining informed consent and, if Approaches to be used for retention, cooperation and follow-up of subjects and to address any anticipated changes in the composition of the study population over the course of the trial; Methods of assignment of subjects to study groups and of If appropriate to the study, a description and justification for the selection of the dose, frequency and administration of the intervention(s); A description of each enrollment site and how data from the site(s) will be obtained, managed, and protected; Descriptions of all clinical, laboratory, physiological, and/or behavioral tests to enable the research questions to be answered; and A description of the data management and quality control plan, including methods for monitoring the quality and consistency of the intervention(s) and data collection; policies and methods for ensuring blinding of study results; and data confidentiality and subject privacy.

Applications that lack the Clinical Protocol Synopsis are nonresponsive and will not be peer reviewed. 2. Statistical Analysis Plan The filename "Statistical Analysis Plan.

pdf" should be used and will be reflected in the final image bookmarking for easy This plan is critical to knowing whether applicants have selected the correct cohort size based on proper power calculations and/or are using the most appropriate methods to analyze the resulting data and make correct conclusions at the end of the study.

The ability to make conclusions of primary outcomes other than safety will be particularly important in small Applications that lack the Statistical Analysis Plan are nonresponsive and will not be peer reviewed. 3. Data and Safety Monitoring (DSM) Plan The filename "Data and Safety Monitoring Plan.

pdf" should be used and will be reflected in the final image bookmarking for easy The DSM plan should be commensurate with the risk level of the proposed clinical research ND must be included for all clinical trials (see http://grants. nih. gov/grants/guide/notice-files/not98-084.

html ).

All applications or study protocols must include a general description of the monitoring plan, policies, procedures, responsible entities, and approaches to identifying, managing and reporting reportable events (adverse events and unanticipated problems), to the applicable regulatory agencies (e.g., Institutional Review Board (IRB)), the Office of Biotechnology Activities (as appropriate), the Office of Human Research Protections, the Food and Drug Administration, and the Data and Safety Monitoring Board (if one is used).

The DSM Plan must address the following areas: Who will manage and conduct the monitoring; Proposed monitoring time points; Where the monitoring will occur; How the reportable events will be managed and reported; and How sites/centers, and participating facilities (labs, pharmacies) will be monitored. Applications that lack the DSM Plan are nonresponsive and will not be peer reviewed. 4.

Milestone Plan and Complete Clinical Protocol The filename Milestone Plan and Complete Clinical Protocol. pdf" should be used and will be reflected in the final image bookmarking for easy Applicants are required to provide detailed project performance and timeline objectives in a section entitled Milestone Plan .

This section must include: A timeline for the following general milestones, as applicable; Completion of regulatory approvals; Enrollment of the first subject; Enrollment of 25%, 50%, 75% and 100% of the projected recruitment time period for all study subjects, including women, minorities and children Completion of data collection time period; Completion of primary endpoint and secondary endpoint data Completion of final study report; and Detailed protocol-specific performance milestones and timeline; these milestones will be negotiated at the time of the award, if appropriate.

The complete Clinical Protocol must be included immediately after the Milestone Plan. Investigators are referred to the Trans-NIAID Clinical Research Toolkit website for clinical protocol guidance and templates ( http://www3. niaid.

nih. gov/LabsAndResources/resources/toolkit/protocol ). Investigators are urged to be succinct.

Applications that lack the Milestone Plan and/or the Complete Clinical Protocol are nonresponsive and will not be reviewed.

SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: This FOA uses non-modular budget formats described in the SF Because all applications must include detailed scientific and operational plans, funding needs for the entire trial and data analysis period must also be included.

Investigators must submit a complete, justified, individual budget for each year of support requested. All costs requested and all changes in budgets after the first year should be clearly identified and justified. Separate itemized budgets must be prepared for each subcontract and/or for each collaborating site, if multiple sites or cores are proposed.

If parts of the costs of the trial are to be borne by sources other than NIH, these contributions must be presented in detail along with supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution (see Letters of Support in the PHS 398 Research Plan below).

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.

Further information concerning budget preparation may be obtained from the Financial/Grants Management Contact(s) listed in Section All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: A letter that summarizes the discussion during prior consultation with NIAID may be obtained from the appropriate NIAID Division Director and attached as a .

pdf file to the PHS398 Cover Letter file. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Aims: The goals of the trial and the expected outcome(s) should be concisely stated in the Specific Aims section.

The specific objectives of the trial must be clearly and concisely presented, including a specification of the primary and major secondary endpoints to be measured. There should be a clear explanation of the importance of various endpoints. Strategy: The following three sections comprise the Research Strategy: Significance, Innovation, and Approach.

a discussion of the significance of the problem being studied, the need for the trial, and the potential impact of the results of the trial, as well as how the trial will test the hypothesis(es) proposed; a concise description of the overall strategy, methodology and analyses to be used to accomplish the goals and specific aims of the trial; a description of and rationale for the proposed study design; a description of the intervention to be tested and the protocol to be followed in each arm of the trial, including a discussion of potential biases or challenges in the protocol and how they will be addressed; statistical methods that are appropriate for the study design, including sample size and power calculations and the underlying assumptions (and data) used to link these calculations to the endpoints and to the hypothesis(es) being tested; 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; and 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 sub-contractors or service providers for personnel or facilities.

A description of the plans to implement and monitor Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), as appropriate. of Support: In the Letters of Support section of the Research Plan, provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium/site participants, cores, laboratories, pharmacies and other collaborators.

If co-funding or in-kind support is planned from non-NIH sources, letter(s) outlining details of the 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 Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application The following additional documents must be included in the Appendix material in the order listed below.

Place all documents in a single the informed consent form(s) and, if applicable, assent form(s) identification and qualifications of clinical trial site(s), pharmacies and laboratories copies of data collection forms, questionnaires or other relevant the Investigator’s Brochure or equivalent for the study the Table of Contents of the Manual of Operations a comprehensive Laboratory Plan documentation of availability of study agents as well as plans and support for acquisition and administration of study agent(s) documentation of cofounding of clinical trials from partners, as Foreign (non-U.S.) institutions must follow policies Grants Policy Statement , and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. 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. 4. Intergovernmental Review This initiative is not subject to intergovernmental All NIH awards are subject