NHLBI Grant Opportunity: Investigator Initiated Multi-Site Clinical Trials (Collaborative R01)

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The NHLBI is offering this grant to support investigator-initiated multi-site randomized controlled clinical trials addressing research questions related to the mission and goals of the NHLBI. Trials may involve clinical or behavioral interventions, phase II and III trials, pragmatic trials, or testing interventions’ efficacy. The trials can randomize at individual or group levels and include rare diseases. The proposed study design should be efficient to achieve specific aims. Applicants must submit Clinical Coordination Center and Data Coordination Center applications when trial costs exceed $500,000 per year. This opportunity does not support single-center or multicenter observational studies without interventions. Closing date for applications is Sep 07, 2016.

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Opportunity ID: 223856

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General Information

Document Type:: Grants Notice
Funding Opportunity Number:: PAR-13-128
Funding Opportunity Title:: Investigator Initiated Multi-Site Clinical Trials (Collaborative R01)
Opportunity Category:: Discretionary
Opportunity Category Explanation::
Funding Instrument Type::
Category of Funding Activity:: Health
Category Explanation::
Expected Number of Awards::
Assistance Listings Number(s):: 93.233 — National Center on Sleep Disorders Research
Cost Sharing or Matching Requirement:: No
Version:: Synopsis 2
Posted Date:: Mar 01, 2013
Last Updated Date:: Feb 05, 2016
Original Closing Date for Applications:: May 07, 2016
Current Closing Date for Applications:: Sep 07, 2016
Archive Date:: Oct 07, 2016
Estimated Total Program Funding::
Award Ceiling:: $
Award Floor:: $

Eligibility

Eligible Applicants:: Private institutions of higher education
Additional Information on Eligibility:: Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed

Additional Information

Agency Name:: National Institutes of Health
Description:: The support of multi-site clinical trials is one strategy NHLBI uses to improve the understanding of the clinical mechanisms of disease and to improve prevention, diagnosis, and treatment. The purpose of this Funding Opportunity Announcement (FOA) is to provide a vehicle for submitting grant applications for investigator-initiated multi-site randomized controlled clinical trials. The trials may address any research question related to the mission and goals of the NHLBI and may test clinical or behavioral interventions. The FOA is appropriate for applications to conduct phase II and phase III randomized clinical trials where participants are recruited from multiple sites. Large-scale pragmatic trials (such as comparative effectiveness trials) as well as trials designed to test efficacy of an intervention are appropriate. The trials may randomize at the individual (patient) level or at a group level (e.g., randomization of clinics, schools, worksites, etc.). Clinical trials involving NHLBI mission-related rare diseases that require coordination across multiple clinical sites are also suitable for submission to this FOA. In any case, the trial should propose the most efficient study design to complete the specific aims. For additional information about the mission, strategic plan, and research interests of the NHLBI, applicants are encouraged to consult the NHLBI website (http://www.nhlbi.nih.gov/about/strategicplan/index.htmThis Funding Opportunity Announcement is not intended for support of single-center studies or multicenter observational studies that are not testing an intervention. Clinical Coordination Center (CCC) and Data Coordination Center (DCC) applications are required to be submitted together when the proposed costs of the clinical trial exceed $500,000 (minus F&A for subcontracts) in any given year.
Link to Additional Information::
Grantor Contact Information:: If you have difficulty accessing the full announcement electronically, please contact:

Version History

Version Modification Description Updated Date
Synopsis 2 Modified the close date field in accordance with NOT-HL-16-297. Feb 05, 2016
Synopsis 1

Package Status

Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:

Package No: 1

Assistance Listings:
Competition ID: ADOBE-FORMS-B2
Competition Title: Adobe-Forms-B2
Opportunity Package ID: PKG00167672
Opening Date: May 05, 2013
Closing Date: Sep 24, 2013
Agency Contact Information:: eRA Commons Help Desk
Who Can Apply:: Organization Applicants
mendatory_forms SF424 (R & R) [V1.2]
Project/Performance Site Location(s) [V1.4]
Research And Related Other Project Information [V1.3]
Research And Related Senior/Key Person Profile (Expanded) [V1.2]
PHS 398 Cover Page Supplement [V1.4]
PHS 398 Research Plan [V1.3]
PHS 398 Checklist [V1.3]
optional_forms R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.2]
PHS 398 Modular Budget [V1.2]
Research & Related Budget [V1.1]
PHS Cover Letter [V1.2]

Package No: 2

Assistance Listings:
Competition ID: FORMS-C
Competition Title: This package should only be used for due dates before May 25, 2016.
Opportunity Package ID: PKG00180703
Opening Date: Sep 08, 2013
Closing Date: May 07, 2016
Agency Contact Information:: eRA Commons Help Desk
Who Can Apply:: Organization Applicants
mendatory_forms SF424 (R & R) [V2.0]
PHS 398 Research Plan [V2.0]
PHS 398 Cover Page Supplement [V2.0]
Research and Related Senior/Key Person Profile (Expanded) [V2.0]
Research And Related Other Project Information [V1.3]
Project/Performance Site Location(s) [V2.0]
optional_forms R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.3]
Planned Enrollment Report [V1.0]
PHS 398 Cumulative Inclusion Enrollment Report [V1.0]
PHS 398 Modular Budget [V1.2]
Research & Related Budget [V1.3]

Package No: 3

Assistance Listings:
Competition ID: FORMS-D
Competition Title: Use for due dates on or after May 25, 2016
Opportunity Package ID: PKG00222204
Opening Date: Apr 17, 2016
Closing Date: Sep 07, 2016
Agency Contact Information:: eRA Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/
Who Can Apply:: Organization Applicants
mendatory_forms SF424 (R & R) [V2.0]
PHS 398 Cover Page Supplement [V3.0]
Research And Related Other Project Information [V1.3]
Project/Performance Site Location(s) [V2.0]
Research and Related Senior/Key Person Profile (Expanded) [V2.0]
PHS 398 Research Plan [V3.0]
optional_forms Research & Related Budget [V1.3]
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.3]
PHS 398 Modular Budget [V1.2]
PHS Inclusion Enrollment Report [V1.0]
PHS Assignment Request Form [V1.0]

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