The National Institute of General Medical Sciences (NIGMS) offers this planning grant to support the development of comprehensive plans for clinical trials highly relevant to the NIGMS mission. This grant provides essential time and resources for pre-trial preparations, including creating manuals of procedures, establishing data safety and monitoring boards, developing data handling and statistical analysis plans, setting up recruitment sites, and preparing preliminary regulatory submissions and training materials. Successful completion enables researchers to submit a well-prepared clinical trial application to NIGMS via appropriate funding opportunities, fostering robust and impactful research.
Opportunity ID: 293577
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-17-268 |
| Funding Opportunity Title: | Planning Grants for Clinical Trials of High Relevance to the NIGMS Mission (R34) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.859 — Biomedical Research and Research Training |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 03, 2017 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Aug 01, 2019 |
| Current Closing Date for Applications: | Aug 01, 2019 |
| Archive Date: | Sep 06, 2019 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $100,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| 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); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs) ; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not 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 purpose of this funding opportunity announcement is to provide time and support for the applicant to develop plans for the design and execution of clinical trials that are highly relevant to the NIGMS mission. Activities supported by a planning grant could include development of a Manual of Procedures, creation of a Data Safety and Monitoring Board charter, development of data handling and statistical analysis plans, establishment of recruitment sites, preparation of preliminary submissions for regulatory approvals, development of training materials, and other tasks essential to a trial. Following funding and successful completion of a planning grant, an application for a clinical trial that is highly relevant to the institute’s mission may be submitted to NIGMS via an appropriate clinical trial funding opportunity announcement. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-17-268.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-D | Use for due dates on or before January 24, 2018 | PKG00232285 | Jul 07, 2017 | Jan 24, 2018 | View | |
| FORMS-E | Use for due dates on or after January 25, 2018 | PKG00236302 | Nov 16, 2017 | Aug 01, 2019 | View |
Package 1
Mandatory forms
293577 RR_SF424_2_0-2.0.pdf
293577 PHS398_CoverPageSupplement_3_0-3.0.pdf
293577 RR_OtherProjectInfo_1_3-1.3.pdf
293577 PerformanceSite_2_0-2.0.pdf
293577 RR_KeyPersonExpanded_2_0-2.0.pdf
293577 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
293577 RR_Budget_1_3-1.3.pdf
293577 RR_SubawardBudget30_1_3-1.3.pdf
293577 PHS398_ModularBudget_1_2-1.2.pdf
293577 PHS_Inclusion_Enrollment_Report-1.0.pdf
293577 PHS_AssignmentRequestForm-1.0.pdf
Package 2
Mandatory forms
293577 RR_SF424_2_0-2.0.pdf
293577 PHS398_CoverPageSupplement_4_0-4.0.pdf
293577 RR_OtherProjectInfo_1_4-1.4.pdf
293577 PerformanceSite_2_0-2.0.pdf
293577 RR_KeyPersonExpanded_2_0-2.0.pdf
293577 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
293577 RR_Budget_1_4-1.4.pdf
293577 RR_SubawardBudget30_1_4-1.4.pdf
293577 PHS398_ModularBudget_1_2-1.2.pdf
293577 PHS_AssignmentRequestForm_2_0-2.0.pdf
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