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animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” last=”true” border_position=”all” first=”true”][fusion_alert type=”success” accent_color=”#808080″ hue=”” saturation=”” lightness=”” alpha=”” background_color=”#ffffff” border_size=”” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” icon=”” text_align=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” text_transform=”” link_color_inheritance=”” dismissable=”no” box_shadow=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]
The National Institute of General Medical Sciences is offering planning grants to support early peer review and preparation of scientific rationale for proposed clinical trials. These R34 grants aim to assist in organizing oversight arrangements, developing necessary procedures, and obtaining regulatory approvals essential for subsequent full-scale clinical trial grant applications. The funding allows time to establish critical elements like data management plans, safety boards, and recruitment sites. Successful completion of the planning grant enables applicants to submit a comprehensive clinical trial proposal aligned with NIGMS’s mission, such as an R01 grant application. Application deadline: November 1, 2013.
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Opportunity ID: 110053
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General Information
| Document Type:: | Grants Notice |
| Funding Opportunity Number:: | PAR-11-287 |
| 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:: | |
| Category of Funding Activity:: | Health |
| Category Explanation:: | |
| Expected Number of Awards:: | |
| Assistance Listings Number(s):: | 93.859 — Biomedical Research and Research Training |
| Cost Sharing or Matching Requirement:: | No |
| Version:: | Synopsis 2 |
| Posted Date:: | Aug 01, 2011 |
| Last Updated Date:: | Oct 21, 2013 |
| Original Closing Date for Applications:: | Oct 24, 2013 |
| Current Closing Date for Applications:: | Nov 01, 2013 |
| Archive Date:: | Dec 01, 2013 |
| Estimated Total Program Funding:: | |
| Award Ceiling:: | $100,000 |
| Award Floor:: | $ |
Eligibility
| Eligible Applicants:: | Independent school districts |
| Additional Information on Eligibility:: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; 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); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. |
Additional Information
| Agency Name:: | National Institutes of Health |
| Description:: | The purpose of this funding opportunity announcement is to permit early peer review of the scientific rationale for a proposed clinical trial, and to facilitate the complete submission of a subsequent research grant application to support the full scale clinical trial. The R34 planning grant mechanism is intended to provide time and support for an applicant to prepare, organize, and make oversight arrangements prior to consideration of an investigator-initiated application for a full clinical trial. 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, a clinical trial that is highly relevant to the institute’s mission may be submitted to NIGMS as an R01 grant application. |
| 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 Archive Date based on new Expiration Date, per NOT-OD-14-003. | Oct 21, 2013 |
| Synopsis 1 |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | 93.859 |
| Competition ID: | ADOBE-FORMS-B2 |
| Competition Title: | ADOBE-FORMS-B2 |
| Opportunity Package ID: | PKG00068270 |
| Opening Date: | Sep 24, 2011 |
| Closing Date: | Sep 24, 2013 |
| Agency Contact Information:: | Grants Info |
| 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: | 93.859 |
| Competition ID: | FORMS-C |
| Competition Title: | Use for due dates after 9/24/2013. |
| Opportunity Package ID: | PKG00181219 |
| Opening Date: | Sep 16, 2013 |
| Closing Date: | Nov 01, 2013 |
| 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] |
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Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Agency Contact Information: | Who Can Apply: |
|---|---|---|---|---|---|---|---|---|
| 93.859 | ADOBE-FORMS-B2 | ADOBE-FORMS-B2 | PKG00068270 | Sep 24, 2011 | Sep 24, 2013 | View | Grants Info | Organization Applicants |
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Agency Contact Information: | Who Can Apply: |
|---|---|---|---|---|---|---|---|---|
| 93.859 | FORMS-C | Use for due dates after 9/24/2013. | PKG00181219 | Sep 16, 2013 | Nov 01, 2013 | View | eRA Commons Help Desk | Organization Applicants |
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