DoD Spinal Cord Injury Clinical Trial Award — Defense Health Agency Contracting Activity - DHACA funding opportunity
Defense Health Agency Contracting Activity - DHACA · Federal agency

DoD Spinal Cord Injury Clinical Trial Award

The SCIRP Clinical Trial Award mechanism was first offered in FY12. Since then, 30 Clinical Trial Award applications have been received, and 7 have been recommended for funding. The SCIRP Clinical Trial Award supports hu...

88
match
Award $0 Deadline 4251 days ago Location Alabama Type grant Level Federal Closed posted Jun 4, 2014
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Funding amount: total funding pool ~$9,600,000.
  • Next deadline: October 30, 2014.
  • Issued by: Defense Health Agency Contracting Activity - DHACA.
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How was this generated?

The “key facts” mode pulls structured fields directly from the official source posting (amount, deadline, eligibility tags). The AI mode adds a short plain-English narrative on top, generated from the same source. Always verify with the agency before applying.

AI-generated. Always verify with the official source.

Award amount
$0
Deadline
4251 days ago
Oct 30, 2014
Total pool
$9.6M

About this opportunity

The SCIRP Clinical Trial Award mechanism was first offered in FY12. Since then, 30 Clinical Trial Award applications have been received, and 7 have been recommended for funding. The SCIRP Clinical Trial Award supports human subjects research with the potential to have a major impact on the treatment or management of SCI and its consequences in military Service other individuals. Funding from this award mechanism must support a clinical trial and may not be used for preclinical research studies. A clinical trial is defined as a prospective accrual of human subjects where an intervention ( procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory , and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other award mechanisms/funding opportunities being offered. The term “human subjects” is used in this Program Announcement/Funding Opportunity to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/ If the clinical trial involves the use of a drug that has not been approved by the Food and Drug Administration (FDA) for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA that meets all requirements under the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312) may be required and must be submitted to the FDA prior to the application submission deadline. If the investigational product is a device, evidence that an Investigational Device Exemption (IDE) application that meets all requirements under 21 CFR 812 has been submitted to the FDA prior to the application submission deadline, or that the device is exempt from an IDE, is required. Documentation of approval of the IND or IDE must be obtained and submitted to the CDMRP Help Desk ([email protected]) prior to Programmatic Review; otherwise, the Government reserves the right to withdraw the application. The following are important aspects of submission for the Clinical Trial Award:  The proposed clinical trial is expected to begin no later than 6 months after the award date.  The proposed intervention to be tested should offer significant potential impact for individuals living with SCI and its consequences.  Inclusion of preliminary data relevant to the proposed clinical trial is required.  The proposed clinical trial must be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature.  The application should describe the planned indication for the product label, if appropriate, and include an outline of the development plan required to support that indication.  The application should demonstrate availability of, and access to, a suitable patient population that will support a meaningful outcome for the study. The PI should discuss how accrual goals will be achieved and how standards of care may impact the study population.  The application should demonstrate documented availability of and access to the drug/ compound, device, and/or other materials needed, as appropriate. The quality of the product should be commensurate with FDA manufacturing standards applicable to the type and phase of product being developed ( Quality System Regulation, Good Manufacturing Practices).  The proposed clinical trial design should include clearly defined and appropriate endpoints, and follow Good Clinical Practice (GCP) guidelines.

Funding agency

Defense Health Agency Contracting Activity - DHACA
Federal agency

Tags

Healthcare & Biotech Manufacturing Education & Research Veterans Transportation & Logistics Science, Tech & Engineering (STEM)
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Who can apply

Eligibility details aren't on file yet — check the agency source link in the Documents tab for the latest rules.

Geographic eligibility

  • Alabama
  • Alaska
  • Arizona
  • Arkansas
  • California
  • Colorado
  • Connecticut
  • Delaware
  • Florida
  • Georgia
  • Hawaii
  • Idaho
  • Illinois
  • Indiana
  • Iowa
  • Kansas
  • Kentucky
  • Louisiana
  • Maine
  • Maryland
  • Massachusetts
  • Michigan
  • Minnesota
  • Mississippi
  • Missouri
  • Montana
  • Nebraska
  • Nevada
  • New Hampshire
  • New Jersey
  • New Mexico
  • New York
  • North Carolina
  • North Dakota
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Vermont
  • Virginia
  • Washington
  • West Virginia
  • Wisconsin
  • Wyoming
  • District of Columbia

How to apply

We don't have application instructions on file yet — head straight to the official source.

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Source documents

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Canonical NOFO, application packet, and forms
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Direct downloads (NOFO PDFs, application forms, FAQs) will appear here once our team attaches them. For now, the agency site has the canonical packet.

Citation details

Source systemgrants.gov
Source ID256734
PostedJun 4, 2014

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