Peer Reviewed Orthopaedic Integrated Clinical Trial Award — Defense Health Agency Contracting Activity - DHACA funding opportunity
Defense Health Agency Contracting Activity - DHACA · Federal agency

Peer Reviewed Orthopaedic Integrated Clinical Trial Award

The PRORP is offering the Integrated Clinical Trial Award (ICTA) for the first time in FY16. The PRORP ICTA supports the rapid implementation of an interdisciplinary clinical trial that integrates both surgical and rehab...

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Deadline 3483 days ago Location Alabama Type grant Level Federal Closed posted Aug 10, 2016
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Funding amount: total funding pool ~$30,000,000.
  • Next deadline: December 7, 2016.
  • Issued by: Defense Health Agency Contracting Activity - DHACA.
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.

Deadline
3483 days ago
Dec 7, 2016
Total pool
$30M

About this opportunity

The PRORP is offering the Integrated Clinical Trial Award (ICTA) for the first time in FY16. The PRORP ICTA supports the rapid implementation of an interdisciplinary clinical trial that integrates both surgical and rehabilitation strategies and has the potential to have a major impact on both the treatment of combat-related orthopaedic injuries, as well as the treatment of non-battle injuries that significantly impact unit readiness and return-to-duty/work rates. Projects that follow patients across the continuum of care are highly encouraged. The projects should include both surgical and rehabilitation strategies that create a cohesive project. Surgical strategies are reconstruction and repair and/or application of devices for the purpose of restoration of native function of traumatically injured tissues. Rehabilitative strategies are those that restore function following injury or illness, with the goal of optimal health and independence. Projects should integrate principles and approaches from surgical and rehabilitative strategies, beyond what each approach would result in alone, with the goal of optimizing independence for those who have sustained traumatic orthopaedic injuries. Care should be taken to avoid or account for confounding factors in the analyses.All applications are required to articulate the relevance of the proposed interdisciplinary project to military and/or Veteran populations affected by orthopaedic injury. Collaboration with military and Department of Veteran Affairs (VA) researchers and /or clinicians is encouraged. Studies that include active duty military or Veteran participants as all or a portion of the study population are encouraged. All funding amounts requested should be well-justified and appropriate to the scope of work proposed. Funding from this award mechanism must support one cohesive clinical trial and may not be used for preclinical research studies. Animal research is not allowed under the FY16 PRORP ICTA. 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 safety, effectiveness, 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 within 6 months of the award date. 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 within 6 months of the award date, or that the device is exempt from an IDE or qualifies for an abbreviated IDE, is required.

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Geographic eligibility

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  • District of Columbia

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Citation details

Source systemgrants.gov
Source ID287286
PostedAug 10, 2016

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