Opportunity Information: Apply for PAR 11 338
Apply for PAR 11 338
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCR Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant (R34)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121 Oral Diseases and Disorders Research.
- This funding opportunity was created on Sep 16, 2011 and posted on Sep 16, 2011.
- Applicants must submit their applications by Sep 7, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) County governments Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education Small businesses State governments For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Independent school districts Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized).
- 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 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.
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Opportunity Summary:
The NIDCR Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant (R34) is a National Institutes of Health funding opportunity focused on helping research teams get a clinical trial or biomarker clinical evaluation study fully planned and ready to launch. Rather than paying for the trial itself, this grant is meant to cover the upfront work that turns a promising idea into a well-designed, operationally realistic study with a clear protocol, defined procedures, and the practical infrastructure needed to run the study safely and consistently.
A central feature of this R34 is that it supports planning and design activities. That includes building and organizing the research team, clarifying roles and responsibilities, and establishing the collaborative structure needed for a complex human subjects study. It also supports development of the clinical protocol and the Clinical Investigators Brochure (or an equivalent document), which are key materials for standardizing how the intervention or biomarker evaluation will be conducted and how information will be communicated to investigators and sites. In addition, the grant can be used to create or refine systems for data management and for safety and operational oversight, which typically means planning how data will be collected, stored, monitored for quality, and reviewed for participant safety and study integrity.
The opportunity also emphasizes the importance of practical study operations. Applicants are expected to define recruitment strategies and work through the essential elements required to conduct the study successfully, such as creating a Manual of Procedures for a clinical trial or biomarker clinical evaluation study. For behavioral, community, or services interventions, the planning work may include producing a draft of a manualized intervention, which is often necessary to ensure the intervention can be delivered consistently across staff, sites, and participants. In other words, the R34 is designed to help applicants fully specify what will happen in the study, how it will happen, who will do it, and how the work will be monitored and documented.
Just as important is what this grant does not support. The announcement makes clear that the R34 is not intended for collecting preliminary data, whether clinical or preclinical, and it is not meant for collecting prospective data to justify the rationale for a clinical trial or biomarker study. The goal is planning, not generating new evidence to prove the study is worth doing. Applicants are expected to come in with sufficient scientific rationale already in hand and use the R34 period to produce the study-ready materials and operational blueprint that would position them to move into a full-scale clinical trial or biomarker evaluation study funding mechanism afterward.
Administratively, this opportunity was issued as PAR-11-338 under the NIH, with the activity tied to oral diseases and disorders research (CFDA 93.121). It is a discretionary grant mechanism with no cost sharing or matching requirement. The posting date was September 16, 2011, and the final closing date listed was September 7, 2014, with the archive date of October 8, 2014, indicating the announcement is no longer active but remains relevant as a reference point for how NIDCR structures planning support for clinical trials and biomarker evaluation efforts.
Eligibility is broad and includes many types of domestic and non-domestic applicants. Eligible organizations include public and private institutions of higher education, nonprofits (including both 501(c)(3) and certain nonprofits without 501(c)(3) status), small businesses, for-profit organizations (including those other than small businesses), and multiple levels of government such as state, county, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities. The announcement also specifies additional eligible applicants such as historically Black colleges and universities, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, U.S. territories or possessions, and eligible federal agencies. Foreign institutions are explicitly allowed to apply, and foreign components of U.S. organizations are permitted, consistent with NIH policy.
For reference and official details, the full announcement was available through the NIH grants website under PAR-11-338, and the NIH Office of Extramural Research webmaster contact was provided for access or linking issues.
FAQs: NIDCR Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant (R34) - PAR-11-338
What is the NIDCR R34 Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant?
This R34 is an NIH (NIDCR) funding opportunity designed to support the planning and design work needed to get a clinical trial or biomarker clinical evaluation study fully prepared to launch. It focuses on creating study-ready materials and an operational blueprint rather than paying for the trial or evaluation study itself.
What is the main purpose of this grant?
The main purpose is to help a research team turn an already well-supported scientific idea into a clearly specified, operationally realistic, and safety-conscious study plan. The expected outcome is a complete set of protocols, procedures, oversight plans, and practical infrastructure needed to run a human subjects study consistently and safely.
Does this grant pay for running the clinical trial or biomarker evaluation study?
No. This R34 is intended to cover upfront planning work. It is not intended to fund the conduct of the clinical trial or biomarker clinical evaluation study itself.
What types of activities does the R34 support?
The R34 supports planning and design activities, including organizing the research team, defining roles and responsibilities, establishing collaborative structures, developing the clinical protocol, preparing a Clinical Investigators Brochure (or equivalent), planning data management systems, and planning safety and operational oversight.
Does the grant support development of a clinical protocol?
Yes. Protocol development is a central planning activity supported by this opportunity, with the goal of producing a study-ready protocol that standardizes how the intervention or biomarker evaluation will be conducted.
What is the Clinical Investigators Brochure and is it supported under this R34?
The opportunity specifically mentions support for developing a Clinical Investigators Brochure (or an equivalent document). This is a key planning product used to communicate standardized information to investigators and sites so the study is implemented consistently.
Can R34 funds be used for planning data management?
Yes. The grant can be used to create or refine plans and systems for data management, including how data will be collected, stored, monitored for quality, and handled in a way that supports study integrity.
Does the R34 support participant safety and study oversight planning?
Yes. The funding supports planning for safety and operational oversight, including how participant safety and study integrity will be monitored and reviewed.
Are recruitment strategies part of what applicants should plan during the R34?
Yes. Applicants are expected to define recruitment strategies and work through essential operational elements required to conduct the study successfully.
What is a Manual of Procedures (MOP), and does this R34 support creating one?
The opportunity highlights creating a Manual of Procedures for a clinical trial or biomarker clinical evaluation study as a key planning activity. The MOP helps specify procedures so the study can be carried out consistently across staff and sites.
How does the R34 apply to behavioral, community, or services interventions?
For behavioral, community, or services interventions, the planning work may include producing a draft of a manualized intervention. This supports consistent delivery across staff, sites, and participants.
What is the R34 not intended to support?
The announcement makes clear that the R34 is not intended for collecting preliminary data (clinical or preclinical) and is not meant for collecting prospective data to justify the rationale for a clinical trial or biomarker study.
Can this R34 be used to generate new evidence to prove the study is worth doing?
No. The goal is planning, not generating new evidence. Applicants are expected to already have sufficient scientific rationale and use the R34 period to produce study-ready materials and an operational plan.
What is the expected outcome of the R34 planning period?
The expected outcome is a complete, launch-ready package of study materials and infrastructure planning, such as the protocol, procedures documentation, oversight approaches, recruitment planning, and standardized materials needed to run the study safely and consistently.
What research area is this opportunity associated with?
The activity is tied to oral diseases and disorders research under NIDCR, and it is associated with CFDA 93.121.
What is the funding opportunity number for this announcement?
The opportunity was issued as PAR-11-338.
Is cost sharing or matching required?
No. The announcement indicates there is no cost sharing or matching requirement.
What type of grant mechanism is this?
It is described as a discretionary grant mechanism.
Is this funding opportunity still active?
No. The information provided indicates the posting date was September 16, 2011, the final closing date was September 7, 2014, and the archive date was October 8, 2014. That means the announcement is no longer active, but it remains useful as a reference for how NIDCR structures planning support.
Who is eligible to apply?
Eligibility is broad and includes many domestic and non-domestic applicants. Eligible organizations include public and private institutions of higher education, nonprofits (including 501(c)(3) and certain nonprofits without 501(c)(3) status), small businesses, for-profit organizations (including those other than small businesses), and multiple levels of government (state, county, city or township), as well as special district governments, independent school districts, and public housing authorities/Indian housing authorities.
Are minority-serving institutions specifically included in eligibility?
Yes. The announcement lists historically Black colleges and universities, Hispanic-serving institutions, tribally controlled colleges and universities, and Alaska Native and Native Hawaiian Serving Institutions among eligible applicants.
Can faith-based or community-based organizations apply?
Yes. The eligibility list explicitly includes faith-based or community-based organizations.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are specifically listed as eligible applicants.
Are foreign institutions allowed to apply?
Yes. Foreign institutions are explicitly allowed to apply, and foreign components of U.S. organizations are permitted consistent with NIH policy.
Where could applicants find the official announcement details?
The full announcement was available through the NIH grants website under PAR-11-338. The NIH Office of Extramural Research webmaster contact was provided for access or linking issues.
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