Friday, November 20, 2015

NEI Clinical Study Planning Grant (R34)

Agency: National Eye Institute
Program: NEI Clinical Study Planning Grant (R34)
Funding Opportunity Number: PA-16-038
Deadline: February 16, June 16 and October 16 for new applications
Award Budget: Direct Costs of $150,000 per year
Award Project Period: The scope of the proposed project should determine the project period. The maximum period is two years.

Summary:
The NEI Clinical Study Planning Grant provides support for the development of a comprehensive research protocol for a large-scale clinical trial or epidemiologic study. This grant provides early peer review of the proposed clinical study in terms of its rationale, design, organizational structure and implementation plan. The Planning Grant is used to support the development of a detailed MOP.  While the grant may be used to support preliminary studies which refine study procedures or document recruitment potential, the grant must not be used to generate preliminary data in support of the rationale for the trial.

Prospective applicants should note that funding of a Clinical Study Planning Grant does not guarantee nor imply funding for any subsequent competitive application for the support of a full-scale study.

Applicants are encouraged to consider the relevance of their proposed research to NEI programs and priorities as described in the NEI Vision Research, Needs, Gaps, and Opportunities.

Scope:
This FOA is designed to: (1) permit early peer review of the rationale for the proposed clinical trial or epidemiology study; (2) provide support for the development of a detailed MOP; and (3) support the development of other essential elements of the clinical study.

Activities supported by this FOA may include, but are not limited to, the following examples:

- Developing/finalizing the MOP. Basic elements in the MOP should include identification of the patient population; inclusion and exclusion criteria; adequate plans for recruitment and retention of participants; experimental   design and protocols; clear definition of the research hypothesis and outcome measures; quality control/assurance procedures; data management and analytical techniques; sample size estimates with justification; administrative procedures, including regulatory approvals if necessary; collaborative arrangements; duties and responsibilities of the study chairperson, clinical sites, coordinating center, and other central resources such as a reading center; monitoring plans to assure patient protection and data integrity; and plans for addressing Federal gender/minority inclusion and human subjects protection requirements.
- Establishing and documenting collaborative arrangements.
- Instituting means to assure standardization of procedures across sites and among staff.
- Developing tools needed for data collection and data management.
- Developing/finalizing data and safety monitoring plans in the application.  Do not name individuals for the Data and Safety Monitoring Board (DSMB) or Data Monitoring and Oversight Committee (DMOC), but include areas of expertise that will be pertinent in forming these groups.
- Developing plans for any training that is required to carry out the proposed study. This may include, for example, training of data collectors and individuals who will carry out the planned intervention.

See the full announcement for more information.

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