Provost’s Pilot Clinical Research Award Submission

Pre-Application: Note that a pre-application is required.

• Deadline for Submission of Letter of Intent: February 28, 2021
  Complete Letter of Intent / pre-application through InfoReady

• Notification of Invitation to Submit Full Application: May 1, 2021

• Font size for all documents must be font 11 or larger with no more than 6 lines per inch.
• Margins must be at least 0.5” on all sides for documents that do not have templates.
• Do not alter any templates.
• As this funding mechanism is internal, RACE and ORA do not need to be involved in the process.

Upload the completed cover page template.

Upload the completed justification page template.

• Upload a biosketch from each PI and each co-investigator.
• Each biosketch must contain a personal statement related to this proposal.

Upload a specific aims page. This document should include a brief introduction, the overall objective, and the specific aims and hypotheses of the proposed work.

Significance. How does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that may drive this field and lead to extramural grant funding?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are these novel to one field of research or in a broader sense?

Approach. Present a well-reasoned strategy with a brief methodology section that gives confidence in the proposed approach and discuss how the approach will accomplish the specific aims of the project. Include potential problems to achieving the goals of the project and what benchmarks will be used to determine success. The strategy must address feasibility with the one year timeframe and thus the ability to recruit subjects for the study.

Expected Outcomes. Specify expected scientific outcomes.

Statistical Analysis & Power Analysis. Describe how data will be analyzed. Provide a power calculation that estimates the number of subjects required to demonstrate statistical significance (or an acceptable trend that would justify further pursuit), for data with specific mean group differences and variance, for each outcome.

Upload the reference list.

1. Upload the IRB approval letter and consent if approved
2. Complete and upload an NIH Targeted/Planned Enrollment Table
   
3. Upload a document outlining human subjects’ protection. This section must conform to the rules for the Protection of Human Subjects sectioned required for NIH grants. This section must also include statements regarding inclusion of women, minorities, and children, and should be organized as follows:

• Human Subjects Involvement and Characteristics
• Sources of Materials
• Potential Risks
• Recruitment and Informed Consent
• Potential Benefits of the Proposed Research to Subjects and Others
• Importance the Knowledge to be Gained
• Data and Safety Monitoring Plan
• Women and Minorities Inclusion
• Inclusion of Children

Upload the completed justification page template.

Note that page 2 is for the budget justification. No salary can be requested for the PI(s) or faculty. Other personnel can receive salary support. Do not request more than $25,000 total.

Upload a letter from each PI’s chair indicating support for the project and any needed release time.

Upload a document with the names and contact information for three suggested Jefferson reviewers with content expertise.