Materials must be submitted electronically via the NICO Research page.
To help to prepare a successful concept, we are providing the following guidance. Please be aware that this is a highly competitive process with numerous studies approved. It is best to check https://www.clinicaltrials.gov/ to ensure similar studies are not ongoing.
The program encourages Residents/Fellows to be involved in conducting IIS under the guidance of a mentor. In such cases, please specifically mention, in concept form, the intent of a mentored IIS, include CVs of both the investigator and mentor, and provide a detailed letter from the mentor describing the mentoring plan and how this IIS will help the investigator meet his or her career objectives.
An accurate budget is essential for evaluating IIS proposals. Approved “Summary Protocols”that have increases in budgets may be withdrawn or subject to supplementation by third parties (i.e. grants procured by other mechanisms).
The IIS program does not include any investigational pipeline devices at this time for independent clinical investigations and will not be considered. Should you choose to apply, please follow the instructions beginning on the NICO Research page.
The IIS program is under Medical/Clinical Affairs. Sales representatives/marketing personnel may not participate in the process or receive/accept/forward research proposals or respond to research/IIS questions. Specific questions should be directed to Clinical_Affairs@niconeuro.com.
Only preliminary approval will be granted following review of PARTS I and II of the application materials. If preliminary approval of your request is granted, you will be required to submit a Complete Protocol. Protocol instructions will be provided via NICO Clinical Affairs upon preliminary approval of Proposal Summary. IIS proposals may not be submitted through any NICO sales, clinical,or marketing representative(s).
PART I: Request for Funding Proposal Summary
To standardize the information to be reviewed for the IIS, all “Proposal Summaries” submitted must contain information on each of the following bolded sub-headings. Electronic submission forms are available at the NICO Research page.
|Rationale:||Study rationale and how it relates to clinical and/or economic outcomes.|
|Previous Work:||Work/findings by the PI and/or other investigators in the area of proposed research.|
|Primary and Secondary Objective(s):||
|Primary and Secondary Measure(s):||
|Anticipated Findings:||Results anticipated from the proposed research.|
|Type of Financial Support Requested:||Use Part II of application materials to provide a proposed budget for the study. You may add to the form to include detail as needed.|
|Additional Information:||Any additional information you feel the committee should be aware of in the evaluation of your request should be included.|
PART II: Investigator Initiated Study Budget Worksheet
- Briefly describe budget items using the downloadable Proposed Budget TEMPLATE.
General Clinical Study Payment Schedule
- 20% -Initial payment
- 20% -At midpoint of project
- 20% -At conclusion of the project
- 40% -After receipt of final manuscript suitable for publication and documentation of submission to a journal