Clinical Research Application | American Society of Neurorehabilitation

CLINICAL RESEARCH APPLICATION

Principal and Co-investigator(s):
Please list names and affiliation of the Principal and Co-Investigator(s) for the proposed research. Please attach a NIH formatted Biosketch for each investigator.

It is the responsibility of the Principal Investigator to ensure that all participating sites receive IRB/REB approval before engaging in any study related activities.

Name: *

Please attach a NIH formatted Biosketch for investigator. *

Name: *

Please attach a NIH formatted Biosketch for investigator. *

Name: *

Please attach a NIH formatted Biosketch for investigator. *

Is the Principal investigator a member of the ASNR? *

Yes

Clear Selection

The proposing Principal investigator must be a member of ASNR. If you wish to propose a study and are not a member, you can easily become a member.

Contact information for Principal investigator:

Phone Number: *

Email: *

IRB approval status: *

Yes

Pending

Clear Selection

If yes, attach approval letter and a copy of the Informed Consent Form

If pending, when do you expect approval?

Research Proposal Upload: *

Study Population:

Other:

Will you be recruiting research participants at your site? *

Yes

Clear Selection

How many sites do you anticipate involving in the study?

Have any sites confirmed interest as of now?

Yes

Clear Selection

Have you previously worked with any of the sites/investigators before?

Yes

Clear Selection

Would you be requesting resources from ANSR to help locate sites and collaborators?

Yes

Clear Selection

Would you be available to present your proposal to interested ASNR members at the annual meeting to solicit interested sites in your proposal? *

Yes

Clear Selection

Anticipated study duration and how you determined this (Proposed research should be able to be completed in 2 years):

Do you have data management and biostatistical support? *

Yes

Clear Selection

Briefly explain your data management and analysis plan and include how you plan to transfer data from the recruitment sites to the administering site? *
(Maximum characters: 2000)
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Provide a detailed budget and budget justification for how you plan to use the requested funding. Remember that these funds are to be used mainly for the costs of starting a collaborative clinical trial. Allowable expense categories include: travel between sites (e.g., car mileage, train); catering (excluding alcoholic beverages) for collaboration meetings; Online meeting services (e.g., WebEx or Go-to-Meeting); conference call services etc.; training and start-up costs; and IRB costs for additional sites. See below for a full list of eligible expenses. Non-allowable expense categories include: salary; excessive travel costs; alcoholic beverages. *
(Maximum characters: 2000)
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Budget Justification must include a rationale for how the expense category is necessary to foster a collaboration for the proposed pilot study. Explain how the 5K funds will be used to develop your collaboration and/or project and provide a timeline for achieving the goals of this award (include target date for completion of collaborative proposal for larger grant funding)

A statement from the PI that she/he will review and approve all reimbursement requests according to guidelines before they are submitted to the ASNR Executive Office for disbursement.

Provide a summary of your project for ASNR advertisement and publicity purposes (3 sentences maximum and in lay language): *
(Maximum characters: 2000)
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Note: If IRB/REB approval at the proposing site is pending, ASNR can only provide a conditional approval until this is obtained. An IRB/REB approved protocol at the proposing site is eligible for full consideration by ASNR and full funding if everything else meets criteria.

It is the responsibility of the Principal Investigator to assure that all participating sites receive IRB/REB approval before engaging in any study related activities.

If your proposal is selected for funding there will be some reporting responsibilities detailed at the time of notification. When the study is completed, a final report must be submitted within 6 months of completion.

If you have questions pertaining to appropriateness of your research, contact: Dr. Carolee Winstein at Winstein@usc.edu. If you have questions pertaining to the submission process, contact ASNR staff support. In the subject line indicate: ASNR Clinical Trial Application Question

Eligible expenses with examples:

1. Travel
Economy airfare, or other ground transportation for planning meetings; for initial training of personnel at different sites

2. Planning Meeting expenses
Including catering and accommodation (no alcoholic beverages)

3. Communication between sites for planning
Teleconference charges; long distance charges

4. Biostatistical consultation
If you think you need biostatistical consultation for design, stats, power analysis etc. we encourage use of these funds for such purposes. There are too many underpowered studies that are of little value to clinical practice. Note: Costs for biostatistical support needed for project development are permissible, but investigator salary support is otherwise not an allowable cost.

5. Training and start-up expenses within reason and commensurate with a relatively simple protocol.
Charges for certification on assessments, (e.g., UPDRS; NIHSS)

6. Student Worker
Help with tasks specifically associated with start-up of collaboration (e.g., creation of standard operating procedure manuals; Case report forms for recording data; photocopying, printing)

7. IRB/REB ethics application review fees for collaborating sites only
While the PI might have approval (and it is needed for the application), a new site might still need to obtain IRB approval.

Fields marked with * are required.

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