DOD Tuberous Sclerosis Complex Clinical and Translational Research Award | Apply Online

Frequently Asked Questions (FAQs)

What is the DOD Tuberous Sclerosis Complex Clinical and Translational Research Award (CTRA)?

The CTRA is an FY2009 funding opportunity from the Department of the Army/USAMRAA under the Tuberous Sclerosis Complex Research Program (TSCRP). It was introduced for the first time in FY09 and is intended to support research that moves promising tuberous sclerosis complex (TSC) findings toward practical clinical impact.

What is the main purpose of this award mechanism?

The mechanism is designed to advance TSC research toward clinically meaningful outcomes. The focus is on work that can translate promising findings into practical clinical impact rather than remaining at an exploratory stage.

Does the program require preliminary data?

Yes. Projects must be grounded in relevant preliminary data. Applicants are expected to provide early evidence that the approach is feasible and scientifically justified, rather than proposing purely exploratory concepts.

What types of projects are supported under this award?

The award supports either (1) clinical/translational research studies or (2) clinical trials. Applicants must choose one category per application.

Can a single application include both a clinical/translational study and a clinical trial?

No. The opportunity specifies that an application may propose either a clinical/translational research study or a clinical trial, but not both within the same application.

How does the program distinguish a clinical trial from other clinical research?

The program expects applicants to follow the guidance in the application instructions and referenced appendices associated with the announcement for correctly distinguishing a clinical trial from other forms of clinical research.

Is collaboration required?

A collaborator is optional, but the award strongly encourages meaningful collaboration, especially partnerships that add new disciplinary perspectives or help recruit new investigators into TSC research.

Why does the opportunity emphasize collaboration so strongly?

The mechanism incentivizes partnerships that are genuinely interdependent and bring unique expertise or capabilities to the project, with the intent of strengthening the translational pathway and expanding participation in the TSC research space.

Can including a collaborator affect the funding level?

Yes. Applications that include a qualified collaborator may be eligible for a higher level of funding, but only if the collaboration meets the specific requirements and is documented as required.

What makes a collaborator "qualified" under this opportunity?

Based on the announcement description, a qualified collaborator must meet multiple criteria, including: (1) making a substantial contribution such that the work could not be completed without their unique expertise/capabilities; (2) being at least the Assistant Professor level (or equivalent); (3) committing at least 10 percent level of effort; and (4) being part of a team where either the PI or the collaborator has demonstrated TSC research experience through prior publications and/or a funding track record.

What documentation is required to include a qualified collaborator?

The PI must submit a Statement of Collaboration naming the collaborator and explaining how the collaboration criteria are satisfied. The collaborator must also provide a formal letter describing their role.

How substantial does the collaborator's role need to be?

The collaboration is expected to be truly interdependent. The collaborator must contribute in a way that is operationally important, with unique expertise or capabilities that are essential for completing the proposed work.

Is an advisory-only collaborator sufficient to qualify for the collaboration incentive?

The description indicates the collaborator should not be merely advisory. Their minimum effort requirement (10 percent) and the expectation that their contribution is reflected in the budget signals an operational role rather than a limited consulting role.

What is the minimum level of effort required for a qualified collaborator?

The collaborator must commit a minimum of 10 percent level of effort.

Does the collaborator's effort need to appear in the budget?

Yes. The collaborator's effort and contribution are expected to be reflected in the project budget, reinforcing that the collaborator is substantively involved.

Does either the PI or collaborator need prior TSC experience?

Yes. Either the PI or the collaborator must already have demonstrated TSC research experience through prior publications and/or a funding track record.

Are there rank or position requirements for the collaborator?

Yes. The collaborator must be at least at the Assistant Professor level (or equivalent).

When was this funding opportunity posted, and what were the key dates?

The opportunity was posted on January 20, 2009. The application deadline was April 14, 2009. The opportunity was archived on May 14, 2009.

What is the funding instrument for this award?

The funding instrument is listed as a cooperative agreement and/or grant.

What is the activity category associated with this opportunity?

The activity category is science and technology research and development.

How much total funding was estimated for the program, and how many awards were expected?

The estimated total program funding was $1,350,000, with an expected single award. This suggests a competitive opportunity intended to support a sizable, focused project.

Is cost sharing required?

No. Cost sharing was not required.

Who was eligible to apply?

Eligibility was listed as unrestricted (open to any type of entity), subject to any additional eligibility clarifications contained in the full program announcement.

Where does this opportunity sit within the Department of Defense structure?

It is described as a Department of the Army/USAMRAA opportunity under the Tuberous Sclerosis Complex Research Program (TSCRP).

What kind of submission support was mentioned in the announcement?

The announcement included contact channels for assistance obtaining the full announcement and for technical submission help, including CDMRP and eReceipt helpdesk contacts, indicating the use of the standard CDMRP submission infrastructure.

What should applicants pay special attention to when structuring their proposal?

Applicants should ensure their project is grounded in relevant preliminary data, choose only one project category (clinical/translational study or clinical trial), follow the program's guidance for classifying the project correctly, and (if using a collaborator to qualify for the incentive) provide the required collaboration documentation and ensure the collaborator's role, effort, and budget alignment meet the stated expectations.