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Submission of an Ancillary Studies Proposal


Potential applicants should follow the steps and guidelines described below in preparing and submitting applications.

Timing of submissions: Proposals that will be submitted to NIH (or any other sponsor) for funding should be submitted to the ASSC no less than three months prior to planned date of submission to the sponsor to assure that Teen-LABS review, input and approval can be provided in ample time to meet sponsor deadlines. Teen-LABS will make every effort to complete review of such proposals by its ASSC within four to six weeks, allowing successful applicants six to eight weeks to prepare and submit applications for funding. Note that detailed scientific reviews of such proposed ancillary studies that are submitted to NIH for funding will be conducted by the NIH study sections that review the associated applications. For proposals that will not undergo future rigorous, scientific peer-review, the deadline for receipt of the completed full proposal will be modified to include eight weeks for the ASSC to conduct its own scientific review (see scientific review section). Deadlines for the various steps in the evaluation process for ancillary studies that are intended for submission to NIH and other sources under any of the above sets of deadlines are indicated in Table 1.

Proposals for ancillary studies to Teen-LABS for which funding has already been secured or for which application will be made to some other potential funding source should be submitted to Teen-LABS for its approval at least three months prior to the intended project starting date, allowing Teen-LABS to conduct its own evaluation and impact analysis.


Teen-LABS Ancillary Study Applications:
Timeline Related to NIH Submission Deadlines

Ancillary Applicant Action Item Weeks / Months Prior to NIH Submission Deadline

Three-page preliminary proposals to DCC

Three months

Proposal PIs must contact DCC if they require DCC data management and analytical support

Two months

Proposals to DCC for minimal budget analysis or for those who want Teen-LABS data only

Six weeks

Completed proposals for NIH submission to DCC for distribution to clinical centers for burden analysis and to ASC to confirm conformity with approved three-page proposal

Four weeks

Completed proposals that require ASSC scientific review

Eight weeks

NIH R01 or other grant submission

Deadline


Upon NIH submission, send an electronic copy of the submitted proposal to the DCC at the e-mail address below:

Jenn Black
Phone: 513-498-0989
E-mail: jennifer.2.black@ucdenver.edu



Steps for Submission of an Ancillary Studies Proposal

Step 1. The Initial Proposal

Cover Letter: The proposal should be accompanied with a cover letter of no more than one page that indicates why the proposed study should be conducted as an ancillary study to Teen-LABS rather than as a separate and independent project.

Proposal: Proposals should be concise, but contain sufficient detail to allow a thorough assessment of the relevance of the proposal to the goals of Teen-LABS, its scientific importance and possible impact on patient recruitment and follow-up, as well as any anticipated additional workload for Teen-LABS staff. Proposals will be three pages in length, single-spaced in an easily readable type font (not less than 11pt) on 8½x11-inch paper with one-inch margins on all sides. The components of the proposal should include:

  1. Project title
  2. List of principal and coinvestigators by name and institution
  3. An abstract including (a) background, (b) specific aims; (c) clear statement of hypotheses to be tested; (c) outline of the protocol, clearly indicating procedures to be performed and samples to be collected from patients, (d) list and brief description of any nonroutine analytical methods employed; and (e) informative reference citations.
  4. The approximate number(s) of patients required, with statistical justification including sample size and power calculations
  5. The need and justification for the use of any specialized equipment, not utilized in Teen-LABS
  6. List of Teen-LABS sites contributing patients or other resources, and any other collaborating Teen-LABS or non-Teen-LABS sites.  Close collaboration with the participating Teen-LABS sites through the entire process is highly encouraged.
  7. Indication of numbers and sizes of biological samples required, and other data elements to be collected, including data required from the Teen-LABS core database
  8. Projected costs including budget for Teen-LABS DCC staff and analytical support if relevant.