Submit A Proposal

To determine if a study idea is unique and feasible, download a Feasibility and Overlap Form and submit by email to Mary Thielen at mthielen@uabmc.edu. You will receive aggregate data to determine if sufficient numbers of patients qualify for your study. No actual clinical data will be transmitted.

To receive the CNICS resources to pursue your study idea, scientific review of a fully developed concept proposal by the Research Coordinating Committee (RCC) is required before patient data, specimens linked to data or patient reported outcomes (PROs) are provided. 

Prospective studies require scientific review by the RCC. Inclusion of a member of the CNICS leadership to the study team is required before scientific review of any concept proposal study.

For Data, PROs and data-linked to Specimens Requests: Requests for most CNICS resources requires scientific review of a concept proposal. This process is initiated by submission of a Feasibility and Overlap Form, followed by email submission of a Concept Proposal Form to the CNICS Project Coordinator Mary Thielen.  A CNICS collaborator is necessary to pursue studies in CNICS.

There is no cost to access CNICS data or PROs.  To receive specimens, an investigator is expected to pay shipping costs. Concept proposals for scientific review should be submitted 3 weeks prior to the scientific review call date. Details of the scientific review process are described in the CNICS Concept SOP and below.  Any investigator who can conduct the proposed work is eligible to submit a concept proposal to CNICS. This includes, but is not limited to: researchers at CNICS sites, academic centers, and biotech/pharmaceutical companies. For biotech/pharmaceutical companies, note that all analyses will be conducted by the CNICS Epidemiology and Biostatistical Core. CNICS data is not shared with for-profit or third party entities.

Requests for data not currently available in the CNICS dataset from patient records may be obtained through CNICS, under certain circumstances. Costs and additional time will be required for such requests and receipt of such data from some or all CNICS sites is not guaranteed.  Study leaders will be expected to discuss the budgetary considerations with the Administrative Core prior to submission of the Concept Proposal form for scientific review by the RCC.

For Specimen Only Requests: To request or check availability of specimens only, submit a Specimen Feasibility Request Form. Requests for CNICS specimens do not require scientific review by the Research Coordinating Committee (RCC). Requests for specimens linked to data require scientific review by the RCC as described above.

 Payment for shipments is necessary to receive CNICS specimens. Please note that specimens are not stored centrally and may come from more than one site repository.

Concept proposals are accepted year around. Submission of the Concept Proposal Form to initiate a scientific review requires inclusion of a CNICS investigator from one of the CNICS sites. Study ideas must be reviewed for feasibility and overlap before a study is submitted for scientific review. Evidence that your CNICS collaborator has agreed that a project is ready for scientific review must be included in the concept proposal form. This collaborator will facilitate the review process to help avoid overlap with existing proposals, refine study questions and address questions of feasibility. The CNICS Mentoring Core is able to provide assistance identifying a collaborator- visit the Mentoring page.

Concept proposals are reviewed on a conference call of the RCC on the 2nd Friday of each month at 12:30pm PT/2:30pm CT/3:30pm ET. Reviews last approximately 30 minutes. Additional dates/times for reviews may be requested under special circumstances. Review the Concept Proposal SOP for more information.

PIs will receive written reviews from two thought leaders in the field to be discussed on the conference call. Review by the CNICS Epidemiology and Biostatistics team is also included. Final discussion points and a decision will be emailed to the investigator within two weeks after the RCC review call. In some instances, revisions may be required before a study is approved for implementation. Official letters of support may be requested for grant submissions based on approved CNICS concept studies. Please submit such requests within 7-10 days of submission deadlines – request form.

Submission of a Feasibility/Overlap Form will ensure your data is available and avoid any overlap.  Email the form to Mary Thielen mthielen@uabmc.edu for processing.

For all data, specimen, and PRO requests, a Data Request Form is required from the study team before the transfer of any data from the CNICS Data Management Core. There are no costs associated with the transfer of the data; investigators are required to pay for costs associated with the shipment of specimens.

The Administrative Core will initiate a Site Participation Survey to determine which sites will participate in a given study and to provide a unique contact person at participating sites. This contact/site designee will represent participating sites on writing teams related to the study.

For newly approved studies, investigators  will sign an acknowledgment that they understand the regulations and responsibilities for the use of CNICS resources and the appropriate steps for publishing results. For more information, review the CNICS Concept Proposal SOP. 

Local IRB review and approval must be provided to the CNICS Administrative Director before data transfers will be initiated. 

A CNICS progress report may be requested from the concept study PI at any time.  Any findings to be published (manuscripts, abstracts) as a result of a CNICS study must be reviewed by the study site contacts designated in the site participation survey. Investigators will receive a listing of participating site leaders prior to initiation of a study. The CNICS data use acknowledgement provides guidelines for the proper use of resources. A signed version must be submitted to the Administrative Core before the sharing of CNICS resources.  Review the data use acknowledgment..

CNICS strives to approve concept proposals whenever possible for implementation in the full cohort or depending on the data needs, with as many sites participating as possible. In most instances, if studies are not approved upon initial review, investigators receive specific, detailed instructions for revisions. Revised studies are then reviewed by email to expedite the process. Decisions by the RCC may be appealed as described in the Concept Proposal SOP.

Contact us regarding questions about the application process, requests to identify a CNICS collaborator or assistance with developing an idea. The CNICS Mentoring Core assists with assigning collaborators from the CNICS leadership. Request a collaborator here.