CNICS supports translational, clinical, and behavioral research projects from any investigator who desires to use the platform as part of their funded research projects or to gain research support. Any investigator who can be reasonably expected to conduct the study is eligible to submit a concept proposal.
This includes, but is not limited to researchers at CNICS sites, CFAR academic centers, non-CFAR academic centers, funding entities, and biotech/pharmaceutical companies.
For more information and guidelines on how to submit a proposal, access CNICS data, specimens or Patient Reported Outcomes (PROs), review the instructions provided below.
Determining Study Feasibility (optional)
For studies requesting data from the cohort dataset, a Study Feasibility Form may be submitted. You will receive aggregate data to determine if sufficient numbers of patients qualify for your study. No actual clinical data will be transmitted. Formal review of fully developed concept studies by the Research Coordinating Committee (RCC) is required before patient data or PROs are shared for study. Study feasibility cannot be determined for requests of data that are not currently available in the cohort dataset. Such requests require evaluation by the RCC using the formal review process. Inclusion of a member of the CNICS leadership to the study team is required before formal review of any concept study.
New Concept Proposal and Specimen Request Guidelines
Formal requests for projects utilizing CNICS data from the cohort dataset are initiated by submission of a Concept Proposal Application to be submitted to the CNICS Project Coordinator Mary Thielen by email. Concepts are due 3 weeks prior to the formal review call date – details of the formal review process are found below and in the CNICS Concept SOP. 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, CFAR academic centers, non-CFAR academic centers, funding entities, 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 which is 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 submit a draft Case Report Form with the Concept Proposal Application prior to review by the RCC. The following information must be included in requests for additional data:
- Medical record abstraction form and data elements
- Number of participants requiring chart review per site
- Timeline for completion (specific date)
- Availability of funds to support additional chart review/abstraction costs
Specimen Requests: To request or check availability of specimens only, submit a Specimen Feasibility Request Form. Requests for CNICS specimens do not require formal review by the Research Coordinating Committee. Requests for specimens linked to data require formal review by the RCC.
Requests for specimens only do not require submission of a Concept Proposal Application for formal review by the RCC.
Details of the Research Coordinating Committee (RCC) Formal Review Process
Concept Proposal Applications for formal review are accepted year around. Applications require inclusion of a CNICS investigator from one of the CNICS sites. Evidence that a CNICS investigator has cleared a project for review must be provided before a concept study is accepted by the RCC. This collaborator will facilitate the review process to 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 proposal applications 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.
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.
Determining if a CNICS Study Idea is Unique
Next Steps after RCC Approval of a Study
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 or designee will represent participating sites on writing teams related to the study.
Local IRB review and approval must be provided to the CNICS Administrative Director or Operations Center before data transfers will be initiated.
Terms and Conditions for Use of CNICS Data or Specimens
A CNICS progress report form will be provided to the Research Coordinating Committee (RCC) at yearly intervals upon request from the Administrative Director/Operations Center. This generally occurs in January or February prior to the CNICS Annual Meeting (Feb/March). Any findings to be published (manuscripts, abstracts) as a result of a CNICS study must be reviewed by the study site contacts determined from the site participation survey. Investigators will receive a listing of all site participants prior to initiation of a study.
Project Approval Rate
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 section 3.4.4 in the Concept Proposal SOP.