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Conducting an Ancillary Study in CHS

 

Getting started

  • Explore the website.
     
  • Read about Ancillary Study Policies.
     
  • Identify a CHS sponsor.
    When the PI of an ancillary study is not a CHS investigator, a CHS sponsor must be identified. The sponsor is a contract-funded CHS investigator who serves as a liason to CHS and is responsible for monitoring the ancillary study to assure compatibility with CHS policies and procedures. A CHS sponsor is an active CHS investigator who is a member of the Steering Committe or associated with a CHS field center (UC-Davis, University of Pittsburgh, Wake Forest, Johns Hopkins), the Coordinating Center (University of Washington, Seattle), the NHLBI (Bethesda), or a reading center: Echocardiography (Roslyn, NY or UC-Irvine), Ultrasound (Tufts University), Blood Laboratory (University of Vermont), MRI (Johns Hopkins), Brachial (Wake Forest), Retinal (Madison, WI), Pulmonary (Tucson, AZ), or ECG (Wake Forest).
     
  • With the help of your CHS sponsor, check for overlap with approved research projects by searching existing ancillary study and manuscript proposal topics.
     
  • Consult the Central Laboratory if your study involves biological specimens. For initial determination of specimen availability consult the Repository Status report in the internal CHS Data & Documentation menu, as well as the Biospecimen Policy. The Laboratory will provide you with a Biospecimen Repository Impact Report that must be submitted with your new proposal. Note that it may take several days to generate this report so please plan accordingly.
     
  • Go directly to the Submission Page
      Ancillary study proposals must be submitted to the CC at least 6 weeks before submission to a funding source. This allows time for review by the Ancillary Studies Committee, Laboratory Committee (if applicable), Steering Committee, and NHLBI prior to grant submission. Ancillary studies must provide funds to support CC activities and the CHS core. Information in the ancillary study proposal will be used to estimate the scope of work at the CC.

To proceed with an approved ancillary study:

  • Visit our Forms & Agreements menu to download a Data and Materials Distribution Agreement.
  • Obtain IRB approval (if necessary).
        Proof of approval is needed from studies based at non-CHS institutions.
        Secondary data analyses require IRB review.
  • Submit a manuscript proposal or series of proposals using our online form on the internal website.
        Approved manuscript proposals are required for ancillary study papers.
  • Work with your CHS sponsor and the CC to proceed with the study.
  • Submit data collected by the ancillary study to the Coordinating Center for
        archiving and later distribution.