Ancillary Studies

Policies and Procedures

Please refer to the SPIROMICS and SOURCE Ancillary Studies Policy (pdf found in the table below) prior to submitting a proposal.  For C4R related ancillary studies, please refer to the associated policy in the table below.

Ancillary study proposal submissions are required via the Ancillary Study Proposal and Tracking Form (AST) in the Carolina Data Acquisition and Reporting Tool (CDART) Manuscript and Ancillary Study Tracking (MAST) Data Management System (DMS).  Please contact the Genomics and Informatics Center (GIC) at spiromics@unc.edu to obtain access to CDART and for any issues or questions.

Ancillary study proposals must be submitted to the GIC at a minimum of 8 weeks prior to the funding application deadline and at a minimum of 9 weeks prior to the funding application deadline for genetics related proposals to receive timely management, circulation, and review.  The proposal will be reviewed by necessary Working Groups, the GIC, the Ancillary Studies Committee, and the Steering Committee, and in specific cases, the Observational Data and Safety Monitoring Board (OSMB), sIRB, and National Heart, Lung, and Blood Institute (NHLBI).

Once approved, it is the responsibility of the ancillary study investigator to update the GIC regarding funding information, start date, changes in protocol, as well as any resulting publications or presentations.  The GIC will query investigators twice per year, or as needed, for a status update of their ancillary studies.

Abstract and Manuscript Publication Information for Approved Ancillary Studies

Ancillary study investigators are encouraged to publish and/or present their data.

Manuscript proposals and abstracts based on ancillary study data require approval of the Publications Committee.  Authors must submit a proposal via the Abstract, Proposal, and Manuscript Tracking Form (MTS) in CDART MAST prior to writing the manuscript/abstract.  If approved, the final manuscript draft (that has been reviewed by all co-authors) must be reviewed and approved by the Publications Committee prior to journal submission.  The SPIROMICS and SOURCE Publications and Presentations Policy as well as the MTS form are located on the Policies and Forms page.

Title Resources
Ancillary Study Proposal Abstract Template DOCX
Ancillary Study Proposal and Tracking Form (AST) DOCX
Ancillary Study Tracking (AST) System Demo Video link
AST CDART User Guide PDF
C4R Ancillary Studies Policy PDF
SPIROMICS and SOURCE Ancillary Studies Policy