Data Management Administrative Supplement for grant R01AA030548

PROJECT ABSTRACT This application requests an administrative supplement to support data submission activities required by the National Institute of Mental Health (NIMH) National Data Archive (NDA) for our ongoing study. The initial parent project (R01AA030548) budget did not include a line item for costs related to data reporting requirements. The funding requested in the proposed supplement is based off amounts calculated using the NDA Data Submission Cost Estimation Tool. The proposed supplement will enable substantial additions and adjustments to the study's data management processes to comply with NDA reporting standards. Specifically, these changes include the establishment of a dedicated Data Manager position to oversee GUID creation and ensure adherence to the NDA Data Dictionary Templates. The Project Manager will integrate NDA reporting into study workflows, manage submission timelines, and align IRB consent language with NDA requirements. The Principal Investigator will provide scientific oversight and training related to data submission processes. Additionally, the supplement will cover mandatory costs associated with UNC’s Research Data Management Core (RDMC) to ensure compliance with data management and sharing policies. These updates will ensure accurate, timely, and high-quality data submissions to the NDA. We note that the research aims have not changed and will remain the same as in the funded proposal. The additional costs requested are to support data reporting requirements and do not represent a change to the research scope.