Research data storage options have expanded far beyond keeping paper records secure in a locked filing cabinet in a locked room. The CLARA new submission form has now been updated to collect more specific information about study data storage. All study data should be carefully stored, whether it’s protected health information (PHI) or not. Study data storage relates not only to HIPAA and its possible breach penalties, but also to research subject privacy and data access and ownership concerns.
The new questions first ask if any study data (including consent forms) will be stored on paper, with a follow-up question requesting storage details if the first query is answered “yes.” This section is followed by questions related to electronic data storage media. These questions are designed to document that the risk of unauthorized data access is minimized and institutional data storage requirements are met.