SPARC Long Term Storage

In order to better protect our patients’ data and meet research regulatory requirements, we are implementing a new long-term data storage solution through SPARC, our secure research environment, for ALL projects, not just those using SPARC during the research project time period. In collaboration with the IRB Office: For Initial Review IRB Applications, the language should be included in the data management and storage plan.  For studies that are concluding, the language can either be embedded in the IRB Conclusion Form or uploaded as an attachment titled, “SPARC- long term data storage.”  Alternatively, for active studies, the language can be added to the IRB Application when the next Change Update Form is submitted.

Carilion HART will utilize the SPARC system for secure long-term storage at the time a project is concluded.  This process provides a new long-term storage solution with appropriate automated deletion of data/records at the protocol-specific required timeframe.  HART will transfer data and/or documents related to the IRB approved project to SPARC in a secure folder for cold storage to comply with the retention and deletion requirements according to the IRB approved protocol.  An expiration date will be set on the files to allow for appropriate tracking of the time for deletion. The automatic process will prevent the“orphaning” of data/documents in other folders/directories in the event that no research team members remain at Carilion at the time data deletion is required.  Access to the data/documents will not be available without specific IRB approval to do so, in which case, the file(s) will be recovered as stipulated in the new IRB approved submission.