Biomedical Translational Research Information System (BTRIS) Data Reuse Protocol

Clinical Center

Investigators

Linked publications & trials

Abstract

Each terminated protocol to be included will be added as an amendment to this protocol. An appendix will be provided for each covered protocol that will describe the original protocol, the start and end dates and number of subjects enrolled in the original protocol, and the types of analyses to be conducted under the reuse protocol. All data will have been previously stored in the NIH Biomedical Translational Research Information System (BTRIS) and will be made available in identified form only to the PI and Associate PIs under the original research plan for the original protocol. Each year, the PI on this BTRIS Data Reuse Protocol will report to the IRB the activities carried out on the data from each of the appended original protocols. This will facilitate efficient and effective reuse of data collected in human subjects research and provide compliance with IRB monitoring of the use of identifiable human subjects data, while reducing the administrative burden related to reporting. No inactive protocols have yet been moved to this Data Reuse protocol.