1. Logical observation identifiers names and codes for in vitro diagnostic tests: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, June 15, 2018 Subject(s): Electronic Health RecordsHealth Information InteroperabilityLogical Observation Identifiers Names and CodesReagent Kits, DiagnosticDevice ApprovalIn Vitro Techniques -- standardsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Use of electronic health record data in clinical investigations Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018 Subject(s): Clinical Trials as TopicElectronic Health Records -- utilizationHealth Information InteroperabilityForms and Records ControlInformed ConsentReproducibility of ResultsSingle-Blind MethodHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
