1. E6(R2) good clinical practice: integrated addendum to ICH E6(R1) Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018 Subject(s): Clinical Trials as Topic -- ethicsClinical Trials as Topic -- methodsEthics Committees, ResearchInformed ConsentRandomized Controlled Trials as Topic -- ethicsRandomized Controlled Trials as Topic -- methodsResearch DesignResearch SubjectsHumansEuropeJapanUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. E18 genomic sampling and management of genomic data Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018 Subject(s): Data Collection -- standardsGenomics -- standardsSpecimen Handling -- standardsConfidentialityGenetic TestingGenotyping TechniquesInformation Management -- standardsInformed ConsentInternational CooperationPrivacyHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
3. 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.