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. Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, August 30, 2021 Subject(s): Clinical Trial Protocols as TopicClinical Trials as Topic -- methodsCOVID-19United StatesUnited States. Department of Health and Human ServicesUnited States. Food and Drug Administration