1. 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.
2. Certificates of confidentiality: guidance for sponsors, sponsor-investigators, researchers, industry, and food and drug administration staff Publication: Silver Spring, MD : Center for Biologics Evaluation and Research September 2020 Subject(s): Biomedical ResearchConfidentialityPrivacyResearch SubjectsUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.