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Visualizing and Validating Metadata Traceability within the CDISC Standards

The Food & Drug Administration has begun requiring that electronic submissions of regulated clinical studies utilize the Clinical Data Information Standards Consortium data standards. Within regulated clinical research, traceability is a requirement and indicates that the analysis results can be...

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Detalles Bibliográficos
Autores principales: Hume, Sam, Sarnikar, Surendra, Becnel, Lauren, Bennett, Dorine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Informatics Association 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5543378/
https://www.ncbi.nlm.nih.gov/pubmed/28815125