EPro : electronic solutions for patient-reported data /

Mostrar otras versiones (1)

Recently, there has been much open debate with the regulators around the use of ePRO in clinical drug submissions. US and European agencies have approved new drugs that have included ePRO data in the submission dossier, but there are many questions around the adoption of the technology that concern...

Descripción completa

Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Byrom, Bill, Tiplady, Brian
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Farnham : Gower, 2010.
Temas:
Clinical trials > Data processing.
Information storage and retrieval systems > Medical care.
Medical records > Data processing.
Self-report inventories > Data processing.
Outcome assessment (Medical care) > Data processing.
Electrical Equipment and Supplies
Outcome Assessment, Health Care > methods
Clinical Trials as Topic
Medical Informatics > instrumentation
Études cliniques > Informatique.
Évaluation des résultats (Soins médicaux) > Informatique.
Dossiers médicaux > Informatique.
Auto-évaluation > Tests > Informatique.
Acceso en línea:Texto completo
Descripción
Sumario:Recently, there has been much open debate with the regulators around the use of ePRO in clinical drug submissions. US and European agencies have approved new drugs that have included ePRO data in the submission dossier, but there are many questions around the adoption of the technology that concern the community. Bill Byrom and Brian Tiplady's ePro addresses these questions, reviews the new FDA guidance, and provides a very contemporary view on this important subject.
Descripción Física:1 online resource (200 pages)
Bibliografía:Includes bibliographical references and index.
ISBN:9780566087714
0566087715
1317141911
9781317141914
1317141903
9781317141907
1282857673
9781282857674
9786612857676
6612857676
1409412423
9781409412427

Ejemplares similares