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eSource Records in Clinical Research: Keeping it Simple.
- Source :
- Applied Clinical Trials; Aug/Sep2015, Vol. 24 Issue 8/9, p30-38, 7p
- Publication Year :
- 2015
-
Abstract
- The article offers suggestions for meeting regulatory concerns regarding Electronic Data Capture (EDC) data integrity and site control over the source of data in clinical trials. Topics include the consensus across the pharmaceutical industry regarding the maintenance of clinical data by writing results on papers; the guidelines of the U.S. Food and Drug Administration regarding use of electronic data in clinical trials; and guidelines of European Medicines Agency regarding electronic data.
- Subjects :
- CLINICAL trials
ELECTRONIC data processing
DATA integrity
PHARMACEUTICAL industry
Subjects
Details
- Language :
- English
- ISSN :
- 10648542
- Volume :
- 24
- Issue :
- 8/9
- Database :
- Complementary Index
- Journal :
- Applied Clinical Trials
- Publication Type :
- Academic Journal
- Accession number :
- 109151420