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From Paper to Electronic the FDA Way.
- Source :
-
Applied Clinical Trials . Sep2008, Vol. 17 Issue 9, p44-48. 4p. - Publication Year :
- 2008
-
Abstract
- The article focuses on the guidelines released by the Food & Drug Administration (FDA), which demonstrates the flexibility and willingness of the department to engage regulated entities in the U.S. It provides specific definitions for source documentation and direct data entry, and recommendations on how to use computerized systems in clinical investigations. It also includes advice for clinical sites, analytical laboratories, and central laboratories. INSET: FDA Regulations vs Guidances.
- Subjects :
- *HEALTH policy
*MEDICARE
*PUBLIC health
*CLINICAL trials
*GOVERNMENT policy
Subjects
Details
- Language :
- English
- ISSN :
- 10648542
- Volume :
- 17
- Issue :
- 9
- Database :
- Academic Search Index
- Journal :
- Applied Clinical Trials
- Publication Type :
- Academic Journal
- Accession number :
- 34384133