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Revision of the ICH guideline on clinical safety data management : data elements for transmission of individual case safety reports.

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U.S. Government Documents Available online

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Format:
Book
Conference/Event
Government document
Contributor:
Center for Drug Evaluation and Research (U.S.)
Center for Biologics Evaluation and Research (U.S.)
Conference Name:
International Conference on Harmonisation http://viaf.org/viaf/130234339
Language:
English
Subjects (All):
Clinical pharmacology.
Clinical trials--Reporting.
Clinical trials.
Drugs--Testing.
Drugs.
Physical Description:
1 online resource (25 pages)
Other Title:
PDF cover has title: E2B(R) clinical safety data management
Data elements for transmission of individual case safety reports
Place of Publication:
[Rockville, MD] : [Center for Drug Evaluation and Research] : [Center for Biologics Evaluation and Research], [2005]
Notes:
Title from PDF title page (viewed on June 18, 2009).
"ICH harmonised tripartite guideline."
"Version 2.0."
"12 May 2005."
OCLC:
402677963

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