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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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Bibliographic Details
Corporate Authors: Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.), International Conference on Harmonisation
Format: Government Document Conference Proceeding eBook
Language:English
Published: [Rockville, Md.] : [Center for Drug Evaluation and Research] : [Center for Biologics Evaluation and Research], [2005]
Subjects:
Clinical pharmacology.
Clinical trials > Reporting.
Drugs > Testing.
Online Access:https://purl.fdlp.gov/GPO/LPS113904
Description
Item Description:Title from PDF title page (viewed on June 18, 2009).
"ICH harmonised tripartite guideline".
"Version 2.0".
"12 May 2005".
Electronic resource.
Physical Description:25 pages : digital, PDF file.
Format:Mode of access: Internet at the FDA web site. Address as of 6/18/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129399.pdf ; current access is available via PURL.