Research Catalog

Title

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

Publication

[Rockville, MD : Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2005]

Details

Additional Authors

• Center for Drug Evaluation and Research (U.S.)
• Center for Biologics Evaluation and Research (U.S.)
• International Conference on Harmonisation.

Description

25 p. : digital, PDF file.

Alternative Title

• E2B(R) clinical safety data management
• Data elements for transmission of individual case safety reports

Subject

• Clinical pharmacology
• Clinical trials > Reporting
• Drugs > Testing

Note

• Title from PDF title page (viewed on June 18, 2009).
• "ICH harmonised tripartite guideline".
• "Version 2.0".
• "12 May 2005".

System Details (note)

• 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.

Call Number

GPO Internet HE 20.4702:D 26

OCLC

402677963

Title

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

Imprint

[Rockville, MD : Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2005]

System Details

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.

Connect to:

http://purl.access.gpo.gov/GPO/LPS113904

Added Author

Center for Drug Evaluation and Research (U.S.)

Center for Biologics Evaluation and Research (U.S.)

International Conference on Harmonisation.

Gpo Item No.

0499-T (online)

Sudoc No.

HE 20.4702:D 26

Research Call Number

GPO Internet HE 20.4702:D 26