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

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

Label
Revision of the ICH guideline on clinical safety data management : data elements for transmission of individual case safety reports
Title
Revision of the ICH guideline on clinical safety data management
Title remainder
data elements for transmission of individual case safety reports
Title variation
  • E2B(R) clinical safety data management
  • Data elements for transmission of individual case safety reports
Contributor
Subject
Language
eng
Cataloging source
GPO
Government publication
federal national government publication
Index
no index present
Literary form
non fiction
Nature of contents
dictionaries
http://library.link/vocab/relatedWorkOrContributorName
  • Center for Drug Evaluation and Research (U.S.)
  • Center for Biologics Evaluation and Research (U.S.)
  • International Conference on Harmonisation
http://library.link/vocab/subjectName
  • Clinical pharmacology
  • Clinical trials
  • Drugs
Label
Revision of the ICH guideline on clinical safety data management : data elements for transmission of individual case safety reports
Instantiates
Publication
Note
  • Title from PDF title page (viewed on June 18, 2009)
  • "ICH harmonised tripartite guideline"
  • "Version 2.0"
  • "12 May 2005"
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
one color
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Dimensions
unknown
Extent
25 pages
Form of item
electronic
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
digital, PDF file
Specific material designation
remote
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
Label
Revision of the ICH guideline on clinical safety data management : data elements for transmission of individual case safety reports
Publication
Note
  • Title from PDF title page (viewed on June 18, 2009)
  • "ICH harmonised tripartite guideline"
  • "Version 2.0"
  • "12 May 2005"
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
one color
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Dimensions
unknown
Extent
25 pages
Form of item
electronic
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
digital, PDF file
Specific material designation
remote
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

Library Locations

    • Biddle Law LibraryBorrow it
      3400 Chestnut Street, Philadelphia, Pennsylvania, 19104, US
      39.954941 -75.193362
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