EMA report on ICSRs

Draft guideline on detection and management of duplicate individual cases and individual case safety reports (ICSRs).

The European Medicines Agency has published a Draft guideline on detection and management of duplicate individual cases and individual case safety reports (ICSRs).

This guideline proposes methods for detecting, confirming and managing duplicate cases suitable for organisations receiving pharmacovigilance data in various different formats.

The document is available on the following webpage:
http://www.ema.europa.eu/pdfs/human/phvwp/1343209en.pdf

Comments should be provided using this template. The completed comments form should be sent to tom.paternoster (at) ema.europa.eu.

Please note that the deadline for comments is 29 September 2010.

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EMA report on ICSRs

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