Maintenance of the Clinical Safety Data Management including Data Elements for Transmission of Individual Case Safety Reports

Regulatory Resource: Maintenance of the Clinical Safety Data Management including Data Elements for Transmission of Individual Case Safety Reports

Description:

The tripartite harmonised ICH guideline was finalised as E2B (Step 4) in July 1997 and amended for Maintenance as E2B(R1) on 10 November 2000.
Post Step 4 editorial corrections were given on 5 February 2001 (second revision) and the guideline renamed E2B(R2).

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