CLINICAL SAFETY DATA MANAGEMENT: …

ICH Guidelines CLINICAL SAFETY data management (E2A) 1 WORKBOOK FOR INVESTIGATORS SECTION 1 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALSFOR HUMAN USEICH Harmonised Tripartite GuidelineCLINICAL SAFETY data MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTINGR ecommended for Adoptionat Step 4 of the ICH Processon 27 October 1994by the ICH Steering CommitteeThis Guideline has been developed by the appropriate ICH Expert Working Group andhas been subject to consultation by the regulatory parties, in accordance with theICH Process. At Step 4 of the Process the final draft is recommended for adoptionto the regulatory bodies of the European Union, Japan and 8/26/02 16:38 Page 1 CLINICAL SAFETY data MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTINGICH Harmonised Tripartite GuidelineHaving reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 27 October 1994, this guideline is recommended for adoption to the three regulatory parties to is important to harmonize the way to gather and, if necessary, to take action o

CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the

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  Management, Data, Safety, Clinical, Clinical safety data management

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