Wednesday, April 1 2020, 08:42 am
E 2 A Clinical Safety Data Management: Definitions and …

E 2 A Clinical Safety Data Management: Definitions and …

terminology, as well as procedures, will ensure uniform Good Clinical Practice standards in this area. The initiatives already undertaken for marketed medicines through the CIOMS-1 and CIOMS-2 Working Groups on expedited (alert) reports and periodic safety update reporting, respectively, are important precedents and models. However, there are …