Serious adverse event data reconciliation

NONMEM code for Antimalarial – Lumefantrine POP/PK Study Group



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Serious adverse event (SAE) data are often stored and managed in a separate database to the rest of the trial data. This procedure provides instruction to those data management team members delegated responsibility for SAE reconciliation during a clinical study, where SAE data are stored in the Clinical Data Management System (CDMS) as well as a safety database, and the two databases are maintained separately.