A Quick Overview of Clinical Data Management & Analytics

Before we continue, let's have a quick overview of the clinical data management process.

Clinical data are initially captured on CRF (Case Report Form) that is filled in, either electronically or manually.

Below is a sample CRF that captures the vital signs of the subjects:

The data on the CRF form will then be converted and cleaned up by the CDM (Clinical Data Management) team. 

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The data will then be further converted into standard SDTM (Study Data Tabulation Model) data sets and ADaM (Analysis Data Model) data sets. Below are some examples:

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The ADaM data sets are then used to create the statistical tables, listings and figures:

In this project, we will learn how to create the SDTM DM data set, based on the CDM data sets.

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