Data If They Are Needed for Analysis

If data will be summarized or analyzed as part of the protocol-defined statistical analysis, they should be cleaned first. Cleaned in this context means that erroneous data entered into a variable are repaired before data analysis. Under the direction of the statistics group, the data management group is responsible for cleaning the clinical data. 

Before the statistical programmer receives data that are ready for analysis, the clinical data management group cleans the data. This is done through a query process, which is built into the clinical data management system. The clinical data management query process usually looks like this  

A programmatic or manual investigation finds an errant data point. 

A query or data clarification form (DCF) for that data point is sent to the clinical site. 

The clinical data management group updates the database or CRF based on the response from the clinical site. 

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Clean the Data If They Are Needed for Analysis 20 Categorize Data If Necessary 21 Avoid Hardcoding Data 24... 

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