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CDM- QC of Data Entry

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Question
Answer
What are the 3 data entry methods?   Single, independent double & interactive double  
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Describe Single Data entry   One person captures data into a database from a source or during interview  
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Describe Independent Double data entry   two people enter data from a pCRF into two databases, then a 3rd person compares and corrects in the master DB  
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Describe Interactive Double Data entry   Two peope enter data from a pCRF into two databases, then data is automatically compared and the 2nd person reviews and edits master DB  
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Why do we have Data entry guidelines?   Standards ensure evaluation/higher quality  
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Define spot check   the comparison of source vs. database listings Every deviation equates to one error  
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Equation for error rate calc?   ER= (E*100%)/S  
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QC/Spot Check: Target   data in clinical database and source should be identical  
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Tolerable ER for non critical (secondary) data   Spot Check: 5-10% Er: 0.25-0.6%  
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Tolerable ER for primary data   Spot check: 100% ER: 0-0.25%  
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What is considered primary data?   Safety & efficacy data  
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