CDM- QC of Data Entry
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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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Created by:
marlice
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