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Data Entry Methods

CDM- QC of Data Entry

What are the 3 data entry methods? Single, independent double & interactive double
Describe Single Data entry One person captures data into a database from a source or during interview
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
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
Why do we have Data entry guidelines? Standards ensure evaluation/higher quality
Define spot check the comparison of source vs. database listings Every deviation equates to one error
Equation for error rate calc? ER= (E*100%)/S
QC/Spot Check: Target data in clinical database and source should be identical
Tolerable ER for non critical (secondary) data Spot Check: 5-10% Er: 0.25-0.6%
Tolerable ER for primary data Spot check: 100% ER: 0-0.25%
What is considered primary data? Safety & efficacy data
Created by: marlice