Question | Answer |
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 |