We still have a couple of paper based studies where our internal data entry staff transcribe into our system (single data entry). Based on the size and complexity of the study we then QC a random sample to ensure that our staff are accurate.
Historically we have always allowed up to a 5% error rate as ‘acceptable’ before we would consider retraining a staff member (or upping the level of checking for that person’s work). I understand from ex-pharma colleagues that this is a quite generous… Usually we find individuals QC levels to range between 1 to 3.5% error rate.
Would others be happy to share their data entry QC aspirations; at what point would you consider retraining data entry staff?
(Tried searching the boards but couldn’t find anything that quite matched my question.)
Mike Radford
Data Manager
Southampton Clinical Trials Unit