Dear Members
I sent this mail out just before christmas, and, although i received a
few mails expressing interest in the subject, there were only two or
three ideas on how to handle this problem. If anyone has anymore ideas,
please let me know. Thanks.
*****
I have been given the task of writing an SOP following a full data check
on 10% of the patients in the database of data that has been entered for
a clinical trial. After the data has been cleaned, a random sample of
10% of patients in the study are chosen and their data is checked. If
too many errors occur then action is taken(i.e. re-clean). Critical data
is checked 100% (i.e adverse events).
Does anyone know if there is an industry standard for this issue?
What would be considered as an acceptable error rate and should this
be different for text and numeric fields?What other items should be
considered?
I understand that this has been a point of discussion for ACDM
members but I am unsure where I can find further information on the
subject.
Can anyone help me with this please?
Many thanks
Michelle
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