A QC Plan for A Quality Clinical Database

Before a clinical database can be locked, data management run a set
of qualify control checklists to ensure that quality is built into the
clinical database.This process is also known as ?estimated error rate?
which is a calculation of an error occurred during the course of the
clinical trial, from the data management point of view.The formula
is:Percentage error rate = # of errors detected/total #'s of items
checked x 100Depending upon the tool you are using, i.e. OC or
Clintrial, you will need to count and determine the number of items
for a particular dataset. 80% of the time, SAS tool is used for this
step. Other times, a manual count is required.Not every issue or
discrepancy found is considered an error. This is described in a
section of the QC plan. Each Sponsor or CRO is different. For example,
misspelling mistakes or changes in punctuation are not considered an
error. Also, your statistical team member should be able to identified
those items considered 'critical' for the statistical analysis.Common
panels/items are: Demography (date of birth, sex, race), lab data,
randomization data, Study Conclusion/final status table.When a
clinical database is considered 80-90% clean, the data manager will
randomly select a set of patients, as discussed with the statistical
leader for the study, to be included in the final QC.Sample size = ?n
+ 1 where n=the number of patients in the study.If a study has 34
patients and 1 study site then ?34 = 5.83, 5.83 + 1= 6.83. We also
determined that only 20% of the patient enrolled will be QC'd
therefore, 7 case report forms will be included in the final review.In
order for a clinical data to be considered acceptable, the error rate
must be below 0.1% or less.In conclusion, a good QC plan identify what
quality control tasks are needed and that all activities are completed
in the most effective way through out the project.