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Patrick R. Ayd, BSN, MBA – Advisor, Clinical Sites

Quality Control (QC) in clinical research facilities can simply mean that documented data (or data found to be missing) has had at least two sets of eyes review the data for correctness and completion.  The end result of a good QC system/process is having good clean data in a timely manner which is one of the primary goals in a clinical research trial.

One of the issues I find during our site audits is that the QC system is not a “formal” process followed on a consistent basis or there is no documentation that a document has received a QC review.  Another common mistake is that one person is given the responsibility to QC all documents which turns out to be a next to impossible expectation.  Your entire staff should have a role in the QC process which should be completed prior to data entry.  When involving other staff, you give that staff member an incentive to double check their own work knowing that someone else will be looking at their work.

Make sure that your QC process is clearly documented and your staff is well trained with your Quality Control process.  There is a significant difference between Quality Control and Quality Assurance.  Stay tuned for more information related to QA or Quality Assurance.

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