IQ/OQ/PQ

CRF Validation Done Right – Part 2

February 4, 2012 | Category: Blog | Tags: clinical trial data collection, CRF Validation, EDC, electronic data capture, IQ/OQ/PQ

This is the second part of our two-part blog series on CRF validation. If you haven’t read the first part yet, you can access it here for a comprehensive glimpse on the topic. We talked about all the potential pitfalls of CRF validation – there are many. However, one system was designed from the very beginning […]

CRF Validation Done Right – Part 1

January 18, 2012 | Category: Blog | Tags: clinical trial data collection, CRF Validation, EDC, electronic data capture, IQ/OQ/PQ

One of the most painful parts of EDC is validating case report forms. CRFs must be rigorously tested. The standard used by most governing bodies, including the FDA, is IQ/OQ/PQ. I will try to define each in the CRF validation context: IQ – Installation Qualification. Does the form capture the intended data? Mostly this can […]