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  • Lorrie D. Divers, President, QRCP Solutions, Inc.

Put Yourself in the Driver's Seat

A colleague and I were recently sharing QA ‘war stories.’ She was relating to me her encounter with a, ‘But why?’ person in the GCP operations world. These are the folks who demand you point to ‘the specific regulation that says we have to have SOPs.’

After many years working in clinical research and development, there is nothing I would like more than GCP regulations that provide as many clear-cut requirements as GLP and GMP regulations seem to do. But alas, wishing has not made it so.

GCP does need, and is subject to, more interpretation, at least in part because GCP regulations are not as ‘black and white’ as GMP and GLP. In clinical research and development, there is a significant business need for guidance and best practices based on real (and realistic) GCP compliance experience.

To answer the question, ‘where does it say we have to have SOPs for clinical research?’ my experience with multiple FDA and EMA inspections is this:

  • In the absence of documented processes, policies and procedures, and well-maintained evidence (documentation, data audit trials, system design and validation, etc.), the interpretation of what your organization did or did not do and how it was done will not be in your control. Rather, the regulatory authorities and especially the regulatory investigator (inspector) will be in the driver’s seat.

  • Being able to point to evidence that illustrates clearly and specifically how subjects, rights, safety and welfare were protected and how data integrity was assured, will make that interpretive process by the inspector go much more smoothly than just saying “we did it….” without being able to prove it.

  • Clear, concise process documentation and detailed, well-maintained data and operational evidence puts you in the position to steer!

And yes, I know that’s almost the epitome of irony – the regulations are not clear-cut but we have to be? – but that is why you so often hear the adage, “If it isn’t documented, it didn’t happen.” As my QA colleague said, you can tell the police officer you weren’t speeding but it won’t do you much good unless you have the (validated) radar reading to prove it.

Let’s start a conversation! Follow QCRP Solutions, Inc. on LinkedIn for future quality assurance, regulatory compliance and process excellence topics. Contact me at to learn more about our consulting services.

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