The Importance of Quality Assurance to Improve Accuracy & Integrity in Clinical Research

The Importance of Quality Assurance in Clinical Research

With decades of collective experience in clinical research, it’s not uncommon to see mistakes and deviations made in clinical studies.  Despite spending endless hours training on GCPs, competency testing, regulatory requirements, re-certification, and additional courses, there can still be those times when things can slip through the cracks. This is why having a strong Quality Assurance Team is important to help correct and mitigate mistakes that can be made in good clinical practice.

Just when we think we’ve seen everything there is to see in the research, there are common errors that can happen, but should be avoided. Some examples would be shredding a source document because of a transcription error, trying to recall and enter clinical data on a new source when the source data has been lost, or mislabeling a subject’s labs with another subject’s information.

Perfection is an impossible standard in clinical research.  For that reason, it’s important to know that avoiding or correcting these mistakes is an important step to achieving accurate study results.  Catching and correcting mistakes helps maintain the integrity of the study, and usually just involves additional paperwork to remedy any mistakes.

The FDA, the Sponsor, the CRO, and the PI don’t expect perfection, or at least they shouldn’t.  They do however expect quality assurance and that mistakes be corrected after the fact and steps are taken to prevent the same mistake in the future.

Steps to help correcting/avoiding quality errors in the future:

1. Acknowledge and own the error.  This may lead to additional paperwork, but the integrity of the study can remain intact and will help avoid any similar issues down the road.
2. Give the details so it is clear that the error was not intentional, it was a mistake, it was discovered, and it was corrected.  Document everything.
3. Use quality management to help. Utilize your team to cross-check your data collection and verify it is the correct solution to the mistake.
4. If you have a knowledge deficit, reach out and learn.  There is no shame in making mistakes if you are willing to learn from them and help prevent others from making the same mistakes.

While the precision of clinical research can lead to a feeling of guilt or embarrassment if a mistake is made, catching the mistake is key.  That allows the research team to not only correct the mistake but also provides a learning opportunity to prevent the same mistakes in the future.  To learn more about how DaVita Clinical Research is spearheading essential renal research, click here.