You have probably been in this situation before. A site prone to issues is having problems yet again, and this time it may be serious. You need to figure out what to do, and you are feeling frustrated. Your first thought might be retraining the site. After all, if they didn’t do the right thing, they must not understand what they are supposed to do. Isn’t that how we have always taken care of compliance issues? Retrain, document the training, and then hope for the best? Isn’t there something better?
You have probably heard about the changes to Good Clinical Practice (GCP) with the revisions to ICH E6(R2). Now, the sponsor has responsibilities to “perform a root cause analysis and implement appropriate corrective and preventive actions” for significant noncompliance. Training the site on GCP seems to be the best solution, or is it? How do you know what the root cause is so that you can figure out what actions to take?
There is a better solution to getting to root cause in a more productive way- to developing actions and implementing them. It is a solution that uses the available information about the problem rather than relying on retraining yet again.
Coming soon, DIGR-ACT® is a solution for those looking to dig further into the root cause to develop appropriate corrective and preventive measures. It’s developed by industry experts to improve critical thinking skills and is a new and an exciting composite of well-tested approaches from other industries synthesized specifically for the clinical trial professional in an eLearning format.
- The Clinical Pathways Team
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