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It’s all or nothing with ICH E6(R2) Quality Management

There are seven steps in the ICH E6(R2) Quality Management process. Our experience with both Sponsors and CROs is that if you don’t implement all of them, you won’t get the benefits you want.



Often customers come to us when they’ve tried an RBQM related initiative, but it’s failed, stalled or just isn’t delivering. Those initiatives range from trying to run risk management in a home-grown and ever-expanding Excel spreadsheet (it never works) to buying an expensive BI tool they are told will deliver Central Monitoring.

Typically, companies focus on the first four Quality Management steps above, but completely ignore the last three…arguably the most important ones in making the whole process work.

Take Risk Communications as an example. We’ve heard teams say that they’ve been given generic Protocol Risk Assessments, often with little that is specific to the study. Because there is no specificity, it’s not clear who is collecting what data, how they are collecting it, what they are looking for in that data and why that data is important. Because there is no Integrated Strategic Monitoring Plan, information about risks doesn’t get to the people who need it most, including sites, monitors and other study team members.

The next failure is in reviewing risks. Yes, risks should be reviewed regularly, and I don’t just mean a cursory ‘is everything ok?’ There should be a thorough review of all the available information. But there should also be reviews EVERY TIME something changes. For example, when a risk occurs and becomes an issue.


Teams often treat this scenario like managing a project management risk rather than a trial risk. There is an important difference between the two. In project management, once an issue is resolved it is usually considered ‘fixed’, then discarded and ignored. What should happen with a trial risk is, there should be a full review and re-evaluation of that risk, all of which should be documented for compliance. We need to determine if that risk is likely to occur again, and what we could do to detect it sooner or mitigate the impact of that risk if it does occur. This is part of the ongoing enterprise learning process which will allow better trial design, an area which is being heavily focused on in the upcoming revision of ICH E8. Which leads on to the final step in the Quality Management process, Risk Reporting.

Too often study teams make it hard for themselves by leaving it to the end of a trial to try and bring together all the information from different sources, such as Excel spreadsheets which have no version control and no audit trail. You’ll have guessed that trying to manage clinical trial risks with Excel is a big bugbear of mine.


A much better way is to run risk management status reports as part of your periodic risk review. This results in a historic log of reports which can be referred to during the trial by study team members but also submitted as part of the trial master file. At the end of the trial, your reports will all be in place, and the final suggested activity is to perform a lessons learned review to determine what you would have done differently with the benefit of hindsight and make sure those lessons are built into your corporate knowledge base ready for the next trial.

Of course, what you need is a tool that will deliver each of the seven Quality Management process steps for you…but then I would say that, wouldn’t I? 😊