Montrium

We’re all about constant improvement here at Montrium. And we think the only way for the life sciences industry to constantly improve is if we all take the time to learn from one another. What do you think we should take away from the top 5 most common MHRA TMF inspection findings? 💭

Improving collaboration between sites, sponsors, and CROs starts with one three-letter word: Why. When coordinating with sites, it’s crucial for sponsors and CROs to explain why documentation needs to be timely, complete, and accurate. It’s the best way to help the site help YOU. Matt shares his view from the site perspective:

If you’ve been following us this past year, you know that we strongly believe in crafting a robust risk-based approach to TMF QC. We’ve even come up with a 5-step process, the last step of which is to consider all the risk factors involved. So, what are these additional factors? We’ll let Paul (Fenton) Carter explain:

Silos? Miscommunication? Confusion? There’s a FAR better way to manage the relationship between sites and sponsors/CROs. The 3 Cs framework can help you build better working relationships with those most crucial to the success of your clinical study.

Your TMF processes are risky by nature. But there are tools that can be used to help uncover some of the hidden risks: 1. TMF risk management plan 2. TMF risk log Donatella Ballerini takes us on a deep dive on both, and discusses how and when they can be used to your advantage:

Just getting started with risk assessments? You’ll want to watch this. Paul (Fenton) Carter walks us through an example of a risk assessment at the artifact dimension. He shows us how to calculate a risk score of all the monitoring visit reports in a study.

Processes aren’t the only thing you need to keep in order when implementing a risk-based approach. You also need to understand artifact risks. In a world where not all documents are created equal, Donatella Ballerini walks us through document types and how we can use them to assess TMF risk:

If you’re analyzing your TMF for non-compliance, this will be one of your greatest assets: Query rate scores. Using this scoring method, you can easily detect issues within documents and resolve them. Paul (Fenton) Carter demonstrates how to define different risk categories, identify which issues will have the greatest impact, and how to focus your efforts:

There’s no “if” when it comes to risk-based approaches to TMF QC. From a regulatory perspective, it is a requirement. So, the only thing to consider then, is “how.” Donatella Ballerini’s recommendation? Be proactive rather than reactive. Here’s her advice for getting your processes in order so you can catch potential issues before they occur:

A shift toward a more standardized, collaborative approach to clinical trial data management is on the horizon. Thanks to initiatives like Digital Data Flow, we will soon begin to unlock the goldmine of information contained in the TMF (and other clinical data resources) in order to drive better decision making and realize positive inspection outcomes. Here’s Nick Hargaden’s advice for how to prepare yourself: