What are mid-study changes and why are they so important to the lifecycle of a clinical trial? Mid-study changes are changes that occur after a trial goes live, due to protocol amendments or design optimizations, and they require utilities to help incorporate those changes into the existing study. These utilities are called post-production utilities. They can range from adding new questions to existing forms, re-evaluating logic that has been updated on a form (new edit check logic or calculation updates), or inserting a newly added form. Trials are becoming increasingly more complex which means understanding mid-study changes and how to prepare for them is essential.
As a Trial Designer, preparing for a mid-study change is a crucial part of the process. The preparation includes reviewing the trial, understanding the mid-study change, asking the client questions to gather further information, assessing the impact the change will have on the existing study, and formulating a plan. During preparation, we are in constant communication with the client to make sure the plan, execution, and impact meet the expectations and needs set in place by the client. Being transparent, clear, and concise are key to a successful mid-study change. When the mid-study change goes to design, the preparation will allow the designer to make informed decisions throughout the process. These informed decisions will allow the designer to avoid impacting the database in a negative way. Data related to clinical trials is imperative and our designers strive to reduce/eliminate the risk all together.
Being a Trial Designer at Datatrak for one and half years, I have seen my share of mid-study changes. I will always remember designing and processing my first one as it taught me so much about our product and best practices to follow, because you cannot fully understand how a system works until you need to make changes to it. Mid-study changes have become one of my favorite things to work on within our product. I enjoy the challenge and education that each change brings to the table as they make me a better designer in the end. Although, I couldn’t do any of the work without the flexibility and features our system offers. Datatrak EDC is one of the most robust, flexible, and feature rich systems I have ever had the pleasure of working in. As a result of the flexibility and features, our designers are able to come up with the most efficient solution when designing and deploying mid-study changes.
As discussed, mid-study changes can be complex and take a considerable amount of thought and planning to process on a day-to-day basis. At Datatrak, we understand time is money and that even though changes might be complicated, we are dedicated to quickly implementing changes to ensure it does not affect the trial’s timeline. Mid-study changes not only require a well thought out plan but also require a robust, flexible, and feature rich system to process. As the medical industry becomes more intricate, a system like Datatrak EDC is needed to handle these types of requests.
– Ryan Kinstler | Trial Designer