Clinical Data Management News & Insights

Newsletter Committee’s Christmas Copilot Tips

December 4, 2025

In a time when we are constantly surrounded by artificial intelligence and feel the need to integrate new tools into our daily work to keep pace with rapid innovation, it’s natural to wonder: are we truly making the most of these powerful technologies? AI can support us in many ways, often more than we realize. So, in the spirit of the season, and in the context of protocol amendments, here are some practical Christmas tips on how Copilot (or other tools of choice) can brighten your daily Clinical Data Management tasks.

DOCUMENTS COMPARISON

• How often do we rely on track changes to identify updates in a new protocol amendment? And yet, do we truly catch everything, every tiny detail, even a small footnote where perhaps only a single number has been added or removed? This is where Copilot can support us in document review and comparison. You can ask it to compare the full document or focus on specific sections (such as the Schedule of Assessments) and even generate a clear, visual summary of the changes, including tables.
• Many of us have had to update CRF Completion Guidelines following a Protocol Amendment. When an amendment significantly impacts the CRF, the number of updates required can be substantial, and naturally, the guidelines must be adjusted accordingly. To ensure nothing is missed, Copilot can help verify that the written guidance aligns with the corresponding EDC screenshots included in the guidelines themselves. It’s easy to focus on updating every possible instruction and then forget to capture a screenshot of the revised CRF. This is exactly where Copilot can be a valuable assistant.

DOCUMENT ANALYSIS

• Staying on the topic of Post-Production Changes, when a protocol amendment has a significant impact on the CRF, working on edit checks becomes almost inevitable. Before starting any updates, we typically estimate how many new edit checks will need to be implemented and how many will be modified or retired. But as we all know, these estimates often change once the real work begins, and the initial projection must be reconciled with the actual numbers. Depending on the structure of your Data Validation Plan, this reconciliation may not always be straightforward. If all information on Post-Production Changes is captured only in the Version History (resulting in long narrative text) manually counting how many checks were added, updated, or removed can be time-consuming. With the right prompts, Copilot can instantly deliver the detailed breakdown you need, like a helpful gift waiting under the tree.

This holiday season, let Copilot be your little helper in Clinical Data Management!  From comparing documents faster than Santa’s sleigh to wrapping up discrepancy checks like perfect gifts, Copilot keeps your workflows merry and bright!

However, always keep in mind our Santa’s recommendation: human validation of the output is always needed!