Using a CTMS to Manage Multiple Protocol Versions

Complexities in research today often call for a variety of study protocols and protocol amendments within a single study. As studies take on multiple arms, keeping which track of which protocols are being used and which consent forms need to be signed by each patient becomes a daunting task. Today, great CTMS applications have functionality that makes it simple to know which protocols apply to which patients and study arms. What’s more, these CTMS vendors make it easy for you and your team to add and delete new and old protocols. When looking at CTMS vendors, here are some import features to ask about that are related to protocol versioning:

Simple Add/Delete Functionality

As your studies evolve over time, your CTMS should have clearly-laid-out functionality that allows your team to add new study elements or delete irrelevant elements from your new protocol versions. What’s more, anytime you need to add or delete study arms, your CTMS should have that functionality. Without it, your ability to track complex studies quickly becomes diminished.

Patient Movement Ability

With the addition of these new study arms and protocol versions, you should be able to easily transfer patients between study arms and know which consent form they need to sign. This functionality is essential if your patients transfer to different arms of a study depending on their treatment.

Cost Allocation Functionality

Part of having adaptive and dynamic protocol functionality in your CTMS includes understanding costs at a granular level. Make sure to ask CTMS vendors if their CTMS allows you to view your visit costs by protocol version. This way, you have a more complete cost situation of your study and can see which versions are profitable or not.

Protocol Activation

With protocol updates, it’s important to know which protocols are active and which are no longer used. Make sure to ask CTMS vendors if their system has a way to label this for you. If not, your study’s data quality and accuracy could be put at risk.

Consent Summary

As you review your study patients and the consent forms they have signed, your CTMS should also be able to tell you which patients no longer have an updated signed consent form. From there, you can ensure the next time you see those patients that they are quickly brought up to speed.

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