Protocol updates and unforeseen changes to a clinical trial may be a fact-of-life. When a change control is required to a validated IRT system it can be a daunting task to ensure that all progresses smoothly.

If your study team finds itself facing a protocol amendment one of the first things you should do is find out if the amendment has an impact on the IRT system for your trial. If the answer is “Yes”  you should communicate this to your IRT team as soon as possible. Depending on the amendment and the amount of effort required for an update the IRT team may need to secure  additional resources or come up with a work around if the amendment will go live before the change control.

Depending on the type of change control your study team may or may not want to perform user acceptance testing (UAT) on the change. Factors that might influence this decision are the complexity of the change. For example,  if the change is a configuration update to a setting within the IRT no UAT may be warranted.  On the other hand if the change is complex and modifies randomization, drug dispensing , re-supply or eligibility, then UAT is likely going to be required.

Performing a change control to a validated system can be a high-risk event for an IRT system, it’s important for the IRT vendor to manage the installation of the change carefully.  This would include ensuring that any pre-existing configurations and settings and services that are not part of the change control are maintained through the installation of the changes. For example:

By taking into account the items above in addition to any other items that may be specific to your study your change controls can be executed with minimal disruption to the study in general.

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