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:
- Study Caps and limits You wouldn’t want your IRT randomization cap to be reset as the result of the change control installation.
- Study Documentation and user training Also consider items outside the programming aspects of the system, will the user guides need to be updated? How are users at the investigational sites going to be trained if that is needed?
- Drug supply Is an additional drug release part of the change control? If so consider the transit time for depot to site and depot to depot shipments.
- Data Changes in Process If your change control affects the way particular visit or demographic data points are handled ensure that you take into account any outstanding data changes that are in progress.
- Global vs Piecemeal roll out Some change controls are related to countries or sites being approved for a protocol amendment. Think about how to manage and track which sites or countries are approved and updated and which ones are still outstanding
- . Helpdesk Make sure your helpdesk is aware of any ongoing change controls and knows how to answer or direct inquiries from users while a change control is in progress. If the change control involves a new country ensure that the study budget is appropriate for any new interpretation services needed.
- Additional Activities The sponsor may want to schedule additional investigator meetings especially in the case of a large protocol amendment. They may also want custom reports generated to identify subjects who are include pre change control vs post change control.
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.
