How Do Protocol Amendments Factor into Your Clinical Trial Monitoring Plan?
Given the complexity of today’s clinical trials, protocol amendments and modifications that impact the lab manual are all but certain. Study changes can happen for any number of reasons, but these updates are likely to have downstream impacts on inventory management and sample management workflows.
Consider the times you have seen modifications to your own trials. Maybe a certain assay is added or removed from a specific visit, resulting in supplies being added or removed from lab kits. Perhaps an entire visit is added or removed from the schedule of events, resulting in an entire lab kit being added or removed from the study. Even changes as minor as adding a field to a requisition form or changing the lab destination for a particular sample will have downstream implications for research sites that need to be taken into consideration.
Rolling out these updates on a global scale can be challenging in itself, but ensuring that sites remain compliant with these changes is an even greater feat. With that in mind, what are the potential implications of an insufficient strategy for managing study amendments? And how can sponsors ensure that their monitoring plans have a robust strategy in place for optimizing site compliance with the most current versions of study documents?
What do ICH GCP guidelines say about monitoring and protocol amendments?
ICH GCP guidelines clearly state that one of the core purposes of monitoring is to ensure that study conduct is “in compliance with the currently approved protocol/amendment(s).” This also aligns with the other purposes of monitoring: to protect patient well-being and ensure the completion and accuracy of study data.
These standards highlight the importance of incorporating a robust amendment management strategy into the monitoring plan. Changes to the protocol can have downstream effects on different aspects of study operations at the research site level, including inventory management, sample management, and the handling of sample metadata. These workflows have a direct downstream impact on clinical trial data, as well as the patient experience, so it is up to sponsors to make sure that study changes that impact lab kits, samples, and requisition forms are properly rolled out to sites and monitored accordingly.
How does risk-based monitoring factor into amendment management?
Risk-based monitoring involves oversight of specific clinical trial processes that have a significant impact on patient well-being and the reliability of study data. Ensuring that sites are following the most up-to-date versions of study documents is critical to overall data integrity, so amendments and other study modifications should be a major focus of a sponsor’s monitoring strategy.
With this in mind, it’s important to consider the processes that are heavily impacted by study changes. A robust monitoring strategy should consider impacts to lab kits and other clinical supplies, as well as lab manuals and sample management workflows. For example, how can sponsors enable sites to quickly and accurately identify lab kits in their on-hand inventory that may have been impacted by study modifications so that they can be discarded or manually modified? When sample management procedures are updated, how can sponsors roll out these changes to their sites in a streamlined way that also minimizes the risk of error?
It’s important to note that risk-based monitoring also involves scrutinizing processes that are at an elevated risk for error. Because study changes can be hard for sites to keep track of, processes that are impacted by study modifications may have a higher likelihood of experiencing downstream issues with data integrity. For instance, if a sample collection is added to a screening visit as a result of new inclusion/exclusion criteria in the protocol, sites may be at risk of using a lab kit that was assembled prior to the amendment. As a result, the site may forget to collect a critical patient sample, therefore hindering the patient’s ability to enroll in the trial.
Why should sponsors utilize centralized monitoring to ensure site compliance with updated study documents?
When it comes to study modifications that impact lab kits, requisition forms, and lab manuals, sponsors should evaluate solutions that facilitate centralized monitoring of the clinical inventory, samples, and sample metadata that are impacted by these updates. Centralized monitoring empowers study stakeholders to be able to quickly identify missing or inconsistent data, as well as evaluate site performance trends.
For instance, consider a scenario where you are supporting a study that has added a new sample collection to a certain visit. With the help of technology that enables centralized monitoring, you could access real-time data for that specific sample collection across all of the sites that are supporting your trial so that you can quickly identify compliance issues and implement targeted solutions based on site-specific data.
Optimize your amendment management strategy with Slope.
Slope’s Biospecimen360™ software facilitates the quick, seamless implementation of amendments and modifications that directly impact lab kits, requisition forms, and sample management processes. Our in-house clinical operations team can implement amendments in as little as 24 hours, thereby significantly streamlining the process of activating sites under new versions of the protocol and/or lab manual once they are approved.
The inventory management platform in Biospecimen360™ centralizes all of your lab kit data across all of your sites, enabling site staff to better manage their inventory while giving you a more precise, real-time picture into all of the inventory data on your trial. This comes in handy when you are evaluating on-hand inventory that may need to be discarded or modified as a result of a study amendment.
Biospecimen360™’s guided workflows for sample management also eliminate the need for sites to use static lab manuals when performing sample collection, processing, storage, and shipping. This especially comes in handy when rolling out study amendments, because Slope can implement study changes on a site-by-site or study-wide basis so that sponsors never have to worry about making sure that their sites are following the most up-to-date sample management procedures.
When sites perform inventory and sample management activities in Biospecimen360™, they also grant sponsors with instant access to critical sample metadata. Alerts can notify sponsors and site monitors when there are any compliance issues due to a deviation from a study modification — making centralized monitoring of research site activity more seamless than ever.
To learn more about how Biospecimen360™ can streamline your protocol amendments and lab manual modifications, click here to request a free demo.
Interested in learning more about the other ways in which today’s clinical trial landscape is hindering sponsor monitoring strategies and research site compliance? Click here to explore the innovative strategies that sponsors can implement to strengthen their clinical trial monitoring plans, thereby preventing and mitigating common compliance issues.
