4 Reasons That Research Sites Should Prioritize How They’re Managing Protocol Amendments
If you’ve worked at a research site, you know that study amendments and modifications are pretty much inevitable. Clinical trials have a lot of moving parts, and as such they are subject to changes both big and small — especially once the study is already underway.
Unfortunately, sites end up bearing the brunt of the challenges that come with managing amendments and other kinds of modifications that impact lab kits, lab manuals, and requisition forms. At the end of the day, sites are the ones performing the work of capturing source data, managing clinical inventory, and collecting patient samples, so they are on the hook for any and every change that a sponsor decides to implement on their trials.
Sites may rely on sponsors and monitors to support their implementation of and compliance with study changes; and while these organizations do have an obligation to set your site up for success, it is ultimately to the site’s benefit to consider the ways in which they can bolster their own change management processes, with or without direct sponsor buy-in.
So why should research sites prioritize how they are managing their amendments? Here are 4 reasons to consider.
1. Changes from amendments and modifications are hard to keep track of
It goes without saying that sites are often managing a large portfolio of trials — sometimes dozens, or even hundreds of studies at one time. Given that each of those individual trials can go through several changes over the duration of the study — a random collection added or removed here, a random kit added or removed there — sites are expected to manage countless moving parts. Not only do site staff have to account for the clinical inventory and study documents that may already be in circulation, but they need to ensure that site staff are properly informed about and trained on these changes. Unfortunately, some of these updates can be extremely easy to miss — increasing the risk of deviations and other issues.
2. Non-compliance with amendments and modifications put your patients at risk
The consequences of not complying with the most up-to-date trial specifications can have a direct impact on your patients. Amendments may include changes to primary/secondary endpoints or inclusion/exclusion criteria. Failure to collect critical samples that are relevant to important to patient safety or inclusion could result in a patient being unable to enroll or stay enrolled in a trial. Conversely, collecting a sample that was removed from a study is a significant violation of informed consent.
3. Your amendment management strategy can help you build trust with sponsors
Site selection can be competitive, especially given the high standards that dictate clinical research. Sponsors are more inclined to collaborate with sites that are able to demonstrate more robust processes and high rates of compliance. Given the fact that amendment non-compliance can be a huge source of deviations, it goes without saying that sponsors would strongly prefer to collaborate with sites who can demonstrate a commitment to processes that improve the overall quality of the sponsor’s study data. Solutions already exist that enable sites to streamline their amendment processes entirely on their own, across their entire portfolio of trials — with or without sponsor buy-in.
4. A more robust amendment implementation process saves you a ton of time on the back end
Investing in a more thorough protocol amendment strategy may seem like one more task to add to your site’s busy to-do list, but it’s important to consider the ways in which this approach can actually save your organization a significant amount of time. Failing to comply with amendments can lead to deviations and queries that take precious time and resources away from sites. For instance, consider the amount of back and forth that goes into addressing phone calls, faxes, and emails coming from various labs, monitors, and sponsors as a result of lab queries. Think about the amount of time it takes for site staff to address EDC queries that stem from compliance issues.
These are all things that should be considered as a part of a site’s amendment process. Consider how using technology to incorporate amendments into your workflows can reduce your site’s dependency on training. Consider how leveraging software-guided workflows for inventory and sample management can improve site staff compliance with the most current version of the protocol, lab manual, and other study documents — thereby reducing lab queries, EDC queries, and deviations. These solutions lend themselves to driving efficiencies in research site operations.
Slope makes it simple for your site to bolster your compliance with protocol amendments and other study modifications
Slope’s free clinical trial execution platform for sites makes it easier than ever to implement study changes in a way that drives efficiency and compliance. Our software’s inventory management solution makes it easy for sites to quickly and accurately identify any lab kits that have been impacted by amendments and modifications, so that they can discard, modify, and/or reorder the affected kits as needed.
Slope’s sample management solution also streamlines changes to the lab manual that stem from protocol amendments and other study modifications. The platform’s guided workflows facilitate sample collection, processing, storage, and shipment in real time, ensuring that site staff never miss a critical step. This is especially helpful when rolling out study changes across your entire site, when site staff are more susceptible to accidentally missing changes to sample management procedures.
To learn more about how Slope can improve your site’s compliance with study amendments and modifications, check out our white paper on The Value of Turning a Static Lab Manual into Software-Guided Workflows. In the meantime, get started with your free Slope account.
To explore the impact of today's clinical trial landscape on research site compliance and sponsor monitoring strategies even further, click here.
