April 9, 2024

How Can a Clinical Trial Execution Platform Support Your Monitoring Strategy for Protocol Amendments?

Sponsors understand the importance of helping their sites stay compliant with protocol amendments and other study modifications that may impact lab kits and lab manuals. These changes can be a lot for sites to juggle — not only because they are managing several tasks across several trials and sponsors simultaneously, but because lab kits and lab manuals that were created prior to the modification may still be in circulation. This puts sites at an even greater risk of over-collecting or under-collecting samples; using the wrong containers to collect and return samples; shipping samples to the wrong labs on the wrong days; and more.

As we established in our blog, “How Do Protocol Amendments Factor into Your Clinical Trial Monitoring Plan?,” ICH GCP guidelines and regulatory requirements put the onus on sponsors to ensure that study conduct is in compliance with currently approved study documents. Fortunately, a clinical trial execution platform can be effective in optimizing site compliance with study changes that impact clinical inventory and sample management procedures. This technology solution not only enables the quick, seamless rollout of modifications to sites, but it also optimizes site compliance with updated study procedures.

So what does this look like in practice? Let’s walk through a hypothetical example.

Sponsor works with vendors to identify specific changes to lab kits, requisition forms, and samples 

Imagine you’re a clinical operations lead for a sponsor organization, and you’re responsible for rolling out a major protocol amendment that has already been approved by regulatory authorities. The amendment includes the addition of a few new visits, the removal of a pre-existing visit, and the addition and removal of a few primary and secondary endpoints. The new endpoints require the addition of a few new samples, some of which require additional sample metadata to be captured on the requisition form so that the labs can process the samples accordingly.

Once the amendment is finalized and ready to be approved on a rolling basis, you share it with your kitting vendor, lab vendors, and the vendor responsible for creating and updating your lab manual. You determine that you need to add a few new kits to your study, remove a pre-existing kit, update the contents of several pre-existing kits, and update a few of the requisition forms. These changes are eventually implemented through a series of change orders, database updates, and updates to study documents. 

So at what point does your clinical trial execution platform come in? From the moment you are ready to share a draft version or finalized version of your amendment, the vendor who supports your clinical trial execution platform will be standing by, ready to implement the changes to your inventory and sample management system as soon as the updated lab kits and lab manuals are ready to go. Fortunately, your clinical trial execution platform can be configured under a new protocol amendment in as little as 24 hours. 

Vendors provide updated clinical supplies and lab manuals to sites once they are approved for new protocol version

Once study vendors have updated the lab kits, requisition forms, and lab manuals, these new items and documents are ready for sites to use, but only after the sites have been approved under the new version of the protocol. 

This is the phase of amendment management where the process can become challenging. Certain sites may need to continue operating under the previous version of the protocol — which includes different lab kits, requisition forms, and samples — while other sites may be ready to move to the new version of the protocol. Ensuring that sites are only supplied with the clinical inventory and sample management procedures that align with the version of the protocol they’re approved for is often complicated and rife with risk.

Fortunately, the software keeps track of amendment versions for you so that you have more control over when new lab kits and sample management workflows are rolled out to each site. This eliminates the risk of certain sites using lab kits or following sample management procedures under the wrong version of the protocol by only allowing them to execute on lab kits and sample workflows that support the amended protocol.

Sites and sponsors identify which lab kits need to be taken out of circulation and/or ordered

Once a site has been approved under the new version of the protocol, they will need to quickly take stock of their current clinical inventory to determine which kits need to be discarded/modified and which kits need to be ordered. Under traditional inventory management workflows, sites may have trouble locating kits in their facility — meaning an outdated version of a lab kit could remain in circulation and be pulled for a patient visit that is being performed under the new version of the protocol. 

Fortunately, a clinical trial execution platform can empower sites to organize their clinical inventory so they can easily identify and locate kits that may be impacted by the protocol amendment. The software can also enable alerts that prompt sites to discard unusable inventory. This ensures that sites are never using outdated lab kits, while also improving collaboration between sponsors and sites as they determine how many of the new/updated lab kits to send to each site based on current demand.

Sites utilize the updated lab manual to perform sample management activities

Once sites have been approved for the new protocol version and have received their updated supplies, they are ready to perform patient visits under the new amendment. Many sites today continue to rely on static lab manuals to conduct sample management activities, which puts them at increased risk of missing critical updates to procedures that may have been impacted by study changes. 

Fortunately, your clinical trial execution platform can configure sample management workflows for your sites so that you never have to worry about them missing a critical step or using an old version of the lab manual. This not only saves sites a significant amount of time, but it saves you (the sponsor) the headache of having to manage the fallout of a site not following the correct version of the protocol.

Slope is the clinical trial execution platform you need for your amendment management strategy

The above example demonstrates the importance of a clinical trial execution platform for your monitoring strategy, including as it pertains to the management of amendments and other study modifications. With Slope, sponsors can streamline the implementation of any study updates that impact your lab kits or sample management workflows. Our Clinical Operations team is always standing by to support you, offering the ability to roll out study changes to your sites in as little as 24 hours as soon as your updated lab kits and lab manuals are ready, and as soon as sites are approved under the new version of the protocol. Our platform also makes it easy to identify which lab kits pertain to each protocol version, so that you and your sites can quickly and easily identify lab kits that may need to be modified, discarded, and/or ordered. 

To learn more about how Slope can help you finetune your monitoring strategy, check out our e-book, “Optimizing Your Clinical Trial Monitoring Strategy to Boost Research Site Compliance.” In the meantime, click here to learn more about the impact of today's clinical trial landscape on sponsor monitoring strategies and research site compliance.

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