December 19, 2023

Are Study Amendments Complicating Your Research Site’s Sample Management Workflows? Here Are 3 Things You Can Do to Fix It.

Most research sites intimately understand the challenges with implementing study amendments on clinical trials. Complex trials are more likely to undergo changes that may impact the Schedule of Events, lab kit contents, lab manual instructions, and more. This in turn has a downstream effect on site operations; once a site has been approved for the latest version of a protocol, or once a sponsor has rolled out a new version of a lab manual, the onus is on the site to ensure a seamless transition. 

Unfortunately, traditional methods for transitioning to new study amendments are imperfect. Critical changes may slip through the cracks, increasing the potential for visit deviations and negative impacts to the patient experience. In addition, site staff may experience greater inefficiencies as they exercise more caution in navigating study changes that have direct implications on sample management workflows. 

What can sites do to mitigate these challenges? Here are 3 easy-to-implement solutions that can streamline your change management processes across all of your sample management workflows.

1. Take Stock of Your Lab Kits

Lab kits are incredibly susceptible to changes throughout the clinical trial lifecycle — especially in response to study design changes, collection supply updates, and more. New kit types may be added or removed, and individual components of lab kits may change in response to Schedule of Events changes or updates to the clinical supplies that are used for certain biospecimens. These revisions require prompt attention as soon as they are implemented, as they may have a downstream impact on the research samples that are collected during patient visits. If an older version of a lab kit is used against a newer version of the protocol, the research site may commit accidental deviations that result in critical samples not being collected. As discussed in our recent blog on the risks associated with traditional methods for managing clinical inventory, these incidents can put patient screening and enrollment in jeopardy, and even increase the likelihood that a patient may need to come in for an additional sample draw.

It’s important that site staff review their current inventory of lab kits anytime there are modifications to a study protocol or lab manual. A centralized, digitized platform for managing lab kits can help with this, as it makes it easy to identify any lab kits that a site may have in stock that may be impacted by amendments and other study modifications. For instance, if a site moves to a new version of a protocol that adds new samples to a Screening visit, the site can leverage a clinical inventory management system to quickly identify any Screening kits that are currently in stock and may need to be discarded and replaced.

2. Tell Your Sponsors and CROs What They Can Do to Improve Amendment Training and Communications

As highlighted in our recent blog that discusses how sites can stand out as leaders in clinical research, sponsors appreciate feedback from their research sites when it comes to understanding how they can help sites do their jobs better. This is certainly the case for protocol amendments, which are subject to sponsor-specific processes for rolling out such changes. 

Sponsors may rely on various forms of training or mass communications in order to get site staff up to speed with any changes that may have been implemented under a study modification, but these processes may need to be optimized. For instance, could sponsors and CROs leverage a better process for disseminating information about study changes to their sites? Are there digital systems or solutions that exist that can streamline the implementation of study amendments across an entire trial? Sharing this kind of information with study sponsors may prove valuable to your clinical research operation, as it not only maximizes your organization’s ability to comply with study changes, but it shows sponsors that you are invested in shared success. 

3. Ditch Your Paper- or PDF- Based Lab Manuals

Most research sites continue to rely on static lab manuals or templatized versions of lab manuals in order to execute the sample management procedures for patient visits. Unfortunately, sifting through these documents may result in accidental oversights, especially when managing the changes associated with study amendments. Updates to lab kits, the components of those lab kits, or the processing, storage, and shipping procedures for a patient may not be immediately obvious when sifting through dense lab manual instructions. Critical updates can be missed, resulting in deviations that put the patient experience at risk and require a greater amount of downstream reconciliation.

Fortunately, innovative solutions exist that can replace static lab manual documents with interactive workflows that streamline clinical trial execution at the site level. These software-based applications minimize the need for site staff to reference any lab manuals or templatized documents when performing patient visits or managing patient samples, thereby maximizing efficiencies and minimizing accidental oversights when transitioning to the latest version of a protocol and/or lab manual. 

Make study amendment transitions a breeze with Slope

Using Slope’s clinical trial execution platform — which is free for sites — research staff can avoid deviating from the latest version of the protocol and lab manual thanks to software-guided workflows that walk coordinators and other staff members through every sample management step for every biospecimen. Sites can standardize their amendment management processes across all of their studies and sponsors, using Slope’s built-in guardrails to enforce compliance with any changes that impact lab kits, sample collection and processing instructions, and shipping guidelines. The best part? Amendments can be implemented in Slope within 24 hours after they are approved to be rolled out to sites, thanks to Slope’s ability to allow users to quickly modify pre-existing workflows. 

To learn more, check out our white paper, which dives into the value of using the Slope platform to turn your lab manuals into software-guided workflows. And if you’re ready to take your site operations to the next level, click here to sign up for Slope — it’s free for sites!

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