When using electronic clinical outcome assessment (eCOA) or  electronic patient-reported outcome (ePRO) software to collect electronic patient data in clinical trials, study sponsors must ensure it functions as expected and aligns with each study’s design and requirements. Although some sponsors may choose to conduct user acceptance testing (UAT) internally, it’s more typical (and less costly) to hire a team of experts to independently test eCOA software before deploying it into a live clinical trial environment.

So, what are the UAT best practices for clinical trials—and how can they help improve the quality of ePRO and eCOA data collection?

Below, we’ll provide an overview of the best practices recommended by the electronic patient-reported outcome (ePRO) Consortium and the patient-reported outcome (PRO) Consortium and explore how Studion’s expertise in clinical trial UAT testing can help speed up your study timelines and improve data quality.

What is UAT and why is it important?

Before exploring these recommendations, let’s define UAT for clinical trials.

User acceptance testing is required during the software development lifecycle (SDLC) of any clinical trial software to validate its performance in scenarios similar to the live study environment where it will eventually be used. 

Although UAT is a small portion of the clinical trial process, it’s critical because patients enrolled in clinical studies will interact with the software when they provide their sensitive data.

Besides validating the performance of eCOA software in scenarios similar to a real-life clinical study, UAT helps determine if the software aligns with a sponsor’s study requirements and expectations. The outcomes of UAT will capture whether an eCOA provider accurately translated a sponsor’s clinical trial requirements into designing the system.    

Compliance with regulatory requirements for software validation

The Food and Drug Administration (FDA) also requires all software used to collect electronic clinical trial data to comply with its General Principles of Software Validation. 

These regulatory expectations require all testing activities, such as beta testing, site validation, and user acceptance testing, to occur outside a developer’s controlled environment. The eCOA provider may provide guidance and/or participate simultaneously in UAT.

Additionally, the FDA requires study sponsors and their designees for UAT to pre-plan all testing activities and document testing procedures, input data, and test results.

In many instances, satisfying the UAT requirements stipulated by the FDA or EU is challenging, considering the bandwidth and testing expertise involved. That’s where Studion’s UAT experience can help clinical trial sponsors or eClinical SaaS providers streamline their path to regulatory compliance across various UAT needs.

Stages of UAT

A well designed UAT approach can take as little as two weeks for execution.  The key is in the preparation and clearly defined requirements.  The process spans the following four stages:

Startup 

When a sponsor contracts with an entity to conduct UAT, the entity will create three sets of documents:

• A testing overview to explain what’s involved in the UAT process and best practices for completing the testing

• A test plan created by quality engineers that includes the technical details of the test scripts to validate the software being tested 

• The test scripts being used in the UAT procedures.

Planning

In the planning phase, sponsors and eCOA providers develop timelines and define the scope of testing. The testing entities also create training documents to help testers properly run test scripts, ensuring applications are tested based on how developers built them.

Delivery

Here, testing entities perform UAT using test scripts, document their findings, and review these findings with the study sponsors. 

When Studion’s team tests clinical trial software, we make recommendations about any issues or bugs we identify. For instance, some defects are critical and must be fixed before the software can be released into production because they impact data collection. 

On the other hand, major defects may impact data collection to some extent, but fixing them before deploying the eCOA/ePRO software would be ideal. Less critical issues like bugs in the user interface that developers can easily resolve via enhancement requests are considered optional fixes.  

Closeout

In the final stage of UAT, the entity contracted to conduct UAT debriefs with the sponsor on any impactful findings identified during the testing. At this stage, re-testing may be conducted if needed. Upon sponsor approval of the eCOA system, it’s ready for deployment in a clinical trial environment.

UAT roles and responsibilities

The two main stakeholders involved in UAT are:

• Sponsors or designees: A sponsor is accountable for the entire clinical study and funds its build, design, and execution. Sponsors contract eCOA providers to develop the clinical trial software and are responsible for designating other entities to conduct UAT on their behalf.

• eCOA providers: An eClinical SaaS provider is typically contracted by a sponsor or CRO to design, build, and support the eCOA software. However, the entity that develops the eCOA solution should not be the same one validating its performance via UAT. When sponsors must manage multiple end-to-end aspects of clinical trials, such as patient recruitment, study design, or regulatory compliance, it becomes challenging to handle UAT internally.

That’s where third parties like Studion come in to help conduct UAT speedily and get the eCOA/ePRO software ready for the trial to start. A third-party UAT expert also meets the independent tester requirement, meaning sponsors can increase their confidence in the objectivity of the UAT findings and recommendations.

UAT documentation workflow

Documentation of UAT activities and outcomes is not just a regulatory requirement; it also increases testing effectiveness as testers are more likely to identify gaps that might impact UAT outcomes.

The entities contracted by the sponsor to conduct UAT are responsible for developing testing Standard Operating Procedures (SOPs), Working Instructions (WIs), and other guidance documents to align the expected system performance with its intended design and study requirements.

Along those lines, SOPs should outline:

• Documents required for testers to complete UAT

• Roles and responsibilities for testing activities

• Processes for conducting UAT (the when and how)

Maximize your ROI on UAT

With staffing shortages and budget cuts, it’s increasingly common for study sponsors or eClinical SaaS providers to outsource their UAT testing needs to third-party entities to streamline the path to clinical trial software validation before it's used to collect patient data.

But it’s crucial to find the right UAT provider. 

At Studion, we’ve built our expertise in testing configurations for clinical trial software for over 15 years across 2,000+ clinical trials. With our full-service UAT offering, you’ll minimize the strain on internal bandwidth, complete testing timely and effectively, and meet regulatory expectations for each study. We ensure each eCOA/ePRO solutions we test internally meets its intended requirements—helping study sponsors confidently gather clinical trial data once the software is released to end users.