User acceptance testing (UAT), a critical phase in the lifecycle of IRT-supported clinical trials, serves as the guardrail that ensures patient safety, upholds data integrity, and propels your study in a timely manner. This phase is specifically designed to detect and fix issues before they can morph into more serious challenges. However, it can uncover problems that threaten your trial timeline.
So how do you deal with UAT errors while staying on schedule?
A best practices approach to addressing errors keeps the study progressing, minimizes delays, and avoids unnecessary costs. The following best practices are especially impactful when it comes to addressing critical errors found during the UAT process.
1. Communicate clearly and often.
Getting the right people in the room at the right times is critical to ensuring the key players are communicating about critical decisions, especially when an error surfaces. Setting up a productive meeting cadence and structure, collaborating well before UAT begins, and agreeing on roles, responsibilities, and expectations, set the stage for good collaboration when it comes time to address a UAT-identified issue.
2. Prioritize errors based on risk.
UAT can uncover a wide variety of errors, but only some are critical to the study outcome. That’s why Poxy Clinical takes a risk-based approach to UAT, helping sponsors triage and prioritize errors.
Minor issues that don’t affect patient safety, data integrity, or regulatory compliance—such as report formatting errors—might be able to wait until after the study goes live. Or if a provider notification is missing a data value, that might not impact the study substantively and could be deemed lower priority.
3. Document a detailed test schedule.
The UAT plan should include a clearly defined date for testing completion. Keeping everyone working toward that date avoids the common problem of getting side-tracked by inconsequential errors or overlooking a temporary fix for a minor issue that doesn’t impact safety, integrity, or compliance.
4. Partner with an advocate.
A third-party UAT provider can advocate on your behalf with the IRT vendor, ensuring they’re addressing the highest risk errors effectively and aggressively. An experienced UAT provider also knows the IRT vendor’s “technical speak” and can ensure you fully understand how they’re responding to errors.
5. Stay agile.
If errors come up at a point when you’re up against your FPI date, you’ll need your providers to be nimble to keep your timeline on track. For example, Poxy Clinical maintains enough resources to provide flexibility and agility when UAT uncovers an error that needs correcting and retesting so they can get your study back on track.
6. Apply lessons learned.
Keeping good records of errors can help prevent similar issues from recurring or identify ways to improve the process for future studies. Poxy Clinical maintains and reviews historical records for that purpose, advising sponsors on how to avoid IRT errors going forward. For example, if there was misalignment between the business needs and the system design, we recommend ways to ensure the IRT vendor sufficiently reflects those needs on future projects.
In addition to corrective measures, proper pre-planning can help prevent IRT-related errors before UAT begins. That’s where a third-party UAT services provider proves especially valuable. When the UAT provider is involved early, they can review specifications with a critical eye and spot misalignment with the business needs. Identifying and correcting these problems before UAT begins avoids the more significant delays and costs that result when such issues go undetected until much later.
How Poxy Clinical Helps Address UAT Errors
Poxy Clinical recognizes how important it is to validate your IRT-supported clinical trial with confidence in order to protect patient safety, maintain data integrity, and keep your study schedule intact. And while UAT plays an important role in proactively finding errors that impact safety, integrity, and timelines, it’s equally important to address those errors in a way that helps to keep your study timeline and launch date on track.
We provide leading clinical trial sponsors with the highest quality UAT services, customized to your needs, through a proven risk-based approach that minimizes the impact on your study timeline. As the only company that specializes in IRT user acceptance testing services globally, we’re the partner you can depend on to head-off errors that impact patient safety, data integrity, and the study schedule.
Get in touch to learn how Poxy Clinical can support your next clinical trial.