The difference between lost data and flawless compliance? One crucial change in oversight.
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In a sponsor’s Phase 1/2 study conducted without TruTechnology’s involvement and oversight, critical lapses at one site led to missed baseline sample collections, resulting in the exclusion of nearly 20% of patient data — a significant setback. For the subsequent Phase 2/3 study, however, the sponsor brought on TruTechnologies to provide real-time oversight, creating a unique opportunity to compare outcomes. With TruTechnology’s advanced protocol support, the same site achieved flawless compliance, ensuring no missed or mishandled baseline samples. This case study illustrates how TruTechnologies’ proactive approach transformed site performance and safeguarded data integrity in the later phase study.
Baseline samples are critical in many studies, serving as a foundation for evaluating treatment effects and enabling meaningful comparisons between pre- and post-treatment outcomes. Without properly collected and managed baseline data, patient results may become unusable, jeopardizing the study’s validity and overall success.
This is precisely what occurred in a Phase 1/2 study, where significant issues arose at one site that had enrolled nearly 20% of the trial’s patients. According to the sponsor, the site failed to collect most of its predose samples, effectively invalidating the data. To make matters worse, the extent of these errors only became apparent as the sponsor prepared to lock the database — nearly 46 months into the study — far too late to course correct and intervene.
The fact that these issues persisted for so long underscores the critical importance of ongoing oversight throughout a trial. Reflecting on this experience, one sponsor representative noted, “It's a great example of why we need to do ongoing SDV instead of just at database lock.” The consequences of these compounded errors were significant: Nearly 20% of the study’s patients did all of that work for inclusion, and then none of their data was eligible for analysis.
The errors at the Phase 1/2 site revealed significant breakdowns across multiple layers of responsibility, including site staff, clinical research associates (CRAs), and data management.
1. Site-Level Failures
At the site, clinical research coordinators (CRCs) failed to collect and document baseline samples consistently. While some EDC fields for these samples were indeed populated, indicating initial collection, mishandling may have rendered many unusable. Mishandling could include improper processing, failure to ship samples to the central lab, or deviation from storage requirements, all of which can compromise sample integrity.
In the Phase 2/3 study, for example, TruTechnologies identified and escalated a similar issue at another site, where a pre-dose sample had been frozen instead of processed and shipped as required. Thanks to TruTechnologies’ real-time monitoring, the sponsor was able to recollect the sample within the baseline window, preserving the patient’s data for analysis.
For the Phase 1/2 site in question, however, these errors went unnoticed for years. Theoretically, source documents at the site should contain information about these samples, but reconstructing the data years later is a monumental task. Locating specific records among thousands of documents is time-consuming, especially if staff familiar with the trial are no longer available or if the documents were incomplete or improperly stored. Given these challenges, the missing baseline data is effectively unrecoverable.
This underscores the critical importance of site-level oversight, not only in ensuring compliance with the study protocol but also in documenting and escalating deviations. While site staff may carry out the day-to-day operations, the buck ultimately stops with the principal investigator (PI) to ensure major deviations — such as missed baseline samples tied to the study’s primary endpoint — are identified and reported promptly to safeguard the integrity of the trial.
2. CRA Oversight Challenges
CRAs also missed critical opportunities to correct these errors. Effective pre-study training should have emphasized the importance of baseline sample collection, but the issue could have been deprioritized among competing training topics. Additionally, if site staff turnover occurred, CRAs may not have ensured proper retraining, leaving gaps in site-level knowledge.
Ongoing source data verification also may have been inconsistent. Given the sheer number of fields CRAs must review across multiple data points, it’s not unexpected that something could be missed. What’s more, if both the source documents and EDC fields were blank, the absence of critical data could go unnoticed entirely. These challenges illustrate how manual processes, even with diligent on-site monitoring, can leave critical omissions undetected.
3. CRO and Data Management Gaps
The configuration of the EDC system may also have contributed to the missed baseline samples. If pre-dose sample fields were incorrectly classified as optional, this could have prevented automated queries from flagging missing data. While the CRO may have been responsible for building the database, the sponsor’s involvement in user acceptance testing (UAT) should have included a thorough review to ensure all critical data fields were properly configured.
However, automated EDC queries alone are not sufficient for effective data oversight. While these systems are useful for identifying some discrepancies, they cannot account for human errors (i.e. sample mishandling during processing) or contextual nuances, such as recognizing the critical importance of baseline samples tied to a primary endpoint. The absence of proactive oversight allows errors like these to persist undetected, underscoring the need for a more comprehensive approach that combines automation with human intervention to prevent such oversights.
In the Phase 2/3 study, however, the same site that struggled with baseline sample collection in the Phase 1/2 study achieved perfect compliance under TruTechnologies’ oversight. Every baseline sample was collected, processed, and shipped according to protocol — an outcome made possible by TruTechnologies’ blend of proactive alerts and human oversight.
Had TruTechnologies been in place during the Phase 1/2 study, the following features could have prevented the issues:
• Real-Time Monitoring: TruTechnologies’ system and team tracks sample collection as it happens, ensuring no critical steps are missed.
• Automated Alerts: If a baseline sample isn’t scanned at the time of collection, the TruLab application immediately flags the issue for follow-up.
• Escalation Protocols: Deviations are escalated to the sponsor and site staff promptly, allowing for corrective action within protocol windows.
• Data Visibility: TruTechnologies provides sponsors with clear, real-time insight into site-level activities, enabling proactive intervention instead of reactive troubleshooting.
By addressing these challenges before they escalate, TruTechnologies ensures protocol compliance and prevents the kinds of errors that rendered close to 20% of the Phase 1/2 study data unusable.
The stark contrast between the Phase 1/2 and Phase 2/3 studies underscores the critical importance of proactive oversight in clinical trials. Traditional processes on the Phase 1/2 study, which were reliant on manual checks and insufficient automated systems, left critical gaps that resulted in significant, unrecoverable data loss. By contrast, TruTechnologies’ real-time monitoring ensured flawless compliance at the same site during the Phase 2/3 study and allowed for the inclusion of all patient data.
By addressing potential deviations early and combining automation with contextual understanding, TruTechnologies provided the visibility and intervention necessary to safeguard data integrity. This case study illustrates not only how TruTechnologies prevents critical errors but also how its approach transforms clinical site oversight, setting a new benchmark for compliance and quality in clinical research.
