Conflicting study documents put patient safety at risk — until proactive oversight uncovered the issue before sites did.
For the Day 8 visit, the protocol called for a single PK sample at pre-dose, while the lab manual and kit specified collection at the 3-hour timepoint. This discrepancy was a critical oversight that could have compromised data integrity and, more importantly, patient safety.
Oncology studies often involve multiple schedules, making precision in study documents critical. Despite rigorous QC and revisions, small but important discrepancies can still slip through — overlooked by sponsors, CROs, and central labs alike.
TruTechnologies' app integrates both the protocol and lab manual, ensuring alignment between the two. During study startup, TruTechnologies plays a unique role in harmonizing these documents, surfacing even the smallest inconsistencies before they lead to protocol deviations.
An oncology sponsor provided TruTechnologies with the study protocol, lab manual, and other key documents for a Phase 1/2 study. During the quality check process, TruTechnologies caught the discrepancies below between the lab manual and the protocol.
The lab manual instructed sites to collect a PK sample at the 3-hour post-dose timepoint for both Schedule 1 and Schedule 2 visits, including tube labeling. However, the protocol specified a pre-dose collection for Schedule 2, while Schedule 1 had no specified timepoint.
Without clarifying, how might the various sites interpret the appropriate collection time?
Some sites might have assumed the protocol instructions were correct even though the instructions were inconsistent. Some sites might have assumed the lab manual and the kit was correct because it contained clearer instructions, leading to sites collecting this PK sample three hours after the dose.
In this case, the sponsor didn’t have to wonder what sites would have assumed. TruTechnologies alerted the sponsor team to the discrepancy, and it was determined that the pre-dose PK collection was correct. The study team immediately updated the language throughout all study documents to correct and clarify, and new updated kits were shipped to the sites.
As a result of TruLab’s configuration and QC process:
• TruTechnologies surfaced small but material discrepancies between the lab manual and protocol to escalate to the sponsor
• TruTechnologies prevented important protocol deviations, which would have resulted in tainted study data
• TruTechnologies prevented a potential patient safety event, including collecting an unnecessary sample from an oncology patient where blood volume is a concern
• TruTechnologies saved the sponsor considerable time, money, and resources that would have been required to correct the issue once the study had gone live at the sites
100% of protocols and lab manuals provided to TruTechnologies by study teams have included some inconsistencies and/or discrepancies. By harmonizing the protocol and lab manual during the configuration and thorough quality check process, TruTechnologies surfaces conflicts like this and others to ensure a smoother, protocol-compliant study.
