It is crucial to keep clinical study data consistent and accurate. When auditing, anything trial teams can do to streamline the process of pinpointing inconsistencies in data, deviations from protocol, and errors in data collection and reporting is a plus.
Almac Clinical Technologies recently introduced its OVERSIGHT suite of audit trail report tools. The idea is to provide on-demand visibility to the data history of kits, subjects, and sites to enable personnel to quickly pinpoint issues, then find the information needed to take action.
Outsourcing-Pharma discussed the data monitoring technology with a pair of Almac Clinical Technologies representatives:
- Matthew Lowrie, quality assurance manager
- Cheryl Kole, head of solutions strategy and commercialization
OSP: Could you please tell us about some of the issues trial teams face regarding achieving and maintaining quality and integrity in their study data?
ML: One of the biggest issues clients face is not fully taking into account the flow of data in their systems, the various integrations and data exchanges that occur between them, and which are considered source data. Too often there is a disconnect between the siloed teams who aren’t fully aware or consulted on the requirements for the various systems. This leads to large reconciliation efforts at the end of the trial and questions around why the data is being updated sometimes years after its initial entry.
CK: To the point of data corrections or reconciliation, it’s important to understand which systems are the first point of entry, especially for Investigator owned data, and what downstream systems receive that data. When changes are required to those data points, the Investigator must be in control as the owner of that data.
Additionally, data integrity guidance from MHRA, FDA, and EMA is evolving around sponsors' responsibilities with respect to trial data oversight. As stated in ICH E6(R2), inspectors expect to see documented evidence on how the sponsor performed oversight of the study data. Section 5.18.3 emphasizes the importance of centralized monitoring processes to “complement and reduce the extent and/or frequency of onsite monitoring and help distinguish between reliable data and potentially unreliable data.” Further, the Data Integrity guidance put out by the MHRA, FDA, and the current (2021) draft guidance by the EMA aimed to not only assure data integrity but to enhance and ensure sponsors take a more proactive approach.
We are seeing a rise in the number of findings where there was a lack of real-time data monitoring and/or data monitoring was not done in a contemporaneous manner to show continuous oversight of the trial. Inspectors are expecting to see established data monitoring processes and to ensure that this does happen, action needs to be taken by sponsors now.
OSP: What are some of the tools/solutions sites and sponsors typically use in an attempt to achieve a higher level of data integrity? What are some of the challenges associated with such solutions?
ML: There are two user stories here— typically, Sponsors attempt to utilize various reports and audit trails to review their data. This works great if that audit trail is parsed and presented in an easily read format. Sites will attempt to utilize various systems to look for errors (e.g. IRT vs. EDC) and determine what changed first. Focusing on both of these- the main challenge is around being able to consume the data in a way that is relevant and approachable.
It is much easier to look for a specific entry in an audit trail than to look through an entire audit trail for an anomaly. It’s important to have a solution that highlights key, critical control points, and that presents the data in a way that someone can work through and understand what is happening.
One additional factor we see is when both sites and sponsors attempt to do this and don’t utilize the support and expertise of their partners who developed the technology.
CK: Up-front planning for management and oversight of trial data is key. When multiple systems are in play, which is most often the case, planning for how data changes will flow between systems must be accounted for. Oftentimes, the initial data entry is the primary focus.
Taking the time to plan for mistakes and errors will help to ensure quality and efficiency are built in. Just as important is planning the study’s approach to proactive data reviews and knowing what tools are available from your technology partners and how they will be used.
OSP: Please tell us a bit about your new data integrity monitoring system, OVERSIGHT—how does it work, and how does this technology solve some of the problems mentioned above?
CK: The audit trail is an integral part of any e-clinical system, and should be utilized as a tool to drive data reviews forward. The OVERSIGHT solution within Almac’s IXRS platform is a critical control point given that in many instances the IXRS acts as an eCRF given it is the first point of entry and as such the source of data that is ultimately pushed to other systems (EDC, eCOA, CTMS). Such, it can be used to investigate any potential discrepancies between systems or ongoing reconciliation activities during the trial.
Audit trail reviews conducted by data managers, statisticians, safety staff, and other roles can help identify data inconsistencies, outliers, and protocol deviations; plus, any errors in data collection and reporting at a site or across sites; and other data integrity issues. It is critical to be able to quickly see trends and issues, then drill down into the details to accurately analyze what the trends show and take necessary action.
OSP: Could you please provide some additional detail about the features and components, and how they together enable on-demand visibility to data history?
CK: Sponsors can be successful and comply with regulations by using Almac’s OVERSIGHT solution for audit trail reviews. The key benefits provided are:
- On-demand access to the data as the study progresses, allowing identification of risk or needed action.
- The data is presented in a way allowing for ease of review. Both summary and detailed data views are provided. The summary view allows compare and contrast amongst sites, as well as identification of outliers. The detailed data views then allows to drill down into the data points and identify any necessary action.
- Sponsors can establish processes and procedures around periodic review and risk identification and remediation.
OSP: I understand you spoke about your new technology with SCOPE 2022 attendees. Would you please share how people responded when you explained the tech to them?
ML: When we discussed our approach it was incredibly well-received. Since their creation, audit trails have been cumbersome data mines. They are generally several columns on a spreadsheet that simply are running logs of all changes.
What we’ve done is create something that gives a more realistic and modern view into the happenings of the trial. It allows Sponsors to meet their regulatory obligations and proactively monitor their data for potential problem sites, or areas. The potential for continuous improvement initiatives was something we discussed at our booth, where data trends can be analyzed to look at risk-based monitoring approaches to sites as well as looking at potential areas to clarify system functionality or training.
Ultimately, this makes for a smoother trial, while reducing the burdensome costs of reconciliation, and related inspection findings.
OSP: Anything to add?
CK: As both regulatory guidance and technology capabilities continue to evolve, it’s important to ensure both systems and processes stay up to speed. Almac is committed to helping sponsors navigate the regulations and providing solutions to ease the burden.
