De-Risking Data Audits through Monitoring
April 6th, 2018
Over the recent past, there has been no lack of articles, presentations and discussions around managing risk in a clinical development environment, particularly in lieu of the upcoming ICH E6 (R2) guidelines. However, how many of these proposed methods have actually been proven to help with minimizing the risk of failed data audits?
Comprehend Systems recently discussed key steps to help sponsors improve their clinical data audits. In the webinar, “Five Best Practices to Improve Clinical Trial Data Audits,” guidance was provided to address this need, as well as how automation can now take much of the burden away from managing data and risk.
Looking at all the data
If you look at the causes of concern over data audits, some key areas of focus become clear.
The ability to see and act on all relevant data, not just some of it, is integral to accurate reporting. If a site reported that they met their enrollment goal and was ready for FPI, but you found out later that some of the subjects counted as enrolled had failed screening, obviously there was data missing that directly impacted the validity of the information. Having the ability to quickly and accurately integrate and harmonize data from sites, CROs, and systems makes a significant difference in how well a data inspection will go.
Managing data expeditiously
In all trials, there comes a time when data management needs to wrap up their work and make sure all queries are closed. However, this is more easily said than done. In some cases, data managers have not even been aware of the fact that they had long-running queries outstanding, until an auditor found them. Other times, the demand for queries buried the data manager’s ability to respond in a reasonable amount of time, delaying milestones and causing protocol changes and extra costs. Being able to see query status and performance in real-time prevents these issues.
Resolving issues quickly, both with or without CRO partners
When working with data that is sourced from multiple systems and activities, sponsors are challenged with having to rationalize that information before they can get to the task of resolving issues. This can add a significant delay, as well as opportunity for data errors, to any trial. When you add the burden of a data audit, finding the reasons, explanations and proof of investigations and resolutions across all those systems becomes a time-consuming and frustrating task. Often, sponsors receive information about issues from their CRO partners in a scheduled reporting sequence – possibly much after the incident – and the information arrives in either an email or a spreadsheet. Again, this data needs to be collated with the sponsor’s inhouse information for a true picture of the event, its consequences and the resulting actions taken.
Reporting on quality metrics, changes and decisions
“How can I keep and report on all quality metrics, data changes and decisions made?”
With automation, sponsors can now record, collaborate and keep track of incidents and activities easily, reliably and quickly. The Comprehend presentation defined a number of ways to do this, including the application of dashboards to see continuous performance and status with the ability to track and save the information for any investigative purpose.
With dashboard views, sponsors can quickly see query performance, open queries, cycle time and queries by specific areas such as eCRF, Sites and Subjects. They can quickly see where portfolios, sites and subjects are out of compliance or exceeding thresholds of acceptable risk. As well, dashboards can immediately provide insights into how well CROs are performing to plan, trends in site, adverse event and protocol deviation risk, as well as detailed information such as SDV backlog and delta changes in patient status. All of these areas, if evaluated through the use of purpose-built automation, can be more quickly addressed, rectified and recorded than if using manual or custom methods of integration.
Summary: A Better Method and Better Results
By streamlining the ability to manage and report on key clinical information, sponsors can improve trials, traceability and evidence. Having harmonized data across all relevant subject data ensures safety and best data quality. And by using a more efficient, effective process through automation, sponsors can feel confident they are able to successfully produce quality information for a data audit.
To view the webinar, please click here.