Prelude’s ePro Mobile App Enhances Patient Data Integrity, Compliance, and Efficiency During Clinical Trials

Of all the effective methods used to ensure subjects complete a clinical trial, our favorite is probably the ePRO mobile application. This ingenious app reduces the need for in-person visits to clinics. And who doesn’t love playing with new apps on their phone?

Both human subjects and owners of animal subjects can download this app (on either iOS or Android devices) and use it to fill in surveys and forms from anywhere. All entered data gets uploaded straight to the VISION database with a fully attributable audit trail. That means wherever your patients have cell service, they can intuitively perform contemporaneous data entry. The ePRO app offers a huge advantage over having to wait for a visit or telephone call with the clinic in order to relay daily or weekly observations. Now subjects and owners can don’t even have to get dressed or get in their cars to participate in a clinical trial anymore. Finally, a data management solution for the Netflix and Chill generation!

The ePRO app reduces the loss of subjects who do not want to risk their health by coming into the clinic for a checkup. It gives them the opportunity to enter their data into the system before they forget. Sites can even set up notifications for the users to ensure they enter their information within the expected timeline. This in turn ensures data integrity and reduces site follow-up requirements.

Data can be entered remotely using radios, check boxes, dates, times, text boxes, drop-down menus, and visual analogue scales. Images and videos can be recorded and uploaded for uses such as wound healing checks. All this flexibility and ease-of-use makes subjects significantly more inclined to continue their clinical trial participation. It will also continue to be useful into the future for subjects who would normally have a long commute to get to their required clinic.

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Best Practices for Remote Clinical Monitoring 

What does it mean to conduct effective remote clinical monitoring? It’s critical to be using an EDC in order to accomplish this, but what else is necessary? Keeping the primary goals of the monitor in mind, we will outline several techniques for streamlining this process.   

What are the primary goals of the study monitor? First, and most critical, is to ensure the safety of all study participants – including clinical personnel. Second, is ensuring data quality and integrity.  

Letdiscuss the EDC features that can help in each of these areas. 

Ensuring Safety 

Monitors are relied upon to use their knowledge and expertise to recognize potential safety risks, and to report them when discovered.  The EDC can’t replace monitors, but it can assist them greatly in their daily workflow. 

Use of Notifications. The EDC can be configured to automatically notify monitors when certain events occur. Examples of this include the entry of adverse eventsthe reporting of out-ofrange lab results and new subject enrollmentWhen automatic notifications are used, monitors are informed in real time and the need to continually review eCRFs for potential issues is eliminated – saving valuable time. Think about the potential risk factors for a study and consider how notifications can be configured to assist the monitor.  

Use of Reports and Graphs. Some EDCs support flexible, configurable reporting tools that facilitate the aggregation of data for review. Graphs can be used to more intuitively spot outliers and aid in understanding trends. If such tools are not available, consider asking your EDC provider for custom summary reports that can be used to review study endpoints, exam results and adverse events in a comprehensive way. 

Use of Study Dashboards. Dashboards that aggregate reports from multiple sources can provide a convenient starting point for a monitor’s daily workflow. Monitors can log in to the EDC and navigate to a central page to review notifications, study metrics and risk-aware reports. 

By proactively thinking about the types of information monitors need, each study can be configured to provide tools such as these before the first subject is enrolled. With the VISION EDC systemmid-study updates can easily be made to support data monitoring needs that weren’t anticipated at study build time. 

Ensuring Data Quality and Integrity 

Sophisticated EDC systems support automated data cleaning in a variety of wayswhich naturally improves data qualityMonitors and data managers can contribute their expertise at study build time to make sure that this automation is included as comprehensively as possible.  

Use of “Completeness” Checks. Completeness checks answer the question “is all required data on the eCRF?”. This is especially important when some data can be entered conditionally (e.g., only if another data entry element has a certain value). related question is “why wasn’t this form been filled out?”. It’s a good practice to implement a “Not Done” checkbox on forms such as Adverse Events and Necropsy that are (hopefully) not often used. This practice lets monitors know in a proactive way that the form is intentionally blank, which effectively reduces the amount of questions from the monitor. 

Use of “Correctness” Checks. Correctness checks help answer the question “is the data correct and in the right format?”. While study protocols usually provide information about the resolution (e.g., number of decimal places) of data to be collected, they don’t always specify things such as the expected range for data points. Enlisting the support of data managers at study build time will help ensure these checks are in place and are as complete as possible. 

Use of Visual Error Indicators. When visual error clues are present and easily viewable, monitors don’t have to spend time manually reviewing each form for errors. They can focus their efforts on strategic reviews instead. Such indicators also provide immediate feedback when data is entered, which prompts clinical personnel to correct entries in real time. 

Use of Document Uploads. When it is necessary to transcribe data from paper forms, it’s good practice to provide an upload mechanism for those forms so the transcription can be reviewed more easily. This mechanism, along with Source Data Verification (SDV) functionality, is also useful in converting a paper study to EDC. VISION’s SDV functionality allows the monitor to sign off on each data entry field individually or at the form level. 

Use of Integrated Query Functionality. Having the ability to enter queries directly into the EDC system, and to easily see whether queries have been resolved, is an enormous aid to monitors. It eliminates the need for them to revisit queries that have been resolved and move on to more important work. 

Qualify the EDC Vendor’s Infrastructure. We’ve defined mechanisms for ensuring the completeness and correctness of data, but how secure is it? EDC vendors should be asked about their backup strategy.  How often is data backed up? How much data could I potentially lose? How long does it take to restore data? How long is data retained? These are some good questions to ask your EDC provider before your study commences.  Prelude recommends (and performs) hourly backups. Questions about barriers to system access are also importantAsk your vendor what their average up-time is. If clinical personnel can’t enter data in real time, data integrity could be impacted. 

Monitor Workflow – Continuous Monitoring 

 Here are some recommendations for conducting remote clinical monitoring using VISION™. 

  • Identify a monitoring schedule and stick to it. For slow-enrolling studies, this might be once or twice a week. Larger, more active, studies may require full time monitoring efforts. 
  • Create focused reports that highlight potential risk areas and promote identification of outliers or undesired patternsConfigure the Dashboard to include these reports and share them with other clinical personnel to promote awareness. 
  • Consult the Dashboard to make sure notifications have been handled and to get an idea of emerging trends that require analysis. 
  • Review forms that have been submitted by clinical personnel and use the Query function to call attention to questionable data. 
  • Review recent lab results for out-of-range results and determine if those relate to Adverse Events. 
  • Review fields with changes to see if there are any patterns and clarify their use with clinical personnel. 

It’s important to perform these activities continuously. Contemporaneous identification of issues is critical when safety is concerned and helps clinical personnel recall specifics they are likely to forget after time passes. Also, when monitoring is done continuously, study close-out activities can be completed much earlier since most of the work has already been done! 

Conclusion 

Monitors who understand the capabilities of their EDC provider and the automation that has been included in their study have an advantage. They can rely on the EDC system to handle the “grunt work” and concentrate instead on critical outcomes and analyses that can’t be automated.