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.  

Four more Project Managers received CCDM Certification

Senior project managers Anita Iyer, Amy Ashford and Andrew Tieken, and project manager, Corina Bereanu passed the Certified Clinical Data Manager exam this week. The CCDM Certification represents the highest level of knowledge, education and experience in clinical data management.

Alicia Browner, Chief Technology Officer at Prelude said, “Our Clients deserve the best trained staff in the industry. Prelude is committed to both quality and excellence in data management. Our investment in our staff shows that we have attained this high level of achievement. Our Clients can be confident in choosing Prelude as their EDC partner.”

With a total of 6 project managers having received the Society of Clinical Data Management’s Certified Clinical Data Management certification, Prelude is well on its way to becoming a SCDM CCDM® industry partner.

Dr. Alicia Browner participates in Artificial Intelligence Panel at SQA CVIC Meeting

Alicia Browner, Ph.D., Chief Technology Officer at Prelude Dynamics, presented today at the Society of Quality Assurance CVIC Meeting. Dr. Browner was selected to present as one of the panelist on the topic of artificial intelligence (AI) in health care and clinical trials.

The presentation focused on approaches to validation and how the FDA treats artificial intelligence technologies. The ultimate goal of AI is to get the computer to think and act like humans with the focus on thinking and acting rationally in order to be able to perform some of the functions we currently rely on humans to do. Currently, popular AI include Alexa, Siri and Sophia, all of which can do the simple task of looking for and retrieving information and sometime taking action such as playing a song. Yet, AI could do so much more.

Dr. Browner worked with neural networks and optimization in aerospace before founding Prelude Dynamics. She is currently developing an AI risk-based monitoring (RBM) tool to aid clinical study monitors in managing and monitoring the data. VISION™ Clinical Trial Optimization Platform already contains an innovative technology in its dictionary coding function. The function instantaneously matches the best options as the user types, allowing them to quickly select from a dictionary like WHO Drug, that contains over 300,000 entries. This IntelliMatch functionality is also used in search, reports, and exports as well as in the combo fields. Prelude is also planning to augment this technology with a learning algorithm to help offer the most prevalent options.

Dr. Browner said, “AI is going to change the landscape of clinical research. At Prelude we are strategically implementing our AI strategy and helping lead the industry into its implementation.”

Applications in artificial intelligence use methodologies to present knowledge, plan, process natural language, perceive things like speech, facial and object recognition, move (motion, as in robotics), and have social intelligence. One of the challenges, as an example, is that communication is known to be 80% or more non-verbal. So how do you teach a computer to understand that? The current strategy is machine learning.

Machine learning is the process of teaching a computer to learn by providing it with information and learning experiences. Initially, programmers teach the computer to learn through supervised learning. The end goal is for the computer to learn unsupervised. In order to accomplish this, technologies such as Baysian Networks, Neural Networks and Evolutionary Algorithms can be applied to assist decision making.

Senior Project Manager received CCDM Certification

Senior Project Manager, Jasmine Granado, passed the Certified Clinical Data Manager exam today. Jasmine’s passing this exam represents her attainment of the highest level of knowledge, education and experience in clinical data management. Alicia Browner, Chief Technology Officer at Prelude said, “Our Company is committed to excellence, not only in our technology, but also in our people. We congratulate Jasmine on obtaining certification. She is an excellent project manager and we were confident she would pass.” With Jasmine’s certification Prelude is one step closer to achieving SCDM’s designation of CCDM® industry partner, a designation only held by 14 other companies in 2017.

First CCDM designation received by Staff

Congratulations to Dr. Karina Loyo for becoming the first in our office to be a Certified Clinical Data Manager by the Society of Clinical Data Managers. Dr. Loyo passed the certification exam on August 22nd. This represents the first step towards SCDM industry partner certification for Prelude.

Prelude’s staff are integral in implementing best clinical data management practices to Client’s studies. Gaining recognition through SCDM’s CCDM certification provides an independent qualification and assurance to our clients about the quality of the staff they interact with and who manage their studies.

Richard Tieken, CEO, said, “We want every client to know they are in the best hands possible. Providing staff who are Certified Clinical Data Managers is just one way in which we continue to elevate the bar of excellence for our customer service, and show our commitment to the industry to always be at the leading edge of technology.” Prelude expects for other project managers to obtain their CCDM in the near future and is on track to achieve SCDM’s designation of CCDM® Industry Partner in the following months.