How NOT to Design eCRFs

There are so many ways to design electronic CRFs. Perhaps by looking at how NOT to design them, we can come up with some fresh ideas for how to make your next study a smashing success.

Fail to consider how well the forms will function on handheld devices.

The sun us setting on big screens and desktop workstations. Soon a new day will dawn, and the sun will shine solely on small screens. They provide mobility and greater access across the board. They are the key to conducting business in the information age.

Take, for example, form layout. Regardless of whether you are viewing it in landscape or portrait, a long list of fields is not conducive to the thought-processes of the human brain. Fields need to be grouped together in a way that makes sense to the person filling it out. And news flash: the person filling out the forms for your study is guaranteed to be relying on a human brain.

Put simply: don’t shortchange the design process of the study build in favor of a quick turnaround. You will thank yourself later when you are parsing through the raw data for usable statistics.

Require users to navigate extensively to do their jobs.

Do not bury important fields at the bottom of the form. Don’t force your sites to have to dig deep to get what you need. Cater the form configurations to quick and easy navigation.

Employ checkboxes instead of radios.

Simplify the investigators’ jobs before they even begin. Give them less options when possible. Dummy-proof your study to the point where the patients themselves could fill out their forms.

Don’t provide options for “Neither,” “N/A,” “Not Done,” or “Other.”

Bottlenecks happen when a field is lacking necessary options. The investigator will simply leave it blank if they do not see the option they need. Then the monitor goes in and queries the blank field. The investigator responds that they didn’t perform that particular test. The issue gets shunted up the line until it gets to Prelude and a mid-study update is requested to add the pertinent option to the field in question. This takes time, causes confusion, and costs extra support hours, depending on the complexity of the request. There will always be mid-study updates. It’s a normal part of the process, but some things can be prevented. Do your best to predict issues before they happen, and your study will run much more efficiently. Just don’t overthink it…

Assume that the data will be entered in a certain order.

After taking into account all of the above, we’ll leave you with this: You can’t predict everything. Put as much thought into your eCRF’s as you can, but first you have to learn the difference between what you can control and what you cannot. Providing a radio in place of a list of checkboxes is all well and god, but don’t assume they will fill out the first item on the form first. Don’t go overboard with field suppressions and calculations. Try to think the way a clinical would. That’s all you can do.

 
 

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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.

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.

Prelude Commits to Excellence in Data Management

Clients trust Prelude’s expertise in helping them with their electronic data capture (EDC) and data management needs. This trust has been honed through years of dedication to providing the gold-standard in EDC functionality.  We have taken VISION™ beyond EDC to provide an all-in-one comprehensive platform that provides not only EDC, but also Clinical Trial Management System (CTMS) and Clinical Data Management System (CDMS) functionality.

Now, Prelude is taking our excellence in Data Management to the next level by committing to obtain recognition from the Society of Clinical Data Management as an industry partner in Data Management Excellence. Obtaining this designation is no easy feat. At least 25% of all personnel or a minimum of 10 employees engaged in data management must be Certified Clinical Data Managers (CCDM). The CCDM certification exam is comprehensive and rigorous. The passing rate is around 55% of those who take the exam. Currently, there are less than 20 industry partners.  Achieving it truly represents excellence in data management.

Prelude is committed to obtaining the SCDM CCDM Data Management Industry Partner status in the next 6 months.

Richard Tieken, CEO at Prelude said, “Showing our clients that they are dealing with only the best and most qualified company is as important to us as making sure our Client’s data is clean and safe. Becoming an industry partner is a natural step in letting our Clients know how committed we are to ensuring excellence in our software system and in their data.”

About half of Prelude’s staff is directly engaged in data management functions which include project management and building of studies. All project managers currently meet the qualifications to take the certification exam and most of them have already been approved to take it.

The Future of Visual Study Archives

Your EDC study has come to a close. All data has been finalized and the database has been locked, and now –it’s time to generate your study archive. How do you make sense of all that data visually? The last thing you or your data reviewers want to do is struggle to make sense of overwhelming data delivered in an endless and flat-lined, row-by-row spreadsheet.

In Today’s results-driven landscape, data aesthetics can often play a back-seat role. Large XML files storing computer-strung data points are comprehensive but not entirely human intuitive. Data reviewers can easily overlook relevant data while struggling to understand the visual context in which that data was entered. Flat XML files provide the full data in a raw form, but the visual picture of the study’s conductive methods is incomplete without…. well, visuals of the CRFs. What are the current solutions around this data presentation problem?

In recent years, visual PDF copies of case report forms have been the answer, but with PDFs there is still the problem of how to manage and bookmark every single screen of the study that was once viewed online, in a web-based EDC system. The PDFs are stagnant screenshots and require scrolling through a library of them, in a tiresome fashion. The ability to scroll through and navigate among every single PDF, paralleling the method in which the data was entered is just not feasible.

Prelude Dynamics has a better solution: an offline HTML archive. Dynamic and intuitive in structure it is easy to generate, access, and use. an HTML archive means no longer becoming entangled in a web of spreadsheet columns, unmanageable libraries of PDFs, and no more costly server fees to perpetually host the study for intermittent visual access. The HTML archive displays the entire study and its layout for you with a visual presentation of all data and function captured in one place.

The beauty of an offline HTML archive lies in its dynamic use and its cost reduction; all the appropriate links, highlights and audit trail per form are preserved and navigable exactly as they were presented within the EDC upon collection, but without the cost and security concerns of keeping a server running indefinitely. An offline HTML archive captures all the same data and their hierarchies in a read-only format just as it appeared within the EDC. This makes it infinitely easier for the auditor or data reviewer to navigate and visually scrutinize data results in question. Who entered what where and why are frequent data review questions easily answered with a visual archive.

With Prelude Dynamics’ VISION™ solutions, clients can receive the offline HTML archive in addition to a fully provided XML database (a SAS-approved import format and a native format.) The HTML archive really shines in providing a visual glimpse of studies past in read-only fashion, without altering the data format and results which were initially entered. HTML pages remain locked so they are not editable or alterable when viewing through any browser.

As clients grow the scope of their studies to get the most out of EDC, Prelude Dynamics provides greater solutions for data organization and presentation, in line with the expanding data submission requirements from regulatory agencies world-wide. Regulatory groups are putting increasing emphasis on the review process, and we believe that an offline HTML archive solution will surpass the PDF standard in greater visual accuracy, navigation, and preservation of data.

The future of visual study archives is offline HTML, an emerging standard that makes archives, data review and submission simpler and more fluid for all stakeholders and sponsors, and effectively expedites and refines the review of clinically studied products and their efficacy. HTML archive is an archive solution worth the investment.