Prelude Dynamics’ VISION™ platform is the only EDC that provides an electronic interface with IDEXX labs – making VISION the preferred EDC in animal health. This interface greatly reduces the errors inherent in manual reporting, which saves clinicians and pet owners time and saves sponsors/CROs money.
IDEXX recently upgraded their Laboratory Information Management System (LIMS) to include some backend improvements as well as a new customer-facing feature that will clarify some aspects of reporting. Prelude and IDEXX developed and conducted a formal validation on this improved interface in a collaborative fashion – ensuring future smooth operations.
Previously, IDEXX provided the following flags with each reported lab result:
- Normal – the result was within normal ranges.
- High – the result was higher than normal.
- Low – the result was lower than normal.
- None (blank) – an observation for which there is no normal range.
An additional flag of “Not Applicable” has been added and is now used for results of “Do Not Report” (DNR) or “Quantity Not Sufficient”, which were previously not flagged. This new flag will serve to alert clinicians when samples should be re-taken (or other appropriate action) and lessen the chance they will overlook these findings and assume they are normal.
Prelude Dynamics and IDEXX continue to be committed to improving the efficiency and accuracy of clinical data and streamlining clinical research.
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Source Data Verification
Prelude Dynamics continues to enhance our VISION™ platform with crucial features requested by our clinical trial user community. The ability to perform Source Data Verification (SDV) in the context of EDC has become more and more important as we’re migrating away from paper. VISION’s SDV functionality operates at the field level and complements the existing form review capability. How does it work?
Users who have permission to review forms can activate the SDV feature simply by clicking an icon on the form. When this is done, check boxes appear next to the fields on the form.
Check boxes are automatically cleared if the reviewed field is later changed – letting monitors easily see which fields need to be re-reviewed, while preserving the reviewed state of other data entry elements on the form. This is a time-saver for monitors, and saving time saves money!
These field-level SDV reviews are fully attributed and preserved in the audit trail in a 21 CFR compliant manner.
Even though most of our clients use VISION to directly enter data as the source (eSOURCE), in some cases there might be a need for SDV. Let’s consider a few scenarios.
Transcription of data from paper forms
First consider the transcription of data from paper forms (or pictures of paper forms) such as subject/owner logs or paper patient reported outcome forms to EDC. In the past, Double Data Entry (DDE) was typically used for situations such as these. SDV is an improved replacement for DDE, especially when used along with a file upload that allows a copy of the original paper form to be uploaded directly to the EDC.
Review of Adverse Events
Monitors typically want to review Adverse Events as soon as they are entered into the EDC as part of their safety assurance responsibilities. Occasionally, investigators haven’t completed all the information in the Adverse Event eCRF because they are still conducting analysis on the possible cause. In cases such as this, Monitors can review the data that has been already entered. When they revisit the form later, they will know which information has already been reviewed. This also works well for Concomitant Medications.
Want to learn more? Contact us to schedule a demo and stay tuned for news of other new features such as Site Level Batch Data Entry and quick report filters!
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The importance of testing all aspects and features of a study before Go-Live cannot be over-emphasized. That being said, testing can be a very messy process. If not undertaken with a great deal of planning and documentation, the whole process of testing a study can be rendered not only ineffective but counterproductive. In comes User Acceptance Testing (UAT) to the rescue!
First, you might ask, what is UAT and how is it different from other forms of testing? Think of UAT as a dress rehearsal before a play. The actors all know their lines, the lighting director knows all their queues, and the sets have all been built and tested for safety. But you need to see it all together before you fill the seats with spectators. What if those perfectly built sets don’t line up with the spotlights or what if the bulky costumes get in the way of the actors’ performances? All the parts are there and accounted for, but the picture as a whole has yet to be validated.
The study-build process is similar. After each form has been tested separately, and all of the summaries and reports have been set up to your satisfaction, there is still the issue of unforeseen scenarios. You won’t be able to find or fix all the potential conflicts until you test the entire study as one. Set up a new site, enroll several patients, take each one through the entire screening/dosing/withdrawal/etc., process. Then do it again with another patient and another, until you have ironed out as many eventualities as possible. Even then, there may still be unforeseen problematic scenarios, but the purpose of UAT is to mitigate the number of issues that might come up during the Live study as thoroughly as possible. UAT is also a good way to provide you and your team with a finalized, succinct idea of what, exactly, you are signing off on before your sites begin entering patients. Once you complete your final run-through of the study, you can rest assured that you have done everything you can to make your study run smoothly.
Currently FDA official submissions must be in XML or PDF format, with the preference being the submission of at least the XML format. The rationale for these is the need to have a document that will be readable and accessible in perpetuity. This is definitely an important consideration. However, these formats contain limitations when it comes to the review, oversight and approval process as clinical reviewers are more effective “seeing” a case as a set of forms the way the Investigator filled out those forms, while analysis staff are more effective with the XML raw information. How do you handle ancillary data, such as images and graphical information that were part of the process which cannot be imbedded in XML?
Below we will present a case for allowing HTML archives to be added as a part of or one of the allowable formats for FDA submission, fundamentally to support clinical case review. The raw XML would continue to be favored format for data analysis.
HTML, Hyper Text Markup Language, is the foundation of all computer languages used to create web-based interfaces. HTML is a specialized form of XML that when combined with images and style sheets (CSS) make a web page appear as it does. The Internet has been growing exponentially since its inception transforming business and everyday life; the Internet is here to stay and so is HTML. “Billions and billions” of HTML web pages exist in the world today. HTML can be compared to the alphabet. Like the alphabet, it provides us with basic element in which we can combine in order to communicate via web pages. HTML does for computer language what the alphabet does for our language. It is safe to say HTML will stand the test of time.
One might assume that HTML requires a web server to operate, but in fact, an HTML page is just a document that resides on a computer hard drive on a server, and can also be saved locally. All browsers support “Save As” and can save a web page for later viewing when the computer is disconnected from the Internet. All that’s needed is any brand of web-browser. As such, these HTML/XML pages are safe, secure, and as perpetual as any computer file on the hard drive.
Now that we have established that HTML is a viable solution in perpetuity, let’s examine the differences between XML, PDF and HTML archives. The main differences are listed in the table below.
[table id=archives /]
In conclusion, while the XML archive is a natural non-proprietary requirement for data submission because it does allow quick processing of the data in order to analyze the safety and efficacy of a drug, providing HTML data in addition is superior to PDF files in that it facilitates the case review within the same context in which the data was originally collected by Investigators. HTML will increase FDA reviewer’s confidence in the quality of the data and its outcomes.
Prelude Dynamics has initiated conversations with FDA CVM to discuss allowing HTML archives to be submitted. Among the discussion is also the possibility that Sponsors could chose to allow CVM to have access to the server in read-only mode where they could interact with the study data and even run reports, statistics and graphs within the system before final submission occurs in order to guide sponsors on any additional requirements or concerns they might have in order to help expedite the final review process, reduce the need for clarifications, and be quicker to market.
Jim Pedzinski – VP of Business Development
jpedzinski[at]preludedynamics.com – 512-476-5100 ext. 210