Exciting Updates to the VISION DIY Study Builder!

The VISION 10.8 maintenance release is now available and is being rolled out to live studies. This release includes some much-anticipated enhancements, which were developed to facilitate the experience of both study builders and end users. Let’s look at a few of these in more detail! 

  • Use of images instead of textual labels.
  • IDEXX Labs – configure specific tests for study visit days.
  • Calculation copy feature.
  • Set calculation priority using Drag and Drop.
  • Data encryption at rest.

Use of Images instead of textual labels

Sometimes, a picture is worth a thousand words. VISION now supports the ability to use images to describe data entry fields. End users find images easier to relate to and understand than text, which means they can enter data more efficiently and correctly. These images can also be used in VISION’s ePRO app.

IDEXX study visit lab configuration

Now you can easily configure the lab tests for each study visit using an intuitive interface. This reduces training requirements for sites and increases protocol compliance.

Calculation copy feature

When specifying calculations for a particular eCRF, it is common to have a set of operations that behave in a similar fashion. Instead of building each calculation from scratch, users can now simply copy an existing calculation and then modify it as needed. This significantly streamlines the time required to program eCRF calculations and increases usability.

Set calculation priority using Drag and Drop.

Until recently, calculation priorities were set using an explicit numeric value. Now users can set an “Auto-Prioritization” attribute – which allows calculation priorities to be set to the order the calculation cards are displayed in. This feature helps form builders gain a quicker and more intuitive understanding of the logic used in form calculations.

Data Encryption at rest

All data in the VISION database is encrypted in transit (e.g., over the internet). It’s now possible to specify that data be encrypted at rest – offering an extra level of security for Protected Health Information.

Introducing the VISION SOP Manager

Why use two different systems to manage clinical data and SOPs?

Organizations who use VISION™ will be interested to know that Prelude Dynamics offers an out-of-the-box SOP Management tool.  This flexible tool is implemented using VISION and supports all the familiar tools and features our user community is familiar with. The SOP Manager fosters compliance by providing notifications in advance of required SOP review dates and is 21 CFR Part 11 Compliant.

The concept of Sites and Subjects is overloaded in the VISION SOP Manager. Sites are SOP Sections and Subjects are SOPs. Two key areas of functionality are supported: SOP Management and SOP Training Records.

SOP Management

SOPs are authored using any standard text editor (i.e., Microsoft Word) that supports change tracking, and a description of revisions is contained within each document. The following process is used to revise an SOP.

  1. With change tracking turned on, a subject matter expert authors/edits the content to comply with current best practices.
  2. The edited source document along with a PDF is uploaded to the SOP’s form.
  3. A different subject matter expert performs a content review of the SOP and electronically signs off on the SOP’s form.
  4. A QA staff member performs a QC review of the SOP and electronically signs off on the SOP’s form.
  5. Once the reviews are done, the SOP is finalized.
The SOP List page contains columns that show the effective date, last review date and next required review date for each SOP. These columns can be used to sort the list page and quickly see which SOPs are due for review in the near future. This helps the quality department stay on top of SOP update deadlines.
There is also a feature that allows users to view all the SOPs that were effective on a certain date. This is especially useful when regulators are interested in knowing the state of the organization’s SOPs when a particular clinical trial was conducted. We use the VISION SOP Manager internally and have noted that auditors find it easy to navigate.

As a bonus, we have an “SOP Management” SOP that we can provide as a template. This template can be used as a baseline and adapted to suit your organization’s process.

SOP Training Records

An important aspect of any organization’s Quality System Management Plan is to record and track staff SOP training. This is done in the context of study users, who each have a demographics form and an annual training form group. This form group contains on-demand forms that can be created for each training session. These on-demand forms are automatically populated with the list of SOPs and are used to record when training on each SOP was completed.

The system supports multiple types of training including “self study”, “group training”, “annual training” and “new employee training”. It also supports an annual training summary for each staff member that facilitates compliance assessment.

Customization Options

While the SOP Management tool can be used “out-of-the-box”, it is natural for organizations to request customizations. Because the tool is implemented in VISION, these can be accommodated in a fast, cost-effective manner. Some popular customization options include:

  • Setting up user roles to match your organization structure.
  • Review cycle requirements (e.g., Annual, Biennial, etc.). Internally, we use Biennial – but this can easily be modified.
  • Custom summaries.

Conclusion

The VISION SOP Management tool is an intuitive and flexible system that is already familiar to VISION users – reducing the training requirements associated with migrating to a new SOP Management tool. It allows organizations to migrate completely away from binders of paper documents and seamlessly integrates staff training – helping to assure compliance.

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VISION + IDEXX Labs – a Powerful Partnership

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.

Prelude Dynamics and IDEXX Laboratories - A Powerful Partnership in Animal Health

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.

IDEXX High/Normal/Low Flags

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.

New IDEXX "Not Applicable" Flag for results
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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VISION™ Incorporates AI Technology for Monitors

Study Monitors have a lot on their plates. While VISION’s automated data cleaning capabilities make their jobs easier, we thought it be useful to provide them with a tool that would automatically flag database fields that are more “challenging” for sites to complete. Our new AI Monitoring Enhancement Engine (AIMEE) does just that. When monitors are reviewing a form, they can turn AIMEE on with a single click of the mouse and instantly focus on database fields that are historically known to require attention.

A single click of an icon turns on AIMEE.

AIMEE calculates a score for each field and highlights those that require attention.

AIMEE calculates a score for each field and highlights those that require attention.

How does it work? AIMEE learns over time and calculates a risk score for each field on the form, and highlights those that merit further scrutiny. What is this score based on? AIMEE looks across all instances of the form in the study and considers the number of changes, queries, comments, and occurrences of errors and warnings for each field on the form. It uses that information to generate a score, which is intuitively displayed next to each field on the eCRF. Low scores are “good” and high scores are “concerning”.

AIMEE works well in conjunction with VISION’s field-by-field review functionality – which monitors can use to indicate which fields they have already investigated. This in turn lowers monitor workload by helping them avoid duplicate efforts.

Reach out and ask for an AIMEE demo today!

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CVM’s Remote Access Pilot Program

CVM’s Office of New Animal Drug Evaluation (ONADE) has launched an initiative that will greatly increase the efficiency of the study submission process. They will now allow submissions through read-only access to online databases in lieu of the submission of copies of the data. Prelude Dynamics is participating in this pilot program with two study sponsors, and we are optimistic for successful outcomes in both. The primary advantages of allowing CVM direct study access as opposed to the submission of copies of the data are:

  • For CVM: With access to the online database they will be able to view the data in a more natural, intuitive way. Spreadsheets do not provide the context that the full database can and are therefore not as suitable. With access to the database, CVM can view all the audit trail information right alongside the source data.
  • For Sponsors/CROs: Online access eliminates problems with multiple file uploads and file size restrictions that make the current submission process cumbersome. The burden of “packaging up” study data in a eSubmitter-ready format is removed. Submissions will be faster and less costly.

Preliminary results with one EDC system are promising. Both CVM and pharmaceutical companies are enthusiastic for the future of the study submission process.

For studies to participate in the program, some documentation is required up front. Prelude Dynamics has also removed this burden from Sponsors and CROs by offering prepared templates for interested parties. If you are interested, ask your Prelude project manager for a template today! They can help you submit your information to the right people at CVM.

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VISION™’s Invoicing Incentivises Sites

Integrated invoicing is a powerful mechanism for incentivising site participation. It also eliminates extraneous trial management activities. What is it and how does it work? This article takes a closer look at integrated invoicing and how it can work for you. 

Sites deserve to be paid for completed study activities in a timely manner.  Payment milestones such as examination completion, lab result analysis, subject visits are known in advance and documented in the master fee schedule for the study or site. Since these billing milestones are well-defined, the study can be configured to automate the creation and submission of site invoices. This eliminates paperwork for the sites, ensures accuracy, relieves study managers of invoice verification activity and speeds payment.

VISION™’s integrated invoicing functionality allows configuration of invoice line items in a flexible and powerful manner. Examples include:

  • Subject enrollment
  • Study visit completion
  • Physical exam completion
  • Lab samples drawn and sent to lab 

Invoice line item generation can be tied to field completion, a form’s state (e.g., Reviewed or Finalized), the states of a set of related forms, or a combination of the above. Sites across a study are rarely run the same, and it is not uncommon to see a variation in payment schedules across sites. VISION™ allows the invoiced amount for each line item to be configured for each individual site if desired.

It’s common practice to configure the EDC so that the investigator sign off on each invoice activates submission. This serves as an indication that the investigator has reviewed and approved each invoice. Did you know that VISION™ can also be configured so that the invoice can be annotated when payment has been made? Study monitors and project managers can easily see the real-time status of all invoices using VISION’s reporting tool. 

Streamline trail administration activities by using this powerful feature! Sponsors/CROs who don’t take advantage of integrated invoicing often tell us they wish they had used it.

Learn more about integrated invoicing in this International Animal Health Journal article. 

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