VISION™ Tips & Tricks: Viewing Subject Form State Details

Do you know you can view a Subject’s (or Site’s) forms and their status (aka. Form state) at a glance? Navigate to the Subject List Page. For any given Subject, click on the plus/minus (+/-) icon next to the Subject ID field (see Figure 1). The above is also applicable for Site-level forms!

Figure 1. Displays expanded list of Subject ATL-012-IUM Forms.

This will show this Subject’s listing of applicable forms, if any of those forms have Queries (and the status of those queries), and the *Form State of the forms. Additionally, hover over any of the form icons to view the specific form’s title, form state/status (see Figure 2).

Figure 2. Displays tool tip for the first form within the “Screening” form group. Vitals/Phys Exam has a form state of In-Work and has errors that the user should resolve.

*Form States are used to determine the state of the form. The form icon is color-coded to indicate the status of that form.

  • Blue = In-Work
  • Orange = Submitted for Review (User has signed the form)
  • Yellow = Reviewed (User with appropriate privileges has reviewed the data on the form)
  • Green = Finalized (User with appropriate privileges has finalized the form- edits can no longer be made to the form unless a user with appropriate privileges revers the finalized status)
  • No color indicates that the form is “new” and no data has been entered.
  • A Red form icon indicates that there is an error(s) on the form that must be resolved before the user can Submit for Review.

The Future of EDC is Here!

Last month we attended SCDM Annual Conference to present a panel on “Cleaner Data Faster: Leveraging EDC/CTMS in Global Studies”, we also attended a session on the “Future of EDC”.

The session began with a discussion surrounding eConsent, eSource and ePRO as the future of EDC, the next frontier of eClinical solutions. We were over the moon! We could barely contain our excitement. With Prelude and VISION, the future is already here! As many of you know, VISION has been collecting eSource documents for over a decade! Some of you have taken advantage of having patients log into our system for nearly as long. While we have not called it specifically eConsent and ePRO, the functionality of allowing patients to enter their own data, access their consent form and sign it electronically has been a refined capability of VISION for a very long time.

The session also discussed wearable devices and having the ability for an mobile device to input information directly into our system. You might already know that we have direct lab interfaces with IDEXX Labs and Marshfield Labs US and continue to work in partnership with other labs to integrate systems. VISION also seamlessly pairs with RFID and barcode readers. VISION’s technological flexibility allows us to develop an efficient interface with just about any external device or wearable and collect data necessary for your project.

Finally, they discussed advance computer learning and virtual and augmented reality. Much of the advance computer learning is still human driven, i.e. someone has to think about what is important for the computer to focus on and what the computer should do when it identifies that pattern. The reality is that humans are still figuring that out. The same goes for virtual and augmented reality, even the speakers were not sure exactly what that might look like or how it might be applied. We can assure you that we are constantly listening to what your needs and the needs of the industry are and continuously develop functionality to streamline your operations.

Most recently statistics, graphing and a dashboard were added to our VISION product line, just to name a few. These are updated instantaneously as new data is available. We feel that this is the first step towards providing you with advanced computer learning and currently all that can be done until someone is able to verbalize what else is needed; the panel did not provide details.

In conclusion, the future of EDC is here. It is called VISION. It is in your hands. Whether you contract our Premuim package or choose to use our build it yourself Composer tool, you have access today to the future of EDC and it’s never looked so bright!

VISION™ Tips & Tricks: Running Reports on On-Demand Forms

Ever wonder how to run reports for *on-demand forms? Wonder no longer! Navigate to the Subject List Page (or Site if running the report from there), click the Reports (see Figure 1) button towards the bottom of the page.

Figure 1. Reports button

Select the forms and fields you would like to see in the Report. In this example, I am pulling the Subject ID and the Unscheduled Visit date(s). Figure 2 displays the on-demand Unscheduled Visit forms- this example has two of them.

Figure 2. on-demand Unscheduled Visit forms

For an on-demand form (Unscheduled-Vitals/Phys Exam), you will see an extra field appear next to the form name- this is for the form “number.” You can enter 1 to x, depending on which on-demand form you’d like to view data from. Conversely, you can leave it blank which will pull data from all available on-demand forms.

When pulling from all on-demand forms, if more than one form exists, the data will list out within one cell (see Figure 3).

Figure 3. The Visit Exam Date fields from ALL of the Unscheduled Vitals/Phy Exam appear for Subject ATL-003.

*What’s an on-demand form?

On-demand forms are those forms that can be added as required. The first form is always available and subsequent, identical forms can be added as needed. Common examples of these are unscheduled visits, daily assessments, and serious adverse events forms.

Tailored Exports: SAS xport format available with VISION

While XML exports and archives are the preferred format for FDA/CVM submission, the older SAS xport (XPT) format is still allowed by and is being used by some companies for their data submission. VISION™ has always provided XML format and and now it’s possible for you to generate XPT files, on-demand, of any and all your data.

The three acceptable file formats for FDA/CVM submission are XML, XPT and PDF. The choice of which format is largely in the hands of the sponsor uploading the data via e-Submitter. A PDF option is currently available as part of the final archive but Prelude’s VISION™ platform provides Clients with the ability to export both XML and XPT files directly from within the system. Log in, select your data set, and click to download.

XPT has been around for a long time and as such is used in a legacy fashion by those that have been working in the industry for decades. XPT has some limitations, as its variable names are constrained to a maximum of 8 characters; labels, to 40 characters and maximum variable value is 200 characters. The 8 character variable names must be unique and usually require a dictionary (README) that explains what each of the cryptic 8 character names really mean. Despite these limitations, XPT offers the advantage that SAS will read it into row/column tables very quickly compared to SAS’s ability to read XML format.

XML format, which is the VISION™ platform’s raw source data format, is more robust than XPT. It allows data to be stored hierarchically with multiple levels. This provides many advantages in non-proprietary readability without XPT limitations. The FDA has recognized this and for more than a decade has provided guidance on the move to XML in conjunction with standards such as C-DISC and SEND.

In conclusion, even as the XPT format fades away to be replaced by the more robust XML format, Prelude has added the XPT file format to be exported and downloaded with the same ease as XML files. This provides the legacy transformation of XML to XPT at the push of a button and provides Clients with more choices and compatibility and flexibility for older software tools.

Manage Your Clinical Research Budget and Timelines More Effectively with CTOP

Using a Clinical Trial Optimization Platform (CTOP) provides all the benefits of the best Electronic Data Capture (EDC) technologies while also streamlining day to day operations. By going beyond EDC with a comprehensive suite of tools developed to reduce the time it takes to carry out length study management task, Prelude Dynamic’s CTOP is the perfect solution to help reduce waste in research budgets and keep the study timeline on track and even shorten it.

Prelude listens to and understands its client’s pain points in order to continuously develop solutions that will make their studies run more efficiently, make monitoring easier, and ultimately allow data to be cleaned as it is being collected so that once the last patient completes the study, the time to study close is minimal. Many of our clients are locking databases within weeks of the last patient completing the study and are archiving their database the following month. This speed represents a huge cost savings and provides a competitive advantage by allowing the FDA approval process to begin sooner.

CTOP empowers clients to monitor their studies more efficiently by providing standard tools including efficient custom dashboards, integrated query monitoring strategy, access to enrollment information, custom and standard notifications, and mid study analysis tools such as ad-hoc reports, graphing and statistics. As well as, premium tools including just-in-time randomization, inventory management with automatic reordering, invoicing, and document management

Efficient custom dashboards allow users to quickly gain valuable information at various levels. At the patient level, easily filter by sites, create custom filters to view only patients meeting certain criteria for example, only enrolled patients, only females or only males. Sort the data by any column in order to find a patient by patient ID or to quickly find the unresolved queries. A quick look at the form state graphics gives immediate information as to the form states letting monitors know how far a patient has progressed. You can also sort by next event or next event date to identify upcoming work load.

Integrated query monitoring strategy quickly provides monitors with instant information about the state of queries. A query graph shows each site’s total and unresolved queries side by side so it is easy to see if a site is having more issues than another. Two query summaries provide details about the time since the query was entered until it was resolved. Select the query to be taken directly to the field where it is located; after reviewing it click to quickly return to the summary. No need to create reports; these standard summaries are included.

Quickly find unresolved queries on the dashboard by sorting the patients by the query column. Click the query to navigate to it. Within a patient, query icons located on tabs show the state of the query and help users navigate to fields with queries. A query tab lists all the queries for that patient and allows users to respond in line or click to go directly to the field. One  more way in which CTOP accelerates a monitor’s work.

Access enrollment information at a glance by using study-wide or site specific enrollment graph which displays the expected enrollment versus actual enrollment or view the information in table format. This information quickly lets you know how your recruitment efforts are going and whether additional marketing campaigns or incentives are needed to keep your study recruitment on track.

Custom and standard notifications ensure both study management personnel and sites are notified of important information so they don’t miss taking action in a timely manner. For example, notifications are sent to sites when lab results have been uploaded into the system to remind them to review the labs results. Sponsors and project managers receive standard notifications when a patient is enrolled, terminated, or completes the study. Prelude project managers work with clients to determine the best strategy to employ notifications for their study to ensure timely information is provide as pertinent.

Just-in-time randomization provides clients with the same algorithms they can expect to get from a statistician who develops a randomization table. The big differences: 1) the treatment is generated when needed eliminating accidental unmasking by a printed randomization table, 2) if a patient is accidentally given the wrong treatment, just-in-time randomization can adjust its algorithm to ensure the blocks integrity reducing the need for additional patients to be enrolled, 3) if a treatment arm is eliminated mid study, it quickly adjusts the remaining treatments by removing the arm from the settings.

Ad-hoc reports are available to users any time. They are easy to customize and share. Whatever custom information is not part of a standard summary can quickly be turned into an ad-hoc report. Reports can be printed, exported and shared. Existing reports are always up to date with the latest information; no need to run a report – just access it. Many of our clients indicate they love the reporting function because they no longer have to export into excel and send weekly reports. Instead, once the report is shared, anyone can access it anytime.

Graphing and Statistics allow users to quickly view information visually or in a table so they can keep track of what is happening in their study. Using the basic statistical analysis, unmasked users can quickly determine the efficacy of a treatment arm. If a treatment arm appears ineffective, it can quickly be eliminated saving both time and money. Like reports, graphs and statistical reports can be shared and are always up to date.

Inventory management and automatic reordering streamlines the process of managing inventory reducing the time it takes dramatically. As inventory is dispensed to a patient, the system automatically reconciles the available inventory. Once the pre-set low inventory threshold is reached, CTOP’s VISION automatically orders additional inventory and notifies both the site and monitors that the order was placed. Once the order is received, the site and monitors are again notified. Imagine not having to worry about how much inventory a site has because CTOP automatically does that for you. How much time would be saved and how much less stressful would this make the monitor’s job?

Invoicing is a time consuming task for most studies. It is also a stressful part of the relationship with sites when payments are not made in a timely manner. It is not uncommon for both sites and monitors to spend a large percentage of their time just on invoicing. CTOP’s invoicing jut happens! During the normal site’s signing of the forms and monitor’s reviewing the forms, CTOP recognizes that the monitor has approved the forms which trigger a payment to post to the invoice automatically. Sure, the monitor can double check the fee has posted, but since the software is validated and tested before going live, the monitor can simply be confident the invoices being submitted are correct. Sure, occasional additional payments are necessary and there is a place to add those too. Never before has invoicing been so automatic and easy. Suddenly sites are getting paid regularly and monitor’s time is freed up for additional monitoring.

Document management standard summaries quickly allow user to view if a document has been uploaded or is missing. Users can quickly access the document for download and review within a couple of clicks. This allows monitors to be more efficient and to ensure the required data is collected.

Taking advantage of all the tools CTOP has to offer allows studies to operate more efficiently. Like other EDCs as the data is collected edit checks help clean the data and ensure all required data is collected. Yet its many tools allow monitoring to be streamlined, enabling risk based monitoring to occur quickly by using the metrics that could indicate poor site performance. It’s tools such as inventory management, invoicing and document management greatly reduce the time monitors spend tracking and managing these tasks so their time can be spent ensuring quality data and timely recruitment strategies are implemented. Reporting and analyzing mid study data is accelerated when they are shared and automatically updated when accessed. No more time is spent regularly updating reports; it happens automatically.

Providing our clients with the tools they need to operate their studies more efficiently and take their drugs and devices to market sooner drives Prelude Dynamics innovation and desire to provide the industry’s best Clinical Trail Optimization Platform. After all, these are live saving drugs and life changing devices and it is the way we can contribute to better human and animal health.

Improving Measurement Accuracy with Electronic VAS Scales

Visual Analog Scales (VAS) are used because they provide greater accuracy and are more sensitive when measuring a variable that is on a continuum as compared to Likert scales. VAS scales are traditionally used to measure things such as pain and function. Researchers tend to prefer obtaining more accurate data, but have shied away from using VAS because measuring it accurately is time consuming and errors can be easily made. Measuring VAS on paper requires multiple people to measure the location of the mark, and photocopying could change the length of the line.

eVAS captures the same information as previously captured on paper. When the patient touches the screen or clicks on the line, a mark is recorded. The value of this mark is then automatically calculated by the system, eliminating the need of multiple measures and removing errors from the process. This makes eVAS more accurate and superior to Likert scales.

So what are we waiting for? The greatest concern is whether the line can be exactly 100 mm on every screen it is viewed on. Prelude Dynamics solves this issue by using one of two methods: either using a set length line that is not affected by the device’s screen size or by allowing users to calibrate their device using a 10 cm line, such as the length of a credit card. Either will ensure the length of the line.

Alternatively, does it really matter that the line is not exactly a certain length? The length was set when humans needed to be able to easily read the location of the mark on a line, so a scale of 100 mm was appropriate. With computers, the location can be calculated relative to the length of the line with accuracy to infinite decimal points on a by-pixel scale. According to an article in the International Journal of Medical Research, there is no significant difference between the two lengths they examined (100 mm and 75 mm) therefore they recommend the use of eVAS on iPads for patient clinical data collection.

Several studies have been conducted using VISION™’s eVAS. The users report it is easy to use and improves accuracy of the results. Learn more about one such study by reviewing the VAS case study. Consider adding eVAS to your next study if it makes sense for what you are researching.