New EDC Feature for POC and Phase 1 studies

Prelude announces a new EDC feature that streamlines data entry for Proof of Concept (POC) or Phase 1 studies. Multiple Subject Data Entry allows users to enter data for multiple subjects at the same time using a single form. Users can configure this form at the site level by selecting the subject level forms and fields for entry. Filters can then be used to select a subset of subjects for processing.

Screen shot of Multiple Subject Data Entry

The VISION™ EDC will post the data to the each subjects’ eCRFs once the data entry is complete. The system will also update the audit trail so that the field changes are attributed correctly. If errors or warnings resulted from the data entry, the subject list page can used to quickly identify those subjects and forms.

This feature is very useful when values are collected for subjects in rapid succession e.g., taking everyone’s vital signs or (for animal studies) counting fleas. In such instances, data is typically manually entered on a clipboard and then transcribed to EDC. Transcription typically requires navigating from subject to subject, which can be error prone and time consuming.  Use of Multiple Subject Data Entry eases transcription and facilitates using the EDC as eSOURCE.

The new Multiple Subject Data Entry feature was designed to offer an extreme level of efficiency for users. It is easy to configure and easy to use. Ask your Prelude project manager today about including multiple subject data entry in your next POC or Phase 1 study! This feature in combination with our powerful EDC, CTMS and CDMS functionality truly makes the VISION™ EDC an industry leader.

Announcing Source Data Verification in VISION EDC

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 give clinical trial monitors an easy way to see which fields still need to be verified.

 

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 formThis 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. 

 

The audit trail shows information about the user who performed the Source Data Verification.

 

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 responsibilitiesOccasionally, 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! 

 

Schedule a Demo

 

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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How Can Document Management Simplify Your Study?

Streamline data-capture by using Vision’s built-in documents manager. You can keep all of your data and communications in one, easy-to-navigate place. Not only will assigned users have instant access to communications and updates, but you will be able to track who has viewed or edited what. No more unresponsive team members claiming, “No, I didn’t see that last update!” when really, they just forgot to respond to it (you know who you are).
Simply navigate to the applicable patient or site where you intend to upload a file or attach a note. Typically, the last or second-to-last form under each patient and site is labelled Notes/Comments/Errors or Comments/Errors. Under this file group will be a notes form. This can be used to append documents like medical histories or previous labs results to a specific patient or signed forms to a specific site. Team members can also add short comments as necessary throughout the study. Prelude offers this form group as part of every contract, but it can also be customized to suit your unique study’s needs.
There is also a form where users can upload transcribed CRF’s, making it easier than ever for sites to keep a thorough record of all essential documentation for their subjects. This basic form includes a place to record the date and time uploaded, the name of the electronic version of the form where the data was transcribed, as well as a link to that form within the system, the reason for transcription, and checkbox where the monitor can indicate that they reviewed the transcription. But don’t forget: this form can be customized to include any extra details your study requires.
Ask your Prelude Project Manager about even more ways to tailor your study’s forms to meet all your document management needs!

 
 

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How Can the Dynamic Drop-Down Menu be Utilized in a Study?

VISION’s user-friendly tools for customizing forms includes a handy tool known as the dynamic drop-down. This deceivingly simple field packs a lot of punch. While you can leave the drop-down menu as just that, a menu and nothing more, did you know that you can also use this menu to populate other fields or even populate it from other fields?

A great place to use this tool is on the Adverse Events and Concomitant Medications forms, so that the two can communicate with each other. If a con med gets administered to a subject due to an adverse event, both need to be documented. Using a dynamic drop-down menu on each form for the relevant subject saves a great deal of time and streamlines documentation. Once it is noted on the con med form that a medication was administered after an adverse event, then a menu appears with all previously entered adverse events for that subject. Simply select the correct event, and now the medication and adverse event are linked. Vice versa, If an adverse event required the administration of a medication in a subject, then you can select from a drop-down menu on the adverse events form all previously entered con meds.

This tool opens the door to many more opportunities for customization and, therefore, simplification of data-entry. Signature drop-down menus can either be populated from another field, i.e., from a list of names, or be role-based, meaning the names of every user who has been assigned a specified role will appear as an option. The menu for the reason a subject was withdrawn can be pre-populated conditionally, e.g., only if the subject was euthanized. This would save the investigator time as there would be no need to answer a slew of unnecessary questions to close out a patient. The transcribed CRF form features a drop-down menu that can be based on all forms or form groups, or it can include or exclude specific forms or form groups. Dynamic drop-downs can even communicate between subjects and sites, e.g., when updating con med and adverse event dictionaries.

Do you have a need for any other dynamic features? Let us know!

 
 

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What is the Purpose of User Acceptance Testing?

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.