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.
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.
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!
What does it mean to conduct effective remote clinical monitoring? It’s critical to be using an EDC in order to accomplish this, but what else is necessary? Keeping the primary goals of the monitor in mind, we will outline several techniques for streamlining this process.
What are the primary goals of the study monitor? First, and most critical, is to ensure the safety of all study participants – including clinical personnel. Second, is ensuring data quality and integrity.
Let’s discuss the EDC features that can help in each of these areas.
Monitors are relied upon to use their knowledge and expertise to recognize potential safety risks, and to report them when discovered. The EDC can’t replace monitors, but it can assist them greatly in their daily workflow.
Use of Notifications. The EDC can be configured to automatically notify monitors when certain events occur. Examples of this include the entry of adverse events, the reporting of out-of–range lab results and new subject enrollment. When automatic notifications are used, monitors are informed in real time and the need to continually review eCRFs for potential issues is eliminated – saving valuable time. Think about the potential risk factors for a study and consider how notifications can be configured to assist the monitor.
Use of Reports and Graphs. Some EDCs support flexible, configurable reporting tools that facilitate the aggregation of data for review. Graphs can be used to more intuitively spot outliers and aid in understanding trends. If such tools are not available, consider asking your EDC provider for custom summary reports that can be used to review study endpoints, exam results and adverse events in a comprehensive way.
Use of Study Dashboards. Dashboards that aggregate reports from multiple sources can provide a convenient starting point for a monitor’s daily workflow. Monitors can log in to the EDC and navigate to a central page to review notifications, study metrics and risk-aware reports.
By proactively thinking about the types of information monitors need, each study can be configured to provide tools such as these before the first subject is enrolled. With the VISION™ EDC system, mid-study updates can easily be made to support data monitoring needs that weren’t anticipated at study build time.
Ensuring Data Quality and Integrity
Sophisticated EDC systems support automated data cleaning in a variety of ways, which naturally improves data quality. Monitors and data managers can contribute their expertise at study build time to make sure that this automation is included as comprehensively as possible.
Use of “Completeness” Checks. Completeness checks answer the question “is all required data on the eCRF?”. This is especially important when some data can be entered conditionally (e.g., only if another data entry element has a certain value). A related question is “why wasn’t this form been filled out?”. It’s a good practice to implement a “Not Done” checkbox on forms such as Adverse Events and Necropsy that are (hopefully) not often used. This practice lets monitors know in a proactive way that the form is intentionally blank, which effectively reduces the amount of questions from the monitor.
Use of “Correctness” Checks. Correctness checks help answer the question “is the data correct and in the right format?”. While study protocols usually provide information about the resolution (e.g., number of decimal places) of data to be collected, they don’t always specify things such as the expected range for data points. Enlisting the support of data managers at study build time will help ensure these checks are in place and are as complete as possible.
Use of Visual Error Indicators. When visual error clues are present and easily viewable, monitors don’t have to spend time manually reviewing each form for errors. They can focus their efforts on strategic reviews instead. Such indicators also provide immediate feedback when data is entered, which prompts clinical personnel to correct entries in real time.
Use of Document Uploads. When it is necessary to transcribe data from paper forms, it’s good practice to provide an upload mechanism for those forms so the transcription can be reviewed more easily. This mechanism, along with Source Data Verification (SDV) functionality, is also useful in converting a paper study to EDC. VISION’s SDV functionality allows the monitor to sign off on each data entry field individually or at the form level.
Use of Integrated Query Functionality. Having the ability to enter queries directly into the EDC system, and to easily see whether queries have been resolved, is an enormous aid to monitors. It eliminates the need for them to revisit queries that have been resolved and move on to more important work.
Qualify the EDC Vendor’s Infrastructure. We’ve defined mechanisms for ensuring the completeness and correctness of data, but how secure is it? EDC vendors should be asked about their backup strategy. How often is data backed up? How much data could I potentially lose? How long does it take to restore data? How long is data retained? These are some good questions to ask your EDC provider before your study commences. Prelude recommends (and performs) hourly backups. Questions about barriers to system access are also important. Ask your vendor what their average up-time is. If clinical personnel can’t enter data in real time, data integrity could be impacted.
Monitor Workflow – Continuous Monitoring
Here are some recommendations for conducting remote clinical monitoring using VISION™.
- Identify a monitoring schedule and stick to it. For slow-enrolling studies, this might be once or twice a week. Larger, more active, studies may require full time monitoring efforts.
- Create focused reports that highlight potential risk areas and promote identification of outliers or undesired patterns. Configure the Dashboard to include these reports and share them with other clinical personnel to promote awareness.
- Consult the Dashboard to make sure notifications have been handled and to get an idea of emerging trends that require analysis.
- Review forms that have been submitted by clinical personnel and use the Query function to call attention to questionable data.
- Review recent lab results for out-of-range results and determine if those relate to Adverse Events.
- Review fields with changes to see if there are any patterns and clarify their use with clinical personnel.
It’s important to perform these activities continuously. Contemporaneous identification of issues is critical when safety is concerned and helps clinical personnel recall specifics they are likely to forget after time passes. Also, when monitoring is done continuously, study close-out activities can be completed much earlier since most of the work has already been done!
Monitors who understand the capabilities of their EDC provider and the automation that has been included in their study have an advantage. They can rely on the EDC system to handle the “grunt work” and concentrate instead on critical outcomes and analyses that can’t be automated.
For years, technology’s detractors have bemoaned the loss of in-person interaction. While we admit this has been an issue on occasion, it’s now an asset to moving important clinical research forward.
Many human and animal health studies are either still done on paper or require labor-intensive source document verification (SDV). If sites are not using technology for direct data entry, in-person site visits are required to track the data throughout the life of the study.
Another prevalent challenge under current “social distancing” norms is to obtain signatures remotely that are CFR 21 Part 11 compliant. Many data managers are considering eliminating DocuSign as insecure. Adobe Sign has likewise been found by some to be untrustworthy as PDFs can be changed after the original signing. The print/sign/scan method is outdated and cost prohibitive. Many team members do not have printer/scanner combinations in their home office.
Finally, many GCP studies are struggling right now due to a lack of study participants coming into their clinics or bringing their pets back for follow-ups. Enrollment and compliance with a visit schedule are not feasible in these uncertain times where many patients aren’t even allowed in the door.
Given the challenges above, a robust electronic data capture system (EDC) can be more valuable to clinical trials than ever before. Prelude’s EDC, VISION, has been officially CFR 21 Part 11 compliant for close to two decades. The system has been purposefully designed to make direct data entry as seamless as using paper, with eCRFs capable of mirroring the same look and feel as a paper form.
Prelude’s new ePro application gives patients and pet owners unprecedented access to their own forms so that they can follow up on their enrollment schedule from their own home, in many cases eliminating the need to visit clinical sites.
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.
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!