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.
Prelude’s unique eConsent functionality is the latest in a long line of enhancements aimed at eliminating paper from clinical trials. Up until now, most clinicians have obtained owner and subject consent on paper forms that are then uploaded into the system. Now sites can obtain owner and subject consent electronically the same as for any other user signature for the study.Animal Studies
For animal studies, the process for obtaining owner signatures begins with an owner profile added by the site. The owner then logs on and immediately signs an electronic signature agreement. After the generic agreement is signed the owner is able to electronically sign any study-specific consent forms. Once the subject is enrolled the owner is free to fill in their own demographic information as well as any forms that are required for the study such as a dosing schedule or owner diary.
For human studies, brand-new technology has been implemented to attach the signed consent form directly to the appropriate PDF document. No personal data will be collected about the subject until the informed consent is signed electronically by the subject.
The eConsent feature of VISION includes the ability to send (and re-send) notifications to the subject to remind them to sign relevant forms. A notification can also be sent to site personnel to alert them when a form has been signed. The forms can also be provided with multiple language options for studies enrolling non-English-speaking subjects.
An electronic signature is a distinctive mark appended to a document for verification. It offers the same validity as an ink signature yet with an even higher degree of contemporaneousness as it also includes the time/date stamp and logged-on user information. It is a safer, faster, and more cost-effective approach for capturing signatures.
Integrated invoicing is a powerful mechanism for incentivising site participation. It alsoeliminates 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:
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.
Prelude Dynamics, LLC, has released some exciting new enhancements to the VISION™ Reports tool. This function of their Electronic Data Capture (EDC) system allows users to view data according to the criteria of their choosing at any point in the study. Reports can be saved, shared with other users, and added to each user’s Dashboard for convenience.
Users can now…
Easily specify report content using a drag and drop interface.
Include data from forms in multiple visit days (e.g., Physical Exams across all visits)
Sort results by any column’s ascending or descending order by clicking on the column header
Filter fields by typing into a field at the top of each column
Download any report into Excel with a new and improved interface
The Reports feature of VISION™ has always been a useful data management solution, and is one of many ways to ensure data ingegrity. All clinical staff have the ability to create sets of reports that help them focus in on important data such as clinical end points. The ability to export these reports is a valuable tool for bio-statisticians and project managers alike. Now, clinical trial conduct and management have gotten even easier with Prelude’s addition of a convenient, new user interface.
Prelude constantly strives to assist the health industry in their pursuit to bring innovative pharmaceuticals to consumers. Stay tuned for even more updates from Prelude as we make it easier than ever to conduct a successful clinical trial.
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.
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!