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.
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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.
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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.
Out in the fields or inside the barns, sometimes a reliable Internet connection can be hard to come by, if there is one at all. In these cases, professionals often must rely on the error prone method of recording with a pen and paper. However, a lack of an Internet connection should not compromise or disrupt a study.
Digital Paper is an offline Electronic Data Capture (EDC) app developed to work with VISION™ tools and accommodate studies that may operate in a field environment.
Q: What is it?
A: Digital Paper is a unique feature of VISION which allows a user to enter data into the system when there is no internet service available.
Q: What makes it so special?
A: Once internet access is regained, all data entered onto Digital Paper will be automatically synced into the system, maintaining time stamps both for when the data was entered and when it was uploaded.
Q: How does it work?
A: Digital Paper can be customized to feature whichever forms and fields the client specifies. Keep in mind that it is for data-entry only and will not run any calculations or constraints. All of these edit checks will trigger in the system once the data has been synced. The main purpose of Digital Paper is to give investigators in the field a place to synchronously record their findings as they perform physical exams on animals in places where there is limited internet available (e.g., horses out in the country) without having to write it on physical paper then transcribe it later.
Q: Is there anything else to note?
A: Yes, a few things to keep in mind are:
1. The subject for whom data is being entered onto Digital Paper must already be randomized
2. Blinding DOES remain in effect when logged onto Digital Paper
3. Digital Paper currently only works on android devices
4. Digital Paper is a contracted item
5. It’s easy to learn and easy to use!