VISION EDC System Features - See What's Inside!

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VISION Feature Description
Advanced Form Design Robust form design with color coded cross-form soft and hard edit checks with explanatory text and optional custom error messages; extensive set of calculations with custom calculations and edit checks that are easy to add.
Dynamic Drop-downs Drop-downs can be populated dynamically by field values from other patient, site, or study-level forms, or from dictionaries such as MedDRA.
Assignments and Access Participants (users) of the system are assigned to studies, specific sites, and roles, which are used to determine access to the data and functions.
Configurable Roles Roles are configurable as to how they are labeled both short and verbose (e.g., PM, Project Manager, CRA, Monitor, or other), and 10 generic roles are available to be defined for each study.
Configurable Permissions Permissions define which roles can edit/create other roles, and which roles are automatically assigned to new sites; roles include 10 generic roles that the Client can define.
Form Permissions Each form is configured as to which roles can edit, review, query, finalize, and lock the form. Edit privileges can be defined separately for sections and fields, and fields can be blinded to certain roles.
Dictionaries*: Text fields can be “auto-complete” fields, where the system learns the possible values from other entries and/or dictionaries and offers suggestions as the user types. Thirdparty (e.g. MedDRA) can be integrated.
Smart Presentation: Based on other data values, sections of the form can be hidden or visible (e.g., checking “No” can hide the section below, whereas “Yes” makes it visible), or sections can be disabled but visible (e.g., “None” can disable selections).
Dynamic Forms: Forms can be hidden (e.g., early termination can hide subsequent visit forms) or automatically generated (e.g., create an SAE form if an AE is serious), as indicated by data entry, further improving data quality. This includes addition (dynamic) forms for unscheduled visits, protocol updates, etc.
Notifications: Email and in-system notices can be generated from events (new patients, queries), and from text and fields to specified roles with the appropriate triggers (e.g., an AE marked as "serious" or lab value outside acceptable range.) They can also be queued (“pending”) to be sent at a later date, and acknowledgements tracked.
Patient Summaries: Real-time, user-invoked summary charts, graphs and tables can be implemented to depict key trends within the data, and provide consolidated information for subsets of patients.
Site Summaries: Site summaries, covering information such as enrollment statistics, form completion graphs, and patient visit status, can also be configured for each study.
Lab Integration*: Custom interfaces to external (central or local) labs streamline the incorporation of lab data.
Local or Central Lab Normals: Patient lab forms pull from a site-level or study-level page with normal lab ranges and units.
Data Export: At any time, users with appropriate privileges can export the data to XML format that can be imported to SAS, Excel, Access, etc.
Image Handling*: Uploaded images can appear directly inline, so they’re visible on the page. VISION also interfaces with the Aperio imaging system, displaying thumbnails that launch the Aperio application.
Graphics: Images on a form can be configured to allow user to click areas to annotate the image (e.g., showing where a device was inserted).
Document Management*: This optional module allows the user to define standard documents for patients, sites, and personnel; for users to upload standard and other documents; to create study binders with limited access by user role; to download current and previous versions of uploaded documents.
Budgeting and Invoices*: This optional module provides for the setting of budget items and invoicing by the sites based on the progress of patients in the study.
At-a-Glance Study Progress: All users can track the progress of the study with visual cueing for rapid review, and drill-down capable for detailed form review.
Enrollment Graphs and Statistics: Graphs of actual vs. projected patients can show study progress.
Ad-hoc Reports: At any time, the user can generate an ad-hoc report for a population of patients, using as many criteria as desired for each report. These criteria are saved for each user, who can name and save and unlimited number of reports.
Field Comments: Comments (as many as needed) can be entered for any field with system capturing author and date/time.
Query Tracking: The user can manage queries for any field with a single click which brings up a pop-up for amplifying information and data entry; summaries synopsize the information at both the patient and site level.
Complete Audit Trail: Each field has a complete audit trail (user, role, date/time, old and new value) available for view to the user; reasons for field changes can be entered and can be made mandatory (study parameter).
Randomization*: Automated, integrated randomization modules can be optionally customized for each study, which can be configured to incorporate multiple levels of blinding.
Patient Diaries*: Studies can be configured to allow patient access to specific forms (e.g., diaries, surveys, informed consent).
Review: Forms, queries, comments, and changes can be marked as “reviewed” to easily see what information has been entered or changed since the last review.
Search: User can enter multiple sets of search criteria for fast retrieval, and results apply to Summaries, Reports, and Export; criteria are saved for future use.
Dynamic Tables: Tables with repeating sets of information (such as Con Meds and AEs) contain one blank set for new data entry, adding as many as are needed. Information is entered directly into the table, with no pop-ups to navigate.
Configurable AEs: AE forms can be configurable for each study as dynamic tables (all AEs on one form) or dynamic forms (one AE for each form), can have a dictionary (dynamic or static), and can reference Con Meds, Medical History, or other data.
Configurable Con Meds: Con Med forms can be configurable for each study, can have a dictionary (dynamic or static), and can reference AEs, Medical History, or other data.
User Account Management: Users of certain (configurable) roles can create other user accounts and assign them to studies, sites, and roles.
Study Calendar: A study calendar keeps track of study-level and site-level (limited by site access) events.
Help: Inline help can be added to any form, and a user’s manual is tailored to each study and made available online.
Electronic Signatures: Signatures correspond to form status changes, which go from New to In-Work to In-Review to Reviewed to Final.
Annotated CRF: Users can view annotated CRF information at the bottom of each form with a single click.
Visit Logs: Site visit logs can be kept and reports uploaded.
Regulatory Documents*: Optional forms can be added to track (and optionally, upload) regulatory documents; automated reminders can be set upon expiration.
Additional Site Management: Customized (optional) forms with edit checks, queries, comments, audit trail, notifications, etc., can be configured for each study, similar to Patient CRFs for items such as Drug Accountability, refrigerator logs, Communication logs, etc.
User Activity Monitoring*: This (optional) module is used to monitor user activity, and display to appropriate roles per user and summarized over all users.
Double Data Entry: Studies can be optionally configured to allow for some or all of the case forms to be double-data-entered.
Training Studies: Each study has a corresponding “training study” to allow new users to experiment with the forms without impacting the live database. Training materials are also provided, customized to each study.
Offline Capability: VISION EDC can be run for studies that require data-entry in the absence of an internet connection. Ask about VISION Digital Paper for your tablet today.
Quick Print Function: Each indivudal digital CRF has a quick link icon that prints the form in a clear tabled layout that mirrors that which you interact with in VISION.
Multi-language Translations: VISION EDC is maintained in 8 different languages (English, French, German, Chinese, Japanese, Spanish, Portuguese, & Hungarian) and holds the capability to incoporate any language you require.
Inventory Management & Reconciliation: Your study can incoroprate VISION's inventory management with links to shipping tracking by waybill numbers and reconciliation of unused, dispensed, destroyed and/or returned test article.
Automated Invoice Generation: Invoices are tied to patient and/or site events and are viewable in your native language and currency. Customization of currency and invoice amounts can be made on a per-site basis if needed.
Interactive Feedback: Clients can comment on specific and/or broad aspects of study and CRF development. The Feedback tool delivers those comments directly to your Prelude Project Manager to be addressed.
Universal Uploader: Our uploader can be integrated into CRFs giving users the abililty to upload files into the database that were once thought to be too large (DICOM images, brain scans, echocardiogram videos, etc.) File size is no issue as the uploader runs on a seperate secure server which allows you to work in VISION while your file(s) upload in the background.
Dynamic Charting: Our charts and graphics package allows you to visualize your summary and report data in six different ways (line chart, bar chart, radar chart, polar area chart, pie or doughnut chart. All charts are animated with a multitude of customization and interactivity options.
Data Variable Naming: We have normal names and we have CDASH name so users can name each variable as they wish.
Predictive Coding & Searches: VISION turned the medical coding process into a simple field entry by incorporating real-time predictive search and coding function. As you type, a drop down of potential entries is displayed based on your ongoing entry. Selecting the appropriate entry is as simle as clicking your selection.
Composer: Do-It-Yourself tool with a form library, part of the VISION Clinical Trial Optimization Platform allowing DIY and Full-Service data solutions in all or part of a study build.
Templates: Templates are our reusable groups of full-function form sets which are collaboratively built, between Prelude and the client, for a particular type of study and maximizing reuse of the templates for future projects.
RFID & Barcode Scanning: VISION offers quick and easy technology tool integration. If you're using RFID and/or barcode identifier tools they can be synced with VISION for fast, automated and validated identification of patients.
Statistical Package: VISION includes a statistical package for charting and graphing your study data, reducing the need for a separate stats analysis step.
Site Qualification Questionnaire: Prelude's Site Qualification Questionnaire or SQQ can be used to qualify and enroll study sites via the internet.
Chat-O-Matic: This is a built-in secure chat tool that allows sponsors, data managers, monitors and site personnel chat with one another about the study from within their logged in session. The chat is captured withn the study audit trail.