VISION System Features

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 popup 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 send an email to the trial pharmacist, keeping other users blinded to the assignment.

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 Inventory Management (with links to shipping tracking by waybill numbers), 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.

Easy navigation           
› Single click on patient/site to view forms for that patient/site
› Forms look like paper CRFs
› Queries generation and resolution, change history, notes - available with a mouse click.
› No dialog boxes to navigate through - edit AE's and ConMeds directly into summary forms

Easy form completion - validation at point of entry
› Pull downs, radios, checkboxes and calendars facilitate data entry and minimize mistakes
› Auto-complete feature has system recommended text based on previously-entered values
› Field restrictions reduce errors

Easy form verification - validation at posting to server
› Edit check text automatically generated for errors
› Fields color-coded for errors: red for hard edit check violations, yellow for soft warnings

Displays easily configured
› Client specifies any data items to appear on overview page (all sortable)
› Privileges to view, edit, review, query, and lock set on a form-by-form basis by role
› Roles - Coordinator, Investigator, Monitor, Project Manager, Sponsor, Data Manager,

Lab Technician, and Patient/Owner
› New roles easily added

Automated email notification
› Adding a patient (study parameter)
› Form ready for review (study parameter)
› Custom - works like other edit checks, including triggers

MedDRA Coding           
› Category, Supra-ordinate, Event, Grade, Short name, Code
› Other dictionaries easily integrated; autocomplete from dictionary

Central or site-specific lab interfaces
› Can specify site-specific lab normals as defaults for patients

Works seamlessly with Tablet PCs and iPhone

› Software FDA 21 CFR 11 compliant           
› Tier-3 data center is used for data security
› Backups and archives at regular intervals
› Single logon account for multiple studies
› Works on any standard browser via Internet
› Secure Linux operating system
› Automatic data change tracking and display (audit trail).
› Software - independently validated
› Architecture is elegant, flexible, and robust
› Architecture facilitates rapid study development
› Easily configured to show study-specific data on overview list

Comprehensive and extensible set of edit checks
› Soft and hard edit checks for any field or combination of fields
› Cross form edit checks, e.g., visit date must be within a week of previous visit, +-2 days
› Can depend upon other edit checks passing (“triggers”)
› Java architecture makes adding new edit check types easy

Robust set of calculations to minimize workload and errors           
› Calculations specify derived values
› Can set field values on current form or other forms, creating field if necessary
› Can depend upon edit checks passing (“triggers”)
› Java architecture makes adding new calculation types easy

Summaries for specified populations
› Graphical summaries show trend lines, bar charts, pie charts
› Tabular summaries for groups of patients/sites (e.g., Adverse Events)
› Summaries display for populations specified by search/filter action

Create Reports to view progress anytime
› Ad-hoc reporting for any set of fields and population group.
› Select any collection of fields from any forms.
› Name and store an unlimited number of reports.
› Reports always up to date - populated at time of user request to view.
› Reports display for populations specified by search/filter action

Search/Filter patients and sites
› Specify search criteria for any form and field
› Use logical (>, <, contains, etc.) relationships to specify search
› Search criteria saved for each user for both patients and sites
› View patients or sites meeting criteria
› Name and store an unlimited number of search criteria sets

› XML database highly portable & handles mid-study updates with ease.
› Export to “standard” XML, imported by multiple commercial products, including SAS, MS Access, and Excel.           
› FDA preferred data format           
› Human-readable
› Extremely fast data transactions