Summary

This article covers the 4.0.0 DBP Release notes.  

Introduction

Welcome to the DATATRAK Business Platform version 4.0.0!

The 4.0.0 release of the DBP contains some great enhancements and the Beta version of the VisualArchitect design utility. The VisualArchitect component enables users to manage the DataArchitect technical specification visually.

Trials can be developed using the Beta version of VisualArchitect, however, there are a few known issues. Most notably, it only works with Mozilla Firefox 2.0 and greater. The Internet Explorer version is expected in the next release.

VisualArchitect was validated by DATATRAK‘s Software Validation Group. The noted issues are documented in the Outstanding Issues section of the Release Notes for DBP 4.0.0. DATATRAK is using the VisualArchitect tool in select studies so that we can provide the best product to our customers. DATATRAK is also providing Enterprise customers with access to this new design utility so that they can gain valuable experience with this new tool.

The next version of VisualArchitect will be released in the first quarter of 2008.

Marketing for this Release

Marketing webpage splash screens will be provided starting with the 4.0.0 release

  • 4.0.0 New Release Flier Is Not Available 

Updates in this 4.0.x Release

This section describes what’s changed in the most recent patch releases of DBP after 4.0.0. We list the most recent patch first.

4.0.3

  • 11179: Updated addressing to dynamic forms for basic filter to work in Data Genie
  • 11338: Scripting Language: Enhance the comparison commands to accept lists and merge results
  • 11394: Apostrophe in display values of question causes report to fail
  • 11428: Exports fail in a VM environment

4.0.2

  • 11244: Support Shared Sales and Training Image and Ops Image
  • 11245: Script: Add a “Date Difference” Function
  • 11249: Extension naming in text export is not working
  • 11250: Line separator is not behaving properly in text exports
  • 11263: Special archiveID Key for Accessing Latest
  • 11283: containerSummary2 Report – deleted forms
  • 11288: Addition of CSV File to PDF Archival Export
  • 11289: Dependency on partial date can fail in any case
  • 11293: Dynamic form ending in integer compiler check is incorrect

4.0.1

  • 11183: serverSetup.properties has incorrect server names
  • 11190: Update maven to use maven-resources-plugin v 2.2
  • 11214: Update container summary report for trials using Randomization 2.0
  • 11215: Investigate performance of system when changing metadata at the record level
  • 11225: Electronic signature information and audits missing on eCRF

New Features and Improvements

7102: Standard Export Enhancement

Provides helpful information in standard export by describing the full path information for forms.

Many forms are used repeatedly within a study and it is hard for customer statisticians to determine where data comes from when the parent is the same, but it is repeated in several visits.

A new property was added to the standard export formatter called ‘exportPathDetails’. If this property is set ‘true’ (not case sensitive):

  1. The columns visit and path will be added to the value export. The column visit contains the top most form of the current form path. The column path contains the path information to the current form.
  2. For query, violation, comment and question audit, the following columns will be added; visit – see above, path – see above, parentForm – parentform of the current form, questionTitle – title(name) of the question.

7871: Change out ClickRequest to be a Context

It is now easier for programmers to extend and interface with the DBP.

8140: Alert Manager: Show current answer

An additional column has been added to the Alert Manager displaying the current answer.

This allows for faster reviews/easier sorting for users, which means less time sorting information which means cost savings for clients paying monitors.

8933: Order “add dynamic links” properly

The sequence of the links to add dynamic forms appears in the same order as it is defined in the DataArchitet file.

8958: Compiler Check: Form ID Naming

Dynamic forms identifiers should not end with a number, and this compiler check helps the designer avoid that problem.

10002: Study Homepage Checklists

Checklist on your Study Homepage gives instant access to your “to do” tasks, right on the homepage. No more logging into individual manager screens to see what work is waiting, you will see it up front. Coordinators, Investigators, Monitors, and Data Managers will find a visible checklist on their study homepage with specific activities to be performed for their individual roles.

10070: Annotated/Non-Annotated CRFs are Written More Efficiently

More options are available for the writing of PDF files. The process also creates smaller file sizes which take up less disk space.

10071: Export Lock

When you run an export it will now run in the background so you can continue working. You can retrieve it at your convenience when it completes. No one else will be able to run that export type while you have it running.

10213: VisualArchitect Interface

The web-based interface is used for designing trials. The Visual Architect interface incorporates the functionality of the current DataArchitect product and provides a drag-and-drop interface for design. It also supports basic library management functionality for rapid trial development.

10214: VisualArchitect Compiler

The VisualArchitect includes the ability to write the trial configuration.

10215: VisualArchitect De-compiler

The VisualArchitect has the ability to read trial configurations and interpret the trial design in the VisualArchitect.

10216: DataArchitect Capability with VisualArchitect

VisualArchitect and DataArchitect should be able to both read and write to XML. The DataArchitect product was modified so that a DataArchitect file can be written/updated from the corresponding trial configuration.

10217: Core Code Changes as a Result of VisualArchitect – Permissions

The internal permissions structure was modified to support the translation of the DataArchitect and VisualArchitect files to XML and vice versa.

10218: Core Code Changes as a Result of VisualArchitect – Code Lists

Code Lists were implemented in DataArchitect to support the translation of the DataArchitect and VisualArchitect files to XML and vice versa.

If a customer contracts for electronic training a link called, My Training, will be available from their Study Homepage.

10705: Help Documentation Infrastructure

A “Help” link will be available in the upper right-hand corner for all users. The link will open the Help Center in a new window. The Help Center is the central location for all information.

10728: VisualArchitect should replicate the functionality of Data Architect

VisualArchitect provides a majority of what is available in DataArchitect. VisualArchitect provides a visually intuitive interface to begin application design.

10729: Application Setup Tab Functionality

The functionality from the Application Setup tab in Data Architect is available in VisualArchitect. Additionally the following functionality is available on the Application Setup tab.

  1. Code Lists – The ability to predefine a set of code lists for use in question answer options. This should integrate seamlessly with our current implementation, meaning that you should either be able to select an available code list for a question or enter a specific answer option list at that question’s level.
  2. Dependency Templates – The ability to specify a starting place when creating dependencies. This list should be pre-populated with templates representing all the dependencies in the trial. A dependency template can be chosen when adding a dependency to a question in order to speed up the process.
  3. Formulas – Formulas as defined in the Data Architect Formulas tab.
  4. Medical Coding – Code configurations should be specified here and then chosen at the question level.
  5. Properties – Properties as defined in the Data Architect App Properties tab.

10730: Casebook Tab Functionality

The functionality from the Form Types – Definition, Forms – Template, Display, Question Layout – Template and Question Types – Definition tabs in Data Architect is present in VisualArchitect. Additionally the following functionality is also available on the Casebook tab.

  1. Code Lists – The ability to choose a predefined code list from the list in the Application Setup tab.
  2. Medical Coding – The ability to choose a predefined code configuration from the Application Setup tab.
  3. Assignments – Assignments as defined in the Data Architect Assignments tab.
  4. Dependencies – Dependencies as defined in the Data Architect Dependencies tab.
  5. Dividers – Question Groups should be represented as Dividers in the application. The initial question group will be tied in with the form definition. With this strategy, we can avoid unnecessary casebook tree depth.

10731: Exports Tab Functionality

The functionality from the Exports tab in Data Architect is available in VisualArchitect. Additionally the following functionality is also available on the Exports tab.

  1. The export controls surrounding Queries, Comments, Audits and Alerts is available at the root level as options.
  2. The export controls surrounding SDV, Alert, Answer, Lock and Signed Status is available in their own metadata interface.
  3. The custom form formatter specification interface may be limited due to the amount of data and the speed restrictions of JavaScript.

10732: Permissions Tab Functionality

The functionality from the Roles tab in Data Architect should be implemented. Additionally the following functionality should be available on the Permissions tab.

  1. Custom Actions – Sets of Actions and Screens should be able to be grouped together and then assigned to a particular role.
  2. Ease of Use – The interface should limit the actions into an explicit set for general use. Each area should have a specifiable access level. For example, when including SDV, one would have the following permission levels:
    • None
    • SDV
    • Clear
    • SDV and Clear

10733: Scripts

The functionality from the Scripts tab in DataArchitect is available.

10735: Application Help

Help is available throughout VisualArchitect.

The help file is a separate file which supports implementation of multilingual functionality.

As a user navigates to different tree nodes and/or properties the help panel should reflect the area on which the user is focused.

10736: External Configuration File

The general configuration of VisualArchitect is externalized in a separate file to reduce future maintenance.

10737: A library should be available when designing a trial

Users have access to load all trials within their current Trial Manager as a library. The user should not have access to additional trials, applications or libraries. The user should be able to load a different library once inside VisualArchitect, presenting them with a list of their choices.

The library should not be editable in any way.

The library should have all tabs available to pull previous configuration tree nodes from. For example, a user cannot only be able to drag over predefined forms and questions, but exports and scripts as well.

10738: A history of actions should be recorded

Each action that is performed in the application should be tracked via a history component. This component is not intended to provide any sort of audit trail functionality, as the record will be lost at the time of refresh, reload or certain other system actions. This component will be used to power a transactional undo/redo feature.

There should be a window displaying the history timeline and allowing the user to click a specific position in the list of actions to undo or redo sets of actions taking them to that place in the design. Steps will not need to be skipped over. The user should not be able to undo step 3 without also undoing step 4 first, or steps 4 and 3 at the same time.

10739: Accessibility of Actions

Several different methods should be used to give the user a feature rich and intuitive interface. These collections of actions can include a menu bar, a toolbar of icons and/or right click menus. These collections of actions should be context sensitive, only allowing valid actions depending on the current selection within the application.

10741: Usability Extensions

Extension functionality will exist that will be needed to enhance the usability of Visual Architect.

10743: Layout Management

Shortcuts are available to quickly adjust the panel sizes within the application. For example, a layout for designing a casebook may be different than a layout for defining a script.

10744: Panel Visibility

Shortcuts are available to quickly adjust the panel visibility within the application. For example, there should be an option allowing the hiding of the help panel.

10745: HTML Editor

An easy to use WYSIWYG HTML Editor is available for use in designing the portions of DataCollector that accept HTML input, such as Question Group Titles.

10746: Help should be freezable

It is possible to freeze the help panel from changing when navigating through different tree nodes.

10747: Help Tips

Different menu items, icons and/or properties have unobtrusive popup help tips when they are hovered over with the mouse. These tips should be configurable in an on or off setting.

When navigating the Casebook design and selecting a tree node, related tree nodes are lightly highlighted. This allows for an easy visual distinction of related elements. For forms, other forms of the same formType should be highlighted. For questions, other questions of the same alias on the same formType should be highlighted. The highlighting behavior should be configurable in an on or off setting.

Accounts are now always created by an administrator.

10757: Abstract the necessary Revision functionality to DBP from Trial Setup

This DBP addition allows programmers to interface with our versioning in a better way.

10814: Default to Sample Chart for Missing Data in DataGenie Graphs

The reporting system has been updated so that each chart type will show a “Sample Chart” with default data when no data is present. In this way, an image placeholder is created when the chart is embedded into other documents.

11012: Ability to publish to the design server must exist in VA.

VisualArchitect should have a menu item which allows the user to publish the current design to the design server. However; it does not save the design to the server.

Corrections

8473: Duplicate query display ID for the same application

It is no longer possible to create two queries with the same DISPLAY ID even if the queries are created at almost the same time.

A link to the Status Manager is now available in the Action box. Previously, it was only available from the Application Menu.

10202: Answer Options Parsed Incorrectly

The answer options now parse properly even if an answer option text contains a colon.

10223: Export of the Comment Manager shows wrong Date Created

The export was not including the time, and it appeared to show the wrong date in certain cases. This is now updated where it reflects the date and time shown in the web interface.

10517: Script, createForm, does not resolve to specified alias

The createForm command was finding the first alias or formId of the specified type. The script now properly finds and inserts the specified formId.

10641: System does not refresh a Workgroup or User after adding an Administrator to a Workgroup

The system now refreshes the Workgroup or User on other clusters after adding an Administrator to a workgroup.

10704: Error occurs if you try to delete Aggregator Condition

If you are creating an Aggregator and you add a condition and try to delete the condition without saving the aggregator, then you get an error. This has been corrected.

10768: PDF Archival does not release objects during procession

The PDF archival is now more efficient with the memory utilization.

10769: Issue of dynamic form path in the dependent path

An issue existed with the resolution of alerts. When a dynamic form path was specified as a dependent path, the alert was not always cleared when the data on another form removed the alert.

The behavior is that when a dynamic dependent is updated the script is re-evaluated for all targets.

10861: isDuplicate command does not account for null values

The isDuplicate command now ignores null values. This occurs when questions are missing.

11008: PDF export – Order of appearance of the patients is not identical with eCRF

The order of the patients or records is now sorted by the patient primary identifier or record name.

11049: Change the URI reference in the eSubmission PDF Archive

The internal PDF structure uses a reference internal to the document, not a URL reference for both the forward and backward.

11084: Cache Consistency Issue with New Logins

When a login is created and access is assigned in other clusters, the login password reset flag is not updated in those clusters when the password is changed on the production cluster. The flag is now evaluated properly.

11096: Export Mapping – Column Lower / Upper Case – Not working

The command that changes the case of the column to lower and upper case does not function. The command actually does not affect the column name at all. This now works as expected.

Outstanding Issues

  • 2575: Format Param maxColumnWidth in Excel Export does not always format the columns properly. The work-around is to format the columns once it is viewed in Excel. This can be done quickly by selecting the top-left cell between “A” and “1″. Once the sheet is selected double-click on the line between columns “A” and “B”.
  • 6663: Calendar Week Number Display – Sometimes the week identifier is not presented properly to the user. It shows Week 2 (27-3) December. It should show Week 1 of December or Week 5 of November for 2006.
  • 6665: You can not insert the image, table, or link into the message using the HTML editor.
  • 6667: The “Active Status” functionality is not implemented
  • 6669: Auto prompt for Request Membership works only if you go to the Login page URL and not with base URL
  • 6670: Documentation is needed for the proper way to remove alerts when the check if blank attribute is used.
  • 6671: Report creation does not present wizard screen for permissions in some situations
  • 6672: State Lookup Field is not searchable in some administrative views
  • 7050: Portal logo uses http not https
  • 7833: Upload document action failed in isolated cases
  • 7933: Spelling errors in the Compiler error messages

    - “Error: Formulas Line X: formulaId must be unique within the Foumulas worksheet..” It should be “Formulas” instead of “Foumulas”.
    - “Error: Dependencies – Definition Line X: Corretion Required can not be empty.” It should be “Correction” instead of “Corretion”.
    - “Error: Question Types – Definition Line X: Field Size must be empty or two positive integers seperated by::, e.g. rowSize::colSize.” It should be “separated” instead of “seperated”.

  • 8002: Expression evaluation related with PartialDate should be better documented
  • 8003: SAS Report issue – The "character string must be used to denote a double-quote (“) string qualifier.
  • 8182: Custom Import with Partial Date should be better documented
  • 8189: Query Detail Audit Trail Does not Show Display and Stored Value
  • 8537: Status Manager Filter Layout – On smaller resolutions, the filters above the listing wrap to the next line, specifically the subject line.
  • 8652: Reconcile doesn’t clear deleted dependencies in some cases
  • 8734: Reference type question to partial date shows internal value – If a reference type question references to a partial date question, then the partial date value shown on the reference question is in internal format.
  • 9861: Fill data doesn’t fill partial dates questions. Fill Data is a useful testing tool for quickly filling a form with data.
  • 10027: Upload/ Attach Files to a form

    In the 2.5 if you have uploaded file through Upload button on a form this file would be attached to the form at the same time. You would be able to see the link to this file on the form and couldn’t delete this file from the File manager.
    Now in 3.0 if you have uploaded a file from a form it would be “partially” attached: you can’t delete it from the File Manager but you also can’t see the link on the form. In this case there is no way to release the hold of these files.

  • 10061: Question assignment may not work with large batch processing
  • 10222: BlockRandomizer: Blocks Cannot Be 3 X or More than Minimum Block Size
  • 10242: Search with wild card by Question Type does not work in Query, Alert, and Comment Managers
  • 10249: Toplink logging error.
  • 10586: formPartialEdit view type does not support viewing of contact control
  • 10602: looping dependency network
  • 10633: Customized formatters are not reloaded
  • 10753: User can agree with EULA before it was saved or canceled
  • 10759: List of Old License Agreeements is not saved correctly.
  • 10791: standard PDF Archival close date for alerts is missing “UTC”
  • 10838: Additional PDFs on footer are sorted by hash code
  • 10869: Undo fails in some scenerios
  • 10872: cannot create form/questions with typeids that were undone.
  • 10962: When editing multiple scripts pressing Ctrl+Z produces unexpected results
  • 10988: query audit will have two records of same action
  • 11001: Dynamic forms must all have same child static forms.
  • 11040: Clicking Other windows locks VA
  • 11043: Issue with “<” symbol
  • 11051: Recursive Forms gives inconsistent results.
  • 11062: It is possible to have same divider ids in two different Forms
  • 11063: It is possible to have same divider ids under different forms when copying from Library
  • 11069: Date Comparision Does not work
  • 11086: Script error should display friendly message
  • 11091: Dynamic forms are not created properly if FormType is changed.
  • 11110: If expression have text such as <variable, then it is not seen on the eCRF with DT Debug Role
  • 11120: Servlet Container holds onto message classes used with Messaging Technology. This only affects internal technical staff.
  • 11127: Navigation Bar for Help Center: The Help Center does not currently use an in depth Navigation Bar.

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