Summary

This article covers the 7.0.0 DBP Release notes.  

Introduction

Welcome to the DATATRAK Business Platform 2008 Q3 Major Release!

The 2008 Q3 Major Release of the DBP contains some great enhancements and some significant performance improvements that will prove to be very valuable and useful.

Marketing for this Release

  • 2008 Q3 Major Release Flier Is Not Available 

Updates in this 2008 Q3 Major Release

This section describes what’s changed in the most recent patch releases of
DBP after 7.0.0. We list the most recent patch first.

7.0.8

  • 15544: Listener 1.0.0 Release Notes
  • 15767: Update Release History in Help Center
  • 15769: DBP 7.0.8 Release Notes
  • 15778: Listener Manual
  • 15784: SDV Transaction Reporting and Classification

7.0.7

  • 15485: Error when accessing tools
  • 15631: DBP 7.0.7 Release Notes

7.0.6

  • 15483: Add Listener Role
  • 15525: Decompiler problem with import worksheet
  • 15542: 7.0.6 Release Notes
  • 15547: Count data points by type error
  • 15560: Automated Trial Manager Role Access

7.0.5

  • 15432: Ability to Designate User Accounts to Override EULA Acceptance
  • 15467: Export to csv, excel in form manager does not export the lock status correctly
  • 15499: Implement a RefCheck dependency
  • 15500: 7.0.5 Release Notes

7.0.4

  • 15380: Data Point Report failing
  • 15394: DA Compiler allows duplicate drug type id with different configurationid in the Inventory sheet
  • 15395: DA Compiler allows non-negative allocation ratio for treatment type
  • 15409: allowEnterSubmit fails in some cases
  • 15426: 7.0.4 Release Notes
  • 15438: Compiler should allow custom email triggers

7.0.3

  • 15261: Update ManagementServlet Properties file
  • 15282: Add Permissions to Create Account Functionality
  • 15296: Modify the Japanese properties file and the email templates.
  • 15314: 7.0.3 Release Notes

7.0.2

  • 15195: Assign DCTool in Management Servlet
  • 15219: dynamic form name was garbled in Japanese trial
  • 15240: Excel Exports fail if more than 32000 rows
  • 15259: 7.0.2 Release Notes

7.0.1

  • 14748: Script assign command is saving entire forms instead of updating single values
  • 14992: Definition XML is reloaded when a form is saved
  • 14993: Definition and properties XML documents are reloaded when a record is created
  • 14994: Definition and template XML documents are reloaded when a new form is created
  • 15030: Scripting – Alert Command functionality
  • 15055: Add additional field in DictionaryEntry table for sorting multiple codes that match a searched term
  • 15059: Empty EULA is displayed to non English-Japanese users
  • 15068: Update Validation Statements
  • 15115: JavaScript that disables submit button not working in IE
  • 15177: 7.0.1 Release Notes

New Features and Improvements

9417: Query Metrics Enhancements

Enhanced query metrics are further defined in 13409: Averages Report.

10435: Update Code to Accommodate Counts when Patient is offStudy

Created the property ‘isOffStudy’ to configure the count for the Visits Behind and Expected Visits to take into account when patients are off study.

10659: Expand Query Manager to Filter on Data Point Changes

Added a filter to the Query Manager that allows the user to filter on data point changes after a query was issued or re-opened.

11161: Training Site eCRF indication

A visual indicator for Training sites is now available. When configured in Trial Manager, a Training label will display on the eCRF above the Patient Demographic Bar.

11332: Update Field Listings Interface to Include Edit Functionality

The union field listing was updated to show edited names of fields along with their original expression; this functionality works just like the normal reports.

11341: Add a Multi-Select Option to the Union Report Tree

Added a multi-check box and select button to the tree that displays the second selection tree in the create union report process. Thus allowing for the selection of multiple reports that match in data structure.

11493: restriction on the entry UI to avoid illegal parameter names

Implemented an error message to display when invalid parameter names are used.

11800: Count override alerts separately

Trial Summary now shows a break down of alerts in the following categories:

  • Alerts Total
  • Alerts with Override
  • Alerts without Override

12354: Count data points by type

Data points are now counted by action with the eClinical system. The following categories define data by action:

  1. Manually Entered Data
  2. Imported Data
  3. Data generated by Assignments or Scripts
  4. Previously Entered Data – data entered prior to new counting mechanism
  5. Other – work views, old imports, unknown custom code

NOTES: Data is counted by the first action from which it is performed. For example, if a data point is imported and then manually updated, it is still counted as an imported data point. Imported Data is counted using the new import. If the data is imported via the old import mechanisms (custom code), it will be counted under category #5 – Other.

12394: Add missing keys to the JSPs to support translation

All files related to the clinical portion of the system now support multiple languages.

12681: Keywords should be caught by the compiler

When reserved words are used for formId, formTypeId, questionId and questionTypeId, the compiler now displays an error.

12962: Fill Data improvement

The Fill Data feature has been modified to populate text fields with short (about 4-8 characters) random alpha-character strings. The first character is capitalized, and the remainder is lower case.

13079: UpdateQuestionType utility

The UpdateQuestionType utility has been enhanced to convert the stored value in a date format to a partialDate format.

13180: Modify the compiler to reduce “invalid file” errors

Upgraded POI to reduce “invalid file” errors in the compiler.

13208: Set focus in Confirm Delete

When deleting a record, the cursor is now set in the text area.

13212: EM: EULA reporting

EULA reporting was created to track Username, Full Name, Last Login Date, Portal Name and EULA Acceptance Date.

13402: Audit log for coding and dynamic synonyms

Audit logs for codes and dynamic synonyms were added to the system. The log is accessed through links in Audits column of Coding Manager and Synonym Manager.

13406: Query Frequency Report

The Top 10 Queries concept in the Trial Summary has been expanded to include a Query Frequency Report. The Query Frequency Report lists all queries by count and QuestionType and is accessible from the Trial Summary or the Study Homepage.

13407: Alert Frequency Table

The Top 10 Alerts concept in the Trial Summary has been expanded to include an Alert Frequency Report. The Alert Frequency Report lists all alerts by count and QuestionType and is accessible from the Trial Summary or the Study Homepage.

13409: Averages Report

An Averages report is now accessible from the Study Homepage’s list of Standard Reports. Below is a partial listing of the types of averages that are available on a study and site basis:

  • Average time between visit date and data entered into the system
  • Average time between data entry and SDV
  • Average time between data entry and Complete Status set
  • Average time between data entry and query issued
  • Average time between query issued and query answered
  • Average time from Lock to eSignature

13416: DataGenie: Add ability to sort and edit parameter choices

The ability to edit and sort parameter choices has been added to DataGenie.

13437: Restructure audit classes for easy maintenance and extension

Audit classes have been restructured to in an effort to make the code and its maintenance more efficient.

13516: Data Point Count Report

The ability to count data points in real time is available in the Data Point Count Report. The report parameters are described below:

  1. Total data points possible
  2. Data points entered (filled)
  3. Data points blank (empty)
  4. Data points marked Completed
  5. Data points SDVed
  6. Data points Locked
  7. Data points Signed
  8. Deleted: count for deleted filled data point

Note: The 1-7 counts are based on non-deleted data points. Filled data points are considered: (1) the value is not empty or (2) missingDataType is answered. Blank data points are considered neither value nor missingDataType are answered.

13517: Interface Change to Study Homepage to Support Study Metrics

The Study Homepage has been updated to include all actions displayed on the left side of the Homepage, including standard actions, randomization related actions and training. All standard reports and any configured documents are listed on the right side of the Study Homepage.

14117: New import framework should allow other ways to identify a form other than questions

The import framework has been expanded to allow for the identification of form in ways other than questions. The system supports multiple; a few examples are name, alias and type.

14134: Clinical Process Manual – User Administration

The flow diagram and description for User Administration within the eClinical system has been added to the Clinical Process Manual.

14145: CPM Modifications to the Help Center Home Page

The individual sections of the Clinical Process Manual have been linked from the Help Center Homepage.

14157: Add System Requirements to Help Center

The System Requirements document has been added to the Help Center under the Resources section. Each of the appropriate product manuals has been updated to reference the Help Center for this information.

14405: VA Manual update to include FireFox

The VisualArchitect manual has been updated to include a reference to FireFox as the preferred browser.

14878: Release Notes 7.0.0

Release Notes for this release.

Corrections

This release contains the translation of the clinical components of the eClinical System (This release supports Japanese). The bugs listed below were identified during this process. Each bug will not be explained individually but collectively as issues found during the translation of the system that have been corrected in this release.

  • 13942: Update all the properties file to remove unused entries
  • 14316: Email from solution center about ID/PW should be in Japanese
  • 14317: ECG Library study, Japanese characters are displayed like ‘????’
  • 14318: PDF of eCRF does not support Japanese
  • 14325: Default query text are remain English, for Example, ‘For Subject’, ‘, the question’, ‘was answered’.
  • 14329: Import and Export Headers are displayed incorrectly in Japanese
  • 14331: Pop up error messages remain in English
  • 14332: Text related Alert remain in English
  • 14333: Japanese characters are ignored in Chart Report
  • 14334: Japanese characters are garbled in the tab text of Excel report
  • 14335: Japanese characters are garbled in the File name of SAS and Text report
  • 14336: Interfaces remain in English in V6.0
  • 14337: MetaData status are displayed as English in the Managers
  • 14338: Manager exports only support English
  • 14342: Query statuses are displayed as English
  • 14351: The Alert status is displayed as English only in the Alert Manager export and PDF archival export.
  • 14369: Code status is displayed as English only in exports
  • 14375: Audit manager contains hard coded English
  • 14377: View Comments page contains hard coded English
  • 14379: Record Manager status are displayed in English Only
  • 14380: Status are displayed as English in Form Manager, Form Summary, Form Manager export, Standard export
  • 14392: Query Manager Exports contain English only column headers
  • 14393: Alert Manager Exports contain English only column headers
  • 14394: Comment manager exports contain English only column header
  • 14406: Code Manager Exports contain English only column headers
  • 14412: Audit Manager exports contain English only header columns
  • 14414: Synonym manager exports contain English only header columns
  • 14416: Form Manager exports contain English only column headers
  • 14417: Record manager exports contain English only column headers
  • 14427: DataCollector Trees contain English only headers
  • 14433: Typo in the ‘EDC Manual’ link
  • 14449: DataGenie contains pages that are not fully internationalized
  • 14454: Japanese file name is garbled in File Manager.
  • 14457: Trial Summary remains in English
  • 14458: Form Statistics remains in English
  • 14459: Subject Management remains in English
  • 14460: Visit Schedule remains in English
  • 14499: Statistics Manager contains hard coded English
  • 14507: Averages Report contains hard coded English
  • 14525: Create Synonym page remains English
  • 14529: Pages related with document uploading remain in English
  • 14535: Modify the rest of the pages that contains hard coded English.
  • 14596: Edit User pages are still in English.
  • 14599: Edit Sign In pages are still in English
  • 14600: Login Support pages are still in English.
  • 14901: Fix two translation keys that have wrong entry
  • 14902: Check in the newly translated Japanese properties file

9861: Fill data doesn’t fill partial dates and reference questions

The Fill Data testing tool fills partial dates and reference questions.

10633: Customized formatters are not reloaded

When clicking the Exports tab, customized formatters are dynamically reloaded for imports and exports.

11173: Show Status filter should be set to Closed.

The Show Status filter is set to Closed for Closed Queries and Closed Alerts links.

11187: Patient Record Restoration Audit not Viewable in Audit Trail

The audit recorded for the restoration of patient displays on the screen.

11236: white screen is displayed when you try to SDV a lot of patients

It is possible to SDV/unSDV 100 patients and have the screen re-display at the completion of the process.

11441: Missing data handling unavailable in group after locked question

The variable initialization is in the correct position so that it is set for every question in a group.

11907: Unions give clickOS error for some reports

The check to determine whether a column datatype of a given report matches the datatype of the same column in a second report when unioning prevents the display of the ClickOS error.

11940: If you try to edit field name more than 41 characters in report then it gives unexpected results.

It is possible to have a field more than 41 characters, and no errors are generated while editing or saving long field names.

12254: Union report should not return duplicate information

It is possible to hide or show duplicate information in union reports.

12514: DataGenie field renaming does not work when original is part of the new name

Updated DataGenie so that the name of a field is taken literally if it is different from the expression value.

12655: Filter is not set correctly in Trial Summary

Alerts and Queries filter for Older Than are set correctly when corresponding link is clicked.

12957: Deleted ManagedObjects are not viewable in the system

Deleted queries, comments and codes should be visible on deleted eCRF pages.

12958: Fill Sample Data output is in a random order

The Fill Sample Data tool outputs the list of questions in the Excel file in the same order that they appear in the application.

12983: Coding manager – reset codes

It is possible to perform Actions on 100 codes at a time. This issue was resolved with 11236: white screen is displayed when you try to SDV a lot of patients.

13082: “Move Record” action shows Global Summary in the navigation bar

When selecting the Move Record utility, “Move Record” is displayed in the Navigation bar.

13083: Issues if report added to Union is Edited or Deleted

It is not possible to edit or delete a report if it is part of a union.

13086: Trial Manager Decompiler – Export Mapping

Form suppression is properly de-compiled in DataArchitect and VisualArchitect.

13098: DataGenie Delete Issues

You cannot delete reports to which you do not have access. Also, the error message displays correctly for selecting reports which you do not have access to delete and clicking Delete from the Actions box.

13716: Form search box clears if you click on a different page in Form manager

When in the Form Manager and filtering on Form, the filter remains persistent across different pages.

13719: Add create date of form to database

The creation date of forms is stored in the database.

13861: serverSetup.properties and management.properties changes

Appropriate properties files have been updated.

13950: Some codes produce ClickOS on export

The export formatter exports data if a code has a null approval status.

14118: New import framework: some log messages should be improved

Changed the log message for when a record or form is not found.

14135: New import framework: create form by type does not work properly

Corrected the import functionality to create dynamic forms if the formTypeId is different from the formId.

14150: Create a new audit type for the question type changes

Added the Mid-Study-Changes audit type for questionType changes.

14237: Extension file is not updated unless restarting the server

Updated Java extension files are dynamically reloaded when published through Trial Manager.

14327: White screen is displayed when you try to apply actions to lots of patients

The following actions can be performed on 100 patients and have the screen re-display at the completion of the process:

  • Delete patients or forms.
  • Restore patients or forms.
  • Set patients or forms complete.
  • Set patients or forms incomplete.
  • SDV patients or forms.
  • UnSDV patients or forms.
  • Lock patients or forms.
  • Unlock patients or forms.
  • Sign patients or forms.
  • Unsign patients or forms.
  • Open or close multiple alerts.
  • Generate queries on multiple alerts.
  • Open or close multiple queries.

14508: Remove old Help Desk numbers

All references to the Bonn office Help Desk have been removed.

Outstanding Issues

  • 2575: Format Param maxColumnWidth in Excel Export did not correlate properly
  • 6663: Calendar Week Number display bug
  • 6665: You can not insert the image, table, or link into the message.
  • 6669: Auto prompt for Request Membership works only if you go to the Login page URL and not with base URL
  • 6670: Document proper process for creating a new dependency
  • 6671: Report creation does not present wizard screen for permissions
  • 6672: ManagementServlet State Lookup Field
  • 7833: upload document action
  • 8652: Reconcile doesn’t clear deleted dependencies in some cases
  • 10027: Upload/ Attach Files to a form
  • 10061: question assignment does not work all the time
  • 10602: looping dependency network
  • 11040: Clicking Other windows locks VA
  • 11051: Recursive Forms gives inconsistent results.
  • 11120: OC4J holds onto message classes used with JGroups
  • 11124: User Profile is not Synchronized Among Clusters
  • 11126: User Profile Can Only Be Updated in Production Cluster
  • 11802: Font Color and Background Color buttons do not work in the HTML Builder in the IE
  • 11810: Toolbar icons are shown enabled in the IE.
  • 11863: VA – Trial config files are put into temp directory and not deleted.
  • 11994: ‘Is Default’ can be answered ‘Yes’ for multiple portals
  • 12081: SAS Import fails for certain reports
  • 12187: export does not push the result to the user
  • 12203: VA – Library panel loses its size in IE
  • 12283: Toplink error when renaming form
  • 12298: Problems if two users commit VA at the same time
  • 12541: Expression Assignment with a date or time field that has blank value gets wrong result
  • 12590: issue with form rename if a question used in naming is also referenced from another question
  • 12659: can’t expand Library and Help panels
  • 12672: it is possible to have same formids for multiple forms in same study
  • 12674: Help contents search box does not allow to select text.
  • 12703: the new line in Annotation note is lost with compilation
  • 12712: can publish commit DA with the name different then the trial name.
  • 12715: Large Trials hang when committing in IE
  • 12717: can’t open trial, committed in CVS, in VA
  • 12861: VA – Version number is not updated after committing the changes made in the Casebook tab
  • 12932: VA – Drag and drop form placement incorrect
  • 12965: toNumber command generate clickOs on blank value
  • 13003: Query PDF always shows Patient for any record name
  • 13016: Rename Dynamic formType fails
  • 13023: When OC4J needs restarted it can hang in the “init” status
  • 13039: OC4J Deadlock occurs when invalidating distributed session
  • 13070: delete, create synonym permissions shouldn’t be lost when decompiled to VA
  • 13159: Toplink not refreshing cached lists on updates
  • 13236: Minor issues in Enterprise Manager Manual
  • 13292: DA Manual Updates
  • 13312: Display of HTML tags in exports
  • 13328: Scripts assign a blank before the actual value
  • 13332: local permissions to Tool and Object Level are lost when DA is red to VA.
  • 13397: Pop-up select question shows internal data value
  • 13414: Internal Server Error on Manage Applications page
  • 13490: Add Validation Statements to Help Center
  • 13505: alert script behavior inconsistent when changing dependent question
  • 13521: password policy does not control login attempts
  • 13537: Decompiler uses an old DA file template
  • 13538: Decompiler changes sequencing of Forms – Template entries
  • 13539: Decompiler changes sequencing of Display tab entries
  • 13540: Decompiler changes sequencing of Question Layout tab entries.
  • 13541: Decompiler drops the scripts tab description column
  • 13542: Decompiler changes DA file Roles
  • 13543: Decompiler overwrites role permissions with default values
  • 13544: Decompiler adds blank rows to excel
  • 13545: Visual Architect drops AppSetup > queryStatus values
  • 13546: Visual Architect drops FormTypes record entry
  • 13547: Visual Architect adds Divider answers to some forms
  • 13548: Visual Architect overwrites role permissions with default values
  • 13557: Visual Architect > Casebook > Form Type Name rename does not appear
  • 13558: Visual Architect > Casebook > Form Id does not auto-name correctly
  • 13559: Visual Architect missing cursor in popup rename windows.
  • 13614: DataGenie: contact control should resolve to user name
  • 13628: Race issue when creating new queries
  • 13642: Scripts: alert appears after entering RFC
  • 13667: Quotes in tool names can cause My Applications tree to disappear
  • 13688: requires the third save to display alerts if alert waits for dependent question
  • 13710: Query address text box always repopulated with the last comment
  • 13711: query comments can be virtually saved blank
  • 13773: Open option in Show Status filter is saved as Open-New
  • 13860: Code Manager “Search For Code ID” filter does not work properly with wildcard search
  • 13866: can’t unlock user account on design
  • 13980: deleting of application properties is not synchronized between the servers.
  • 14029: Script-Errors not displayed for “after” scripts
  • 14042: RuntimeException when delete difference report archive
  • 14296: If you perform any action in record manager on a different page it returns back to the 1st page
  • 14391: when reconcile script might create unexpected forms when forms are locked
  • 14431: Visit Schedule and Patient Management give ClickOS error if studyDateFormat and Visit Date format are different
  • 14504: Queries are not sorted by display id in the viewQuestionQueries page
  • 14674: Fill data doesn’t populate Checkbox question
  • 14691: Script command ‘setDynamicStatus’ should return a string
  • 14739: Update visit expected counter to count days using the Local time
  • 14748: Script assign command is saving entire forms instead of updating single values
  • 14752: Double data entry params in result file
  • 14777: Alerts from Deleted Pages in Data Export
  • 14788: Query PDF shows html tags for the question
  • 14807: Difference Manager shows “View Archive” in the Navigation Bar for the Edit, Customized Run, and Delete pages
  • 14811: NullPointerException when run WorkView
  • 14812: report doesn’t return data with Null value
  • 14832: Difference Manager Warnings have several words that are not tagged
  • 14834: Exports of Managers show html tags for the question name.
  • 14862: SAS Export length/format for double-byte characters
  • 14864: Visits Behind and Visits Expected shouldn’t count visits of if exit study criteria is met.
  • 14887: In Edit EULA Window links for language do not work
  • 14891: Permission Denied to access an object error screen is not translated



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