Summary

This article covers the 3.0.0 DBP Release notes.   

Introduction

Welcome to the DATATRAK Business Platform 3.0!

Marketing for this Release

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

  • 4.0.0 One-page Splash Preview Is Not Available 
  • 3.0.0 One-page Splash Preview Is Not Available

Updates in this 3.0.x Release

This section describes what’s changed in the most recent patch releases of DBP after 3.0.0. We list the most recent patch first.

No patches have been made to this version.

New Features and Improvements

5232: Scripts; Parameter Support for Dependencies, Formulas, Assignments

Special trial functions are now available via the DataCollector Scripting Language. By taking parameters the trial functions can be used in many different ways by the Trial Designer. The uses include but are not limited to dependencies, formulas, and assignments.

Benefits of this feature include reduction of customized solutions provided by DATATRAK. Instead, the Trial Designer has full access to these powerful scripts for all the trials they build.

For example, an age calculation could be passed the paths to the two date questions to be used, removing the need for an entirely new custom function to perform this common operation.

6975: Create Faster Reports

An improved reporting framework provides faster and more consistent reporting times by reducing overhead and accelerating the runtime.

6976: Workview Enhancements

Working views of the data can now be created upon a request to DATATRAK. In the future, we plan to expose this feature to all Trial Designers via DataArchitect and VisualArchitect.

Each Workview is based on a DataGenie report and different actions can be applied to the result set returned by the report. Currently, three types of actions are supported: expression, custom and export.

An example of a useful Workview is the “Clinically Significant” working view. A DataGenie report could list all labs that are out of range and an Investigator could quickly mark labs that are clinically significant. There are also many other useful features for this feature including building custom workflows.

6977: Performance Enhancement for Listings and Managers

A new data retrieval framework changes the overall implementation of the Global Summary, Form Summary, Alert Manager, Query Manager, Comment Manager, and Coding Manager. Now all the managers load results in better more consistent response times.

6981: Enhance DataCollector Expression Language

DataCollector now has a full feature-rich Scripting Language. Scripts may be used to trigger emails, update data, create forms, and many other functions.

See related enhancement 5232: Parameter Support for Dependencies, Formulas, Assignments

6985: Reference questionType (data association)

Associate data between forms and questions.

A question with question type “Reference” can reference other questions or forms within the same record. A common use case is the reference of the adverse event for a concomitant medication.

6986: Form Summary Question Placement

This feature allows the designer to determine where the questions are positioned in relation to the form summary.

A flag may be set denoting whether questions fall above or below the form summary listing. This property is applied to the entire application; it cannot be set on a per form basis. The designer may modify the layout by setting a property in the Application Setup worksheet in the DataArchitect file.

The property name to be set is isQuestionAbove and the possible values are yes and no. Setting the property to yes will position the questions above the form summary. The default is to show the questions below the form summary.

6994: Query Manager Flow Improvement

Added new query features to the query workflow to make it more powerful and flexible.

Enhancements were made in the following areas:

  1. New Query Statuses:

    Prior to 3.0.0, there were only two query statuses: Open and Closed. Open queries are further divided into Open with Answer and Open without Answer based on whether or not someone had responded to the query. In 3.0, there are now five query statuses: Unconfirmed, New, Answered, Reopened and Closed.

    A query can only be changed to another status based on its original status. For example, unconfirmed queries can be changed to new or answered, while closed queries can only be changed to reopened.

  2. Query Update History:

    In 3.0, the query update history is recorded, which includes the name of the user making the change, the change date, the new status and a comment. The history events are listed in the query detail page and ordered by create date, descending. The history is only displayed to those users with the appropriate permissions.

  3. New Query Permission:

    In 3.0, there are new permissions to limit a role’s ability to create, view and set queries as well as view the query update history.

    Create Query: A newly created query can be either new or unconfirmed. By default the query status is new. User must have ‘createQuery’ action permission to create query.

    View Query: View permission can be assigned to individual query status. By default, a user has view permission to all the query statuses. User must have ‘viewQuery’ screen permission to view query details.

    Update and Respond Query: Set permission can be assigned to individual query status. By default, a user has set permission to all the query statuses. User must have ‘updateQuery’ action permission to change query status to ‘New’, ‘Reopened’, ‘Closed’. User must have ‘respondQuery’ action permission to change query status to ‘Answered’.

    View Query Update History: By default, all users have permission to view query update history unless the permission is set to be false.

  4. Query Comment Configuration:

    See related enhancement 6995: Required Comment Configurable for Query Close

6995: Required Comment Configurable for Query Close

Provide ability to configure whether a comment is required when query status is changed.

This is part of the query manager flow improvement. The study designer may specify whether a comment is required when the query status is changed.

6997: Dynamic Form Sequence Number Calculation

A new algorithm is used to calculate sequence number for dynamic forms.

In 2.5, the process to calculate the sequence number can be slow when there are a large number of forms. As part of the performance enhancement, the new algorithm in 3.0 provides faster calculation of dynamic form sequence number.

7000: Enhance Dependency Network for Cross-Form Dependencies

Questions may need to be re-evaluated when dependent questions on other forms have been modified.

This is part of the DataCollector scripting language. It enhances the dependency awareness to include changes to questions on other forms. Questions located on different forms that depend on each other can now be re-evaluated.

7018: Export Archive

Exporting archive functionality is enabled.

To reduce response time, this functionality provides the user with the capability of downloading a recently created file instead of waiting for it to be created again. The default archive size is 0, and the maximum archive size is 3.

7100: Excel/CSV Export of Alerts/Queries/Comments/Codes and Other Managers

The ability to export from managers.

This feature enables the user to export the results from managing views for future analysis. If a user has access to a manager, the user is able to export the result to either an Excel or a Text file.

No special permissions are needed to enable this feature, just the standard access to the manager. The user inherently has the ability to export from a manager if the user has view access of the manager.

7101: Access to Dynamic Form Count from Dependencies

Access to the count of dynamic forms within the DataCollector Expression Language.

This is part of the DataCollector scripting language. The Study Designer has the ability to count the subforms by type. The scripting command is called “count”. Documentation on the “count” command will be provided at a later date. Please contact a DATATRAK Trial Designer for more information.

7388: Trial Summary Performance Enhancement

The Trial Summary display time is now more consistent and faster.

To reduce response time, all the data required for Trial Summary is loaded in a new way.

7400: Date Format Configurable for Audit Log

The Audit Log date format is configurable through DataArchitect.

The Study Designer may specify the date format used in the Audit Log by setting a property in the App Properties worksheet within the DataArchitect.

The property name to be set is studyAuditDateFormat and the value can be any date format supported by the system.

7414: DataCollector Compiler Accepts both “Correction Required” and
“Correction Required”

Spelling error and backward compatibility fixes.

This code update allows the DataCollector compiler to accept “Correction Required” and “Correction Required” as a column in the Dependencies worksheet of the DataArchitect file.

7557: Visit Name on Single Page PDF

Path display of a form for single page PDF.

In 2.5, the path of the eCRF is not displayed when converted to PDF. This correction provides the user with more information (the complete path of the eCRF) when viewing a PDF of a single form so that the user can easily identify the form.

7559: Enrollment Confirmation Screen

Enrollment Confirmation Screen is configurable through the DataArchitect file.

The study designer may enable the Enrollment Confirmation Screen by setting a property in the App Properties worksheet of the DataArchitect file.

The property name to be set is confirmEnrollment, and the values for setting the property are either true or 1, both of which will turn on the confirmation screen.

7583: File Protection for All Exports

Provide method for protecting the export files to avoid manipulation of the files’ contents.

During the export process, a checksum file is generated and can be used to verify whether or not the export content has been modified. The method to generate the checksum file is configurable in the Exports worksheet of the DataArchitect file. A parameter called checksumMethod can be set for the appropriate export writer. The possible values for the parameter are none, md5, sha-1, sha1, sha256, or sha512.

7586: Questions Without Display in Form PDF

Show both Display and Stored values on form PDF.

In 2.5, a question may not have a display value; for example, when asking the question ‘Check here if no Medications were given:’, only a checkbox is used. In this case there is no text associated with the checkbox; there is only a stored value. This may cause confusion when viewing the eCRF in PDF format because it only shows the blank display value. In order to more accurately represent the data, the PDF format has been modified to show both the display and stored values.

7652: Report Permissions Update

Show report permissions based on the overall report access defined per role.

The report permission screen has been updated so that when a user is creating a report, it will automatically fill in the boxes based on the overall report access that is defined for the role in the Roles worksheet of the DataArchitect file. For example: if the DA file designates Admin access to reporting for a role, all three permissions (edit, view, change) will be checked by default. For Viewer access, only the view permission is checked.

NOTE: The Permissions screen must be saved in order for these permissions to be implemented. If the user exits the report creation wizard without saving the Permissions screen (the last screen in the wizard), the permissions are not saved.

7702: Coding Manager Updates

Providing access to medical coding items through Coding Manager.

  1. Approve status is added to the standard export:

    Column ‘…_Approved’ is added to the Code section in the export. By default, the column value will be “approved” for approved codes and “unapproved” for unapproved codes. This value can be overwritten by the export formatter setting: codeApprovedValue/codeUnapprovedValue.

  2. Filter on dictionary type added to the filter section:

    The ‘Show Dictionary:’ drop down list automatically displays the names of all dictionaries used in the study. This allows the user to filter on dictionary type.

7836: Utility Code Improvements

Refactoring of core code.

This is part of the performance enhancement. Internal functions have been optimized, yet external functionality is unchanged.

8128: User Admin: Adding Multiple Sites to a User

Add a user to multiple sites during user setup.

During the user setup process in Enterprise Manager, a user can be added to multiple sites at one time. This reduces user setup time.

8129: User Admin: Default user into study workgroup

Optionally make the user a member of the study workgroup by default.

When a user is added to a study in Enterprise Manager, the user may automatically add to the study workgroup. This reduces user setup time.

8130: User Admin: Random Password Auto Generated and Emailed

Random password generation and email to the given account during user setup.

When a user account is created, the user does not need to provide a password anymore. Instead, a random password is generated and emailed to the given address. The user is required to change the password upon first login.

8132: User Admin: Hover Over Tool Displays Description

Show description of tool/workgroup on mouse over.

When in Enterprise Manager the user mouses over a tool or workgroup, the description for the entity is displayed. This feature provides information about the tool/workgroup to assist in the user set up process.

8133: User Admin: Search Filter for Description Field

Searching tool/workgroup by Description.

New functionality is added to Enterprise Manager to allow the user to search a tool/workgroup by Description, which stores useful information about the tool/workgroup.

8136: Medical Codes in DataGenie

Creating medical coding reports in DataGenie.

This feature allows users to create reports on medical coding information, so that the users can access coding information, such as coding statuses or dictionary levels, in DataGenie.

8227: Adapt PDF-Export/Archive Function for eSubmission

Provides PDF Archival and eSubmission ready archives.

The PDF archival process has been improved to allow faster archival execution, smaller archival files and more functionality within the archives (index files, hyperlinks to audits, alerts, comments, queries). PDF archival can produce eSubmission prepared archives. PDF archival is compatible with the DATATRAK DVD/CD production facility.

8367: Updated System Settings to Increase Performance

Enhance performance using optimization features. The optimization increases speed by 100 percent or more for most activities.

8381: New Writer Property for Removing Blank Rows

Exporting of blank rows is now configurable.

In the Exports worksheet of DataArchitect, the user can specify a new parameter for the writer to exclude blank rows from the export. The name for the parameter is removeBlankRows or [targetTableName]_removeBlankRows and the value for the parameter contains a comma separated list of column names. If all these columns are empty within an export row, the row is considered to be empty and will not be added to the result set. If the first item of the list is $invert$, then the logic is inverted, which means that all but the columns mentioned in the list need to be empty to not have the row added to the result set.

The setting removeBlankRows affects all export tables. It is implemented in a way that the system first looks for a current export table-specific removeBlankRows setting and then for the global one. For example, if the current export table is ae, first it will search for a setting ae_removeBlankRows, and if it is present, we use it. Otherwise the system looks for a setting removeBlankRows.

8382: Enhanced Data Source Configuration

Providing additional methods for database connection.

The username and password for database connection can be set in an external file specified by Technical Services or IT. If the file is present, it is used; otherwise, the standard username and password combination is used.

8417: Shared Tables Implementation

Modifying the database tables’ structure to support Trial Manager.

Part of the Trial Manager deliverable requires the consolidation of the workgroup and login tables.

8536: Status Manager Form Order

Ordering the result set in Status Manager.

The listing order in Status Manager is now alphabetical by primary name and then form.

8607: DataArchitect Derived Compiler Error Messages need to be changed

Changing the Invalid Format Alert error checking within the DataArchitect Compiler.

Update the Invalid Format Alert error checking to ensure the data type of all stored values are consistent with the data type of the question type itself.

8641: Updated search and results listing in the Coding Manager

Coding Manager updates.

The following updates are made to Coding Manager:

  1. Search the questionTypeId by answer text.

    Updated the ‘Question:’ search option to include search for QuestionTypeId or Question name. To allow for the search by QuestionTypeId, thus making it consistent with the other managers. Also, added an additional search criteria ‘Question Answer:’ This feature allows the user to search for all question answers of the same type (ex: headache) and then code them simultaneously.

  2. Consistent ordering of the result set.

    In previous versions, the result set was ordered by Primary Identifier only. This grouped terms by subject but did not always display the terms in the same order within the subject. The result set is now ordered first by Primary Identifier and second by code database id; this combination will ensure the result set is displayed consistently.

8729: Change behavior of recode

Modifying recode to use the existing code object.

In 2.5, the recode feature for DCCode object deletes the existing code object and creates another one. This implementation can cause issues with cache copies of the Coding Manager view in browsers. Recode has been modified so that it will use the existing code object.

8810: User Admin: DATATRAK internal staff members should be able generate user accounts

Provide alternate methods for generating a user account within Enterprise Manager.

New functionality is added to Enterprise Manager to allow DATATRAK internal staff to generate user accounts bypassing the initial account generation page on the login screen.

8812: Search Page Label Updates

Consistent view of Search screens within Enterprise Manager.

The text present on Search screens in Enterprise Manager is modified to use consistent terminology.

8970: Add Script Support within DataCollector Compiler

New worksheet is introduced in DataArchitect file to support the DataCollector Scripting Language.

To support the DataCollector Scripting Language, a new worksheet called Scripts is included in the DataArchitect file. The column header is Script and the value for it is any valid xml.

8997: Modify the isActivated method in Randomization Manager

A record is considered to be activated if a strata item has been assigned to it.

In 2.5, the expression value of the ‘isActivated’ property is checked to determine if a record is activated. However, when the activation assignment fails to set the ‘isActivated’ question, this record is considered to be ‘not activated’ even though a strata item already has been assigned to this record.

In the new implementation, a record is considered activated if a strata item has been assigned to it. This will prevent a record from being activated multiple times.

9184: Remove Hard Coding of Port 8080 for xsd Files

DataCollector Compiler updated to remove the hard-coded URLs.

In definition.xml file, the definition.xsd and script.xsd are referenced via a hard-coded port 8080. This is not functioning correctly in the staging environment because port 8080 is not active. The DataCollector Compiler is updated to remove the hard-coded URLs.

9219: Create Placeholder for Marketable Features

A Help Center is now active and Feature and Release History Pages are included.

The Splash Feature History page provides a running overview of marketable features and is available to users upon login. The features are archived by type:

  1. Platform Scalability
  2. Superior Performance
  3. Trial Initiation-to-Submission Efficiency
  4. Best-of-Breed Functionality
  5. Ease of Use
  6. Online Solutions Delivery

Corrections

7183: Correct Time Reporting in Excel Writer

Removed embedded date value from time value in Excel export.

This is a code correction. Currently, an exported time without a date has a date value of 1/1/1970. The embedded date value is removed from time value during Excel export.

8852: Correct Error Reporting for Excel Writer

Updating the Excel Writer to set badParse to false inside the loop.

This is a code correction to avoid exceptions within the code.

9185: Null pointer exceptions thrown when design server is down

The “COMMUNICATION_ERROR” exception is now handled properly.

Both listFiles and writeFile do not handle a communication exception properly. The internal classes have been adjusted to cope with exceptional situations.

9683: Enrollment Confirmation Displays Fixed “record name”: subject

The enrollment confirmation screen now uses the record name as it is defined in the DataArchitect file.

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
  • 8473: Duplicate query display ID for the same application
  • 8537: Status Manager Filter Layout – On smaller resolutions, the filters above the listing wrap to the next line, specifically the subject line.
  • 8549: Link to Status manager is Missing from Action Box
  • 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.
  • 9799: Coding manager does not work when auxilliary question is missing
  • 9861: Fill Data doesn’t fill partial dates questions. Fill Data is a useful testing tool for quickly filling a form with data.
  • 9910: Missing Data (NA/ND/NK) not working on formPartialEdit and formRestricted
  • 9958: Form ordering of dynamic forms is not correct when data is not saved
  • 10027: Upload/ Attach Files to a form

    In 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

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