Summary

This article covers the 13.2.0 DBP Release notes.

DATATRAK ONE^® 13.2.5 – March 22, 2015

13.2.5 Feature Enhancements

UX Trial Design

Enhance the Update Question Types Utility

Update the mid-study utility Update Question Type to:

• Enforce data type conversion restrictions (if desired)
• Further specify the subjects who should be impacted by the update
• Allow for the selection of questions through a drop-down menu
• Support the ability to select specific question occurrences
• Provide preview of results as well as final results in a searchable table
• Provide a summary of questions and metadata statuses that have changed
• Support the exporting of the results to excel or csv

Read more about the new feature in the Update Question Types Utility page.

UX Randomization and Trial Supply Management

Update Label for Product Type to be Configurable

The Randomization and Trial Management Managers, actions and screens shall display product labels based on the Trial Manager Product Type indication.

Read more about the new features in the Product Label section in the Randomization Trial Design page.

13.2.5 Feature Corrections

DATATRAK ONE^® Unified Platform

The Enterprise Manager should have an Edit Workgroup option in Enterprise Manager

Enterprise Manager does not have an Edit Workgroup option. An ability to edit workgroups should be added such that the user will have permission to edit the ‘Workgroup Name’, ‘Description’, ‘Address’, ‘Country’, ‘City’, ‘State’, ‘Postal Code’, ‘Phone’, ‘Email’, ‘Will the Workgroup be searchable from within the Portal’ and ‘Membership Information’ fields.

Add ability to change membership access in Enterprise Manager

The Enterprise Manager should have an option on Manage Members screen to Change Membership access in Enterprise Manager for each member of the workgroup and designate their access to view Calendar, Contact Directory or File Manager.

Visits on Calendar show up in incorrect cases

Visit Calendar Entries Navigate to incorrect locations when the user has access to multiple sites.

UX EDC & Medical Coding

When running an action from Query Manager, the action screen gives a loading message

When running the Query Manager actions Close, Reopen or Answer, a loading message is displayed on the action screen. This did not prevent the actions from being executed.

The difference reported by the ad-hoc report ‘Minutes_between’ function is off by one minute in some cases

When using the ‘Minutes_between’ Date Calc. function in ad-hoc reports, the difference in time reported can be off by one minute.

Expression evaluation optimization

Improvement in the evaluation of expressions.

Manager links and form renames do not evaluate some characters appropriately

The characters <, >, &, and ” were being interpreted as portions of HTML in progress bars and form names. These characters should be properly handled so the links and progress bars appear appropriately.

Audit Manager Function Optimization

Improve the performance of the Audit Manager.

IE 8 Does not show the String datatype in the Expression Builder for ad-hoc reports

In Internet Explorer 8, the Expression Builder in the ad-hoc reports does not display the String datatype.

Filter values not responding to all characters

The manager’s filter should correctly filter non-ASCII characters.

Randomization notifications do not use custom VM templates

Randomization notifications configured through the Manage Notifications feature do not currently use custom VM templates uploaded in Trial Manager.

For Studies with the internalization plugin configured, the links in the progress bars do not function in some cases

In the cross study and study level Forms Manager, when the user clicks the progress bar for studies with internationalization configured, nothing happens.

Action selection blank in certain situations

Removal of a filter that is applied automatically in some cases. This improvement will allow for the Choose an Action Drop-down Menu to display all the options granted to the user.

UX Trial Design

Limit variable and dataset name length to maximum 32 characters in the SAS import script

The SAS export will enforce a 32 character limit preventing a SAS import failure.

Read more about the feature in the TruncateSASTo32 section in the Exports page.

Add Default Signature Confirmation Text

The English Translation of the signature confirmation will default to read the following: By providing my electronic signature, I certify that I have reviewed and approved the data and I understand that electronic signatures are the legally binding equivalent of traditional handwritten signatures.

UX Training

When viewing training certificates, the course name, training company name and user name can be cut off in some cases

To address names getting cut off on the training certificate the following changes should be made to the training certificate display:

• The course name will be truncated if it exceeds two lines in length
• The user name will be truncated if it exceeds one line in length
• The training company name will be truncated if it exceeds one line in length
  To facilitate these changes for new courses, the following character limits will be enforced in Enterprise Manager when creating or updating courses:
• Course Name: 60 ASCII characters or 50 non-ASCII characters
• Trainer Company: 40 ASCII characters or 33 non-ASCII characters

13.2.5 System Maintenance

Convert datatrak.net web address to datatrak.com

Change references of datatrak.net to datatrak.com

Trial Manager tagging optimization

Trial Manager will now properly tag files for the design server. This will prevent some trials from needing to be republished on design after releases.

Standard Dependency Optimization

Improve performance of the UniqueForAppByAlias and UniqueForToolByAlias standard dependencies.

Restrict ad-hoc reports to 150 fields/columns

To improve ad-hoc report performance, the number of fields allowed in an ad-hoc report should be limited to 150.

Miscellaneous Updates

Translation keys

New translation keys were added for Question Type Utility, Ad-hoc Reports, Product Type Label and Default Signature Confirmation Text and translated into Japanese, Chinese (China) and Chinese (Taiwan).

DATATRAK ONE^® 13.2.4 – February 5, 2015

13.2.4 Feature Enhancements

UX Trial Design

Add ability to set “logChange == no” for all question types using display type “PlainText”

Add a property to set the logChange field at a study level to “no” for PlainText questions regardless of the logChange setting at the question level.

13.2.4 Feature Corrections

UX Trial Design

Script attribute previousValue does not return the correct value

The “question” script command should support the use of the following attributes:

• previousValue to get the data value that the question had when the form was loaded
• previousDisplayValue to get the display value that the question had when the form was load

Script assignments occurring on the currently processed form overwrite the user-entered Reason For Change

If a form contains a preprocessing script (a script whose dependent and target questions exist on the same form) and the system asks for a reason for change on the script’s target question, the text “Script Assignment” is saved as the reason for change rather than the user-entered reason for the change. Additionally, audits on assigned preprocessing questions are being duplicated.

Preprocessing scripts are not evaluated during the form save process in some cases

During the form save process, a preprocessing script that depends on a value on the same form is not evaluated correctly when the dependent is modified but the target question is not modified.

DATATRAK ONE^® 13.2.3 – January 22, 2015

13.2.3 Feature Corrections and Maintenance

UX EDC & Medical Coding

The alert status of questions may not be set properly when new alerts are created

When an alert is triggered, the metadata status may not be updated correctly at the Form Summary or Manager level if an alert has been triggered on a question that has been left blank.

System Feature Maintenance

Drug Container and Shipment Manager Optimization

Performance enhancement of the Drug Container and Shipment Managers.

Create a utility to update the alert status for all questions that have an alert status set to clean but have open alerts

A utility will be created which, when executed, will correct the alert status for any questions which have an alert status of ‘clean’ and have one or more alerts in the ‘open’ status. (See the 13.2.3 UX EDC & Medical Coding Feature Correction).

DATATRAK ONE^® 13.2.2 – January 16, 2015

13.2.2 Feature Enhancements

DATATRAK ONE^® Unified Platform

A message should be added to the Classic Desktop for Retirement Announcement

The following message should be added to the Classic UI Desktop: On the 30th of April 2015, the DATATRAK ONE^® Desktop will no longer be accessible in the Classic User Interface. Starting the 30th of April 2015, the Desktop will automatically be displayed in the DATATRAK ONE^® Unified Interface for all users. DATATRAK has prepared a short training course “Module 01: Know Your Desktop” to assist you in navigating the Unified Interface. If you would like to take advantage of the revolutionary interface prior to the 30th of April 2015, we encourage you to take the training today.

A setting should be added that allows for all users to be switched to the Unified Desktop

A setting shall be added to convert all users to the Unified Desktop after the Desktop retirement date. While all trials currently on the Classic environment will continue to be supported, all features not tied to a Classic study such as the Desktop, Collaboration Tools, Profile page and Enterprise Manager will be converted to the Unified interface. The ability to switch interfaces on the Profile screen will also be disabled.

The Scheduler should be updated to set a default email template and include a log entry regarding notifications sent

For the Scheduler, the Recipient Dialog’s Template dropdown menu should default to the Default template with “None” as an answer option. Additionally, when a notification is sent, an entry should be added to the log that indicates the number of notifications sent, the name of the template file used and the number of internal and external users that the notification was sent to.

The Cross Study Managers should be updated to support form flow forms

The Cross Study Managers should be updated to display form flow forms as appropriate per the users permission and access. The display of the forms should be identical to that experienced at the trial level for the user.

13.2.2 Feature Corrections

DATATRAK ONE^® Unified Platform

After using the Search Workgroup feature in Enterprise Manager, clicking the name of a workgroup in the results can bring up the wrong workgroup in some cases

If the user right-clicks a workgroup, selects “Search” and searches for a workgroup, when the user clicks a workgroup name in the search results, the user is directed to the workgroup that they had originally right-clicked rather than the workgroup they clicked in the search results.

The Cross Study Manager tabs should not be displayed in the Design, Test and Approve environment

The Cross Study Manager tabs should only be displayed in the production environment.

UX EDC & Medical Coding

Values assigned from a preprocessing script are not used in the dependency evaluation

Values assigned from a preprocessing script should be used in dependency evaluations. Currently script calculations are done after the dependency evaluations.

Export of displayed values does not work if data type is inconsistent

If an export configured with showDisplayValues=True has a value with a display type and data type that are incompatible, the column in the export can end up blank.

When the form is saved, alerts on frozen questions are not updated in certain cases

In the following cases, alerts on frozen questions are not updated when the form is saved:

• the question with the alert and the questions that the alert is based on are on the same form
• the frozen question’s alert is using an unfrozen question
• the unfrozen question is modified in a way that changes the alert fire status
  

Missing Data Flags do not consider required alerts

When the missing data flag functionality is enabled on a study and a related alert is triggered on a question that has an alert set to ‘required’ for the ‘correction required’ attribute, providing one of the options for the missing data flags does not allow the user to save the form. Missing data flags should not be triggered when the associated alert is marked as required.

The Automatic Date Format feature does not work in the tabular view

The Tabular View feature should be updated to support the Automatic Date Format feature.

When the alert text in an alert box spans two lines due to the long length of the text, the break from one line to the next may occur in the middle of a word

In the case of a very long Alert Text on a small screen, the browser will break the word up in order to make it fit on that line, and move the remaining portion of the word to the next line. This should not be the case. The alert text should not be divided in the middle of a word.

When using the tabular view, the message for slower browsers can be displayed for quick browsers

In some cases the message displayed to users to warn them about their slow browser is displayed when there are no issues related to browser performance.

In the Managers, the Alert Status Filter does not filter properly

In the Managers, the Alert Status filter classified alerts with the “Open W/Reason” status as “Closed”. They should instead be classified as “Open”.

The answer status for a question changes when the value of a question that its alert depends on changes

The answer status for a question should only change when its value is changed or when its Missing Data Flag is changed.

Question visibility does not check for the existence of alerts in non-preprocessing mode

When a hidden question has an alert, it should always be displayed.

In some cases an import cannot find all sites

If an import has rows with multiple sites and a script or input path is used to map sites, the site may not be found.

UX Training

After a session timeout while taking a course, it is possible that data is not set properly when the course is re-launched

To address session timeouts while taking courses, run-time data should still be available during re-initialization of the course. Additionally, the user should be notified when the session is about to expire.

UX Trial Design

The question visibility expression cannot check question data using the “this” keyword

Using the “this” keyword when configuring question visibility expressions does not work as expected.

DATATRAK ONE^® 13.2.1 – December 18, 2014

13.2.1 Feature Corrections

DATATRAK ONE^® Unified Platform

Enterprise Manager sends English only emails

When emails are sent from Enterprise Manager, all emails are in English disregarding the language setting of the user that triggers the emails. This should not be the case. The email subject and body should be in the language set in the user’s profile.

UX EDC & Medical Coding

Import status is not cleared after import is finished

The Import status on servers is not cleared after the import is finished. Only the server the import initiated on shows the import finished while all other servers show the import is still running. When an import completes, the import status should propagate across servers.

DATATRAK ONE^® 13.2.0 – December 14, 2014

These release notes cover the new features and updates, feature corrections, maintenance updates and outstanding issues for the DATATRAK ONE^® 13.2.0 DBP Release.

New Features

New features for DATATRAK ONE^® include new functionality for UX EDC & Medical Coding^TM, UX Randomization and Trial Supply Management^TM and the Collaboration Tools. This section provides an overview of key features related to the new functionality and impacts to existing functionality. For more detailed information on the new features, view the complete manuals for the Cross Study Managers, File Manager and the Scheduler.

Cross Study Managers

The Cross Study Managers provide a unified view of all study data in the UX EDC & Medical Coding^TM and UX Randomization and Trial Supply Management^TM Managers (Subjects, Forms, Questions, Queries, Alerts, Comments, Visits, Codes, Audits, Synonyms, Shipments, Schedule, Drug Assignment, and Drug Containers) in a single Manager view, so a single user can view data across all of their studies in one location.

Note: Only Unified studies can be included in the Cross Study Managers.

Key Features and Benefits

• See a read-only view of manager data across studies that respects study level permissions and acts as a central hub for review-related activities.
• Drill down into cross study data by clicking the progress bars or drill down to a single-study level by clicking the links within the Cross Study Managers.
• Take advantage of the six new cross study manager columns (Current State, Study, Phase, Product, Product Type and Therapeutic Area) to better sort and filter data in the cross study view.

Note: Since the data used to populate the new columns comes from the Trial Manager Setup form, the Setup form may need to be updated for your trials before these columns will contain data.

• Make use of all study level manager filters at the cross study level, now with more reporting power through the implementation of persistent filters.
• Save manager searches across studies and access them through the My Checklists Widget on the Desktop.

Differences Between Cross Study and Study Level Managers to Keep in Mind

In many ways, the Cross Study Managers behave like the study level managers. However, a few key differences exist.

• Regardless of your Role Selection setting, the Cross Study Managers display the data as if your roles are combined.
  • Where multiple naming conventions exist, the Cross Study Managers use the default name:
  • The subject status filter uses the default label for each subject status; study level subject status labels are displayed as hover text in the Record Status filter when labels vary across studies.
  • The recordName is designated by the word “Record” regardless of the study level configuration.
• If at least one study uses the ‘Needs’ properties in the Cross Study Managers, the metadata filter options use the ‘Needs’ labels.
• When you apply the Study Filter, the other filters will only display options pertaining to the studies selected in the Study Filter.
• A default date and time format of dd/MMM/yyyy and HH:mm:ss is used across studies.
• All dates are displayed in the time zone set in your Profile except for the Drug Assignment Date Column and Activation Date Column, which display the date in the time zone configured for the study; if no time zone is configured for the study, the time zone set in your profile is used.
• Form Flow is not supported in the Cross Study Managers so forms that are currently in a form flow are not displayed in the Cross Study Managers; you will need to access the study level managers to view form flow related data; records with forms that are involved in Form Flow will still appear in the Cross Study Record Manager.

Impacts to Existing Functionality

• Those with access to the Cross Study Managers will see a new tab on the Desktop for each Cross Study Manager.
• As described in the Cross Study Manager and Study Level Manager manuals, manager filters and searches are now persistent such that your filter and search settings are saved when you switch between cross study managers or switch between managers for a study.

How do I get started?

Before you can access the Cross Study Managers, you must request access to the feature through your DATATRAK Project Manager. Additionally, studies will only appear in Cross Study Managers if the feature has been enabled on the Setup Form in Trial Manager.

Once you have been granted access to the Cross Study Managers, you can access each manager from the Desktop.

Read more about the new features and differences between the Cross Study Managers and study level Managers in the Cross Study Manager manual.

File Versioning

File Versioning allows document versioning within File Manager. Users can retrieve and view past versions of files uploaded through the File Manager. Also with this release, the File Manager now only supports the uploading of files. The File Creation feature has been removed.

Key Features and Benefits

• Upload new versions of a file through File Manager’s Update functionality and enter a commit message to associate with the version.
• Track different versions of a file through the Version History Screen 
  • uploading a new version of a file results in an incremented major version number while updating the name of a file via the File Properties Screen results in an incremented minor version number
  • uploading a new version of a file after the file name has been updated through the File Properties Screen will reset the minor version number to 0.
  • Download versions of a file through the Version History Screen by clicking the name of the file.

• In the File Directory Table, view additional information about the file through the following new sortable columns:
  • Current Size – For files, the size of the latest version of the file (this column replaced the “Size” column); for folders, the total size of the latest version of each file contained within the folder.
  • Version – The current version number of the file.
  • Total Size – For files, the sum of the current file size and all previous versions of the file existing in the file system; for folders, the size of the folder including all files and versions of files contained within the folder.
  • Last Modified – The date on which changes were last made to the file or folder.
• Search for files by ‘Name’, ‘Description’ and the newly added ‘Previous Name‘.
• View the history of deleted files that once existed in a folder with the Show Deleted Files button located in the top right corner of the File Directory Table.

Additional Changes and Impacts to Existing Functionality

This section describes enhancements to File Manager that are related to File Versioning. See the New Updates section for additional enhancements made to existing File Manager functionality.

Functionality Updates

• Each major version of a file stored in File Manager counts towards the amount of remaining disk space.
• The ‘Create File’ option has been removed.Since files can no longer be created through the system, the ‘Templates’ section no longer exists on the File Properties Screen.
• Commit messages are required for all updates to a file; a commit message is optional for the first version of a file.
• All files existing in File Manager prior to the DATATRAK ONE^® 13.2.0 Release have an initial version of 1.0.
• When you click a file’s file name, the file is always downloaded; previously text and html file types would open directly in the browser.To better protect against the accidental deletion of files, files and folders can now only be deleted by a member of the DATATRAK Solution Center 
  • a single version of a file or all versions of a file can be deleted by contacting the Solution Center
  • deleted files cannot be retrieved.
  • When a folder containing deleted files is deleted, the history of those deleted files is moved to the folder’s parent folder if the parent folder is not a top-level folder
  • if the only available parent folder is a top-level folder, a folder named “Trash Can” is created at the same level in which the deleted folder existed, and the history of the deleted files is moved to the Trash Can folder.

Note: Deleted files cannot be restored. Only the history of the deleted file is retained.

Cosmetic Updates

• The File History Screen has been renamed to “Permission History” to better define the type of history tracked; share requests and changes to file permissions are tracked on this screen while file uploads and file updates are tracked on the Version History Screen.
• In the File Directory Table, when the user hovers the mouse over the “Total Size” column heading, the hint “Includes all retrievable versions” is displayed.
• In the File Directory Table, when the user hovers the mouse over the file’s version number, the hint “Click Here to view Version History” is displayed.
• Since multiple versions of past files can be considered, the “Former File Size” information was removed from the Update File Screen.
• Since files can no longer be created through the system, the “Create” tab seen when viewing the File Directory Table has been renamed to “Create Folder”.

How do I get started?

Navigate to File Manager and start uploading files. As you create new versions of a file, commit them to File Manager to keep track of your revisions, share revisions with others and manage files across studies.

For more information about File Versioning, view the File Manager manual.

Scheduler

The Scheduler provides the capability to schedule actions within the platform to run at a later date on a defined schedule. The tasks available for scheduling include Standard and Ad-hoc Reports, Exports and Sub-set Exports, Imports and custom tasks, which can be implemented at client request. The Scheduler also allows the option of sending a link to retrieve the results or provide a notification that the results can be retrieved by logging into DATATRAK ONE^®.

Scheduler Definitions

Before reviewing the new features available with the Scheduler, get acquainted with the Scheduler lingo.

• Job – A collection of tasks that runs on a set recurrence schedule and has its own set of recipient settings; all tasks within a job must be of the same type (Export, Import, Report, Custom).
• Task – An individual report generation, export or import; custom tasks can also be created on a per trial basis.
• Job Package – The results of a job execution combined into a single archive.
• Recurrence – The schedule over which the job will run.
• Recipient – Internal and external users who can receive customized email notifications regarding a job’s completion.
• Job Scheduler – A role that enables the user to create, enable, disable and manage the details of jobs that they own.
• Job Admin – A role that enables the user to view job details, disable and enable jobs and change the ownership of a job; the Job Admin is not a super user.
• Job Owner – The Job Scheduler who created the job or received ownership of the job through a Job Admin; Job Schedulers must own the job in order to edit the job details or delete the job.
• Job Credits – the currency for job executions; each time a job runs, credits are deducted from the workgroup that owns the job; credits are added to your workgroup by your DATATRAK Project Manager.

Key Features and Benefits

Scheduler permissions are spread across two defined scheduler roles: Job Schedulers and Job Admins. While the two roles share some permissions, they have distinct purposes. Additionally, most Job Scheduler actions can only be performed by the Job Scheduler that owns the job. For detailed information regarding scheduler permissions, view the permissions table in the Scheduler manual. The following features are broken down by scheduler role.

Job Scheduler Actions

The following list describes the functionality for Job Schedulers working with jobs that they own. For jobs they do not own, Job Schedulers can only view job details.

Job Management

• Create jobs of any of the following types to run on a monthly, weekly or daily recurrence schedule
  • Export – Export Jobs can contain export tasks with any output type such as Text, Excel, PDF and SAS.
  • Import – Import Jobs import data files from File Manager and can contain import tasks with input types: Text, Excel and XML.
  • Report – Report Jobs can contain report tasks for both standard reports and ad-hoc reports; currently, only ad-hoc reports of types Text, Excel and SAS are supported.
  • Custom – Custom tasks can be developed by DATATRAK for a trial in order to fulfill special needs.

• Add tasks to jobs through the Scheduler interface or through the Export Manager, Import Manager, Ad-Hoc Reports Screen and Standard Report Screens
• Manually execute jobs to test your job configuration or initiate a set of tasks when you need them to run.When setting a job’s recurrence, configure the start date, end date and other recurrence settings based on your study’s needs.

Note: Start times are specified by a 2-hour time range.

• Disable jobs that you own as needed to prevent a job from running while maintaining all of its settings; disabled jobs do not run regardless of their recurrence setting but can still be ran manually; newly created jobs are disabled by default.
• Enable jobs that you own when you deem them ready to start executing on their set recurrence schedule.
• Review the history of past job modifications and executions with the Job Log.
• Receive information regarding credits remaining and expected credit depletion dates as you perform actions in the Scheduler interface.

Email Management

• Configure the subject, ‘from’ address and body of email templates for job owners and job recipients using a set of available context keys.Support emails in multiple languages by localizing the template for any of the following supported languages: English, French, German, Japanese, Chinese (China), Chinese (Taiwan), Spanish and Italian.Manage archive encodings per language so that job packages are compressed into an archive format accepted by the recipient’s computer regardless of the characters used.
• Designate recipients as one of the following types and automatically notify them when a job completes; the notification can simply inform them to log into the DATATRAK ONE^®system to retrieve the results or the notification can include a link to the job’s results
  • Internal Users – Those with DATATRAK ONE^® accounts are internal users; internal users receive email notifications in the language specified in their profile (if localized email templates are configured) and are prompted to log in prior to accessing job packages.
  • External Users – Those without a DATATRAK ONE^® account are external users; external users receive email notifications in the language specified in the job’s recipients settings and receive a direct link to the job package that does not require login credentials.

Note: If the report contains confidential or protected data, DATATRAK recommends using internal users as recipients so that authentication is required to access the data.

• Automatically notify job owners when the job completes or fails.

Job Admin Actions

• Change the owner of a job to another Job Scheduler if the current owner leaves the workgroup; in order for a job to continue functioning after the owner is changed, the new owner should have all study permissions required to run the tasks in the job; the system will inform you during the ownership change if the intended new owner does not have all required study permissions. To support multiple workflows for the changing of ownership, the Scheduler does not prevent the ownership change from occurring but the permission changes should be completed before the next job is executed.
• Disable jobs belonging to workgroups for which you are a Job Admin in order to prevent a job from running while maintaining all of its settings; disabled jobs do not run regardless of their recurrence setting but can still be ran manually.
• Enable jobs belonging to workgroups for which you are a Job Admin.

Actions for Both Job Admins and Job Schedulers

• See a read-only view of the following job details in the Scheduler interface for jobs you do not own
  • Job Type, Name and Workgroup
  • Job Tasks
  • Recurrence Settings
  • Recipient Settings
  • Job Log
  • Email Templates
  • Archive Encodings

Impacts to Existing Functionality

• Those with access to the Scheduler will see the Scheduler tab on the Desktop and a link to the Scheduler within the My Tools Menu.
• When the Scheduler runs an export or import for a study, the Import Manager and Export Manager will report that the job is running.
• Upon job completion, the results of an export execution will be available in the corresponding study’s Export Manager for those who have access to the role running the job and have Role Selection enabled.
• Upon job completion, the results of an import execution will be available in the corresponding study’s Import Manager for those who have access to the role running the job and have Role Selection enabled.

New Study Configuration Options

Custom Tasks

While the scheduler supports several standard job types, the scheduler can also support custom jobs made up of custom tasks. These custom tasks are configured on the App Properties and Roles worksheet of the DA by a Trial Designer and must have a corresponding custom Java file uploaded to the study. This section provides a brief overview of the DA configuration. For more information, view the Scheduler Custom Tasks help page.

Trial Design – Custom Tasks – App Properties
Property Name: CustomTask-uniqueID (no spaces are accepted as part of the app property name)
Expected Values (to be comma separated):

• name=’name of the task as it should appear in the Scheduler interface‘
• desc=’description of the task as it should appear in the Scheduler interface‘
• class=’name of the custom java file added to Trial Manager‘
• parameter=’comma separated list of the parameters used in the custom task‘

Trial Design – Custom Tasks – Roles
A role is allowed to run all or no custom tasks. There is no differentiation on the specific custom task. Job Schedulers who have the following permission at the study level will be able to add custom tasks to custom jobs for that study.

How do I get started?

Before you can access the Scheduler, you must request access to the feature through your DATATRAK Project Manager. Additionally, the workgroup owning the job must have job credits available in order for jobs to execute. You can request packages of credits through your DATATRAK Project Manager.

Once you have been granted access to the Scheduler, you can access the Scheduler through the Desktop.

For more information regarding the Scheduler, view the Scheduler manual.

New Updates

This section provides an overview of additional enhancements to existing functionality.

File Manager

• All dates listed in File Manager are in the format DD-MMM-YYYY HH:mm and are in the timezone designated in your profile.
• The ‘Remaining Disk Space’ ribbon at the bottom of the File Directory Table now includes the total amount of disk space allotted as well as the amount of disk space remaining.
• When a file’s permission type is changed, the Permission History Screen’s table shall contain the text “Permission Change” for the Event Name Column and the text “Change permission type” for the Comments Column.
• The screen accessed by clicking the ‘Update’ Icon has been renamed from “Edit [File Name]” to “Update [File Name]“.
• Throughout File Manager, usage of the short label for file size units has been replaced with the long label (e.g. “MB” instead of “M” and “bytes” instead of “b”).
• On the Update File Screen, the “Description” text area was renamed “File Description”.
• References to “uEDC” have been updated to “UX EDC and Medical Coding” on the Change Folder Screen and Change Permission Screen; you will see this text if you attempt to change the folder or permission of a file but do not have permission to perform such actions.

For more information about File Manager, view the File Manager manual.

Study Level Managers

• Filtering and searches performed in a manager are persistent across other managers within that same study until you navigate away from the study or log out of the system.

For more information on persistent filters for study level managers, view the Managers help page.

Miscellaneous Updates

• New translation keys were added for File Manager, Cross Study Manager and Scheduler and translated into Japanese, Chinese (China) and Chinese (Taiwan).

Feature Corrections and Maintenance

DATATRAK ONE^® Unified Platform

Classic UI “Out of Memory” page is unstyled

If a user does not have enough disk space and tries to upload a file on the Classic UI, they are directed to an unstyled version of the “Out of memory” screen.

Single Quotes Not Escaped Correctly

In File Manager if you change a folder name to contain the string \’, that string will be displayed as ‘ in some places and \’ in others.

File manager folders’ names not escaped

If the user places a single quote in the name of a folder in file manager, when clicking the Edit button for that folder, the user will not be able to edit the name but instead will receive an error.

When filter is used in file manager, results table is missing elements

When a search is performed in File Manager that has no results found, the no results found row does not stretch to the end of the table.

File icons do not display properly in File Manager

The file icons in File Manager do not show up correctly. Instead of displaying the icon associated with the file, the default icon is displayed.

The check for enough remaining disk space should occur before the file is uploaded

In File Manager, the check for enough remaining disk space should occur before the file is uploaded in order to prevent large files from being uploaded when no space is remaining.

Extra scroll bar on move to in contacts manager

In the Contacts Manager, hovering over the move to drop down causes a scroll bar to appear on the right side of the screen in some cases.

Extra scroll bar on move to in file manager

In File Manager, the move to drop down menu has a scroll bar always. It should not always have a scroll bar.

Share Files screen has extra quotation marks in the title

In File Manager, the Share File Screen surrounds the file name with an extra quotation mark on each side. This should not be the case.

New file icons need to be added

In File Manager, .xlsx, .docx and pptx currently display the default icon. They should each have their own icon.

“Workgroup Detail” doesn’t redirect correctly

In Enterprise Manager after adding a workgroup in certain situations, the ‘Workgroup Detail’ tab that can be seen from within ‘Manage Account Requests’ did not redirect to the previously navigated location.

UX EDC & Medical Coding

UI Display error when running subset exports

If the user is allowed to run exactly one export, the Subset Export screen’s Export Button is disabled such that the user cannot run the export.

Contact Question Type can remain in “checking” state indefinitely

If the user quickly types a complete, long contact name, the eCRF may stay in the “checking” state indefinitely and not return results.

Unconfirmed query counts on Form Statistics Report should respect view permissions

On the Form Statistics Report, unconfirmed queries should be included in the “Open” count and should only be included for those with permission to see unconfirmed queries.

UX Training

CompletionStatus needs a space

Completion Status on the Training page needs a space between Completion and Status.

UX Trial Design

Decompile Does not Provide Fax Number on Inventory Tab

When Decompile is done the Fax Number values for Depots on the Inventory Tab does not populate. The Decompile should provide the Fax number values stored for each depot defined.

System Feature Maintenance

Ad-Hoc Report display optimization

Improve performance of ad-hoc report output with large data sets.

Trial Manager function optimization

Improve performance of setup form in Trial Manager.

Repeated requests for the system header template can occur under some conditions

If a user attempts to view a form that no longer exists, this can cause a repeated call for the system’s header file which can affect system performance.

Outstanding Issues

Custom export crashes if a formtype is mapped to more than one dataset and the the formtypeID ends with an integer

If a formTypeID ends with an integer and the form type is mapped to more than one dataset in a custom export, the export will not complete.

Double data entry: Basic parameters do not list the Frozen Status restriction

If a double data entry difference report is restricted by the Frozen Status, the restriction is not included in the Basic Parameters for the results.

Question audit is created when the value has no change during reconcile

When reconcile is run, a question audit is created for questions with assignments even if the value of the question is not changed.

Entering dates in the wrong format in the EM Search Tools screen generates an error

When the user enters a date by hand in the search tools instead of using the datepicker, an error is displayed.

Today Option on Date Calendar on Confirm Shipments Does not Work

On the Confirm Shipment screen, when the date calendar pop up appears, the ‘Today’ button does not work. If you select it, nothing happens. This option should populate today’s date like it does in the eCRF.

Unable create course under Classic UI

When the user attempts to create a course in the classic UI an error is displayed.

Select Organization page should be converted to the Unified UI

The screen that the user sees when being prompted to select a root entity for an enterprise manager is not styled for the Unified UI. Since this page is not styled correctly, clicking links on this page can cause errors messages to be displayed.

Loading of properties can cause null pointer exceptions when using character set restrictions

Very rarely, checking character set restrictions may cause an error to be displayed to the user.

“Attach” button for the ‘singleDocument ‘ or the ‘multiDocument’ questions stops working if “Upload” action performed first

For singleDocument or multiDocument questions, the user is unable to attach a document after the upload action is performed.

It is not possible to save single “Radio-button” question in Classic UI.

If a radio button is created with only one option, when the form is saved, the radio button question will not be saved.

Back button after sorting doesn’t work

In the file manager sub folders, when the user clicks the back button, the user receives a confirm resubmission page instead of the previous page.

Basic Setup in Visual Architect Library Panel does not have “Overwrite Design” option

If you go to the Visual Architect, load library, and right click on the Basic Setup node in the Library pane, the “Overwrite Design” option should be displayed.

Translation in the actions menu are not generated properly

In header menu there is an instance where there are 2 keys separated by a space. In some languages this may not be appropriate.

Function ‘Length’ of Ad-hoc report does not work properly

In Ad-hoc Reports, a zero length string is considered null and will make the Length function not work properly.

Alert might not fire when some RFC is missing

When the user saves a form with 2 changes, an RFC and an alert are fired. If the user only answers the RFC and resaves the form, the alert is not saved.

Poor performance in tabular view for the Unified UI

When viewing a form in Tabular View, if the add form button is repeatedly clicked, the system may become slow or unresponsive.

EULA Modification of Chinese Taiwan shows English in preview

If the user is editing the EULA and clicks a preview for Chinese (Taiwan) EULA, the english version will be displayed instead of the Chinese (Taiwan) one.

Dependency variable evaluation can fail depending on date format

It is possible for dependencies with date calculations to work with certain date formats and fail with others.

Characters not displaying properly in SAS database due to utf-8 encoding

In the SAS database, some characters may not be displayed due to the utf-8 encoding.

Form Flow Transition page is not refreshed correctly when the form is locked

When the user attempts to use form flow transitions with locked forms, the user may receive an error.

“IsUniqueWithinDynamicForms” dependency allows to restore the role with the same name

It is possible to create two roles with the same name by creating the role, deleting it, creating it again and then restoring the deleted role.

Hidden questions should be displayed if an open query exists

Questions that have open queries should not be hidden form data entry users, even if the expression to hide them determines it should be so.

“Email Subject” issue for inventory transfer email

When the Email Subject for the inventory transfer email references the [toolID] and the shipment for a child site is initiated from the All Sites node, the Tool ID in the email subject is reported for the All Sites node rather than the destination site.

Billing Report tables expand to incorrect width

When viewing a billing report with at least one facet, expanding and minimizing tables can cause the width of the table to expand until it is no longer completely visible.
When the user expands tables repeatedly. The tables may slowly expand until they are not usable.

Several places missing horizontal scroll bar for the small screens

When the user views the system on a small screen, there are some places in the system that will not have a scroll bar. This issue appears in the contacts, enterprise manager, and uCTMS reports.

Announcements will have delay before being synced

If an announcement is updated, a user on a different cluster may still view the old announcement for some time before it gets updated.

PDF Export of Deleted Subjects With Same Subject ID Should Produce Appended File

If two or more deleted subjects have the same primary record ID, only the casebook of the one with the lowest primary record ID is exported.

Managers screens jump left

If the user scrolls to the very right of a scroll bar in a manager and then changes the sorting order on the filter, the screen will jump left in some browsers.

UX RTSM Reports > Shipment Summary report > Shipment Counts – does not display ‘Shipments Partially at Destination’.

Partial shipments are not displayed in the shipment summary table count and pie chart.

In Zoom mode extra button click is required to get back to container

If the study is configured with useSavePrompt set to ‘yes’ and saveOnExit set to ‘no’, when the user navigates to a dynamic form in the tabular view, fills the form out and clicks the back button, the dialog asking if the user wants to leave the page is displayed twice.

Issues related to the ‘enterKeyAction’ configuration

For some browsers, enterKeyAction does not work to go to the next field properly when the enterKeyAction is set to nextField. In other situations when enterKeyAction is submitted, the form is not submitted properly with certain browsers.

In zoom mode ‘Lock’ and ‘Lock All’ do not disable Close/Open Alert boxes

In the regular list view, the “Lock” and “Lock All” function as expected. However, in the tabular view, locking the question or form does not disable the close alert and open alert check boxes. This issue exists in the Classic UI.

Chrome and Safari do not save data when SaveOnExit is yes in the Classic UI

If a trial is configured to use saveOnExit and SavePrompt, when the user navigates away from the form without saving in safari or chrome, these features do not work properly and the data is not saved.

Some characters cause errors in Visual Architect

Some characters can be entered into a DA which will not allow the file to be opened in VA and will display an error to the user.

Only 1 instance of EM tool should be created

When a sub client is configured on a stand alone server and not a cluster, the Enterprise manager is created 4 times.

notSet Missing Data Flag is saved as red alert

If notSet flag is set in the DA and a question has a red alert, it will be saved as red alert with no reason for override instead of open without reason or closed without reason.

Synonym Manager Export gives clickOS error

In the Classic UI, the user will be presented with an error upon attempting to export the synonym manager.

Dynamic formIds are incremented

When the user copies and pastes a dynamic form into visual architect, the formid is incremented. All dynamic forms of the same formTypeId should have the same formId.

Email Notification cause import to fail

Under the following conditions an error can occur during import:

• updateQueryWhenValueChange=answered
• updateQueryWhenValueChangedByImport=true
• “Query Answered” notification set up at the “Query Manager” location

‘Paste Item’ in Visual Architect does not work until you publish or commit trial

In Visual Architect, if the user attempts to paste an item in a tab other than the casebook tab, the paste item will not work until the trial has been published or committed.

VA delete does not work in IE

In Internet Explorer if the user attempts to delete a VA item using the delete key, there may not be a confirm deletion dialog and the item will not be deleted.

In VA, dropdown menu stays in place on browser resize

In VA, if a browser is resized on the properties page while a dropdown menu is open, the menu will not adjust to the new location. It should adjust location along with the rest of the elements on the page.

Dropdown lists move when highlighted in VA

If the user is using Internet Explorer, the items in a VA dropdown list may shift unexpectedly.

Resolved values in the expression language are parsed and interpreted

Resolved variables in the expression language are further interpreted by the expression language. For example, if a data value of a question is 5<6, the value will be resolved to true instead of ’5<6′.

When the toolname is numeric only it drops leading zeros

The scripting language drops leading zeros for a toolname that is completely numeric.

Improve Scatter Chart

For scatter plots, it is possible that the scale of the chart is incorrect and will cut the point in half.

Property commands are not processed upon reconcile

The setProperty command will not be reconciled even if shouldReconcile is “true”. For incrementProperty, if target is set to “before” is not executed correctly. In following script only the first command will be executed. If target is set to “after” all commands will be executed upon reconcile.

Patient wasn’t reported missing in Difference Report

In some cases the Difference Manager does not report all missing patients.

Do Not Write Branching To XML If Forward To Is Empty

If the forward to is empty, the branching XML is still published.

createForm command issue

Forms may have duplicate sequence ids if createform with sequence is used and the forms are added under a container on a remote server.

Role names containing non-ASCII characters can cause display errors

If role sets contain non ascii characters and the encoding is not utf-8, the name of the roles may be displayed incorrectly in Enterprise Manager.

Remove Randomization permission defaults from dataArchitect template

When a DA is decompiled, the randomization permissions are enabled by default. For trials without randomization they have to be deleted and added back if randomization is configured later.

Secure the user interface to not allow adding invalid chars

If the user copies characters from a different application, these characters may be invalid and stored as a special error character.

Cannot Cleanly Increase Block Sizes

When a randomization schedule needs to be amended, it is not possible to increase the block size without creating a partial block. If this is done, the treatment ratios may also not be correct.

Freeze scripts are not shown in form debug page

If the user is accessing the form debug page, freeze scripts will not be displayed

Total time spent for a parent activity not calculated correctly sometimes

Training time calculation is sometimes not accurate for parent activities. The time should be the sum of all the child activities but sometimes the values do not add up correctly.

With large Case Books sequencing of forms is out of order in some cases

When a very large casebook is created, the order of the forms may not be according to the sequence numbers.

Audit Manager Export issues

If the user views an audit type of Audit Object in Japanese, it will not be translated.

Managers can display an error if the same filter is applied to same manager on different servers simultaneously

If the user has the same manager open in two browsers, each pointing to a different server, and the user runs a filter in both browsers for that manager, one of the managers will display an error.

Nested functions do not parse correctly

If there is a formula with a nested function, the result may be inaccurate.

DA: Remove Visit Schedule granted permission

The DA Template has permission granted for the visit schedule by default which usually will need to be changed by the designer

Add the Shared Inventory ID to the DA

Randomization supports multiple sites sharing inventory, but there is not a place to specify it in the DA

Alert script commands will trigger text commands to work at the wrong time in some cases

A script will fire alert only if both questions are not blank if any of the questions is blank the alert should be removed. A null pointer is generated in some cases.

Audits of type OLD are still being written

There are still a few places in the system where audit types can be created that have a type of OLD.

Activation receipts for blinded fields are not generated in RM

If a user without ‘viewBlind’ permission activates a subject, the blinded fields are not generated and users with the ‘viewBlind’ permission will be unable to review the blinded fields and activation status.

Restriction on Start and End Levels should work in Search Results

When searching for codes, if non-standard start and end export levels have been specified in the study configuration, only those levels should appear in the search.

Actions can be submitted twice on some randomization actions

Across the randomization actions, it is possible to click submit or populate buttons repeatedly. This can cause actions to be executed twice in quick succession

The time zone should be consistent across the randomization trial

When a subject is activated, the time zone that is saved is in local time. For the rest of the system times are stored in UTC.

“missing or broken” container should be considered “Confirmed” in Confirm Shipment table.

If a container is missing or broken, it still displays in the confirm shipment table. The status is partially received.

Ad-hoc Reports: contact control should resolve to user name

Sometimes Ad-hoc Reports will return the id of a user rather than the username for a contact control.

Alert script behavior inconsistent when changing dependent question

In the Classic UI it is possible for there to be dependent questions organized in a way that alerts need to fire but will not appear until after the first save.

Issue with form rename if a question used in naming is also referenced from another question

If a DA has a rename expression and a form is changed that would alter the expression but the reason for change is ignored, the form is not saved but the rename value is changed.

Problems if two users commit VA at the same time

If two users commit to a VA file at the same time from different servers one of the user’s changes will be lost.

‘Is Default’ can be answered ‘Yes’ for multiple portals

In Management Servlet, it is possible for there to be more than one default portal and the order of returned default portals is not consistent.

OC4J holds onto message classes used with JGroups

The wrong class can be used during redeployment for JGroups messages.

If one of design server is down, it still publishes DA file

If a user attempts to publish a DA file while a design server is down, it still publishes the DA file to the other design server. It should not publish to the other server if either server is down.

Management Tool entries are incorrect

In management servlet if the search filter is changed to address only, the entries in the dropdown menu are not correct.

Report creation does not present wizard screen for permissions

When using the creation wizard for Ad-Hoc Reports, it is possible for the Permission screen to not appear if certain fields are modified during report creation. The workaround is to access the screen through the “Permission” link rather than through the wizard.

Exporting auto code variables in all caps does not work

When an export is configured with the parameter columnUpperCase, auto coded variables and non-question columns do not export in all caps as desired.

Question-Select option in Audit Manager does not work

In the classic UI, using the audit type filter in audit manager does not work in some cases.

In Contact Manager if the page is not saved after adding files, the files may not be added

If the user adds a file in contacts but does not save the page, the item will not be attached.

Closing folders upon clicking another link (not keeping the sort)

From the calendar day view, if the user has a filter applied and then clicks on a different day, the filters are forgotten.

Text can be cleared when the “Enter” key is hit while adding a calendar event

If the user hits the “Enter” key when adding a calendar event, it clears the text and does not submit the form.

Some numeric comparisons need to be surrounded by quotes in order for them to work in edit checks

When an edit check is created without quotes, in some cases it will not fire. This only exists for the greater than and less than comparators and “0″.

Locked questions should have disabled checkboxes in the Alerts and Codes Managers

If a question is locked, the checkbox should be disabled in the Alerts and Codes Managers. It’s disabled in the Query Manager but not in the Alerts and Codes Managers. It’s disabled in the all managers in the Classic UI.

When browser’s “Back” button is clicked the Files tree doesn’t respond

In File Manager when the user clicks the browser’s Back button, the Files Tree does not update to show the user’s new location in the Files Tree. It is recommended that the user not use the browser’s Back button when using File Manager.

Approved shared files are stored in wrong folders or get lost

When the user has a sharing request for the same document from multiple workgroups for which the user is an administrator or contributor, if the user clicks the share request from the Desktop and approves the request on the following screen, the file can get lost or be stored in the wrong folder. To work around this, administrators or contributors can approve the share request by navigating to File Manager and accessing the share request from there.

Subject Statistics Report shows a max of 20 records

The Subject Statistics Report only shows a maximum of 20 records. If more exist, they are not displayed.

Shipment Origin filter should display all packaging location and all sites regardless of viewGlobalShipments permission

Currently in Cross Study Manager for a User with no viewGlobalShipments permission, the Shipment Origin filter displays all packaging locations and only the site the user has access to. However the records for the other sites are displayed in the table, because only Shipment Destination filter should restrict to the current site. Shipment Origin filter should display all packaging location and all sites regardless of viewGlobalShipments permission

Shipment filters should display sites within scope of the bridge

When two bridges are configured for randomization, the origin and destination filters in the Cross Study Shipments Manager show sites from the second bridge when the user doesn’t have access to those sites. The records that belong to sites from the second bridge are not displayed, which is correct functionality.

Override Reason filter sorting does not work properly

If you create alerts with override reasons ND, NK, NA and other letters, the applied sorting is not properly applied.

In Synonym Manager, synonym sorting should ignore the case

Currently when sorting is applied to the Synonym column in Synonym Manager, synonyms with capital letters come before those with lower case letters. Sorting should ignore the case.

Decompile Does not Work Correctly on Roles Tab

When a DA is decompiled if the role’s tab is not exactly like the DA Template, permissions are lost. Custom permissions and actions as well as if permissions are split into different rows versus being grouped together, the assigned permission (or X) is not present in the decompile. The decompiled file should contain all permissions and actions assigned to the trial.

Some symbols do not render correctly in the Manage Notifications feature

In the Manage Notifications feature, the Email Subject column for saved notifications displays the greater-than sign as “&gt;” and the lesser-than sign as “&lt;”.

If you add more than 100 fields to a Graph Ad-Hoc report and run the report output, an error displays.

If you add more than 100 fields to an Ad-Hoc report and select any graph report output, an error displays.

Faulty text displays on the Run Report button on the Classic UI Ad-Hoc Report screen

Create an Ad-Hoc report, select any type of parameter and click on the Run Report button. The report screen displays with the faulty Run Report button text (@@RunReport).

Navigation within the Desktop Calendar sometimes resets entries.

If a user adds two trials at the same time to the Desktop Calendar, navigates to one of the trial’s sites, the other trial is deleted from the Calendar upon return to the Desktop.

Similar trial names with different characters will sometimes have duplicate configuration paths

If two trials are enrolled with names that are differentiated only by special characters, the trials will have the same configuration path (i.e. test0101, test0101_).

Import File Name could cause Missing information on import history screen

If an import file name contains a “_”, on import history screen, the imported file, imported by and import file size information will be missing.

Product Label caching problem on Production

On the Product Label for Randomization and Inventory, if you change the Product Type option in Trial Manger Set-up page, the labels are updated on Design, Test and Approve and all Production servers other than the server you are on. So if you make the change on Prod002, every other server will show the updated label but Prod002 will still show the previous label until Prod 002 cache automatically cleans itself up.

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