Summary

This article covers the 13.3.0  DBP Release notes.


DATATRAK ONE® 13.3.7 – May 3, 2016

For 13.3.7, we have a total of six (6) updates including correction and maintenance items outlined below.

Corrections

For 13.3.7, we have included the four (4) correction items outlined below:

Announcements Reappearing [Ticket 169847|DATATRAK ONE|Widgets]

Ensuring announcements stay marked as read after server restarts.

Account Creation [Ticket 169869|DATATRAK ONE|Enterprise Manager]

Preventing errors when manually adding an account if a Country is selected prior to entering other information.

White screen appears for some users [Ticket 169878|DATATRAK ONE|Login]

Correcting an issue that was causing a small amount of users to receive a white screen during system usage.

Management of Workgroups [Ticket 169923|DATATRAK ONE|Systems]

Ensuring workgroup policies are applied properly on all clusters when a user has access to more than one hundred workgroups.

 

Maintenance

For 13.3.7, we have included the two (2) maintenance items outlined below:

Desktop [Ticket 169924|DATATRAK ONE|Systems]

Improving system performance on the Desktop.

Last Login [Ticket 169925|DATATRAK ONE|Systems]

Improving system performance when retrieving the Last Login information to display on the Desktop.

 

DATATRAK ONE® 13.3.6 – March 22, 2016

For v13.3.6, we have a total of ten (10) updates including enhancement and correction items outlined below.

Enhancements

For 13.3.6, we have included six (6) enhancement items outlined below:

Trial Manager Question Length Restrictions [Ticket 50354|UX Trial Design|Trial Manager]

Adding edit checks to the Setup Form and Site Form for field restriction.
Setup Form

  • Protocol – 255 characters or less
  • Product Name – 255 characters or less

Site Form

  • Site Name – 255 characters or less
  • Site Address Line 1 – 100 characters or less
  • Site Address Line 2 – 100 characters or less
  • Suite/Office/Floor – 100 characters or less
  • City – 40 characters or less
  • State/Province – 100 characters or less
  • Postal Code – 20 characters or less
  • Phone Number – 25 characters or less
  • Fax Number – 25 characters or less
  • Email – 255 characters or less

Default Values – on Read-Only Views & PDF [Ticket 122605|UX EDC & Medical Coding|Data Entry & Cleaning]

When an eCRF has defined Default Values for the answer option, the Default Values will only appear on unsaved forms for users with Edit permission on the form. The PDF export will only display saved Default Values.

Option to Disable External Recipients [Ticket 128962|DATATRAK ONE|Scheduler]

Adding the ability to define, at an enterprise manager level, if external recipients can be added to the Scheduler Job notification.
For more information regarding the Scheduler Properties, view the Scheduler Properties.

Restrict File Extension Types [Ticket 140471|DATATRAK ONE|File Manager]

Adding the ability to define, at an enterprise manager level, file extensions that are prevented from being uploaded or define the acceptable file extensions.
For more information regarding the File Properties, view the File Properties.

Concurrent Logins [Ticket 150615|DATATRAK ONE|Login]

Add the ability to manage and be notified of multiple user sessions.

  • Adding to the Login History Screen the browser and hostname used during login.
  • Adding to the Login History Screen the ability to logout all sessions running on the account.
  • Adding to the Desktop the last successful login date and time and hostname used during the last login with the account.
  • Adding a notice to the user when Concurrent Sessions start when the user is already in an authenticated session.

Password Policy [Ticket 164392|DATATRAK ONE|Login]

Strengthening the password policy in DATATRAK ONE UX™. Adding two requirements on top of our existing policy of “8 and 20 characters long, starts with a letter and includes at least one number”.
Added requirements for passwords:

  • At least five characters of the password must be different
  • At least one non-hyphen special character

 

Corrections

For v13.3.6, we have included the four (4) correction items outlined below:

Minimization Algorithm [Ticket 122599|UX RTSM|Randomization]

When there are treatments that have the same distribution scores and configured to have the probability set to 1, the algorithm shall ensure that the next treatment is randomly chosen.

Properties Files [Ticket 153102|DATATRAK ONE|Systems]

Modifying properties files for disaster recovery servers.

Update Question Display [Ticket 164261|UX EDC & Medical Coding|Mid-Study Change Utilities]

Modifying the Update Questions Display utility to improve performance.

XML Exports [Ticket 164329|UX EDC & Medical Coding|Exports]

Modifying XML Exports to allow usage of script instructions.

 
 

DATATRAK ONE® 13.3.5 – December 17, 2015

For v13.3.5, we have a total of three (3) correction items outlined below.

Corrections

For v13.3.5, we have included the three (3) correction items outlined below:

Fill Data [Ticket 150695|UX EDC & Medical Coding|Mid-Study Change Utilities]

Update to ensure that the Fill Data utility completes within the appropriate timeout period.

Date Picker [Ticket 150711|UX EDC & Medical Coding|Data Entry & Cleaning]

Update the Date Fields to follow the settings of the ApplicationSetup.enterKeyAction.
For more information regarding the Date Picker, view the Entering Dates Section.
For more information regarding the Application Setup Enter Key Action, view the Application Setup Section.

Shipment Confirmation Template [Ticket 150720|UX RTSM|Notifications]

Update the default Shipment Confirmation Template to properly indicate a partial versus full shipment confirmation.
 

DATATRAK ONE® 13.3.4 – November 15, 2015

For v13.3.4, we have a total of fifteen (15) updates including enhancement, maintenance, and correction items outlined below.

Enhancements

For 13.3.4, we have included four (4) enhancement items outlined below:

Check Data Button [Ticket 133837|UX EDC & Medical Coding|Data Entry & Cleaning]

The Check Data button shall no longer appear on the form when a user has restricted entry access on the entire form.

Study Level Branding [Ticket 136310|DATATRAK ONE|Branding]

Ability to add an image at a workgroup level to display the branding image for the studies of the workgroup. If clients wish to display an image, the file shall be sent to DATATRAK to upload for display.
Read more about the new Study Level Branding feature.

Korean Language [Ticket 137344|DATATRAK ONE|Profile]

Korean will now be an available language for selection on the user profile which will only display Korean translation on the login page and study level translation.
Read more about how clinical trials can be configured to support multiple languages.

Disabled Scheduler Jobs [Ticket 137561|DATATRAK ONE|Scheduler]

When a Scheduled Job is disabled the job shall not execute, even when reoccurrences are defined.
For more information regarding the Scheduler, view the Scheduler manual.

 

Corrections

For v13.3.4, we have included the four (4) correction items outlined below:

Edit Reason for Change [Ticket 131119|UX EDC & Medical Coding|Data Entry & Cleaning]

Corrected the ‘Close’ button on the edit reason for change dialog to ensure the button text is translated in all configurations.
Read more about Edit Reason for Override.

Properties Files [Ticket 140551|DATATRAK ONE|Systems]

Modified properties files for application servers for production.

Batch Training Certificates [Ticket 140599|DATATRAK ONE|Training]

All Enterprise Manager roles with access to Manage Registration and Courses will have the ability to batch download Training Certificates.
Read more about Batch Export of Training Certificates.

Checklist Widgets [Ticket 140763|UX EDC & Medical Coding|Widgets]

Corrected cache issue when checklist were edited across studies.
Read more about the My Checklist widget.

 

Maintenance

For v13.3.4, we have included the seven (7) maintenance items outlined below:

Favorite Icon [Ticket 57178|DATATRAK ONE|Browser]

DATATRAK ONE website will display a favorite icon in the browser tab.

Desktop Performance [Ticket 135589|DATATRAK ONE|Collaboration

Improving system performance on the Desktop.

CDN Configuration [Ticket 137456|DATATRAK ONE|Systems]

CDN Servlet Selection Configuration will reflect Trial Manager actions.

DTLC Login [Ticket 136503|DATATRAK ONE|Systems]

Users will be required to log into the DTLC with their DATATRAK ONE credentials.

Audit Manager Tab [Ticket 139347|UX EDC & Medical Coding|Managers]

The Audit tab will not link to Question Audit Manager, the user must select from the dropdown menu the Audit Manager they want to navigate to.

Question Audit Manager [Ticket 139556|UX EDC & Medical Coding|Managers]

The Question Audit Manager will prompt user to perform a search or filter for the specific question audit record instead of providing all audit records.
Read more about the Audit Manager.

Manager Search Indicator [Ticket 140598|UX EDC & Medical Coding|Managers]

Users will receive a notification when a Filter or Search is in progress in all Managers.
Read more about the Search Indicator.
 

DATATRAK ONE® 13.3.3 – October 18, 2015

For v13.3.3, we have a total of two (2) updates including maintenance and correction items outlined below.

Corrections

For v13.3.3, we have included one (1) correction item outlined below:

Initiation of Shipment [Ticket 136339|UX RTSM|Inventory]

With corrections to the redirect upon initiating a shipment, the system will now redirect the user to the Shipments Manager.

 

Maintenance

For v13.3.3, we have included one (1) maintenance item outlined below:

Properties Files [Ticket 137241|DATATRAK ONE|Systems]

Created properties files to support new Cloud application servers for production.
 

DATATRAK ONE® 13.3.2– August 21, 2015

For v13.3.2, we have a total of six (6) updates including enhancement, maintenance, and correction items outlined below.

Enhancements

For 13.3.2, we have included the one (1) enhancement outlined below:

CDN Implementation [Ticket 134029|DATATRAK ONE|Systems]

Accelerate page load times for all users with addition of extended servlets.

 

Corrections

For v13.3.2, we have included the three (3) correction items outlined below:

Date/Time Comparisons [Ticket 134078|UX EDC & Medical Coding|Scripts]

With corrections to the DateDiff command, the system is now able to determine time information for dates that are sourced from applicable commands.

Properties Files [Ticket 133862|DATATRAK ONE|Systems]

With corrections to the property files, they will now include current and future staging servers.

Alert Text [Ticket 1344188|UX EDC & Medical Coding|Data Entry & Cleaning]

With corrections to double quotes in the alert text, the system is now able to display the alert text correctly for Multi-lingual trials.

 

Maintenance

For v13.3.2, we have included the two (2) maintenance items outlined below:

Record and Form Manager Loading [Ticket 134551|DATATRAK ONE|Managers]

Improving system performance by removing the need to batch load question audits in the Record and Form Manager.

Average Report Loading [Ticket 134552|DATATRAK ONE|Data Entry & Cleaning]

Improving system performance by removing the need to batch load question audits in the Averages Report.
 

DATATRAK ONE® 13.3.1– July 22, 2015

For v13.3.1, we have a total of twenty-two (22) updates including enhancement, maintenance, and correction items outlined below.

Enhancements

For 13.3.1, we have included the four (4) enhancements outlined below:

Auto-tabbing [Ticket 62040|UX Trial Design|Data Entry & Cleaning]

In the Data Architect file, you can now configure automatic tabbing for text and multi-line text fields on a form. On the Question Types-Definition tab, a new column labeled Auto Tabbing allows you to set auto tabbing to true or false for each question field in a form tied to the value in the Max Length column. If set to true, once the max character length in a field is met the cursor automatically advances to the next field. If set to false, auto tabbing is not enabled for that specific field and you can navigate with a mouse click or using the Tab button.


The auto tabbing enhancement only works for the initial form entries when the form has blank answer status. Once you save the form, use a mouse click or select the Tab button to move from field to field to make any changes or corrections. Note: Once you publish or commit the next version of the Data Architect in Trial Manager, you will see the new Auto Tabbing property for each question in View Changes.

Tab Ordering [Ticket 62041|UX Trial Design|Data Entry & Cleaning]

In the Data Architect file, you can now specify a unique tab order for all fields on a form. On the Display tab, a new column labeled Tab Order allows you to add values that establish the sequence of tabbing from one field to the next.


You do not need to enter values that are strictly sequential. You can specify any order and only the relationship between the values determines the tab movement across the form. The ordering can be numeric or alphanumeric. In the case of numeric ordering, all Tab Order values need to be consistently numeric. In general, the system follows an ‘expected order’ for the values without the need for leading zeros for numerical comparison. For example, the following three orders are equivalent:

  • C|A|B
  • X|D|K
  • 111|88|99

If you do not specify an order for all fields on a form, the fields without an order will be accessed (tabbed to) after the fields with a specified order. In practice, you should specify the tab order for all the fields (or none) within a given form. Note: Once you publish or commit the next version of the Data Architect in Trial Manager, you will see the new Tab Order property for each question in View Changes.

Tabular Views [Ticket 62042|UX EDC & Medical Coding|Data Entry & Cleaning]

In the Data Architect file on the App Properties tab, you can now configure a new simplified tabular layout option for data entry that loads more rapidly and uses the space on the page more efficiently.


The screen width remains static with simple mode. Therefore, if you are going to create a table with a significant number of columns (10 or more), simple mode may cause the columns to run off the page.

Form Preprocessing [Ticket 62166|UX EDC & Medical Coding|Data Entry & Cleaning]

In the Data Architect file on the App Properties tab, you can now configure the system to delay form preprocessing until you save the form. Preprocessing consists of the firing of alerts including required and optional reason for override, format alerts, ‘requires correction’ alerts, ‘triggered by’ scripts, regular and custom dependencies, visibility logic, assignments, script assignments, and local lab ranges and units. The new application property (PreprocessOnSave) provides for rapid data entry or batch processing of data entry. The values are true or false (default=false) and consists of the following entries with definitions.


Maintenance

For v13.3.1, we have included the two (2) maintenance items outlined below:

Servlets [Ticket 122595|DATATRAK ONE|Systems]

A small number of actions now process in parallel instead of waiting for other requests to complete.

Properties Files [Ticket 127130|DATATRAK ONE|Systems]

We have created properties files to support new Cloud staging servers.

 

Corrections

For v13.3.1, we have included the sixteen (16) correction items outlined below:

Unified UI Update [Ticket 40408|DATATRAK ONE|Enterprise Manager]

The Select Organization page is now updated for the Unified interface.

Query Update [Ticket 40434|UX EDC & Medical Coding|Data Entry & Cleaning]

The system now always displays questions that have open queries, regardless of the visibility logic.

Date/Time Comparisons [Ticket 40825|UX EDC & Medical Coding |Data Entry & Cleaning]

With corrections to the DateDiff command, the system now handles the (00:00) case properly.

Scroll Bar Update [Ticket 56840|UX EDC & Medical Coding |Data Entry & Cleaning]

The system now only displays scroll bars in tabular views when needed.

Roles Tab Decompile [Ticket 57054|UX Trial Design|Trial Manager]

As part of the Roles tab compilation, the decompiled file now correctly contains all permissions and actions assigned to the trial.

Search Function [Ticket 58076|DATATRAK ONE|Enterprise Manager]

The search workgroup function now properly expands the navigation tree.

Time Formats [Ticket 61262|UX EDC & Medical Coding|Data Entry & Cleaning]

Invalid entries in a time field are no longer automatically corrected.

Assignment Scripts [Ticket 61439|UX Trial Design|Data Entry & Cleaning]

Date assignments now use an English date format regardless of the language of the user saving the form.

Data Type Flags [Ticket 61444|UX EDC & Medical Coding|Standard Reports]

The Trial Summary and Alert Statistics reports now take into account all missing data type flags for each alert.

Default Question [Ticket 61446|UX Trial Design|Scripts]

The Is-Set command properly returns false in all cases when the target question does not exist.

Date Column Sorting [Ticket 61447|UX EDC & Medical Coding|Ad-Hoc Reports]

Date columns now sort properly.

PDF Export [Ticket 122549|UX EDC & Medical Coding|Exports]

The PDF Archival properly exports even with inconsistent property values for alerts and queries.

Equal and NotEqual Commands [Ticket 122598|UX Trial Design|Scripts]

We have updated the comparison method to address inequality in scale when comparing values.

Divide Command [Ticket 127132|UX Trial Design|Scripts]

We increased the scale of the divide command to return 17 decimal places.

Retired Attributes [Ticket 131116|UX Trial Design|Data Entry & Cleaning]

As a result of the improved automatic layout of the tabular view, we have retired the properties colWidth, width and TableColumnWidth for the Unified UI.

Role Selection [Ticket 133479|UX EDC & Medical Coding|Data Entry & Cleaning]

The Unified UI Role Combination functionality now more accurately reflects multi-role data access configurations.

 

DATATRAK ONE® 13.3.0– May 31, 2015

For v13.3.0, we have a total of twenty-five (25) updates including enhancement, maintenance, and correction items outlined below.

Enhancements

For 13.3.0, we have included the thirteen (13) enhancements outlined below:

Enabling/Disabling Questions [Ticket 44697|UX Trial Design|Mid-Study Change Utilities]

In the Data Architect file, you can now specify enabled and disabled questions for the display and a new Update Question Display utility allows you implement those changes mid-study. If a question is no longer valid, you can remove it from a trial with the Display.Active configuration set to (false) and, if needed, add it back in at a later date. By default the configuration is set to (true).


The Display Utility also reconciles any associated metadata. To designate a role with the ability to run the display utility, assign permissions in the Data Architect file on the Roles tab.


With permissions in place, the Actions tab on your study home page will contain an Update Question Display menu option that launches a confirmation page.



Click the Continue button to initiate a new update, then click the Run button on the following page to start the conversion. After selecting the Run button, you will automatically return to your study home page while the utility executes. Check on the execution status by linking back to the utility through the Actions tab to view the progress bar. Once complete, you can review a summary of the conversion results by linking to the View previous results on the Confirmation page.

Edit Reason for Override [Ticket 50300|UX EDC & Medical Coding |Data Entry & Cleaning]

You now have the ability to edit alert entries using a Reason for Override dialog that you can access from two different locations: Alerts Manager and Form alerts. Find the correct permissions in the Data Architect file on the Roles tab. With either permission the system displays the audit icon whether or not you have an existing audit entry. However, only with editViolation can you update existing entries once in the dialog.

In the Alerts Manager at both Cross Study Managers and study levels, the table has a new column titled Audits containing an audit icon. Additionally, each question on a Form (eCRF) now has an audit icon displayed in the body of the alert followed by a Reason for Override: explanation field.



Regardless of how you access the Reason for Override dialog, it contains two text fields for entries with an Audits table recording the history of that alert for the specific subject record.The updates are listed chronologically, with the most recent entry at the top of the tablular listing. Note that the only required field in the dialog is Reason for Change. If you make a change to the Reason for Override text field (remove entry, etc.), you are required to outline why you made the override text field change in the Reason for Change text field.



Selecting the Edit button closes the dialog and updates the table with your new entries. Optionally, you can select the Close button to close the dialog without making any changes or updates.

Answer Status/Auto Complete [Ticket 58381|UX EDC & Medical Coding|Data Entry & Cleaning]

Upon saving a form at the single study level, you now have the option to set the Answer Status progress bar to automatically update to Completed. Instead of having to perform the step manually, a new property in the Data Architect file allows you to skip the In Progress step. Configure this new feature in the Data Architect file on the App Properties tab.



You no longer need to select the Choose and Action menu – Press Go! to mark a form complete, it is automatic once you save your changes. Note that the default configuration is (false), but upon saving the enableCompleteStatus property to (true) and reconciling a trial:

  • Forms save to Complete regardless of whether or not every field contains a value
  • Option applies to all the Answer Status forms across the study
  • Existing forms or questions already In Progress will need Reconcile to be run to be automatically set to Complete

Important: Unlock any forms or questions that are In Progress prior to running reconcile with this feature enabled, to apply the Complete status properly.

Managing Courses [Ticket 61193|UX Training|Enterprise Manager]

On the Manage Courses screen, the Active Status: field for the course listing now defaults to the Active option. The field lists all available courses with a status of Active, not every possible course regardless of availability.



Preprocess Scripts [Ticket 61194|UX EDC & Medical Coding|Scripts]

To make the conversion of studies from the Classic user interface to the Unified interface easier, we are converting most before scripts to preprocess. The scripts will be converted automatically once your configured application loads into the Unified system.

Properties Update [Ticket 61196|UX EDC & Medical Coding|Data Architect]

The Edit Restrictions properties that currently exist in the Classic user interface allow you to control who can edit an individual question in the system, on a per question basis. We are automatically updating the Unified user interface with the same restriction to make sure that the ability to perform these edits is carried forward and consistent across both systems based on the Classic user interface settings. The properties update will apply for each study automatically converted from Classic to Unified.

Assigning Course Equivalencies [Ticket 61198|UX Training|Training]

In the Enterprise Manager, we can now assign course equivalencies at the course level from either the Create Course or Edit Course screens. The system now tracks which new courses are equal to all modules. The goal is to make sure that users of the system do not lose their study access based on any newly defined pre-requisites for courses already taken.



Equivalency Column [Ticket 61199|UX Training|Training]

On the Manage Courses screen in the Enterprise Manager, a new Equivalency column displays an icon that indicates equivalent courses exist for a course in the list. Clicking the icon launches a Course Equivalency dialog that displays the equivalent courses.


During the transition from the Classic to the Unified interface, as course pre-requisites are combined and/or updated, the Equivalency column and dialog provides a way to track which new courses are equal to past modules.

Batch Export of Certificates [Ticket 61200|UX Training|Training]

On the Manage Registrations screen and on each course details page, we can now batch export training certificates in PDF format. Previously, especially in the case of several hundred certificates, it was time consuming to export multiple certificates individually. Now, you can export certificates from 1 up to 100 at a time in two different ways:

  • For one or more users in different courses
  • For one or more users in the same course

For one or more users in different courses
On the Manage Registrations screen, you now have a Download Certificates tab:

  1. Click one or more checkboxes next to the desired user registrations from the table
  2. Select the Download Certificates tab

A dialog prompts you to save or open the zip file containing your certificates.

For one or more users in the same course
On the Manage Courses screen, select a course name from the table to display the corresponding course details page. At the top of the details page, you now have a Download Certificates tab:

  1. Click one or more checkboxes next to the desired Registration from the table
  2. Select the Download Certificates tab

A dialog prompts you to save or open the zip file containing your certificates. In both cases, the system generates a zip file containing training certificates in PDF format for each of your registration selections with the naming convention (username.coursename). The .zip file default naming convention is a time stamp detailing [year >> milliseconds]:

  • yyyyMMddHHmmssSSS.zip

You need to select at least one (1) registration to start the download process or the system displays a No Item Selected prompt.

Prerequisites Status Report

On the Prerequisites screen at the trial and enterprise level, the system now allows you to generate a report in Excel format to track the status of any user’s pre-requisite level of training. Select an active prerequisites option for a given trial in the Prerequisites column:

On the Prerequisites screen, you now have an Export User Status tab:

  1. Click a checkbox next to the desired entry from the Manage Prerequisites table
  2. Hover over the Export User Status tab, to display the dropdown menu options
  3. Select either All, In Progress, Not Started, or Completed from the menu

A dialog prompts you to save or open a zip file containing your Excel worksheet with the training information. The Excel worksheet inside the zip file is labeled export.xlsx.

The worksheet contains basic user information, completion status and site information. Also, whether or not the user fulfilled the prerequisite by completing the prerequisite course or an equivalent course. The .zip file default naming convention is a time stamp detailing [year >> milliseconds]:

  • yyyyMMddHHmmssSSS.zip

Refreshing Metadata Counts [Ticket 61202|UX EDC & Medical Coding|Mgmt Servlet]

To ensure count accuracy as we automatically convert Classic user interface studies to the Unified interface, an internal system utility will recalculate the metadata counts for all the converted studies without impacting status. Formerly, we did not track counts as part of the Classic user interface, now the Unified system displays counts in casebook progress bars and managers.

Persistent Alerts [Ticket 61236|UX EDC & Medical Coding|Data Entry & Cleaning]

Changes have been made to ensure that alerts will be displayed in cases regardless of how they were processed in the Classic User Interface. This is an adjustment to ensure that all alerts work properly with the Unified User Interface preprocessing.

Email Templates [Ticket 62097|All Products|Enterprise Manager]

On the Manage Email Template screen, we can now define language specific templates and send access emails using the users preferred language.

 

Maintenance

For 13.3.0, we have included the four (4) maintenance items outlined below:

Subject Identifier Update [Ticket 40904|UX Trial Design|Scripts]

Together with an assign command, you can now run a script to update the primary and secondary Subject Identifiers from any form or question in the casebook. You no longer need to run an update names utility or conduct a reconcile process to find inconsistencies with the subject identifiers when the targets of the script do not share the same form. The new command populates changes to the subject identifiers comprehensively across the study.

Schedule Manager Performance [Ticket 61188|UX RTSM|Randomization]

For a study with a large number of sites, we have improved the filter option for Treatment Type in Schedule Manager to speed up performance. The system now pulls all treatment type information directly from each configuration within a site and adds the type to the list of options for that study.

Dependency Network Update [Ticket 61460|UX EDC & Medical Coding|Data Entry & Cleaning]

We have updated the structure of the internal dependency network to operate more efficiently.

Help Desk Information [Ticket 62158|UX EDC & Medical Coding|Translation]

We have updated our email template and translation keys to include a standard set of DATATRAK Helpdesk contact information.

 

Corrections

For 13.3.0, we have included the eight (8) corrections outlined below:

Font Update [Ticket 40834|UX EDC & Medical Coding|Data Architect]

We have incorporated a system font update to better represent HTML special characters in our PDF output, specifically the greater than, less than characters. The update impacts any PDF output from forms in the Actions menu, the Query Report, the export archive, and the Trial Manager (eCRF).

Patient Statistics Report [Ticket 56823|UX EDC & Medical Coding|Standard Reports]

The Patient Statistics report now includes paging to list all available records within a study, the report displays up to 100 records at a time in groups of 10 (20, 30, 40, 50). The paging buttons and page listing are located in the bottom right corner of the screen.

Server Caching Update [Ticket 61957|UX RTSM|Randomization]

On the Product Label for Randomization and Inventory, changing the Product Type option in the Trial Manager now consistently notifies all active servers of the performed change.

Renaming Forms [Ticket 61961|UX EDC & Medical Coding|Data Entry & Cleaning]

You can now rename forms based off of multiline text questions.

Rounding Update [Ticket 62037|UX Trial Design|Scripts]

When rounding decimal values in scripts, we have improved rounding accuracy by applying a lossless conversion.

Scripting Components [Ticket 62087|UX Trial Design|Scripts]

The scripting engine commands now use lossless conversion to perform calculations.

Numeric Command Update [Ticket 62088|UX Trial Design|Scripts]

The numeric script commands now use lossless conversion to perform calculations.

EDC Script Commands [Ticket 62089|UX Trial Design|Scripts]

The EDC numeric script commands now use lossless conversion to perform calculations.

 

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.

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.

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.

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.

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.

“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.

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.

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

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.

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.

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.

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.

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.

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.

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.

Typo in Portal Descriptor

There is a typo in the Portal Descriptor that has an incorrect field name as a result. This triggers an exception in some cases but it is in an area of code that should never be called.

Blank Screen in Trial Manager when Switching Roles After Actions are Performed

If a user performs an action in Trial Manager and then switched to a role that does not have permission to the performed action a blank screen is displayed.

The calendar pop-up box is not displayed after RFO audit icon clicked

If a user opens the Reason For Override Audit screen and the closes the screen and selects a date field the Calendar Pop-up box does not display.

Alerts > 14 Days counts doesn’t show correct value in Cross Trial Summary Report.

Cross Trial Summary Report in Trial Manager does not show correct value for Alerts greater than 14 days.

“Needs SDV” and “Needs Data Review ” counts show incorrect values for Cross Trial Summary report

Cross Trial Summary Report in Trial Manager does not show correct values Form Level Needs SDV and Needs Data Review.

drugAssign command fails to update frozen question with overrideFreeze=”true”

The drugAssign assignment does not update a frozen question when overrideFreeze=”true” is set.

Adding letter to the Drug Container ID gives clickOS error for Populate Inventory action

A ClickOS error occurs upon Populate Inventory Action if a Container ID is updated to include a letter through the Drug Container Manager.

Files with apostrophe sign (‘) in the name cannot be uploaded, Forbidden screen is displayed

A Forbidden error screen appears upon upload of a file with apostrophe sign (‘) in the file name.

It is possible to have Received, Missing, Broken boxes checked for the same row in Confirm Shipment screen

A user can select the “All” Boxes on the Confirm shipment screen and the system does not uncheck any previously checked boxes.

Calendar Sharing Event Details screen has the same fields for different type events

When viewing calendar event details for shared events the screen does not display all event fields for the different type of calendar events.

View Tasks screen sorting does not work when New Task screen is cancelled

When you hit Cancel from the New Task screen, upon selecting any header to sort tasks the New Task screen will be displayed.

Using Browser Back Button from Course History and selecting Reset or Search gives a ClickOS error

A ClickOS error occurs upon selecting Reset or Search buttons on the Manage Courses screen after returning from the Course History page using browser back button.

Blank Course Equivalency dialog pops up

A Course Equivalency dialog appears blank if a Course Equivalency is removed from the course on another server.

View Log screen does not have DATATRAK footer

The View Log screen in Enterprise Manager for Training Courses does not contain the DATATRAK footer.

The Find textbox in the Training screen does not show [Letter]* when the user clicks the Find button

The user Training Screen does not populate the Find textbox when a letter is selected.


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