Summary

This article covers the 11..0 DBP Release notes.  


Welcome to the DATATRAK Business Platform 11.0.0 Major Release!

DBP 11.0.7

  • 21852: Shipment Request Container Lists Should Not Sort By Drug Type
  • 22220: DBP 11.0.7 Release Notes

DBP 11.0.6

  • 22095: Cache Synchronization Fail
  • 22096: Partially Confirming Shipment May Cause Issues Completing Shipment
  • 22097: Containers in a Partial Shipment No Longer Show Received if They are Assigned to a Patient
  • 22098: Date Format Should be Displayed
  • 22099: Message for confirming Kits Should Reference Correct Display Type
  • 22101: Update Shipment Confirmation Date Picker
  • 22102: DBP 11.0.6 Release Notes
  • 22121: Containers In Confirmation Screen Are Not Sorted

DBP 11.0.5

  • 22019: Previously Assigned Drug Containers Changed To Available
  • 22032: DBP 11.0.5 Release Notes

DBP 11.0.4

  • 21987: DBP 11.0.4 Release Notes
  • 21989: Management Servlet Access Changes

DBP 11.0.3

  • 21824: Missing data and automatic reason for override can cause saving problem
  • 21825: DBP 11.0.3 Release Notes
  • 21832: Update POM File For 11.0.3 Release

DBP 11.0.2

  • 20234: Downloading Documents Using IE Produces Zip File With Incorrect File Extension
  • 21759: Update Declined Query Trial Design Configuration Requirements
  • 21784: Certain custom java exports overriding collate method fail
  • 21785: DBP 11.0.2 Release Notes
  • 21799: Update POM File For 11.0.2 Release

DBP 11.0.1

  • 21751: ClickOS Error Triggered By Save of Blank Dynamic Form
  • 21752: Compiler Error Triggered Incorrectly
  • 21753: Username in audit trail
  • 21754: Refresh query manager upon close
  • 21757: Update POM File For 11.0.1 Release
  • 21758: DBP 11.0.1 Release Notes

DBP 11.0.0

The 11.0.0 Major Release contains some great enhancements that are certain to improve your eClinical experience. The changes in this update are grouped into the following sections:

20665 – uCTMS 1.0.0

20942: Visit Summary

Create a Visit Summary Report.

20951: Schedule of Events

Create a Schedule of Events Report.

20966: Create Study Design Visit Forms When Design Summary Is Completed

The value recorded in the Total Number of Visits (designTotalVisits) question should be used to create a set of dynamic subforms (designVisit) to represent each of the visits recorded as the Total Number of Visits.

20620: Create a Stand Alone CTMS Product

Create a standalone CTMS product while maintaining a framework supportive of future versions of the product that can be integrated with non-Datatrak products.

20945: Vendor Summary

Create a Vendor Summary Report.

20974: Create a set of standard reports for CTMS

Create a set of standard reports to support the uCTMS product.

20975: Create a high level dashboard for CTMS

A link from the TM homepage will bring the user to the CTMS standard reports page.

21021: Custom casebook calculations

All monthly summary information should roll up to the site summary and the site summaries should roll up to the study planning summary for enrollment data where applicable. The section under the planning summary should have no manual data entry.

21048: Add summary details to forms to provide further instructions to users

Add instructions to form summaries where there are dynamic forms so the users have a clear indication of how to interact with and use the system to enter their data.

21055: Fix homepage to allow inclusion of datagenie reports

Allow reports listed onthe study homepage to be listed dynamically.

21067: Hide Hourly Rate questions per role

Create role based restriction to hourly rate fields.

21124: Expense Costs Report

Create an Expense Costs Report.

21240: Create a high level dashboard for the Trial Level

Each trial in the uCTMS reporting area should have an overall summary.

21244: Create timeline for the study level summary

Create a timeline that will be added to the ctmsTrialSummary.

21263: All extJS tables that have large amounts of data must have exports

All report data should be exportable.

20935: Site Summary

Create a Site Summary Report.

20957: Create a report for managing differences between sites

The production node in TM will house most of the sites associated with the clinical trial. These sites will also be created in CTMS. A report is needed to verify that there are no differences between the two sets of sites. We also need to create an export of the CTMS sites as well as modifying the import for the TM Production sites.

20928: Hide reports from sibling tools

Reports within DataGenie in the Trial Manager/CTMS product must be from either ancestor tools, the existing tool, or child tools. Reports created by sibling tools must be hidden. The tool where the report is created from should be recorded as part of the report creation.

20929: Modify form view types to allow form hiding

The following form view types must be modified to support the hiding of forms in the summary and the form links tree. formPartialEdit, formEdit, formRestrictEdit, formView.

A link needs to be added (conditionally) to the homeRight.jsp file of Trial Manager for CTMS users to gain access to the reporting area. This link is depending on their being records within the current tool network that have CTMS enabled.

20931: Create a reports page for listing out all CTMS reports

The link from the TM homepage will bring the user to this page. It must have a filter area that includes the list of CTMS records in the TM. Once a record is selected, the filter must remain and the page should refresh with all applicable reports linked to with that record id. The reports will need to be categorized and some roles will not have access to all of the reports (to be defined).

20934: Team Summary

Create the Team Summary Report.

The ability to add dynamic forms should be restricted based on the form type and user role.

Hide the links to add dynamic forms on the Vendor Summary in formSummary.jsp.

21065: Export/Import modifications for transferring sites between uCTMS and uDesign

From the uCTMS site section, we need to generate a CSV export that can be used to create sites under the uDesign Production node

21117: Vendor Costs Report

Create a Vendor Costs Report.

21127: Labor Costs Report

Create a Labor Costs Report.

21129: Team Rates Summary

Create Team Rates Summary Report based on the Team Summary Report.

21209: Create Ability To Suppress Dynamic Form Summaries In Export

Create a configurable parameter/property which can be used to suppress the export of dynamic form summaries when dynamic child form is present and is not blank.

21210: Restrict Export Content to uCTMS Trials

The uCTMS export(s) should only include data for trials that have the uCTMS product enabled.

20937: Protocol Deviations

Create a Protocol Deviations Report.

20939: Subject Enrollment Report

Create a Subject Enrollment Report.

20940: Subject Summary Report

Create a Subject Summary Report.

20949: Serious Adverse Events

Create a Serious Adverse Events Report.

21120: Site Costs Report

Create a Site Costs Report.

20621: Create Framework to Support Unification of eClinical Data/Information

Create a framework to support reporting of study status data and metrics that are drawn directly from unified DATATRAK products (uEDC, uIRT, uDesign, etc.).

20622: Create a ‘Study’ Section

Create a ‘Study’ section of the uCTMS tool which can be used to register studies, capture and identify key study information and track study level approvals.

20623: Create a ‘Planning’ Subsection

Create a ‘Planning’ subsection of the uCTMS tool’s ‘Study’ section which can be used to capture project management information and study planning milestones.

20624: Create a ‘Monitoring’ Subsection

Create a ‘Monitoring’ subsection of the uCTMS tool’s ‘Study’ section which can be used to capture data supporting the monitoring plan, activities and budget for the study. The information recorded should include key monitoring metrics.

20625: Create a ‘Data Management’ Subsection

Create a ‘Data Management’ subsection of the uCTMS tool’s ‘Study’ section which can be used to capture and track data supporting the data management plan, activities and budget for the study. The information recorded should include key data management metrics.

20626: Create a ‘Sites’ Subsection

Create a ‘Sites’ subsection of the uCTMS tool’s ‘Study’ section which can be used to capture relevant site specific information. The information recorded should support tracking and managing site contact information, study related documents, key site personel, site visit information, contract, invoice and payment related information.

20627: Create a ‘Vendors’ Subsection

Create a ‘Vendors’ subsection of the uCTMS tool’s ‘Study’ section which can be used to capture and manage relevant vendor management related data. Information recorded should support tracking and managing of vendor contact information, study responsabilities, contract, invoice and payment related information.

20628: Create a Cost/Payment Management Subsection

Create a ‘Cost’/’Payment Management’ subsection of the CTMS tool’s ‘Study’ section which will be used to capture data and manage study cost related information. Information recorded should support tracking and managing of study budgets including study personel, site costs, vendor costs, etc.

20954: Create new CTMS roles in Trial Manager

Create uCTMS specific roles to support use of the uCTMS product.

20956: Questions need to be restricted to specific roles

The questions within the new forms must be restricted by role using the formPartialEdit/formRestrictEdit viewType.

21114: Create a ‘Documents’ Subsection

Create a ‘Documents’ subsection of the uCTMS tool’s ‘Study’ section which can be used to capture data supporting the review and approval of documents for the study.

21115: Create a ‘Protocol Deviations’ Subsection

Create a ‘Protocol Deviations’ subsection of the uCTMS tool’s ‘Study’ section which can be used to capture data supporting the documentation and tracking of protocol deviations for the study.

21116: Create a ‘Serious Adverse Events’ Subsection

Create a ‘Serious Adverse Events’ subsection of the uCTMS tool’s ‘Study’ section which can be used to capture data supporting the documentation and tracking of serious adverse events through the course of the study.

21119: Support Creation of Vendor Type Specific Vendor Forms

Create a function to support the creation of vendor service type specific vendor forms so that the questions on the form can be targeted toward the service provided.

21122: Support Copying Of Site Address To Pharmacy Address When Applicable

Support the ability to copy the following site address values to the pharmacy address fields on the Site Form.

21123: Support the Controlled Generation of the uCTMS and uDesign Products

Create a trigger to support the controlled generation of the uCTMS product.

21221: Create uCTMS Mapped Export

Create a mapped export to support extracting data from the uCTMS product. The export should group similar formTypes into single data sets. The format should be MS Excel.

21458: Create a ‘Project Team’ Subsection

Create a ‘Project Team’ subsection of the uCTMS tool’s ‘Study’ section
which can be used to support recording members of the project team that are not specifically working on Data Management or Monitoring.

21196: Add tips for reference questions

Add tips associated with reference questions to identify answer option sources.

20511 – uIRT 3.0.0

19192: Assign drug based on data milestones/entry

Assign and/or decrement study drug based on data entry
subject’s casebook

19194: Multiple drug assignments per subject, including history and assignment interface

Create a drug assignment interface/function in which the end user can identify the number of study drug units to assign, the visit at which the drug is assigned and cancel/replace previous assignments based on the subject’s Treatment Type ID assignment.

19195: Missing drug support

Create functionality to support identification, status indication and disposition of study drug units that are missing from a study drug shipment.

19196: Comprehensive status indications

Create inventory status indications to represent all statuses within the inventory request/use cycle.

19199: Expiration date enforcement

Create ability to evaluate the study drug expiration date when requesting study drug for shipment to sites and when allocating study drug to subjects so that expired drug is not requested/allocated.

19200: Damaged or Broken Drug Shipment Support

Create functionality to support identification, status indication and disposition of study drug units that are broken/damaged during study drug shipment or at the site.

19201: Configurable e-mail notification templates

Create e-mail notification templates to represent inventory functions with configurable properties to represent the study specific information. The subject line of the e-mail should be configurable along with the content of the e-mail.

19202: Manually trigger resupply shipments

Create ability to manually trigger study drug resupply shipments.

20512: Create Object Structure To Support Randomization and Inventory Rewrite

Create an API and an object structure to support the rewrite of the randomization and inventory management features.

20548: Assign Treatment Type

Support the ability to assign a treatment type to a subject.

20549: Audit Trail All Entries

Record audit level detail of all entries and changes.

20550: Enforce Randomization Criteria

Support the creation and enforcement of randomization criteria.

20551: Randomization Notification

Create a system generated and transmitted e-mail notification that a subject randomization has occurred.

20552: Randomization Results Screen

Display the results of an attempted subject randomization.

20553: Export Randomization Manager Data

Support the abitlity to export data from the Randomization Manager in a Microsoft Excel or comma separated values file.

Create roles based permissions to permit access to the Randomization Manager and its related features/functions.

20555: Randomization Manager Filters

Create filters and filter parameters that can be used to determine the visible content within the Randomization Manager.

Blinded data from the Randomization Manager should only be accessible to roles with the view blind permission enabled.

20557: Import Randomization Schedule

Create mechanism to import a randomization schedule from an external file/source.

20558: Export Randomization Schedule

Create a mechanism to export the randomization schedule via Microsoft Excel and .txt file formats.

20560: Manually add, delete and edit randomzation schedule

Allow user to manually create, edit and delete slots within randomization schedule.

20561: Ability to Assign Inventory Upon Randomization

Support the ability to assign study drug inventory to a study subject upon randomization.

20562: Ability to Decrement Inventory

Inventory should be decremented after it is assigned to a study subject.

20563: Populate Inventory

Support the ability for the system to generate inventory at a packaging company based on user defined inventory parameters (container ID, treatment type,quantity, etc).

20564: Import Inventory

Support the ability to import inventory to 1 or more packaging companies based on user defined inventory parameters (container ID, treatment type, quantity, etc)

20565: Manually edit and delete Inventory

Support the ability to manually create, edit and delete inventory containers.

20566: Export Inventory Manager Data

Support the abitlity to export data from the Inventory Manager in a Microsoft Excel or comma separated values file.

Create roles based permissions to permit access to the Inventory Manager and its related features/functions.

20568: Inventory Manager Filters

Create filters and filter parameters that can be used to determine the visible content within the Inventory Manager.

20569: Shipment Notifications

Create a system generated and transmitted e-mail notification when a study drug shipment is created.

20570: Create, Edit and Delete Shipments

Support the ability to manually create, edit and delete existing shipments.

20571: Cancel Shipments

Support the ability to cancel existing shipments.

20572: Shipment Cancellation Notification

Create a system generated and transmitted e-mail notification that a shipment has been cancelled.

20573: View Shipments

Support the ability to view shipments, in transit and confirmed at sites.

20575: Stratify Randomized Subjects

Support the randomization related stratification of subjects.

20576: Static Permuted Block Randomization Algorithm

Implement a standardized static permuted block randomization algorithm which produces a randomization schedule.

20578: Blinded / Unblinded View Support

Support blinded and unblinded views of randomization and inventory related data.

20579: Randomization ID – Sequential by Site

Support the allocation of a randomization ID that is assigned sequentially within each site.

20580: Randomization ID – Sequential by Trial

Support the allocation of a randomization ID that is assigned sequentially within the trial.

20581: Randomization ID – Assigned kit ID

Support the allocation of a randomization ID that represents a serialized inventory kit/bottle number assigned to the randomized subject.

20582: Randomization ID – From imported schedule

Support the allocation of a randomization ID from an imported schedule

20583: Randomization assignments

Create a machanism to configure assignments of randomization related data to a specific EDC data field. Data available for assignment should include the randomization Date, Time, User, UserID, Drug Label, Treatment Type, Drug Type, Factor Levels and Randomization ID.

20584: User Friendly Site References

Site references within the Randomization Manager should include the toolName value either with or instead of the toolId value so that the end user will know which site is being referenced.

20585: Confirmation of Shipments

Create mechanism to allows inventory shipments to be confirmed as received at their intended destination. This feature should support the ability to receive partial contents of a shipment.

20586: Threshold Based Resupply

Support threshold based resupply shipment creation.

20587: Shipment Confirmation

Create a system generated and transmitted e-mail notification when a shipment is confirmed as received.

20588: Resupply Groups (Minimize number of shipments based on drug type relationships)

Create mechanism to define resupply groups of drug inventory so that when one drug type is requested, all other drug types from the group are replenished in the same order.

20590: Institutional Balancing Algorithm

Implement a standardized institutional balancing algorithm which produces a randomization schedule.

20591: Minimization Algorithm

Implement a standardized minimization algorithm which produces a randomization schedule.

20592: Emergency Unblinding

Create a mechanism to unblind a single subject based on study role and configurable data entry criteria parameters.

20593: Emergency Unblinding Notification

Create a system generated and transmitted e-mail notification when an emergency unblinding occurs.

20594: Randomization ID – Interchangeable algorithm framework

Create a framework to support the creation of configurable/customizable randomization IDs.

20595: Randomization ID – Custom

Create a mechanism to implement custom randomization IDS written within a study’s extension file.

20596: Trigger Script On Randomization

Create mechanism to trigger a script when a randomization occurs.

20598: Customizable Randomization Notification Templates

Create a framework to support the creation of customizable inventory related randomization e-mails. The framework should support the customization of the e-mail subject line.

20599: Report of Subject Counts By Treatment, aggregated by site & trial

Create a standard report which indicates subject counts by treatment assignment, aggregated by site and trial.

20600: Report of Subject Counts by Factor Level and Strata, aggregated by site & trial

Create a standard report which indicates subject counts by factor level and strata, aggregated by site and trial.

20601: Append Extension to Existing Randomization Schedule (import / generate)

Create mechanism to append an extension to an existing randomization schedule.

20602: Display Study Drug Assignment History

Support the display of all historic study drug assignments for a subject.

20603: Trigger Script On Inventory Assignment

Create mechanism to trigger a script when a drug assignment occurs.

20604: Trigger Script On Shipment Confirmation

Create mechanism to trigger a script when a shipment is confirmed as received.

20605: Trigger Script On Shipment Initiation

Create mechanism to trigger a script when a shipment is initiated.

20606: Customizable Inventory Notification Templates (including subject line)

Create a framework to support the creation of customizable inventory related randomization e-mails.

20607: Bulk Drug Support

Create mechanism to support partial use of bulk study drug units.

20608: Site Specific Shipment Paramters

Support site specific parameters to determine initial shipment, threshold and restock inventory levels

20610: Calculated Inventory Thresholds

Support the ability to set inventory min/max thresholds based on a calculation.

20611: Inventory Listings w/Related Statuses (Not necessarily user friendly)

Create a standard report which provides an indication of the location and status of all inventory created.

20613: Inventory Transfer Notification

Create a system generated and transmitted e-mail notification that an inventory transfer has occurred.

20614: Record Shipment Tracking Information

Record shipping related information including carrier and tracking number.

20615: Generate Inventory Schedule Using Static Permuted Block Algorithm

Support the generation of an inventory schedule (kit/bottle list) utilizing static permuted block algorithm.

20647: Customize Default Error Code Message Using DA

Create a function to support the customization of the default error messages within the dataArchitect file.

20798: Manually Create Slot In Randomization Schedule

Support the ability to manually create a slot within an existing randomziation schedule/stratum.

20799: Delete and Restore Slot

Support the ability to manually delete and restore a slot within an existing randomization schedule/stratum.

20800: Edit Existing Slot (only display id field)

Support the ability to manually edit the display ID field for a slot within an existing randomization schedule/stratum.

20801: Unrandomize a Patient

Support the ability to unrandomize a study subject that was previously randomized.

20802: Randomize a Patient to a User Selected Slot

Support the ability to permit a user to select a spot within an existing randomization schedule and randomize a subject to that specific spot.

20803: Manually Edit Existing Inventory Container

Support the ability to manually edit an existing inventory container.

20804: Update Container Status for Multiple Inventory Containers

Support the ability to update the inventory container status for multiple containers within a single action.

20806: Delete and Restore Inventory Containers

Support the ability to delete and restore existing inventory containers.

20807: Manual Create Shipment

Support the ability to manually create a shipment and select the inventory containers included within the shipment.

20808: Update Shipment Status

Support the ability to manually set the status of an existing shipment.

20809: Edit an Individual Shipment

Support the ability to manually edit an existing shipment.

20810: Manually Delete and Restore Shipment

Support the ability to manually delete and restore an existing shipment.

20891: Update Inventory Expiration Date

Implement a mechanism to update expiration date for multiple inventory containers.

t20924: Global and Local view of managers

Implement a framework to set permissions for users to have a global or local view of the managers.

20925: Manually create drug assignment by selecting inventory containers

Manually create drug assignment by selecting inventory containers.

20978: Inventory Empty Notification

Create a system generated and transmitted e-mail notification that a site inventory is empty.

20979: Inventory Threshold Notification

Create a system generated and transmitted e-mail notification that a site inventory is empty.

21039: Allow Resolver to resolve patient activation status

Allow Resolver to resolve patient activation status.

21041: Create a script to count the number of records within the tool

Create a script to count the number of records within the tool.

21073: Allow resolvers to resolve tool classification

Allow resolvers to resolve tool classification.

21132: Create framework to allow customize functions at trial level

Create framework to allow customize functions at trial level.

21216: Create property to specify the unit for drug assignment

Add a field to allow the drug type amount to be defined.


The following DTLC pages have been created/updated to support the use of the uIRT 3.0.0 product:

Randomization Trial Design
Randomization System


20694 – Introduce a Submission Status Using Workflows

20701: Create Visibility Control For Submission Status

Create visibility control of forms based on the submission status.

20702: Introduce a Submit Action and Status

The system should allow a submit action which allows a user to submit 1 or more forms for review.

20703: Introduce an Open Action and Status

The system should permit an open action which allows a user to open 1 or more forms that have been submitted for review.

20704: Provide Audit Traceability of Submission Status

Date/time and user related actions taken to support the Submission status must be recorded as audit entries.

20705: Create System Filters Based On Submission Status

Filters should be added to all existing managers to support the use of the Submission status.

20706: Display A Confirmation Screen Before Submit Action is Executed

Present a confirmation screen to the user before applying the Submit status to forms.

20707: Display A Confirmation Screen Before Open Action is Executed

Present a confirmation screen to the user before applying the Open status to forms.

20708: Forms Should Be Frozen When the Submit Status is Applied

Forms that have been submitted should be frozen to prevent data changes after submission.

20709: Entering Data on a Submitted Form Will Cause it to Revert to Not Submitted

Entering or changing data on a form with a status of ‘Submitted’ should cause the form to revert to a status of ‘Not Submitted’.

20710: Issuing a Query on a Submitted Form Should Unfreeze the Queried Question

When a query is created for a question, the queried question should be unfrozen to permit data changes if necessary.

20711: A Signature Will Need to Be Applied to Submit a Form

A user signature must be applied to all forms that are to be submitted.

20728: Submit Action Should Be Accessible From Forms Manager

A user should be able to select and submit non-opened forms from the Forms Manager.

20730: Open Action Should Be Accessible From Forms Manager

A user should be able to select and open submitted forms from the Forms Manager.

20731: Once the Open Status is Applied, the Form Will Remain Open Permanently

Forms that have been opened cannot be un-opened.

21223: Encapsulation of forms in form flow

The ‘encapsulated’ attribute should be introduced for the form flow to improve control of metadata status propagation.

21383: Introduce the new property to hide form flow column

It should be possible from Forms Manager to apply new form flow status on multiple records.


The following DTLC pages have been created/updated to support the use of the new Submission Status Workflow features:

Form Flow


20695 – Simplified Query Resolution Process

20697: Support Data Change Triggered Auto-query Resolution

Create an application specific confgurable function which will allow queries to be automatically advanced to either the Answered or Closed status based on the change of data of the queried question.

20712: Be Able to Respond to Queries on eCRF

Support the ability for users to view and respond to queries on an eCRF.

20713: Support Responding to Multiple Queries in a Single Action From the Query Manager

Support Responding to Multiple Queries in a Single Action From the Query Manager, with the opportunity to record Response Text.

20820: Add compiler error check for query status used in the dependencies

Query status should not be used in the dependency evaluation.

20821: Add predefined query comments into DA

Be able to configure a set of predefined query comments in DA.

Add a popup window besides the query comments text box on eCRF, so the user can select a query comment from a set of predefined by clicking the popup link.

21236: Query shouldn’t be auto updated if blank value is saved.

Query shouldn’t be auto updated if blank value is saved.

21286: Missing data flags should trigger Auto-query Resolution

If missing data flags are changed on questions it should trigger Auto-query Resolution.


The following DTLC pages have been created/updated to support the use of the Simplified Query Resolution Process features:

EDC Manual
DataArchitect Manual


20696 – Multi-Level Query Approval

20715: Be Able to Define N Levels of Query Approval/Rejection Within a Workflow

Create a configurable query review and approval process that supports allows the number of review/approval steps to be determined on an application specific level.

20716: Declined Queries Are Not Visible To Site Personnel

Query visibility at different levels of approval should be subject to role based permissions.

21204: Changes to current workflow process

Update workflow process to support ownership of states and state to state transitions.

21598: Comments on approving a query should be configurable.

Create a configurable parameter to control whether a comment is required when approving a query. The default setting will be that comments are not required when approving a query. The parameter will need to be set to false to require a comment.

21599: Declined queries shouldn’t be displayed in query manager.

Declined queries will not be displayed within the query manager.


The following DTLC pages have been created/updated to support the use of the Multi-Level Query Approval features:

Query Workflow


20698 – Email Notification Manager

20717: Support a User Interface Option For Setting Notifications

Create a user interface option to set e-mail distribution lists which does not require study design changes to update each list.

20719: Support Metadata Triggered E-mail Transmissions

Support the configuration of e-mail transmissions triggered by changes in metadata statuses.

20720: Support Query Triggered E-mail Transmissions

Support the configuration of e-mail transmissions triggered by changes in query status.

20724: Support the Use of E-mail Content Defined in a VM File

Support the Use of E-mail Content Defined in a VM File.

20921: Enhance Notifications to support Form Flow Transitions

The notifications need to support the form flow transitions.

21040: Manage Notifications interface enhancements

Added ability to delete notifications and export the table.


The following DTLC pages have been created/updated to support the use of the Email Notifications Manager:

Email Notifications
DataArchitect Manual

20725: Support Hiding Metadata Status Indications in Standard Reports

Create confgurable properties/parameters to support the suppression of metadata references within standard reports.

20726: Support Hiding Metadata Status Indications in Manager

Create confgurable properties/parameters to support the suppression of metadata references within system managers, including filters.

21372: Remove/hide the SDV checkboxes from the formMonitor view

If the hideSDV parameter is enabled, the SDV checkboxes should be removed/hidden from the formMonitor view.


The following DTLC pages have been created/updated to support the use of the Expanded Support For Hiding Metadata Related Detail features:

EDC Manual
DataArchitect Manual


Miscellaneous Updates and Corrections

12228: NA/ND/NK selection should set alert status to open w/ reason

If one of these flags are set and no red alerts appear on the eCRF, the form alert status should show open w/ reason (yellow), not open (red).

13544: Decompiler adds blank rows to excel

Trailing blank rows should not be added to the file.

16903: Dynamic filters do not persist

Dynamic filters should persist after an action is performed.

17315: Form tree does not expand to current form

The form tree should be expanded to show the link for the currently viewed form.

17380: Remove Search For: filter when audit type is not All or Value

If Search For filter is not valid for audit types other then All or Value it should not be displayed along with “Reason for Change” column.

17484: DA compiler should throw error when dynamic form has different Id and TypeId in template document

The compiler checks to see if a dynamic form’s typeId equals its formTypeId and throws an error if it does not.

19546: Alert on frozen question doesn’t reconcile away

Alerts on frozen questions can be resolved with reconcile tool.

20977: Support uat.datatrak.net Server

Update the core code to support the use of the uat.datatrak.net server.

21049: Add Site Address Fields To Site Forms

Expand site forms to include site address information.

21382: Disable SDV boxes for tabular and static tabular view mode

If form is locked, next time it is opened SDV All and Freeze All boxes should be disabled.

21453: Enable SMTP support on UAT environment

A properties file needs to be added to the server configurations to enable SMTP support for the new UAT server.

21597: Make Answered queries invisible

Answered queries should be invisible to site users on eCRF display.

21599: Declined queries shouldn’t be displayed in query manager.

Declined queries will not be displayed within the querymanager.

21600: Enable the uIRT product

A trigger point should be set within the Setup form of the Trial Manager to enable the uIRT product.

21722: Update Translation Keys

Update the translation keys to support Chinese and Japanese use of new DBP 11.0.0 features.

21692 – 11.0.0 Product Documentation

21693: Create uCTMS Users Manual

Create a manual to support the use of the uCTMS product.

21695: Create Randomization Manager 3.0.0 Manual

Create a manual to support end user use of and trial design configuration of the Randomization Manager 3.0.0 product.

21696: Update the EDC Manual

Update the EDC manual to support the implementation of new DBP 11.0.0 features.

21697: Update Data Architect Manual

Update the Data Architect manual to support the implementation of new DBP 11.0.0 features.

21698: Create Form Flow Training Material

Create a page(s) within the DTLC to support the configuration and end user use of the Form Flow features.

21699: Create Email Notification End User Training Materials

Create a page within the DTLC to support the training of end user use of the Email Notification features.

21700: Create Multi-Level Query Approval Training Materials

Create a page within the DTLC to support the configuration and use of the multi-level query approval workflow process.

21701: DBP 11.0.0 Release Notes

Create release notes to support the release of version 11.0.0 of the DBP products.

Outstanding Issues

  • 2575: Format Param maxColumnWidth in Excel Export did not correlate properly
  • 6663: Calendar Week Number display bug
  • 6665: You can not insert the image, table, or link into the message.
  • 6669: Auto prompt for Request Membership works only if you go to the Login page URL and not with base URL
  • 6672: ManagementServlet State Lookup Field
  • 10027: Upload/ Attach Files to a form
  • 10602: looping dependency network
  • 11051: Recursive Forms gives inconsistent results.
  • 11120: OC4J holds onto message classes used with JGroups
  • 11124: User Profile is not Synchronized Among Clusters
  • 11126: User Profile Can Only Be Updated in Production Cluster
  • 11802: Font Color and Background Color buttons do not work in the HTML Builder in the IE
  • 11994: ‘Is Default’ can be answered ‘Yes’ for multiple portals
  • 12283: Toplink error when renaming form
  • 12541: Expression Assignment with a date or time field that has blank value gets wrong result
  • 12590: issue with form rename if a question used in naming is also referenced from another question
  • 12703: the new line in Annotation note is lost with compilation
  • 12717: can’t open trial, commited in CVS, in VA
  • 12861: VA – Version number is not updated after committing the changes made in the Casebook tab
  • 13023: When OC4J needs restarted it can hang in the “init” status
  • 13039: OC4J Deadlock occurs when invalidating distributed session
  • 13490: Add Validation Statements to Help Center
  • 13505: alert script behavior inconsistent when changing dependent question
  • 13537: Decompiler uses an old DA file template
  • 13546: Visual Architect drops FormTypes record entry
  • 13557: Visual Architect > Casebook > Form Type Name rename does not appear
  • 13614: DataGenie: contact control should resolve to user name
  • 13688: requires the third save to display alerts if alert waits for dependent question
  • 13710: Query address text box always repopulated with the last comment
  • 13773: Open option in Show Status filter is saved as Open-New
  • 13866: can’t unlock user account on design
  • 13980: deleteting of application properties is not synchronized between the servers.
  • 14029: Script-Errors not displayed for “after” scripts
  • 14042: RuntimeException when delete difference report archive
  • 14296: If you perform any action in record manager on a different page it returns back to the 1st page
  • 14391: when reconcile script might create unexpected forms when forms are locked
  • 14431: Visit Schedule and Patient Management give ClickOS error if studyDateFormat and Visit Date format are different
  • 14777: Alerts from Deleted Pages in Data Export
  • 14811: NullPointerException when run WorkView
  • 14812: report doesn’t return data with Null value
  • 14995: Configuration files are reloded when performing some actions
  • 15122: EULA Acceptance Date not in user export
  • 15138: Definition XML is reloaded when Fill Sample Data action is used.
  • 15616: Cannot add user to workgroup from client EM
  • 15656: Translation Properties of Automated Text
  • 15757: can’t open trial in VA
  • 15862: EM Reports the wrong toolRoleInstanceID if user has the same role on more that one tool
  • 15962: The file history event name and comments are English only
  • 15977: If you invite a new member via membership in a group it checks the user after the member is invited
  • 16079: There is an inconsistency in the system for the Remove tools from a user in EM
  • 16171: approve code action doesn’t change sorting order
  • 16172: the page number will be reset if use delete code icon
  • 16417: Restriction on Start and End Levels should work in Search Results
  • 16593: Password Error Counter does not get reset after login
  • 16596: Submitting the filter form on Trial Summary should send the user back to Trial Summary with filter activated upon reloggin
  • 16634: Free-text Dynamic Filters do not support wildcards
  • 16646: Dynamic created Synonym Dictionary does not come up in search.
  • 16681: Permission Denied when navigate to statistics reports from Trial Summary
  • 16692: Add error check to make sure the restock level is always larger than the threshold
  • 16718: Union Reports change integer values to float with 2 decimal points for excel output
  • 16846: EM: Users do not appear in a search
  • 16859: Audits of type OLD are still being written.
  • 16876: Do not allow a workgroup to be added under itself
  • 16890: script’s commands under “text” tag are getting executed even when “expression” tag returns “true”
  • 16912: Evaluate the usage of Unicode file names for the PDF archival exports
  • 16970: null page title
  • 17022: EM: Set category of user does not work on locked users
  • 17053: Audits should exisit for insert form action.
  • 17054: Audits should have ReName form actions
  • 17055: Issue with sequence numbers on dynamic forms
  • 17064: issue with clear question’s sdv boxes
  • 17135: DA: Remove Visit Schedule granted permission
  • 17145: Order of parameters changes during or after copying/creating report
  • 17170: The IP address for user in management servlet is not updated properly.
  • 17188: Migrate the changes to VA
  • 17201: Bookmarks to sign out page result error message
  • 17215: The Application History export should show local time
  • 17236: Exported timestamps are not consistent
  • 17249: Record should be reassigned automaticaly with the new modified value of the dynamic filter.
  • 17253: Nested functions do not parse correctly
  • 17255: Many of the export parameters do not function inside CustomFormFormatter
  • 17281: Slider question display type loses keypress functionality when enterKeyAction is set to “nextField”
  • 17304: DA Template: Visit Schedule Permission should not be enabled by default
  • 17305: Comment Manager does not sort properly
  • 17328: Can’t add users to Test,Design,Approve
  • 17347: Compiler should catch missing DA work sheet
  • 17394: Click OS after you click Advanced Filters Show or Hide
  • 17407: Click OS error after you try to re-login after session time out.
  • 17419: tooltip should display help for longer time
  • 17456: A blank email address causes DA decompilation failure
  • 17472: Expression Language math Operators
  • 17476: missing data audits
  • 17497: Code Manager Export shows dictionary name instead of code level under Code column
  • 17498: CODE_FIELD_ACTIVE_STATUS key should be added to the Code Manager Audit
  • 17508: Audit Manager Export issues
  • 17511: If you make a copy in certain cases for reports with lot of fields, the order of fields changes
  • 17527: With large Case Books sequencing of forms is out of order in some cases
  • 17540: Lists of roles in EM do not match between servers
  • 17545: Total time spent for a parent activity not calculated correctly sometimes
  • 17546: Validation for a course during upload
  • 17582: PDFCrfWriter has two help links that do not exist in the new help center Trial Manager manual
  • 17618: Wrong translation key is used to describe the status of partial code
  • 18683: Freeze scripts are not shown in form debug page
  • 18774: Import Log: Insert the summary of rows in the import log
  • 18787: Show the allowed file type for import on the import page
  • 18913: Secure the user interface to not allow adding invalid chars
  • 19268: Data Gene “error in expression”
  • 19548: “Reconcile (Process Assignments)” allows script assignment
  • 19684: form’s sequences issue
  • 19706: createForm command issue
  • 19736: scripts are not processed upon reconcile
  • 20060: issue with “name” dependency
  • 20080: Gauge Report is not shown in IE8
  • 20146: Auto safe problems with Opera and Safari
  • 20277: Exception when forms modified simultaneously in zoom mode
  • 20377: Calendar date Icon doesn’t work in FF
  • 20381: ‘this’ should be available in alert text
  • 20447: saveOnExit set to “no” should allow saving the data
  • 20491: Improve Area Chart on Opera, Safari
  • 20492: Improve Scatter Chart
  • 20493: If the report is included on the application’s home page, everyone with access to the report will be able to view it
  • 20501: Update Safety Case Manager DTLC Page To Support Regulatory Form Addition
  • 20742: Integer edit checks must be surrounded by quotes
  • 21405: User Can Manipulate Multiple Browsers To Edit Plain Text Questions
  • 21494: Lab range was displayed for wrong question type
  • 21665: Methods for post-processing needed
  • 21674: When the toolname is numeric only it drops leading zeros
  • 21694: add notification for declined queries
  • 21716: wild character search is not working on integers
  • 21746: Resolved values in the expression language are parsed and interpreted
  • 21849: Dropdown lists move when highlighted in VA
  • 21901: DCProperty updates do not propagate to cache in other servers
  • 22107: Form Flow unsupported in VA

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