Summary

This article covers the 12.0.0 DBP Release notes.

Welcome to the DATATRAK Business Platform 12.0.0 Major Release!

DBP 12.0.10

  • 28350: Admin Enterprise Manager Users Cannot Manually Reset User Passwords
  • 28351: Unable to Manually Create New Users when Country is selected
  • 28352: DBP 12.0.10 Release Notes

DBP 12.0.9

  • 27553: Add Optional Security Question JSP
  • 27554: Allow Turning Off Optional Security Question Through Profile
  • 27555: Alter Login Process to Support Optional Security Question
  • 27556: Link Optional Security Question to Login Field
  • 27557: Forward to Main Login Page if Authentication Fails
  • 27558: Update Locking to Support Optional Security Question
  • 27559: Resetting Password Via Email or Enterprise Manager Disables Optional Security Question
  • 27560: Update Login History Table To Support Optional Security Question
  • 27561: Add Option to Register PC
  • 27562: Add Security Question Cookie Table
  • 27563: Add Unregister All Computers Button
  • 27564: Add Register This Computer Button
  • 27569: Add Password Dictionary
  • 27570: Remove Password Reset Security Question and Answer
  • 27571: Email Link for Password Reset
  • 27572: Email Link for Password Reset Expires in 24 Hours
  • 27677: Form flow bug: FormFlowStatus needs to be HashMap save
  • 27809: Implement a Password Strength Indicator
  • 27903: If the security answer or password is left blank, the user should be notified and no audit should be recorded
  • 28084: DBP 12.0.9 Release Notes

DBP 12.0.8

  • 27122: Custom email triggers are reported as errors by compiler
  • 27142: DBP 12.0.8 Release Notes

DBP 12.0.7

  • 26834: Audit Entity Not Held In Memory or Recorded
  • 26836: Configure Possibility of Assigning Treat With Minimization Algorithm
  • 26837: Record Seed Number Used to Generate Treatment
  • 26838: Add Configurable Method for Calculating Imbalance Score in a Minimization Algorithm
  • 26839: Simulate Creation of a Minimization Based Randomization Schedule
  • 26840: DBP 12.0.7 Release Notes
  • 26956: Update Randomization manuals for Minimization

DBP 12.0.6

  • 26430: Material login updates should only be made from the production servers
  • 26432: DBP 12.0.6 Release Notes

DBP 12.0.5

  • 26108: Exports running very slow
  • 26159: Update login configuration to maintain the cache
  • 26161: Reconfigure login to prevent storage of login history in cache
  • 26166: DBP 12.0.5 Release Notes

DBP 12.0.4

  • 24483: Update Management Servlet Access
  • 25905: Added Italian As Foreign Language Option
  • 25906: Remove French Language File Used For Core Code Translation Keys
  • 25907: Remove Spanish Language File Used For Core Code Translation Keys
  • 25908: DBP 12.0.4 Release Notes
  • 25930: Add a listing of login attempts to the user profile
  • 25993: Addition of as-prod005, as-prod006, as-prod007, as-prod008 Production Nodes

DBP 12.0.3

  • 25417: Update Properties File To Support 4th Production Node
  • 25419: DBP 12.0.3 Release Notes

DBP 12.0.2

  • 24041: Add Notification Support for Answer Status
  • 24183: Query Role Filter
  • 24207: Changed Data Pop-up Window Not Functioning
  • 24210: enterKeyAction Does Not Always Work With ‘Select’ Questions
  • 24218: Support Ability to Make Import Comparisons Case Insensitive
  • 24219: Drug Container and Shipment Managers Performance is Degraded by Number of Study Sites
  • 24221: Update uIRT Translation Keys to Support Chinese
  • 24222: DBP 12.0.2 Release Notes
  • 24426: Update the imports section of the Data Architect manual for 12.0.2
  • 24430: Incorrect title on Subject Statistic Export files
  • 24433: Custom Synonym can not be coded
  • 24543: Add support for Traditional Chinese
  • 24554: Modify Reconcile Process to Reduce Memory Usage
  • 24653: System throws exceptions when user without language code trys to log in

DBP 12.0.1

  • 22516: Trial Progress report gives clickOS error for new trials
  • 23861: Deleted forms shouldn’t be exported
  • 23911: cvsPath property is not set by create sub-client functionality
  • 23912: Create sub-client does not assign EM roles on design, test and approve
  • 23957: Expense Report Access
  • 23974: New Logo for DATATRAK ONE(TM)
  • 24005: DBP 12.0.1 Release Notes
  • 24009: Managers may not work if roles are not defined in DA
  • 24038: Shipment Manager Export Not Functioning

DBP 12.0.0

The 12.0.0 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:

21853 – uCTMS 2.0.0

21850: Create a Mapping Configuration Screen at the Report Level

Connections to uEDC to be made through reports only

  • A switch will be put in place to allow selecting between pulling data from the CTMS record or the clinical application. This switch can be turned on and off at any time.
  • The ability to turn this switch must be controlled from the setup page in TM to allow them to be sellable module(s) and have it controlled by us (requirement from Chris). The new options should be added as follows:
    • uCTMS uEDC Connection
    • uCTMS uIRT Connection

There will be a permission based button placed on the reports that can be connected. The button will not appear unless the above items are enabled.

NOTE: There should be no manual mapping of uIRT reports. If the uIRT connection is enabled the reports should appear to the necessary team members. If the uEDC Connection is enabled the buttons will appear to allow mapping of the data.

Inside the mapping configuration, the user has the option to pull data from uEDC or from the uCTMS record. This is enabled/disabled at the report level so that demographics could be mapped to uEDC but they can still record and report on Protocol Deviations in the uCTMS record (for example).

The mapping screen should display the column in the report and then the user should be able to select a path to a form and then the question to map to that column.

21851: Create a Report for Displaying Document Expiration

This release will include document expiration fields and reporting

  • Add ‘Expiration Date’ field to both the Document Summary and Site Document forms
  • Add ‘Creation Date’ field to both the Document Summary and Site Document forms
  • Add Document Summary Report
    • Will pull documents from all sites and the document summary section
    • Must include filters for ‘documents expiring in’:
      • Expired
      • 5 days
      • 30 days
      • 60 days
      • 90 days
    • Should provide pie chart for a breakdown of the type of documents that are recorded.
    • Should have a filter for sites so that the user can see which documents a site currently has in the system.
      • This filter should allow them to show ALL site documents in addition
      • Another option in the filter needs to be for ‘global’ documents
    • All columns from the document form should appear in the report:
      • Add ‘Location’ for site name – will say ‘Study’ if from the Document Summary section
      • If type = other, use ‘other’ value
    • The default sort should be set so that the documents that are expiring first are at the top of the report.

21857: Modify Site Differences Report for Site Linking

The site Differences report needs the following modifications:

  • Change the existing matching column to only look at tool name. If the site name matches between uCTMS and uDesign, the sites should be matched in the report (ignoring the address information).
  • Add an additional column that looks at the address matching. The output should simply be yes or no as it currently is but only looking at the addresses.
  • Add an additional column that has a button that allows you to ‘link’ the two sites. When you click the button in this column the tool ID is copied into a tool id field on the uCTMS site form.

21858: Modify uCTMS Site Field to Support Linking

To support the linking of uCTMS sites and uDesign sites, we need to make the following shell changes.

  • Remove the read-only attribute from the Site Label field to allow it to be edited after it is assigned. Whatever is assigning the value should not overwrite the site label if it is already set.
  • Add a reference question to all site forms in the production node for tool id

21859: Class for Retrieving Forms and Questions from the Trial XML

We need an object for easy selection of objects from the XML associated with a clinical study. The XML should only be pulled from the production study configuration.

Along with any other necessary methods, we need the ability to get a list of questions based on passing a form to a method. We also need a method for getting a list of forms and associated paths for mapping questions to columns in the uCTMS reports.

21860: Class for Creating and Retrieving Database Properties

We will be storing the mappings of forms and questions to uCTMS reports in the clinical trial’s database properties. In reality, the properties could be defined in the DA file by the trial designer but I do not expect this to happen. But this class should be able to find the application based on the production application ID on the setup page in Trial Manager and be able to set and get values associated with specific property names.

The property names will use ‘ctms_’ and then use CDASH naming conventions for the associated variables where possible. Not all variables will appear in the CDASH standard, but we should follow it where possible.

21861: Class for Connecting to the Clinical trial associated with the uCTMS Record

We need an object to create the connection between uCTMS reporting and the clinical trial associated with the uCTMS record.

The information that should be used to make the connection is the production application ID on the setup page of the Trial Manager record. The class should ensure that the connection only uses information from the production server, not other servers.

21862: Class for Defining Report Data and for Returning the Data Based on Mappings

We need an object structure that should allow us to define an overall class for taking the mappings from the database properties that are defined and returning data from the clinical trial associated with it.

Subclasses should be created for each specific uCTMS report that tie to the specific columns of those reports. The reports and the specific questions that are mapped will be defined outside of this bug.

21866: Permission to Manage Connections Screen

A new permission, ‘manageConnections’ needs to be added to the Roles tab to enable access to the mappings screens per role. The following roles should have this permission:

  • Configurator
  • DT Debug
  • Clinical Project Manager
  • CTA

This permission places a button on reports that can have mappings to uEDC. The button appears in the upper right corner in the header.

21867: Enrollment Timeline Report

A new report will be created called ‘Enrollment Timeline’. This report should be available regardless of whether uEDC or uCTMS is used.

This report will simply be a line graph similar to the site/vendor cost reports. It should show the duration of the study and enrollments over that timeline and it should be compared to the enrollment summary numbers entered in uCTMS.

This is version 1 and it will only include screened numbers and enrollment counts from the actual sites.

If the report is connected to uEDC, it will pull record creation times.

If the report is only using uCTMS, it will use the Informed Consent date as the date it was enrolled.

Future versions will consider the remaining numbers and statuses.

21868: Projection Data Fields for Site Performance Report

To support the reporting of site performance from both a stand alone and uEDC point of view, the following data points need to be added. They will be added under the Data Management node and the form should be called “Data Entry and Cleaning Performance”:

Site Stats

  • Expected Query Answered Time (New -> Answered)
  • Expected Query Re-answered Time (Reopened -> Answered)
  • Expected Form Data Entry to Completion (Form Data Entry -> Completed)
  • Expected Subject Data Entry to Completion (Subject Data Entry -> Completion)

Monitor/Data Management Stats

  • Expected Query Closure Time (Created -> Closed)
  • Expected Query Answered Closure Time (Answered -> Closed)
  • Expected Query Answered Reopened Time (Answered -> Reopened)
  • Expected Subject Completed to Frozen
  • Expected Form Completed to Frozen
  • Expected Subject Completed to Locked
  • Expected Form Completed to Locked
  • Expected Subject Completed to Signed
  • Expected Form Completed to Signed

Signoff Stats

  • Expected Subject Completion to Signed
  • Expected Form Completion to Signed
  • Expected Subject Signed to Locked
  • Expected Form Signed to Locked
  • Expected Subject Frozen to Signed
  • Expect Form Frozen to Signed

NOTE: Each projection field above must also have a corresponding ‘Actual’ field so this functionality can work in a stand alone manner as well.

21869: Site Performance Report

To support the reporting of site performance from both a stand alone and uEDC point of view, the following report needs to be created:

Site Performance

The following projections below will be added to the casebook with bug 21868. Actuals will be associated with them as well. If this report pulls from uEDC, it will pull data similar to the Averages report that currently exists. The differences are as follows:

  • The default will be to show the overall average for the study.
  • A filter will be present to view a specific site.
  • The categories below should be summarized at the top and it should be clearly indicated using a color coding system how many of the metrics the different groups are meeting.
  • This report should be styled with graphs and visual representations of the data where appropriate.
  • All data that is present on the averages report that is not listed below should also be reported if it is connected to uEDC.

Site Stats

  • Expected Query Answered Time (New -> Answered)
  • Expected Query Re-answered Time (Reopened -> Answered)
  • Expected Form Data Entry to Completion (Form Data Entry -> Completed)
  • Expected Subject Data Entry to Completion (Subject Data Entry -> Completion)

Monitor/Data Management Stats

  • Expected Query Closure Time (Created -> Closed)
  • Expected Query Answered Closure Time (Answered -> Closed)
  • Expected Query Answered Reopened Time (Answered -> Reopened)
  • Expected Subject Completed to Frozen
  • Expected Form Completed to Frozen
  • Expected Subject Completed to Locked
  • Expected Form Completed to Locked
  • Expected Subject Completed to Signed
  • Expected Form Completed to Signed

Signoff Stats

  • Expected Subject Completion to Signed
  • Expected Form Completion to Signed
  • Expected Subject Signed to Locked
  • Expected Form Signed to Locked
  • Expected Subject Frozen to Signed
  • Expect Form Frozen to Signed

NOTE: Each projection field above must also have a corresponding ‘Actual’ field so this functionality can work in a stand alone manner as well.

21870: Make Setup Questions Editable

The following forms/questions should be seen and editable by the following roles:
Setup form can be seen by:

  • Clinical Project Manager
  • CTA

The following questions should be editable by the following roles

  • Description
  • Regulatory Submission Numbers
  • Current Study State
  • Product Type
  • Product Name
  • Phase
  • Therapeutic Area
  • Indications to be Studied

Roles:

  • Clinical Project Manager
  • CTA
  • Project Manager (uDesign role)
  • Trial Designer (uDesign role)

21919: Protocol Deviations Report Modifications

The protocol deviations report must be modified to account for mappings to uEDC.

The default is that this report will work as-is, pulling from the uCTMS record. If the user changes the data source to uEDC and provides the mappings, the data should pull from the mapped locations. If a column is not mapped, it should report blank.

There are statuses mapped to uCTMS status questions, however these may not be available or make sense from the clinical application. Therefore, if the data source for this report is uEDC, the status table should not appear at the top and the status column should simply display the display value from whatever field is mapped to it.

21920: SAE Report Modifications

The Serious Adverse Events report must be modified to account for mappings to uEDC.

The default is that this report will work as-is, pulling from the uCTMS record. If the user changes the data source to uEDC and provides the mappings, the data should pull from the mapped locations. If a column is not mapped, it should report blank.

There are statuses mapped to uCTMS status questions, however these may not be available or make sense from the clinical application. Therefore, if the data source for this report is uEDC, the status table should not appear at the top and the status column should simply display the display value from whatever field is mapped to it.

21921: Trial Summary Report Modifications

The trial Summary report must be modified to account for mappings to uEDC.

The default is that this report will work as-is, pulling from the uCTMS record. If the user changes the data source to uEDC and provides the mappings, the data should pull from the mapped locations. If a data point is not mapped, it should report blank.

For Protocol Deviations, when the uEDC connection is made, a count of Protocol Deviations is all that should show.

For Serious Adverse Events, when the uEDC connection is made, a count of Serious Adverse Events is all that should show.

For Data Cleaning, when the uEDC connection is made, the overall status of all records should be averaged to produce the numbers under data cleaning stats.

For Enrollment numbers, the dynamic statuses for randomization/screen fail should be used to produce the actual numbers. Enrollment should be based on the number of records currently enrolled in the trial.

21978: uIRT Drug Container Report

This report should utilize the manager associated with this data to get the data out. The fields in the listing should be as follows:

  • Container ID
  • Location
  • Available
  • Used
  • Missing
  • Broken
  • Date Received
  • Expiration Date.

Above the listing, we should break down some overall stats (these should be visually impressive):

  • number of containers in the system
  • Locations where drug is present
  • Pie chart of available/used/missing/broken
  • number of containers at a packaging company vs. # of containers at a site
  • number of containers at a site but not confirmed
  • number of containers expiring in the next 30 days.

21979: uIRT Shipment Summary Report

This report should utilize the manager associated with this data to get the data out. The fields in the listing should be as follows:

  • Shipment ID
  • Origin
  • Destination
  • Status
  • Containers
  • Requested Date
  • Received Date
  • Tracking Number
  • Shipment notes/comments

Above the listing, we should break down some overall stats (these should be visually impressive):

  • number of shipments in the system
  • number of origin locations vs. # of destination locations
  • Pie chart of shipments/status breakdown
  • Average number of containers/shipment
  • Average number of days from request to received

21980: uIRT Assignment Summary Report

This report should utilize the manager associated with this data to get the data out. The fields in the listing should be as follows:

  • Patient
  • Assignment Date
  • Assignment By
  • Containers
  • Doses (Assigned/Cancelled/Replaced)
  • Description

Above the listing, we should break down some overall stats (these should be visually impressive):

  • # of patients with vs. without assignment (pie chart)
  • Breakdown of assigned/cancelled/replaced (pie chart)
  • Average # of containers/patient

21985: Subject Summary Report Modifications

The Subject Summary report must be modified to account for mappings to uEDC.

The default is that this report will work as-is, pulling from the uCTMS record.
If the user changes the data source to uEDC and provides the mappings, the data should pull from the mapped locations. If a column is not mapped, it should report blank.

The following items will be mapped:

  • Primary ID
  • Secondary ID (will be combined with primary ID to create patient name)
  • Sex
  • Race

Make sure all mapping names match the column names in the report.

The remaining columns in the report should be mapped to the record level status for each of those columns. It should get the # of forms for the record and the # of forms that match each status and calculate the percentage.

21986: Subject Enrollment Report Modifications

The Subject Enrollment report must be modified to account for mappings to uEDC.

The default is that this report will work as-is, pulling from the uCTMS record.

If the uEDC connection is enabled for this report, all data should be mapped based on the site configuration. Each site will have a reference question to a Production site so that we can determine in the background where to pull projections and actuals from. The actuals will be based on the new standard dynamic statuses that will be created.

22003: Import for Team Members

An import should be created to import team members into the following sections:

  • Monitoring
  • Data Management
  • Project Team

The import should be based on the custom export. In the export, all team members are combined into a single panel so the import needs to account for the ‘category’ to import them into the correct location.

All data, including rates should be able to be imported. For Monitors, ‘sites to be monitored’ should not be imported.

22004: Import for Site Information

An import should be created to import site information. The import should be based on the custom export in terms of import format.

Only the following items should be imported:

  • Site Number
  • Site Name
  • Site Label
  • All address information (contact and pharmacy)
  • Comments

22006: Import for Subjects

An import should be created to import subject information. The import should be based on the custom export in terms of import format.

All items on the subject form must be able to be imported. The import should allow updating of the form in case updates are made concerning study status over time.

The subject will have to be mapped to a site so if the site does not exist the import should not create one.

22007: Import for Protocol Deviations

An import should be created to import protocol deviations. The import should be based on the custom export in terms of import format.

All items on the PD form must be able to be imported. The import should allow updating of the form in case updates are made concerning study status over time.

22008: Import for Serious Adverse Events

An import should be created to import Serious Adverse Events. The import should be based on the custom export in terms of import format.

All items on the Serious Adverse Events form must be able to be imported. The import should allow updating of the form in case updates are made concerning study status over time.

22115: Data Points Needed for Timeline Occurrences

To support timeline information from a standalone perspective, we need the following dates added to the uCTMS subject tracking form:

  • Screen Fail Date
  • Randomization Date
  • Off Study (Early Term/Study Completion) Date

These should be added to the same section where Informed Consent and DOB are collected.

22125: Cross Trial Reporting – Modify Dashboard

The uCTMS reporting dashboard needs to be able to show cross trial reporting options. The listing should appear the same way the listing appears for the reports within a single trial. The following reports should be listed:

  • Team Summary
  • Subject Summary
  • Subject Enrollment
  • Protocol Deviations
  • Serious Adverse Events

22126: Cross Trial Reporting – Team Summary

We need a report that shows cross trial information. The Team Summary should pull 2 ‘top 5′ listings and then a full dump for the remaining users.

  • Top 5 Most Utilized – shows a listing of users that are in the most trials, limited to 5.
  • Top 5 Least Utilized – shows a listing of users that are used the least, limited to 5.

A grid under that should be a listing of all project leads. The project lead grid should match the similar grid on the trial level team summary report with the addition of a column to indicate which trial is referenced. Each trial indication should be a link to that trial’s team summary report.

The second grid of the report should be a listing of all users in all trials, sorted by user. The fields in the report should match the fields in the trial level team summary with the addition of a column to indicate which trial is associate with that row. Each trial name should be a link to the trial’s team summary report.

22127: Cross Trial Reporting – Serious Adverse Events

We need a report that shows cross trial information. The Serious Adverse Events should report some high level information:

  • Pie chart giving a breakdown of studies with the counts of SAEs (all statuses) so the team members can quickly see where there are problems.
  • Pie chart showing a breakdown of the outcomes associated with the SAEs.

A grid should be included that provides a high level listing with statuses for each trial. The columns should be as follows:

  • Trial (should be linked to the trial specific report)
  • Total Count
  • Open
  • Completed
  • Unknown

A second grid should appear under that listing all SAEs from all studies. These should have a default sort by trial (first column). The columns should be the same as the SAE report except we do not need to list the SAE # or Site in this report.

22128: Cross Trial Reporting – Subject Summary

We need a report that shows cross trial information. The Subject Summary should report some high level information that is a collection of the Subject Summary and Subject Enrollment report:

Each trial should have it’s own section of the report with the following information:

  • Pie chart showing race breakdown.
  • Pie chart showing gender breakdown.
  • Numbers from enrollment report.

Clicking on the trial name should take the user to the trial specific Subject Summary report. Clicking on the ‘Screening’/Screen Fail/Randomization’ text should take them to the trial specific Subject Enrollment report.

22131: Cross Trial Reporting – Protocol Deviations

We need a report that shows cross trial information. The Protocol Deviations should report some high level information:

  • Pie chart giving a breakdown of studies with the counts of PDs (all statuses) so the team members can quickly see where there are problems.
  • Pie chart showing a breakdown of the statuses associated with the PDs.

A grid should be included that provides a high level listing with statuses for each trial. The columns should be as follows:

  • Trial (should be linked to the trial specific report)
  • Total Count
  • Approved
  • Unapproved
  • Unknown

A second grid should appear under that listing all PDs from all studies. These should have a default sort by trial (first column). The columns should be the same as the PD report except we do not need to list the PD # or Site in this report.

Clicking the trial on any of the above location should take the user to the trial specific report.

22134: Time Summary

This report should pull data from the following areas:

  • Monitoring Time Record
  • DM Time Record
  • Project Team Time Record

The top of the report should list totals for the above categories on the left and a pie chart with the same breakdown on the right.

A listing below this should show the following:

  • Team Member
  • Team Type (Monitoring, Data Management, General)
  • Date
  • Hours
  • Tasks
  • Comments

22147: Contact Info and Terminology Changes

All Project, Data Management, and Monitoring Team Members need to have the option of adding contact information. Location would be good but we can probably get away with just the email/phone/fax at this point.

Also, all instances of ‘Drug’ or ‘Device’ need to be replaced with ‘Investigational Product’.

Please make sure that all new fields are accessible by the appropriate roles.

22225: Move Subject Visit up to Site Level

The Subject Visit form is currently located under the subjects. When the study is connected to uEDC, the patients will not exist here so the users will not be able to enter the subject visits. To get around this, the following structure needs to be created:

Sites

  • Subject Visit Summary
  • Site 1
  • Site 2
  • etc.

The Subject Visit Summary should have the existing Subject Visit form as a dynamic with the following changes:

  • Remove the casebook % numbers – these are unnecessary
  • Add a question at the top for Subject ID (text field)

The existing subject visit form should be removed.

22773: Project Time Record Form for Time Summary Report

To support Time Summary report new form ‘Project Time Record’ should be added under Monitor, DM, and Project Team forms. Specify what questions the form should have and what access CTMS roles should have (they have no access now).

22855: Roles Assigned to Imports

The roles for specific actions should be as follows:

Import Team Members: DT Debug, Clinical Project Manager, Lead CRA, Lead Data Manager, CTA, Project Manager, Trial Designer and Java Developer

Import Sites: DT Debug, Clinical Project Manager, Lead CRA, Lead Data Manager, CTA, CRA, Data Manager, Project Manager, Trial Designer and Java Developer

Import Subjects: DT Debug, Clinical Project Manager, Lead CRA, Lead Data Manager, CTA, CRA, Data Manager, Project Manager, Trial Designer, Java Developer

Import Protocol Deviations: DT Debug, Clinical Project Manager, Lead CRA, Lead Data Manager, CTA, CRA, Data Manager, Safety, Project Manager, Trial Designer, Java Developer

Import Serious Adverse Event: DT Debug, Clinical Project Manager, Lead CRA, Lead Data Manager, CTA, CRA, Data Manager, Safety, Project Manager, Trial Designer, Java Developer

22885: Site Summary Modifications

This report was not modified along with the others. It has the Manage Connection button but nothing happens when it is switched.

When the data source is uCTMS, it should act as it does today.

When the data source is uEDC, the site name and all 3 patient status fields should report from the uEDC sites (excluding training sites!).

23183: Create Executive Role

Create an ‘Executive’ role within the uCTMS product with the following access/permissions:

  • Read only to all forms
  • Restrict view to the Planning form.
  • Access to the following reports:
    • Main Dashboard
    • Cross Trial Subjects Summary
    • Trial Summary
    • Site Performance Report
    • Subject Summary
    • Subject Enrollment
    • Enrollment Timeline
    • Assignment Summary
    • Shipment Summary

22342: Restrict Access to Cross Trial Reporting

We will be restricting access to the cross trial reports in CTMS that have clinical data in them. There will be a new question ‘Enable uCDR’ on the setup page along with the other ‘Enable’ questions.

If uCDR is enabled, the uCTMS dashboard will show all Cross Trial reports on the left. If not enabled, only the Team Summary Cross Trial report will be available since it does not contain any clinical data.

uDesign

22711: Sub Trial Managers Should be Created Without Using ManagementServlet

We need the ability to create ‘sub trial managers’ (sponsor Trial Managers) without using ManagementServlet. It should create the workgroups, the trial managers for each environment and assign the typical TM roles to the TM instances.

uEDC

18906: Export Instruction – Substring Modifications

Allow for the resolution of issues with the substring function, which was throwing errors for invalid indexes.

22190: Include Data For Deleted Subjects In Standard Exports

A configurable parameter should be created to support the inclusion of data from deleted subjects/forms in the standard datatrak exports. The default parameter setting should be such that the deleted data is not present.

23265: Pre-Screening status should be added to configuration

Update the configuration DA to include the Pre-Screening status.

uIRT

22547: Email Trigger titles should be able to resolve study variables

Email Trigger titles from the Email Triggers tab should be able to accept an expression and resolve variables, such as question values or tool name.

22470 – Billing Tool 

The following DTLC page has been updated to support the newly created properties in the DBP 12.0.0 release:

Billing Tool

22489: Reporting

The billing tool should be able to report on counts of various components of the system. This should include items such as Sites, Users, Records, Data Points & File Space Usage.

22490: Contract

The billing tool should have a representation for a contract.

22492: Permissions

Roles should be created to support the ‘Admin’ and ‘User’.

22493: Detailed Reporting

Upon execution of the series of reports associated with a contract, a user should be presented with a results screen showing the results for each of the contract facets. These facets should be able to be drilled down into to view the actual items being counted. e.g., the first results screen shows the number of sites, while the drill down shows which sites are included in the count.

22494: Contract Facets

Contracts should contain facets. A facet is a unique component of the contract that is accounted for or billed in some way. Every facet will be supported by an underlying report.

22495: Facet Parameters

Contract facets should support parameters to allow for ease of billing. When a parameter for a report will not change from one execution to the next, it can be saved as a Facet Parameter so that it does not need to be entered every time.

22496: Reporting Types

Reports should allow for different mechanisms to gather the needed counts/data. Suggested methods include Java Calculation & SQL Calculation

22497: Report Exporting

Data from reports should be exportable.

22498: Report Parameters

Reports should accept parameters so that one report can be used to do accounting across many trials/time periods/ etc.

22499: Permissions – Admin Role

The Admin role should be allowed to create Contracts, Contract Facets, and Contract Facet Parameters

22500: Permissions – User Role

The User role should be allowed to run contracts associated with the tool or child tools and download the exported results.

22118 – Subject Status 

The following DTLC page has been updated to support the newly created properties in the DBP 12.0.0 release:

Subject Status

22118: Subject Status Configuration

  • Screening
  • Screen Fail
  • Run In
  • Run In Fail
  • Enrolled/Randomized
  • Treatment
  • Complete
  • Early Term

Each should have a paired property that will allow the label to be changed by the designer.

The statuses are set via expression. Evaluation of the expressions should be priority based (starting at the last expression).

Evaluating the expressions should be triggered based on either the Automatic Dependency Reconciliation or the Metadata Change Sniffer if either of these options makes sense.

The status should be recorded in the audit trail and a secondary table in the database. Keys for the table should include application id and record id. A new metadata status should be added to the record table for ease of reporting in the subject manager.

Table contents for subject status:

  • Application ID
  • Record ID
  • Status
  • Date/time status was set

We must be able to determine historical counts for use in uCTMS so we need to be concerned about performance of the above table.

22119: Record Manager Support for Subject Status

Please add a column to the Record Manager to support the Subject Status indication. At the writing of this bug, the intention is to only display the status with no background color.

22120: Study Homepage Support for Subject Status

Please add a placeholder to the study homepage to support the new Subject Status indications. If a subject status property is not defined, it should not appear in the counts. Each label should appear where the ‘Enrolled’ count currently appears with the associated count.

22122: Utility to Modify Subject Status

A utility needs to be created to edit the current status of a record. The user should select a record from the record manager and then enter the utility from the actions menu. They should be allowed to change the status of the record by selecting any of the statuses available in the application. This action should be a record level audit.

We also need to be concerned about historical counts. The user should be able to see the history of the user and be able to either delete or mark a previous status as ‘disabled’ to remove it from the overall application count of records that have been in a specific status.

22293: Subject Status – Standard Report

We need to generate a standard report around the Subject Status configuration.

The report should display a table showing each record and the columns should be all of the statuses. If the status exists for the record, that column will display the date and time associated with the occurrence of the status. The record’s current status shows as green and bold text. All remaining statuses show as black normal text. If a status does not exist for a specific patient that cell is blank.

23415 – DBP 12.0.0 Documentation

23443: DBP 12.0.0 Release Notes

Create release notes to support the DBP 12.0.0 release.

23292: Create Record Status Documentation

Create a manual to support end user use of and trial design configuration of the Record Status feature.

23294: Update uCTMS Manual to Include uCTMS 2.0 Additions

Update uCTMS manual for uCTMS 2.0

23295: Create Billing Tool Manual

Create a manual to support end user use of the Billing Tool.

Outstanding Issues

  • 6663: Calendar Week Number Display Bug
  • 6665: You Cannot 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
  • 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
  • 11994: ‘Is Default’ Can be Answered ‘Yes’ for Multiple Portals
  • 12283: Toplink Error When Renaming Form
  • 12298: Problems If Two Users Commit VA at the Same Time
  • 12541: Expression Assignment With a Date or Time Field That Has Blank Value Gets Wrong Result
  • 12590: Issue With Form Rename if a Question Used in Naming is also Referenced From Another Question
  • 12715: Large Trials Hang When Committing in IE
  • 13023: When OC4J Needs to be Restarted it can Hand 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
  • 13614: DataGenie: Contact Control Should Resolve to User Name
  • 13688: Requires the Third Save to Display Alerts if Alert Waits for Dependent Question
  • 13866: Can’t Unlock User Account on Design
  • 13980: Deleting of Application Properties is not Synchronized Between the Servers
  • 14029: Script-Errors not Displayed for “after” Scripts
  • 14042: RuntimeException When Delete Difference Report Archive
  • 14391: When Reconcile Script Might Create Unexpected Forms When Forms are Locked
  • 14811: NullPointerException When Running WorkView
  • 14812: Report Doesn’t Return Data with Null Value
  • 14995: Configuration Files are Reloaded When Performing Some Actions
  • 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 than 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
  • 16319: Date Format in VA Should Show Warning When Blank For Date Question
  • 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 Relogging
  • 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
  • 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
  • 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
  • 17053: Audits Should Exist for Insert From Action
  • 17054: Audits Should Have ReName Form Actions
  • 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
  • 17249: Record Should be Reassigned Automatically 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 Types Loses Keypress Functionality When enterKeyAction is set to “nextField”
  • 17305: Comment Manager does not Sort Properly
  • 17328: Can’t Add Users to Test, Design, Approve
  • 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
  • 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 Manger Audit
  • 17508: Audit Manager Export Issues
  • 17511: If You Make a Copy in Certain Cases for Reports with Lots of Fields, the Order of Fields Changes
  • 17527: With Large Case Books Sequencing of Forms is Out of Order in Some Cases
  • 17540: List 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 Manage Manual
  • 18683: Freeze Scripts are not Shown in Form Debug Page
  • 18913: Secure the User Interface to not Allow Adding Invalid Chars
  • 18983: RuntimeException when change Assignment Type to sequential
  • 19268: Data Gene “error in expression”
  • 19384: Duplicate translation keys
  • 19548: “Reconcile (Process Assignments)” Allows Scripts Assignments
  • 19684: Form’s Sequences Issue
  • 19706: createForm Command Line
  • 19736: Scripts are not Processed Upon Reconcile
  • 20060: Issue With “name” Dependency
  • 20080: Gauge Report is not Shown in IE8
  • 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
  • 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
  • 21653: add more translation key to Drug Container Manager
  • 21665: Methods for Post-Processing Needed
  • 21674: When the ToolName is Numeric only it Drops Leading Zeros
  • 21716: Wild Character Search is not Working on Integers
  • 21742: Manage Notifications screen does not show existing notifications in IE6
  • 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
  • 21990: Export Instruction codeTerm Might Return a “null” String
  • 22279: Closing Query Window Will not Submit the Parent in Opera
  • 22292: verification of date entered is not implemented across randomization screens
  • 22309: ‘Paste Item’ in Visual Architect does not Work Until You Publish or Commit Trial
  • 22321: Several Issues with Coding Properties in VA
  • 22322: Display Time Property Should Have More Options in VA
  • 22324: VA Export Type Property in Exports is not Changeable
  • 22327: VA is Reloaded with Blank Data if Browser is Refreshed
  • 22329: Help for User Roles Properties in VA Should be Updated
  • 22488: Email Notification cause import to fail
  • 22862: sitePharmacyAddressSame displayed unchecked when imported
  • 22876: Exported file from uCTMS reports has not standard format
  • 22883: Sorting should be done across all pages
  • 22891: All CTMS reports should show tooltips for the cells
  • 23219: reports windows should be re-sized dynamically
  • 23282: Pie chart legends do not show all values in several reports
  • 23283: Study Visit forms are placed in the wrong order under Study Design form
  • 23362: Export issue for reports with Data Item Count Restriction
  • 23445: inventoryTransfer email should display destination tool in the subject
  • 23481: Synonym Manager Export Gives Click OS Error
  • 23915: uIRT Reports Choose All Sites Tool Incorrectly
  • 24378: Cannot change Export Type
  • 24380: Some characters cause errors
  • 24427: Shipment Destination filter should keep its value
  • 24608: Opera saves when clicking ok on useSavePrompt
  • 24609: Chrome and Safari do not save data when SaveOnExit is yes
  • 24628: In zoom mode ‘Lock’ and ‘Lock All’ do not disable Close/Open Alert boxes
  • 24639: ‘enterKeyAction’: unresolved issues from Bug 24210
  • 24672: Several keys need Chinese translations
  • 24679: Data is not saved when broweser window is closed in Opera browser
  • 24684: In Zoom mode extra button click is required to get back to container

Need more help?

Please visit the Fountayn Contact Information page.