Summary

This article covers the Trial Manager 2.2.0 Release notes. 

Introduction

Welcome to the Trial Manager version 2.2.0!

New Features and Improvements

10073: Allow import of site list from csv

Allow an import of a list of sites from a csv file into a trial. This action creates the site forms and related tools. Role Sets should be predefined and referenced by their name in the csv file. The format of the csv file is as follows:

10195: Executive Console for Trial Setup Home Page

The Executive Console provides basic overview information for the user when the Study Home page is shown. The marketing image in the middle portion of the screen is replaced with two graphs and two Milestone tables.

  1. Therapeutic Areas – This is a pie chart describing how many trials are being managed by therapeutic area. The therapeutic area is recorded on the “Setup” form for a particular trial.
  2. Trials by Phase – This is a bar chart describing how many trials are being managed by Phase. The phase is recored on the “Setup” form for a particular trial.
  3. Upcoming Milestones – The upcoming milestones table shows trials that have an expected milestone within the next 10 days. The milestone dates are recorded in the project management estimate form for each trial.
  4. Recent Milestones – The recent milestones table shows trials that had an expected milestone within the last five days. The milestone dates are recorded in the project management estimate form for each trial.
  5. The milestone text will read keyName + ” Expected”.

10368: Change Permission Denied screens to a read only view

The purpose for this is to avoid permission denied when navigating the Trial Manager product. The permission denied makes it difficult to work, and allows for no options from that point. A good example to work with is the setup form. Read only views are provided for…

  1. Flag Version
  2. Load Version
  3. Data Architect
  4. Data Files

10626: Allow opening of a revision in VisualArchitect

Allow the opening of a revision of a trial in VisualArchitect for editing. This will typically be the latest revision but could be any revision if rolling back is needed. Provided by the EditArchitect screen.

10627: Allow opening of a revision in DataArchitect

Allow the opening of a revision of a trial in DataArchitect for editing. This will typically be the latest revision but could be any revision if rolling back is needed. Provided by the EditArchitect screen.

10706: Trial Progress Report

  1. A Gantt Chart detailing the estimates for the following tasks:
    Study Start Date – Entered on Estimate page
    Study Deploy Date – Entered on Estimate page
    First Patient In – Entered on Estimate page
    First Patient Out – Calculated using First Patient In + Patient’s Trial Duration
    Last Patient In – Entered on Estimate page
    Last Patient Out – Calculated using First Patient In + Patient’s Trial Duration
    Study End Date – Calculated using Study Start Date + Study Duration
    DB Lock Date – Entered on Estimate page
  2. Shows the Trial Version running in each of the following environments (if any):
    Test
    Approve
    Production
  3. Replicates the Upcoming Milestone tables from 10195.

10771: Screen after Load Version completes needs formatting

The screen that appears after Load Version completes successfully has been reformatted to appear like the rest of Trial Setup.

Corrections

9800: Illegal database exception when committing

Occasionally, during the first commit of a Trial, an illegal exception would occur.

10628: Site Parent can cause an illegal exception

Occasionally selecting a site parent could throw a clickOS error and neither assign the child relationship or move the form under the parent form.

10796: Executive Console shows missing images when data not present

If there is no data present, then the executive console would show the therapeutic areas and trial by area graphs as missing image icons. It now shows empty graphs.

10803: Illegal exception if you do not specify the test phase Name

If you did not specify the test phase name and try to open the testing manager, then an illegal exception occurred.

10845: Invalid role and sites appear in the tree when cluster is down

If a trial is created with some clusters down and “Do not create Applications at this time” box is not checked the “-2″ role and ” Auto:-2 ” sites are added to the Role set and clusters tree. If any new site is added the “-2″ role will be created in Management Servlet. When clusters are up again and Setup page saved new application ids are created but no tools would be assigned to them.

11018: Misspelling of “Supress”

On the Data Architect screen, the word “Supress” is misspelled for the Suppress Warnings checkbox. It is now “Suppress”.

11019: Re-design of Edit Architect

Changed editArchitect to look more like approve or load version page, with radio buttons next to each version, a select box for actions and a go button. Additionally add pagination.

11020: Rename Data Architect screen to Compile Architect

The Data Architect screen was renamed to “Compile Architect”.

11022: Additional Output missing Form Architecture

The Additional Output zip file no longer includes a Form Architecture file. The annotated CRF file now contains a new Form Architecture chapter for easy printing. This chapter repeats the form architecture from the bookmarks for the record. Description: A form name is embedded in “* *”, when the auto create option is set to false.

A form name is embedded in “[ ]“, when it is a dynamic form that can be inserted at the specified position.

A form name is embedded in “[[ ]]”, when it is a dynamic form that can be inserted at the specified position, but has been inserted at a position on a path to the root before. This means that there is a loop for the insertion possibilities for this form. The form architecture stops visualizing this loop at this level.

Example: We have a record with form A, which allows adding dynamic form B, which allows adding dynamic form B as well. This would be visualized as:

Record
A
[B]
      [[B]]

11048: Answer Options for Do not create Applications question caused exception clutter in the log file

A bad Answer Option in the Trial Manager DataArchitect file was causing useless exceptions to be logged, cluttering the file.

11128: View Button Missing on the Edit Architect Window.

The Edit Architect, View Changes, and Testing Manager did not have a button to submit with the items pre page text box.

Outstanding Issues

  • 9800: If one of the design server is down, it still publishes the DataArchitect file on the other server. It should not publish to the other server if either server is down.
  • 9985: If a cluster is down when saving the setup form then the creation of all “All Sites” forms will fail.
  • 10250: Data Architects containing “{0, 1}” and other similar strings do not appear in the testing manager.
  • 10727: Changes to description on setup page do not update the workgroup.
  • 11090: The name of a DataArchitect file is not checked when publishing and committing.
  • 11129: Permission Denied on edit Architect Screen
  • 11133: Illegal exception when clicking on some forms if Setup form has not been saved
  • 11135: Child site can not become parent again.

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