Summary

This article describes how to grant access to the Cross Study Managers, highlights the differences between the Cross Study Managers and Study Managers and describes the new features.

Table of Contents

• Enable Cross Study Managers
  • Grant Access to User Account
  • Enable Feature for Specific Studies
• Access Cross Study Managers
• Cross Study Manager Differences
  • Additional Manager Columns
  • Click and Hover Actions
    • Link Navigation
    • Progress Bar Navigation
    • Subject Status Data
  • Default Dates and Behaviors
    • Combined Roles
    • Default Dates
    • ‘Needs’ Property In Filtering
    • Read-Only View
    • Record Name
  • Filter Alteration Based on Study Filter
  • Filter Persistence
  • My Checklists Desktop Widget

With the Cross Study Managers, users can access a unified view of Manager data across all studies with the Cross Study Manager feature enabled. Study level permissions are still observed, and the managers are read-only. The following EDC & Medical Coding Managers are included in the Cross Study Manager view: Subjects, Forms, Questions, Queries, Alerts, Comments, Visits, Codes, Audits and Synonyms. The following Randomization and Trial Supply Management Managers are also included in the Cross Study manager view: Shipments, Scheduler, Drug Assignment and Drug Containers.

This page describes how to grant access to the Cross Study Managers, highlights the differences between the Cross Study Managers and Study Managers and describes the new features associated with this module. For additional information on the Managers, view the Manager help pages.

Note: Cross Study Managers can only be accessed in the secure environment.

Enable Cross Study Managers

Before you can access the Cross Study Managers, the Cross Study Manager feature must be enabled for both your user account and for those studies that should be viewable within the Cross Study Managers.

Grant Access to User Account

Access to the Cross Study Manager feature is granted through Enterprise Manager by Fountayn Project Managers.

Enable Feature for Specific Studies

Before a study can be viewed within Cross Study Managers, the Cross Study Manager feature must be enabled for the study in Trial Manager by those with the Configurator role.

Access Cross Study Managers

Once you are granted access to the Cross Study Managers, you can access the Cross Study Manager from the Desktop hamburger menu for any trial that you have access to and has been enabled in Trial Manager.

Note: To access closed studies in Cross Study Managers, the user needs access to the study, it can be read-only access, before it will appear in the Cross Study Managers.

Cross Study Manager Differences

In many ways, the Cross Study Managers behave like the Managers at the study level. This section highlights the differences between the Cross Study Managers and the Study Managers.

Additional Manager Columns

To better organize cross study data, additional columns are available for the cross study managers. As with other managers, these new columns can be dragged and dropped between the Manager and Filter Tables.

Click and Hover Actions

Link Navigation

Similar to the study level manager functionality, the values of certain columns serve as links to subject casebooks. If you have access to both a parent and child site for a study, the link will direct you to the top parent site that you have access to.

Progress Bar Navigation

Just as progress bars at the study level link between the study level managers, progress bars in the Cross Study Managers link between other cross study managers. For example, clicking a progress bar in Form Manager links to the Cross Study Question Manager with applicable filters applied.

Subject Status Data

Since the Subject Status labels can be customized per study, the subject status filter in the Cross Study Managers uses the default label for each subject status. When filtering, you can hover the mouse over the label to check the study level subject status name. Note that only labels that vary across studies will have hover text.

Default Dates and Behaviors

Combined Roles

Regardless of your Role Selection setting, the Cross Study Managers will display the data as if you have roles combined.

Default Dates

All dates in the Cross Study Managers use the date format dd/MMM/yyyy. Time is in the format HH:mm:ss. All date columns except for the Drug Assignment Date Column and Activation Date Column display the date and time in the user’s time zone as specified in the user’s profile. The Drug Assignment Date Column and Activation Date Column display the date in the time zone specified in the Activation worksheet of the study’s DA. If no time zone is configured for the study, the time zone defaults to the time zone specified in the user’s profile. As shown in the following example, the time zone isn’t listed for date columns that default to the user’s time zone while the time zone is displayed for columns that use study-specific time zones.

All date filters in the Cross Study Managers use the user’s time zone as specified in the user’s profile. Since multiple time zones can be specified for the Drug Assignment Date and Activation Date Columns, you can hover the mouse over the filter text fields in those columns to recall what time zone will be used to filter the dates.

‘Needs’ Property In Filtering

If at least one study uses the ‘Needs’ properties, the metadata filter options in the Cross Study Managers use the ‘Needs’ labels. The ‘Not Ready for X’ filter used for studies with the ‘Needs’ properties configured functions in the same way that the ‘Not X’ filter functions for studies without the ‘Needs’ properties configured.

In the following example, the ‘Needs’ properties configured. 

Read-Only View

The Cross Study Managers are read-only. Therefore, no actions can be performed within the managers other than exporting and filtering the data. To apply metadata statuses, change query statuses or make other changes, you must navigate to the study level managers.

Record Name

Though the name used to designate records (such as “Subject” and “Patient”) is configurable per study, they are always called “Records” within the Cross Study Manager feature. Therefore, the manager is called the Records Manager and the column listing subjects is titled “Records.” This will not impact the name used at the study level but does impact the exports generated from Cross Study Managers.

Filter Alteration Based on Study Filter

When you apply the Study Filter in Cross Study Managers, the other filters will only display options pertaining to the studies selected in the Study Filter. The Study Filter is the only filter that alters the options available in other filters.

Filter Persistence

Filters and searches performed in a Cross Study Manager are persistent across other Cross Study Managers until you navigate away from the managers. For example, if you apply the ‘Open Alerts’ filter to the Alert Status Column in the Cross Study Record Manager, the alert status filter will remain when you navigate to the Cross Study Form Manager. Filters and searches also persist between the Cross Study Managers and study level Managers. Sorting does not persist.

The filters will reset when you navigate away from study-specific pages such as when you navigate to the Desktop, the Collaboration Tools or the Scheduler. The filters will also reset when you navigate to a different study or log out of the system.

My Checklists Desktop Widget

Similar to the My Checklists widget for studies, checklists can also be saved across studies. Cross Study Checklists appear on the Desktop when at least one search has been saved through the Cross Study Managers. These checklists are displayed in ascending order based on creation date. The table contains the name of the checklist and the number of items that meet the criteria for the checklist. The table also displays the name of the checklist creator (the Owner) and a delete icon that can be used to delete the checklist. Currently Cross Study Checklists cannot be shared.

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