Release notes version 7.1 - EDC

Dear reader,

The EDC of ResearchManager is being updated to version 7.1. Please find below the list of added functionalities and improvements. We are happy to answer any questions you may have about the update. For inquiries, please email us at support@myresearchmanager.com. 

 

  In short

Among other things in this version:

• Studies can now be easily archived! After archiving, the study will be given the "Archived" status, and only read-only rights can be granted. This provides more control and oversight.
• Column titles can now be customized in Excel export! Choose between component IDs, export tags or titles – completely tailored to your preference.
• Export multiple answer options in one column, separated by commas – perfect for data analysis.
• Simplified query search function in study tasks: This makes the work much more efficient! You can now easily find your own started queries in study tasks, providing quick access to your important information.

• A new column has been added to the patient export, displaying the patient's status, such as "Locked." This makes the data even clearer.

• Bugs, nobody wants them, so we've fixed as many as possible.

Read below for details on all the changes.

 

 

 New

• New default status per study: Archived

Studies in EDC can now be archived through the General Study Information. Once archived, the study status will be updated to "Archived." At that point, all users will only have read-only access, meaning nothing can be modified or added to the study. Only ResearchManager can change the status from Archived to, for example, Active.

On the study overview on the Start page, the user can choose to show or hide archived studies.

• Monitor on component

It is now possible to enable monitoring at the component level instead of the subchapter level. This allows a monitor to specifically indicate which components are being monitored.

To use this functionality:

• Go to General Study Information.
• Check the setting "This study uses monitoring on component level".
• Go to the template and navigate to a component where monitoring needs to be enabled.
• Edit the component and go to Basic Properties.
• At the bottom, check the option "Monitor at component level."
• In the CRF, a new icon will appear to the right of the component row. This icon becomes active (clickable) when the subchapter is signed.

• Roles that are typically allowed to monitor (at the subchapter level) can also use this monitoring button per component. After clicking the icon, they will see the following screen:

• If a component has been monitored, the icon will be filled. If the icon is clicked again, the monitoring action can be undone. The screen will notify the user that they are undoing the monitoring. If a subchapter has the status "Monitored" or "Locked," monitoring at the component level can no longer be undone.

Important Points:

• If the data in a component is changed while it was being monitored, the monitoring for that component is automatically undone when the subchapter is saved.
• Component-level monitoring can be made mandatory in the basic properties of the component.
• A subchapter can only be set to the "Monitored" status if all mandatory components have been monitored. Hidden mandatory components are excluded from this check.
• A new task has been added to the Study Tasks overview: Components to Monitor. A row will show, for each patient and subchapter with the "Signed" status, the mandatory components that have not yet been monitored.

 

• Set which roles can delete a study

It is now possible to set which roles are allowed to delete a study. However, this can only be configured by a consultant. If this is desired, please contact your consultant or support@myresearchmanager.com.

• Reference history available

A new tab has been added to the history on Patient Details: Reference History. Here, you can see all changes to recurring subchapters related to references.

 

  Improved

• Column titles in the Excel export customizable

A new option has been added to the export settings: column titles. There are two options to choose from:

• Component ID
• Component title
• Export tag

By default, the component title is used as the column title, but with this setting, it is now possible to use the unique ID instead of the title as the column header.

Tip: You can export an Excel file with all components and their related settings, titles, options, and unique IDs via Management > Template > Export template. This way, you’ll have a handy key file at your disposal.

• Option to export data from a Multiple Answers component in two ways in an Excel file

Previously, data from Multiple Answers components was exported to Excel files as follows:

Study	Component title, export tag or ID	Answer 1	Answer 2	Answer 3
Test study For RL		1	0	1

In this example, answer options 1 and 3 were selected for the question.

For data analysis, it might be more convenient for the answers to not be split across multiple columns. Therefore, when setting up an export, there is now an option to export multiple answer components comma-separated in a single column. In this case, the above example would look as follows:

Study	Componenttitle, export tag or ID
Test study for RL	1; 3

The values of the answer options will then be displayed in the column with a semicolon between them. To view the descriptions of the answer options, you need to merge this file with the export of the template. It is not possible to export the descriptions comma-separated.

• Management – User and role adjustments

Application managers, module managers, user managers, and Assistant Scientific Officer have access to the 'Users and Roles' configuration page via Management. We’ve made a few changes to the user table:

• • The phone number column has been removed from the overview.
  • Filters have been added for the following columns: email, login method, status, 2FA, and studies.
  • The unique user ID now appears as the first column in the overview.

 

 Bug fixes:

• In the template export (via Management > Template Settings > Export Template), the "Chapter" column for recurring subchapters was not correctly filled. The subchapter title was shown instead of the chapter title. This issue has now been resolved.

• When a subchapter with open queries was set to the "Signed" status, the following occurred per role:

  • Data Manager: The task "Questions to be answered" was correctly displayed on the Project Tasks page.
  • Monitor: The task "Subchapter to Monitor" was incorrectly displayed, despite the subchapter not being ready for monitoring.

  Tasks for subchapters with open queries are now hidden for users with the Monitor role. Monitor users will no longer see the "Subchapter to Monitor" task for subchapters in the "Signed" status if there are open queries. This ensures that only valid tasks are displayed, preventing workflow disruptions and errors.