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Release Notes version 6.10 - EDC

  • Bijgewerkt

Dear reader,

ResearchManager's EDC will be updated to version 6.10. You can read here which functionalities have been added and which improvements have been made. If you have questions about the Release notes, we are happy to answer them. Please send us an email at support@myresearchmanager.com. 

 

stream-solid.svg  In short:

  • All changes to patient details are now clearly displayed in a new audit trail.
  • Lock the CRF template completely for changes after the study is activated? That's now possible with the new lock function.
  • "Frederik van Eeden", or "Eeden, Dr F.W. (Frederik)"? It is now possible to set how user names are formatted application-wide.
  • A clear overview of queries and subchapter statuses is made visible under Study Tasks. And, queries and comments can now be exported to Excel.
  • The speed of calculations and saving subchapters has been improved.
  • All exports now take into account the date format of components and the application's culture settings.
  • Building a CRF is made a little easier by improvements in the template views and because you can now search for components when setting conditions.
  • Bugs, nobody wants them so we fixed as many as we could!

plus-square-regular.svg  New:

  • Patient audit trail

A new audit trail has been added in the EDC showing everything related to the following changes and actions of/on patient data:

  • Field changed: Patient number
  • Field changed: Comments
  • Field changed: E-mail
  • Field changed: Registration date
  • Field changed: Notification
  • Field changed: Date of birth
  • Field changed: Site
  • Activated
  • Created
  • Deleted
  • Blocked
  • Randomised

The audit trail shows when and who performed the action and can be filtered by the date of the action, site, patient number, type of action and user. The audit trail can be found via: CRF > Audit Trail > Patients. Like the other audit trails, it can be exported to an Excel via the button at the top right of the table.

  • Lock the study template

A new setting has been added to 'General study information' that allows the study template to be completely locked after the study has been activated. If this setting is checked, the template can no longer be modified, even by setting the study to 'Under construction'. Only the application administrator can still unlock the template.

  • Format of user names to be set

It has been made possible to set the format of all user names in the module via the module settings. The following options can be selected:

  • First name prefixes surname (Example: Frederik van Eeden)
  • Title initials (first name) insertions surname (Example: Dr F.W. (Frederik) van Eeden)
  • Surname, title initials (first name) inserts (Example: Eeden, Dr F.W. (Frederik) van)
  • Surname, first name prefixes (Example: Eeden, Frederik van)
  • Initials prefixes surname (Example: F.W. van Eeden)
  • Surname prefixes, first name (Example: Eeden van, Frederik)

The format is maintained throughout the module.

  • Component ID is shown in the template

In the template, you now see a new column per component: the ID of the component. The ID of a component is always unique in the template. We show this ID in the template to make it a bit easier to refer to and search for certain components. The ID cannot be modified.

  • Export for queries and comments

It is now possible to export queries and comments on a component in CRF. This can be done via CRF > Export > Queries. On this page, filtering can be done by patients, subchapter status and query status. The export will then show the query number, the status of the query and the text in the query. The export also shows which component the query is for with the corresponding paragraph, subchapter and chapter.

  • Queries in any subchapter status, queries and subchapters in an overview

We changed the display of queries and statuses of subchapters. For this, 'Study dashboard' has been replaced with 'Study tasks', which can be found via Start. Here an overview is visualised with:

  • Queries per subchapter and patient including the status of the queries under 'Task'
  • Subchapters (starting from the status 'Completed') per patient including the status of the subchapter under 'Task'.

The different tasks consist of queries to be answered and queries answered, and subchapter to be signed, monitored and blocked. The 'Reference' column is displayed only if the study contains recurring subchapters a displays the reference of a recurring subchapter.

On this page, it is also possible to adjust the status of queries and subchapters. This can be done by changing the status in the last column. For subchapters, the status can also be adjusted by selecting a number and moving this selection to the next status with a click on the 'Change to next status' button.

When the action of a query is clicked in the right-hand column, the queries of this subchapter for this patient are opened in a pop-up. The number, component, component value (for numeric components, for example), status and history of the queries are visible here. Thereby, the query can be expanded to show changes to the query. On this page, the query can also be answered by clicking the text cloud in the line and closed when the query has been answered by clicking the lock icon in the line.

In addition, the CRF can be opened from here, so that it is immediately visible where in the CRF the query is located.

 

chart-line-solid.svg  Improved:

  • Speed of calculations and saving subcomponents

In the template, scores of answer options from single- and multiple-answer components can be calculated in calculation components. However, this calculation sometimes took longer than we wanted. We have therefore improved the speed of those calculations. In addition, saving CRF data in a subchapter has become significantly faster. We made a performance improvement for this.

  • Search for a component and clock icon visible when setting a condition

It is now possible to search for a component by typing text when you want to set a condition for a component. When you edit a component and go to the 'Conditions' tab, there is the 'Template Component' dropdown. Previously, you could only scroll and search, but now you can type and search for a specific title of one of the components. That saves time!

Additionally, there was no clock icon present when setting a condition on a date/time component with a format that includes the time. We have now added this clock icon so you can also set the condition on the time of this component.

  • Display of descriptions in the PDF printout of a CRF

Via CRF > Overview > Print, it is possible to create a PDF of the CRF. However, if descriptions were added to the component and it was chosen to show these descriptions in the PFD, they were not (clearly) visible in the PDF. This has been changed so that the description is now visible in the PDF. 

  • Date formats in Excel exports

Date fields are customizable based on culture. For example, the Netherlands may have a different date-time format than the United States. This is the default setting of the environment. Additionally, it is possible to choose a format for a date/time component. The result of a calculation component can also be a date and/or time in a specific format.

For Excel exports, these formats were not previously taken into account. A predetermined format was used when creating the export. We have now adjusted this. When an export is made, the cultural setting of the environment and the format of date/time components and calculations are taken into account.

  • Activities

For activities, we made some minor improvements. For instance, the activities overview per patient did not yet show an icon per activity in which the comments could be read, as in the activities overview per study or site. We have now added these. We also added the codes of a activity to the options in the activities filter, so that you can also filter on the code of a activity. It's not an extra filter, but the codes are listed before the activity name, so you can filter on both in the same filter. Also, filtering by workset in activities by selecting a workset at 'Use only the patients from the workset' did not work as we wanted, so we improved this.

 

bug-solid.svg  Bug fixes:

  • The status of references of recurring subchapters were not shown in the CRF overview, now they are shown.

  • When a patient was blocked, Self Service emails were still sent that, before the patient was blocked, had already been scheduled. If the patient opened the questionnaire, an error code was reported and the patient could not complete the questionnaire. It makes more sense to stop sending the mail when a patient is blocked, so we have now taken care of that. When a patient is blocked, the Self Service schedule is updated and the emails for the blocked patient are given the status 'Blocked by patient status'.
  • The 'Patient details' page of the CRF shows when and by which user the last change was made for the patient. The user's name was not updated when blocking a patient, only the date and time. This was shown correctly in the audit trail, but we have ensured that 'Patient details' always shows the correct user as well.
  • If a comment on a transaction had multiple lines, it was not shown as multiple lines in the export. This is now fixed; the export also shows multiple lines if the comment has multiple lines.
  • If a data view component is used to show a calculation with a date/time component, no data was shown if the outcome of this calculation was also a date and/or time; the component remained empty. This has been resolved, so that a date and/or time resulting from a calculation is also displayed in a data view component.