Create a report form

Reports can be used to register adverse events (AE) and also to record any other data which is not part of the main study protocol, for instance any unexpected hospital visits or emergency surgical procedure. Creating reports is almost the same as creating steps and forms - in the article below, you can learn about how to create a report structure.

Create a report structure

Navigate to the 'Structure' tab and then to 'Reports' to open the Reports structure editor. Click the '+ Add' button to create a new Report:

The 'Add a report' dialog window will open in which you can enter details about the report you will create:

Required - enter the report name
Required - select the relevant report type from the dropdown menu - Adverse Event, Event, Medication, Other, Repeated Measure and Unscheduled phase. The report type "repeated measure" may only consist of one step.
Optional - you can provide a short description of the report, if preferred.
Required - report naming strategy - allows you to specify how reports will be named. By default this is set to <Report Name> - <Date><Time> (for example, Adverse Event - 22-04-2021 13:12:11). It is also possible to choose generate reports based on the incremental number within study <Report Name> - <Incremental Number within Study> or within a record <Report Name> - <Incremental Number within Record>.
Allow manual editing of generated name - possibility to allow edit the report name during the data enty.

Once the fields are complete, click 'Create report' to return to the Form Editor. The new report will be displayed in the sidebar. To add steps to your report, click the '+ Add' button to create a new step in the report:

Add a step to the report by specifying its position, name and description - click 'Save' to save the step. The Repeated Measure reports can only have one step, so it is not possible to add another step.

Add fields to the report

When finished adding steps, navigate to the 'Form' tab to start adding the fields to your reports:

Select the 'Reports' sub-tab
Choose the report you created from the report dropdown
Select a step to which you want to add fields

You can now start adding fields to your new report, and you can try making a report button to enable quick access from your CRF to the report.

Adding a Repeated Measure field to a Step.

When adding a Repeated Measure Report to a step, it is possible to select custom variables to be displayed in the data entry view for an overview of the most relevant information in the reports. The selection of variables is optional - When no variables are selected, the report_created_date + the first 6 report variables are displayed in data entry by default.

Edit a report or report step

Once you have your report or report step(s) created you may need to make changes to any of the fields that you needed to fill out when you created them. Some examples are the name and the position of the step, or the report type.

To make changes to these fields, once again you need to use the cogwheel close to the name of the report or report step. This time you will select the option "Edit report" or "Edit step":

Introduce your changes and click "Save" when you are done.

Delete a report or report step

To delete a report or report step, click on the cogwheel next to the concerning report or step and select the option "Delete report" or "Delete step":

Next, enter the exact name of the report or report step in the confirmation pop-up that appears. Pay attention to the upper- and lower-case letters of the name: