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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.
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