Data Event in SMART-TRIAL

Data events are points in time where you want to collect data during your study, using the forms you have created. Data events can be answered by your subjects or data entry staff, depending on the selected event type. 

All data events in your study will appear in your site overview from where you can see the status for each of the different data events. Read about how to use and manage site overview in our Site Overview article. 

In SMART-TRIAL there are three different data event types, each one suitable for different data gathering events. The three types are:

If you have multiple visits in your study, use multiple data events! A data event for each visit will make it easier for you to get an overview of each of your subject's progress in the study. 

What is data event status?

  • Inactive - Inactive is the status prior to activation, the data event cannot collect data in the current state. How the data event is activated is selected when the particular data event is added to the process. 

  • Activated - The data event can be accessed and is available for data collection. When the data event is activated it is possible to "lock" the data event, in this mode you are not allowed to alter data in the data event. This includes responding to queries. To see how to lock/unlock data events, go to our Lock/Unlock Data Event article.

  • Incomplete - A data event can contain both mandatory and optional questions. If some data has been collected but not all mandatory questions are answered the data event will be 'incomplete'. If incomplete data events are accessed and already saved data is changed, you will be required to state a reason for the change.

  • Expired - When the data event is expired, it is no longer possible to collect data for that particular data event, but if you have the right permissions, you are still allowed to edit the collected data. When the data event is generated the expiring settings can be selected to be either never expiring or a specific duration of time before expiring. 

  • Completed - This status is achieved when all mandatory questions have been answered.
  • Canceled - A data event gets the canceled status if the subject is discontinued or data gathering is initiated in a data event later in the process, allow the user to select "cancel previously unused data event".

  • Excluded - When the patient does not meet the inclusion or exclusion criteria, resulting in exclusion from the study.

  • Missing data - Additional questions can be added in an ongoing study, in such cases, the particular data event containing the new question will have the status "missing data" for all subject who has already answered a form.

 Additional Markings: 

  • Missing data - Data event contains a form(s) with missing data due to answer marked as not available.

  • Locked - Data event has been locked and can no longer have its answers changed (requires special permission to lock/unlock).

  • Verification I - Verification I is a tool that allows monitors, sponsors, or data managers to mark data as verified. The images below illustrate that the data events are partially and fully verified, respectively.

  • Verification II - Verification II is a tool that allows monitors, sponsors, or data managers to mark data as verified. The images below illustrate that the data events are partially and fully verified, respectively.

  • Query - Query icon is shown on data events in the site overview if the data events contain an open or responded query. Queries can be used by investigators and monitors to raise queries to the data collected, by the data entry staff, in case of the monitors finding something strange, peculiar, or missing values/answers.