Site Overview in SMART-TRIAL is a place from where you can monitor and manage most of your data collection of a specific site. Site Overview gives you a great overview of the subjects' progress within the study. Each data event is represented by a colored square and an icon, indicating the current status of the data event.
The study overview is the same whether your study is in Test Study or Start Study (data collection mode). It’s from here you control your subjects. Every subject enrolled to the study has its own row, with its Subject ID, an Actions menu, where you can perform individual actions to each subject, and the Data Event Overview on the right side. See the following sections to learn how to use the different possibilities.
Subject ID may be replaced with Email or other forms of Subject identification depending on your study.
Data Event Status Indicators:
- 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 - Data event can be accessed and forms are "pending" to be answered. 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 - Data event was activated, fill out process began, but not all forms/questions were answered. 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'.
- Expired - When the data event is expired, it's 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 Amendment-mode, 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 prior to the changes.
- Missing data - Data event contains 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.
In the site overview information of subjects and data events can be displayed and hidden by applying filters.
Status filters - Can be used to filter subjects based on the status of enrolment, i.e., show only ongoing, discontinued, excluded, completed subjects, or a combination of any of these.
Display filters - Is used to make the site overview well-arranged, by adding/hiding information of status icons, subject attributes, and unscheduled events. In the drop-down you will find the following options:
Status icons - Answer not available, Lock, Open/Responded Query, Verification I & Verification II.
When selecting the status icons a maximum of four (4) icons can be selected at a time!
- Subject attributes - Subject ID, Name, Initials & E-mail.
- Unscheduled - Highlight Unscheduled Events