Studies in SMART-TRIAL

To design a study that makes it easy for both the staff and subjects to navigate, take a look around these pages and see how to design a study in SMART-TRIAL. In SMART-TRIAL you can create as many studies as you want. Your studies, and the studies you are collaborating on, will be shown under the Studies overview which is the first you see upon login. Here you can see the names and the current status of the studies.

What is a study status?

In SMART-TRIAL the status of the study determines what can be done in the study. 

A study is split into two parts: The study structure (made during study setup) and the data collection.

The study setup includes; forms, processes, and the choice of site(s) etc., whereas the data collection, is data gathering and the consecutive data management. 

Throughout the process of conducting clinical data collection in SMART-TRIAL, your study may obtain the following statuses:

  • Building - Study in building mode allows you to create and manage forms, processes, sites, add study translations, modify study information, etc., but you cannot collect data nor manage subjects. 


  • Testing - Can only be accessed from building-mode. Test-mode allows you to test your study setup with up to 5 fictive subjects, to ensure your forms and processes work the way you intended them to. In test-mode you are not allowed to alter the study structure, to make changes you have to return to building-mode. To see more, please go to our Test Study article.


  • Collecting Data - Once your study has been validated and it has been started, the status changes to “collecting data”, which is visualised by a change in color, from grey to orange. The features for patient enrolment and data collection are now available. In this mode, you are unable to alter the structure of the study, but you are still allowed to change the text of e.g. the questions in the forms. 
    To see more, please go to our Start Study article. 


  • Amendment - The status of the study can be changed to amendment-mode, to alter the structure of an ongoing study including; adding or removing questions in forms and alter text. 

    In amendment-mode you cannot:

    • Collect data.
    • Manage subjects.
    • Alter the processes. You can however create a new process
    • Add/remove or change order of data events, if a subject has been enrolled in the process.
    • Add or remove show rules to question that has been used to collect data.
    • Alter question type nor show rules if form has been used to collect data.
    To see more, please go to our Study Amendment article.


  • Completed - When the study is completed, the color of the platform turns green and you are no longer able to:
    • Alter the structure of the study.
    • Manage subjects.
    • Collect data.
    • Alter the data.

    At this point, you are only allowed to export and monitoring the data. To see more, please go to our End Study article.
     

     

  • Locked - It is possible to inactivate the study, if you want to keep it, but no one should be allowed to make changes. This can only be done by SMART-TRIAL personnel.


  • Deleted - It is possible to delete your study if desired, but you should be aware that it cannot be restored. To see more, please go to our Delete Study article.