Participant statuses

Modified on Thu, 15 Feb at 3:20 PM

Please note! You may not see all the data or have access to all functionalities. This depends on your role and permissions set by the administrator of your organization. If you miss essential data, please contact the administrator.


In the particpants overview, statuses can be assigned to participants. The overview below shows which statuses there are and how they can be changed. A status can change:

  1. Manually: selecting the icon below and choose an available status. 
  2. Automatically based on specific study configuration and triggers.

 


PreEnrolled 

When a participant is pre-registered without creating an account, the participation status becomes "PreEnrolled." This can be seen as a pre-registration step. 


 

Continued statuses

  • Invited: When the participant is finally registered (once an account is created), the status of this participant is set to "Invited" via process flow.  
  • NotEnrolled: When the registration is not completed and the participant drops out before they are registered at all, the status is set to "NotEnrolled" manually or via process flow.

 

Assigned through

  • Via import: This status can be set automatically when a participant is imported without an email address 
  • Via API: When a participant is registered via the API link without a mail address.

Invited 

This means that the participant has been invited or started participating but no screening has taken place yet or no consent has been given.  

 

Continued statuses

  • PreScreened: When the participant is notified and meets the inclusion criteria to participate, the status "PreScreened" is assigned via process flow. 
  • NotEnrolled: When the participant no longer wishes to participate or appears unavailable or doesn’t reply anymore, the status is set to "NotEnrolled" manually or via process flow. 
  • PreScreenFail: When the participant is notified and, based on data, does not meet the inclusion criteria, the status "PreScreenFail" is assigned manually or via process flow.

 

Assigned through

  • This status is set automatically after the registration of a participant where an account is created.

PreScreened 

This means that the participant has started participating and prescreening has taken place but no screening and consent visit has taken place.  

 

Continued statuses

  • Enrolled: When the participant has been prescreened and accepted the consent, the status is set to “Enrolled”. The participant is now participating in the study. This state is set automatically via process flow. 
  • PreScreenFail: When the participant is notified and, based on data, does not meet the inclusion criteria, the status "PreScreenFail" is assigned manually or via process flow.

 

Assigned through

  • This status is set manually or automatically via process flow.

NotEnrolled  

This means that the participant before the screening appointment no longer wishes to participate, appears unavailable or does not reply anymore.

 

Continued statuses

  • Invited: If it still appears that the participant wants to join, they can be returned to the process and manually set to "Invited." 

 

Assigned through

  • This status is set manually or via process flow.

PreScreenfail  

This means that there has been contact with the participant and he/she doesn’t meet the inclusion criteria.

 

Continued statuses

  • Invited: When the state was changed by mistake or the inclusion criteria changed, then the user can continue to the previous state and start the flow. This is done manually.
  • PreScreened: When the state was changed by mistake or the inclusion criteria changed, then the user can continue to the previous state and start the flow. This is done manually.

 

Assigned through

  • This status is set manually or via process flow.

Enrolled 

Once a participant has been prescreened and accepted the consent, the status is set to “Enrolled”. The participant is now participating in the study. 

 

Continued statuses

  • Completed: When the study is completed for the participant, the participant has completed the protocol. The participant has completed the study. This state is set automatically by the process flow.
  • ScreenFail: When the participant has been wrongly included (based on inclusion criteria), then the state is set manually set to “ScreenFail”.
  • Paused: When the participant wishes to temporarily pause participation, the state can be set to “Paused”. 
  • DropOut: If the participant is no longer allowed/able to participate for any reason (not responding etc), the status can be manually set to “DropOut”.
  • Withdrawn: If the participant wants to quit early, they will be given the “Withdrawn” status.

 

Assigned through

  • This status is set automatically by process flow.

Completed 

This means the participant completed the study and has finished the participation.

 

 

Continued statuses

N.A.

 

Assigned through

  • This status is set automatically by process flow.

ScreenFail 

Once a participant has been enrolled, but it appears it was wrongly done, then the state is set to “ScreenFail”. 

 

Continued statuses

  • Enrolled: When the participant has been wrongly set to “ScreenFail”, then the state is set manually back to “Enrolled”.

 

Assigned through

  • This status is set manually.

Paused

This means the participant wishes to temporarily pause participation. This state is temporarily, when the participant resumes participation, the state can be set back to “Enrolled”.

 

Continued statuses

  • Enrolled: When the participant resume participating, then the state is set manually back to “Enrolled”.

 

Assigned through

  • This status is set manually.

DropOut 

This means the participant is no longer allowed/able to participate for any reason (not responding etc).


 

Continued statuses

  • Enrolled: When the participant has been incorrectly  set to “DropOut”, then the state is set manually back to “Enrolled”.

 

Assigned through

  • This status is set manually.

Withdrawn

This means the participant wants to quit early.


 

Continued statuses

  • Enrolled: When the participant has been wrongly set to “Withdrawn”, then the state is set manually back to “Enrolled”.

 

Assigned through

  • This status is set manually but does trigger a flow (questionnaire).
Please note! You may not see all the data or have access to all functionalities. This depends on your role and permissions set by the administrator of your organization. If you miss essential data, please contact the administrator.


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