Summary

This article covers Setting Up the Scheduled Visits and Visit Cohorts

The Create or Edit Scheduled Subject Visits or Events allows Study Designers to create scheduled visit intervals per your defined protocol visit schedule. 

For multiple visit schedules in a single study, continue reading to the bottom.


The application is accessed from the Study Configuration menu, assuming the user has access to the corresponding Role Security Permission, Subject Record Page Design:


Website

Mobile App (Right side slide-out menu)


  
If this is your first study build, there is a pre-set example of a visit schedule already in place. You can begin by editing the current rows and then adding additional visits depending on the number of visits needed. The examples following are done via the mobile app:



Tapping on the header of any visit will allow for editing the parameters of that visit (all defined below). New visit intervals can be added via the "New Interval" button at the top.


Scheduled visit interval parameter Definitions:

  • Interval Name:  Name the Interval that will display in the subject records..
  • Time Post Treatment: Amount of time the interval will occur after the interval indicated in the "Relative to Which Visit" parameter.
  • Visit Time Unit: Unit of time measurement (Days or Hours) applicable to the Time post-treatment in column 2.
  • Low Range of Visit Window: Acceptable time window prior to the targe time from column 2.
  • High Range of Visit Window: Acceptable time window beyond the target time from column 2.
  • Relative to Interval: The Interval, which "Time Post Treatment", is calculated from. In other words, the dependency of the interval calculation.0
  • Visit Date Form: Any interval which is relative to the current interval will also need to know which form specifically to calculate off of.
  • Sequence: Set the order the Intervals display in Scheduled Visits/Event Forms Table. Note, visit date calculations work only moving forward through the sequence. On the mobile app, the sequence is set simply by tapping, holding, and dragging a visit column to a different location.


As the parameters are changed, there is a "Preview" option to see how that schedule looks in different scenarios. This is merely a quick testing function without needing to go into a test subject and enter data.


Other options:

  • Do not show date: Checking this box or indicating Yes will hide the date window for the corresponding visit. This is helpful in instances where a window is not applicable.
  • Included Forms: Forms that will be included and/or required in that particular interval.
  • Edit: Click Edit to edit any of the settings of that interval.
  • Delete: Click to delete the interval row.


Datatrak Direct offers two types of scheduled visit interfaces when users are viewing the subject records:

  • The Traditional Type is a grid of all scheduled visits and the forms that need completion within each visit interval.  
  • The Single Interval Selection drop-down is a grid by interval and creates a listing of forms only for the interval selected.  This is useful if you have many visits in an interval or huge amounts of data in many forms in a data-intensive study.  It is more efficient in the performance of the site to only show forms per interval.


Over the period of a study, if changes need to be made to the visits schedule, the best way to do this is by simply making edits to the current working version. Alternatively, a separate visit cohort can be created and subjects can then be moved to that new cohort as needed. When the Interval Name is updated in an existing Cohort, the name change will be applied to all intervals with an identical Interval Name assigned, across all Cohorts in the study.

 

Other Options at Web:

  • Scheduled Visit Interface Type: this allows users to set the view for the Scheduled Events screen in the Subject Manager at the Study level
  • Recreate Missed Visit Table: this allows users to assign updates to the Fixed Scheduled visits are applied to the Scheduled Visits screen at the Subject Manager 
  • Move Subjects: this allows users to assign mass Cohort changes across multiple Subjects at a selected Site

Need more help?

Please visit the Datatrak Contact Information page.