Clicking on the “Participants“ tab directs the user to a list of study participants.

Users can also be search for using the search bar at the top of the page. Users can be searched by their Subject ID, Status, or Group Name.

Selecting “+ Add Participant“ opens the form to create a new participant. Required fields are marked with “*”.

Selecting the edit icon for an existing participant opens the same form but with the information populated from the existing participant.

After adding the subject ID and selecting a group, select “Next“ to go to the next page to create the participant schedule. A pop-up window will ask you to confirm the changes. Select “Yes“ to continue.

Selecting a time field allows the option to set the participant schedule for wake time, sleep time, and preferred time for each day of the week. The times selected for a participant can be used to set their survey times, events, assessments, and offsetting their surveys as related to these times.

Participant wake time is a time the participant has indicated in which they usually wake up.

Participant sleep time is a time the participant has indicated in which they usually go to sleep (should not be later than 11:30 PM).

Participant preferred time is a time indicated by the participant in which they prefer to receive an assessment.

The default time values for new participants are wake time of 7:00 am, sleep time of 10:00 pm, and preferred time of 6:00 pm.

When all of the times have been set for the participant, select “Next“ to continue to the PHI page (only for studies that collect PHI). An additional pop-up window will ask to confirm the changes. Select “Yes“ to continue.

Please note PHI fields can be piped into assessments and tailored messages. Additional information can be viewed here https://mhealthotrc.atlassian.net/wiki/spaces/EDCW/pages/2313388035/Useful+EDC+Formulas#Display-PHI-information.

Registration Code Form - When the participant installs and opens the application, the app will generate a registration code that will need to be entered into the “Registration Code” field as shown below. The code will be a series of letters without any special characters.

Please note the participant can be created in the EDC without the registration code, but the participant will not be able to start the study on their phone until their unique code is entered here.

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Selecting “Done“ and selecting “Yes“ saves all of the updated information for the participant.

To view the participant activity, click on the view icon next to the participant.

A list of assessments appears with component time(s) which indicate when an assessment is scheduled to alert the participant, start time(s) which indicate when the participant started the assessment, completion time(s) which indicate when the participant completed the assessment, and the response count(s) which indicate how many questions were recorded from the participant for that specific assessment.

If the start and completed times are blank, it could be that the components are scheduled for a future time.

When viewing the participant’s activity log, the research team has the option to change the timezone. By default, the participant activity will be ”Participant Local Time.” The other two options available are UTC (which shows the time as per the Coordinated Universal Time) and your local time.

Insight is only able to schedule less than or equal to 64 events at any one time. Events that are included in the total are Random, Fixed, Offset, and Rescheduled Events. Please note, the number of days Insight schedules out for is subject to the study design and is in no way a one design fits all approach.

For Example:

Day 1

• Number of
  Fixed Component: 1 (x2 reschedule) = 3

• Number of
  Random Component: 2 (x2 reschedule) = 6

• Number of
  Participant Offset Component: 2 (x2 reschedule) = 6

Total Number of Events for Day 1 = 15

Number of days Insight EDC will schedule out: 4 Days = 60 Total Events (if scheduling is consistent for each day of the week)

Another Example:

Day 1

• Number of
  Fixed Component: 3 (x3 reschedule) = 12

• Number of
  Random Component: 2 (x3 reschedule) = 8

• Number of
  Participant Offset Component: 2 (x3 reschedule) = 8

Total Number of Events for Day 1 = 28

Number of days Insight EDC will schedule out: 2 Days = 56 Total Events (if scheduling is consistent for each day of the week).Below the Activity view for the participant is the stages view. Clicking on it will expand the participant’s transition from stage to stage, detailing when they have started a stage and when it has or will end. The default timezone is the user’s timezone and can be changed to the participant’s time zone or UTC.

Notifications will look similar to the following: