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Participant Info |
Clicking on the “Participants“ tab directs the user to a list
of existing Study Participants.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
Participantparticipant. Required fields are marked with “*”.
Selecting
“Edit“the edit icon for an existing
Participantparticipant opens the same form but with the information populated from the existing
Participantparticipant.
After adding the
Participantsubject ID and selecting a
Groupgroup, select
“Next““Next“ to go to the next page to create the
Participant Scheduleparticipant schedule. A pop-up window will ask you to confirm the changes. Select “Yes“ to continue.
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It is imperative that the participant'sSleep Timesleep time is NOT set past 11:30 pm. ASleep Timesleep time beyond 11:30 pm will interfere with the assessment schedule. |
Selecting a
Time Fieldtime field allows the option to set the
Participant Schedule for Wake Time, Sleep Time, and Preferred Timeparticipant schedule for wake time, sleep time, and preferred time for each day of the week. The times selected for a
Participantparticipant can be used to set their survey times, events, assessments, and offsetting their surveys as related to these times.
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Wake Time |
Participant
Wakewake time is a time the participant has indicated in which they usually wake up.
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Sleep Time |
Participant
Sleepsleep time is a time the participant has indicated in which they usually go to sleep (should not be later than 11:30 PM).
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Preferred Time |
Participant
Preferred Timepreferred time is a time indicated by the participant in which they prefer to receive an assessment.
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The Participant Schedule form uses a 12-hour time format. |
The default time values for new participants are
Wake Time 07:00 (wake time of 7:00 am
), Sleep Time 22:00 (, sleep time of 10:00 pm
), and
Preferred Time 18:00 (preferred time of 6:00 pm
).
When all of the times have been set for the
Participantparticipant, select “Next“ to continue to the PHI page (only for
Studiesstudies that collect PHI). An additional pop-up window will ask to confirm the changes. Select
“Yes““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 Coderegistration 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 Coderegistration code, but the participant will not be able to start the
Studystudy on their phone until their unique code is entered here.
Selecting “Done“ and selecting “Yes“ saves all of the updated information for the
Participantparticipant.
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Participant Activity |
When viewing the participant’s activity log, the Research Team has the option to change the timezone. By default, the Participant Activity will be” Your Local Time” which is the Research Team timezone. The other two options available are UTC (which shows the time as per the Coordinated Universal Time) and Participant Local Time (which shows the activity according to the timezone for that participant for that activity).
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Activity |
To view the participant activity, click on the
“View” buttonview icon next to the participant.
A list of assessments appears with
schedulecomponent 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.
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Notification Limit |
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 SchedulesComponent: 1 (x2 Reschedulereschedule) = 3Number of
Random SchedulesComponent: 2 (x2 Reschedulereschedule) = 6Number of
Participant Offset Component: 2 (x2 Reschedulereschedule) = 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 SchedulesComponent: 3 (x3 Reschedulereschedule) = 12Number of
Random SchedulesComponent: 2 (x3 Reschedulereschedule) = 8Number of
Participant Offset Component: 2 (x3 Reschedulereschedule) = 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 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:
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Stages |
The participant’s stages tab includes a variety of helpful information such as details when a stage starts/ends, the number of scheduled events, the number of participant initiated attempts, and the amount of scheduled events.
For Time Based stages, the End Date will calculate when the participant will leave the stage they are in. For example, if a Stage is set to last 5 days and a participant enters the Stage on 09/
1018/2023. The stage’s
EndDateEnd Date will calculate to 09/
1523/2023.
For
FormulaBasedFormula Based stages, the
EndDate will default to 1/1/0001 12:00:00AM. This will stay this way until the formula for the stage is fulfilledEnd Date will be blank until the condition is met. For example, if a Stage is set to end when the variable [Begin] == 1 . This occurs when the participant answers the [Begin] variable with the answer that is valued at 1, then the Stage
EndDateEnd Date will update to
the currentthat date and time the condition was met.
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Participation |
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In order to see participant progress in this section, a percentage payment log needs to be set up. Additional information on how to set this log up can be found here: ➡️https://mhealthotrc.atlassian.net/wiki/spaces/EDCW/pages/2339405825/Payments+-+Percentage#Percentage-Payment⬅️ |
Depending on the
schedulecomponent(s) included in the
Percentage Payment Scheme applied to this participantpercentage payment scheme, the
Participationparticipation tab will show the participant’s progress in the study stage by calculating the percentage of
how many of the requisite events scheduled werecomponents completed over
thetotal
requisite eventscomponents scheduled thus far.
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Uploaded Photos |
Uploaded photos from the photo picker question type will be found under the “Uploaded Photos” tab when viewing a participant.
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Payments |
The participant payments tab will identify payments that have been created and/or paid to the participant.
Manual payments can also be created for the participant by clicking on the “Create manual payment” button in the participant’s payment dropdown.
After clicking the button, enter the amount to be paid and click the “Send Payment” button.
After creating the payment, the payment will appear under the payment dropdown.
To manually mark as paid, click the checkbox icon.
The previous status of payments can be viewed by clicking on the expand icon (+) under payments.
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