How Diary Schedules Work
Tip
This article expands on concepts initially covered in the article on configuring epro studies to build a full understanding of the flexibility in ePRO form deployment options. It's recommended to understand those fundamentals before reading this article.
Diaries are the recommended method for delivering surveys or forms to Participants as action items to complete. A diary schedule is simply a diary configuration consisting of one or more forms that need to be deployed to Participants at a specific time interval or on specific days of the week for a pre-defined period of time. For example, a survey that needs to be completed everyday for 7 days prior to the 1 month follow up visit interval.
How a diary schedule in a study is applied in a study:
Based on how a diary is configured, when the defined diary trigger date is saved for a Participant, TrialKit builds and stores the diary schedule(s) behind the scenes. This is a timeline table of all the forms that will need to be deployed to that specific Participant.
If a diary is triggered multiple times, it will be scheduled based off of the record with the most recent visit date.
If the subject is not a Participant user in TrialKit and a diary schedule is triggered to be built, the trigger form will receive an error. This is the system telling you it cannot build a schedule for a Participant that does not exist.
Viewing Diary schedules can be done at the subject level, for the whole site, or the entire study.
Diary Schedules For a Specific Subject
The diary schedules can be accessed within each subject's casebook.
Web Browser:
Mobile App:
Within this area, a specific diary can be selected above the table to view the corresponding schedule, if one exists for the current Participant.
As shown above, the purpose of this table is to display what is expected of a given diary schedule for that Participant and how well they have been keeping up with their form submissions over time (diary compliance)
Note: A diary schedule is different from an event schedule. Event schedules are intended for use in event follow up scenarios, where the "event" is something that the Participant will trigger at any time. Read more here about event schedules.
When the Diary Schedule is not Created
There are a few scenarios where the timeline cannot be built:
The diary frequency is set as zero, or always available.
The Participant's study exit form has been entered with a date that precedes the diary start.
The form that starts the diary is not yet known. For example, if a diary is set to start when a date on the screening form is saved, but that date has not yet been entered. This means TrialKit cannot build the timeline for that diary until that date is saved.
Diary Notifications
Since the diary schedules drive notifications that Participants receive, there is a helpful report to see which notifications are pending and sent across the whole study. If a Participant is missing many of their forms, it could be due to notification reminders not being received. This report will show if TrialKit has sent those notifications.
Access is dependent on user having permissions for eDiaries > Interval Diary Notifications Report and/or the Event Diary Notifications Report.
These reports are currently available via the mobile app under the Reports Menu.
Diary Compliance
Diary Schedules For All Subjects at a Site
This level is helpful for Site Staff to see which Participants at their own site are keeping up with planned diaries. It also allows for viewing upcoming expiration dates in the case that contact needs to be made to maintain compliance.
From the Subject Manger screen, the Diary Schedules for the current site can be accessed:
From the resulting report, an expiration value (hours) can optionally be entered to filter for all subjects that have diaries that will expire within the designated window. For example, entering “24” will display only the subjects/diaries that will be expiring within the next 24 hours.
TIP
Use the expiration filter to help stay in touch with Participants that appear to be falling behind
Diary Schedules For The Entire Study
A table of diary compliance can be viewed across the entire study, or by Site
Prerequisites
User must have permissions granted for access to eDiaries>eDiary compliance report
Web Browser:
Found under the Reports menu
Mobile App:
In this very simple example, a 1-day diary is scheduled for each subject. There are only 2 subjects in the study where one of them has completed the Day 1 diary within the expected window. Therefore, the compliance is at 50% for the study.
From the web, the same report can be exported with additional details about each diary interval and when it was completed.
The exported file includes the low and high window of each interval and the date that each form was completed. In this example below, one form is collected for 2-days. The date of completion in the last column also includes the record ID and status of the form (DateEntered | RecordID | RecordStatus )