Subject Casebooks

Accessing Participants Records and Navigating Casebooks

The Subject Manager is the most common location for data entry within TrialKit. It is where study participants are registered within a study and where existing subject casebooks can be accessed for data entry and review. Use the links below to jump to each section.

Subject Manager

Subject Search and Loading Speed

Subject Progress Chart

Summary of Record Review Progress

Subject Casebook Navigation

Site Summary Report

Data Entry

Viewing A Form's Errors

Flagged Reasons For Change

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Subject Manager

Locate the Subject Manager under the Subject menu in the menu bar.  

Web Browser:

It can also be accessed via the button at the top of the screen, or from the study home screen:

Once you selected the Subject Manager, a table will be shown with a list of information on subjects entered into the system. From this table subjects can be accessed and new subjects can be registered at the current selected site. If only one site is available, there will not be an option to select a site at the top of the table. Read more here about registering new subjects.

Mobile App:

From the main home screen tap the Access My Subjects button at the top, or the Subject tab in the navigation bar at the bottom.

From here select a site (if applicable), and tap on any subject to open the casebook. 

 

Subject Search and Loading Speed

Use the search box above the subject listing to quickly search for a specific subject ID. This will get retained on a per user basis until it's cleared or changed.

Mobile app:

 

Web browser:

On the web, you can also use the universal search to quickly jump to a subject's casebook (requires full ID). If only a partial ID is entered, it will filter the subject manager list of IDs for matches.

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Subject Progress Chart

The Subject Manager screen displays a helpful overview of the progress of each subject. This is represented as a percentage of how many required forms have been completed by the subject. The logic is as follows:

• Total number of saved records with no open system queries / Total number of required forms across all scheduled visits 

The web browser also displays a percentage of the number of forms that have been reviewed by at least one review level. The formula is as follows:

• Number of records with at least one review level / Total number of saved records.

This progress bar can then be tapped for additional details about the review levels (continue reading).

 

The mobile app displays one metric related to the number of completed visits. 

 

Summary of Review Progress

When the subject progress bar is tapped on the web browser, it opens additional details related to the progress/status of that subject. This further breaks down the review levels component to show a history of review progress for each review level as shown below.

 

Tapping on the the mobile app will also open a more detailed view displaying the current status of each of the review levels - in other words, as level 2 review rises, level 1 will decrease as shown below.

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Subject Casebook Navigation

Once a subject has been opened, there are are three types of forms that can be accessed depending on the requirements of the study:

• Scheduled Forms - Scheduled visits based on protocol-defined data windows.
• Unscheduled Forms - Visits that can be entered at any time where a pre-defined set of forms can be added within each visit.
• Log Forms - Individual forms that can be entered at any time in repetition.
• Event Schedules - For ePRO studies only. This displays triggered events that have occurred for the current subject.

Other things to know (tap on each to learn more):

• Longitudinal List of Records
• Viewing Current Subject Summary Information
• Navigating Between Forms
• Data Entry

Scheduled Visits

When a subject is opened, the default view will be the scheduled visits. Reference the image below for the meaning of the various areas on the screen.

1. Tap the Scheduled Events tab at the top of the screen if it's not already selected.

2. Reference the expected visit window for the visit. This shows the low and high range acceptable (visit window). Sometimes this can be blank or "TBD" based on study design. 

3. Tap on a form's status icon to open the corresponding form within that visit.

Changing View Preference

Some visit schedules are bigger than others. The table shown above is scrollable, but can also be switched to a 'Dropdown' view of one visit at a time for a more focused perspective. Do this by selecting "Switch to Drop Down View" as shown below.

Some studies may be configured to default to the dropdown view for all users.

Web Browser:

Mobile App:

An added function in the mobile app is the ability to quickly jump to another site or subject at the top without returning to the subject manager list.

Unscheduled Visits

1. Tap the Unscheduled Visits tab at the top of the screen.

Web Browser:

2. Add a new event by entering and saving a new date.

3. Select a form from the dropdown list and select Add New Form to open and fill it out.  Once the form is saved it will display on the right side of that visit.

Mobile App:

Depending on the screen width, the top section can be scrolled to access the additional functions.

Log Forms

Web Browser:

1. Tap the Log Forms option at the top of the casebook

2. Add a new form by using the button under the desired table where a new record is needed.

3. Tap any existing status icon in the table(s) to open the corresponding existing record.

4. "Rec ID" is the unique ID of each record. Note, this may be different from the log number built into a form.

Mobile App:

After saving, each record will populate the Log table. 

 

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Event Schedules

Events are specific to ePRO studies where participants individually trigger a schedule of data collection that must occur. The Event schedule report displays those events and which forms within each interval have been completed.

To access the report within a subject's casebook, tap the "Events" button as shown below.

Web browser:

Mobile App:

This opens up a list of events that have occurred based on a chosen trigger. The trigger can be selected at the top of the report to open the corresponding events. 

 

Each event in the list can then be tapped to open the intervals and forms that were completed in each event.

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Longitudinal List of Records

This is merely a list of all the records saved under the current subject to-date, in date order. It's an alternative way to see all records in one view.

This is also a handy place to export PDFs of individual records or delete forms - based on permissions granted.

Web Browser:

Current Subject Information

When a subject's casebook is open, the current subject ID and other summary information can be seen at the right side of the screen (web browser).

With a specific form open, additional details will display such as the current visit. This serves as easy reference during data entry or review to verify you are in the correct subject's records.

Web Browser:

 

Mobile App:

Opening the subject information window will display:

• The subject’s pin - This is for ePRO studies only and is permission-dependent

• The visit ti which the current record belongs

• Site name

• Starting date (this is the date from the registration form)

• Study version

• Visit Schedule cohort (if applicable)

Navigating Between Records and Accessing Forms

When a form is open either for data entry or review, there are a couple of options to jump to other forms within the current subject. 

1. Return back to the visit schedule with the quick-link at the right side of the screen (Web Browser only). If the form was opened from some other location like the Action Items or Queries Report, this link will return you to that location without the need to manually navigate back to where you were.

 

2. The arrows at the top of the form, regarded as the "Record Index" can be used to scroll through the list of existing records in date order. This is an alternative to navigating back to the visit grid/casebook to select the next desired form.

3. The Index list popup will open a list of all forms to quickly select one by tapping on an icon. The current form is highlighted.

4. To return all the way back to the list of subjects, use the main menu.

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 Site Summary Report

The Site Summary Report provides a comprehensive listing of the progress at each site.

Once open, a series of counts display the number of visits in various categories. Tapping on any of the numbers will expand the corresponding list. Tap on any subject ID to drill into that subject.

The following information is provided in the report:

• List of subjects and the progress of each subject:
  • Number of required forms saved without errors / Total required unhidden forms within scheduled visits. If study exit occurs within a visit date window, that visit and all later visits will not be counted.
  • Number of records reviewed at each level
• Number of visits that are missing, counted based on at least one missing form in the visit

• Visits that are currently in window where data entry has started but not yet complete
• Visits in window where all required forms have been completed
• Visits in window where no required forms have yet been entered
• Visits upcoming within the next 30 days

The upper right corner of the screen also gives quick access to a couple other related reports:

• Dashboard Report
• Subject Visit Report download - for a detailed list of each visit across all subjects:

Column summary	Column header	Data type	Description
Site ID	site_id	Number	Internal System site ID
Site Name	site	Text	Site Name from Site Manager
Subject ID	subject	Text	External Subject Profile ID
System Subject ID	sub_id	Number	Internal System Subject ID
Visit Name	visit	Text	External visit name
Visit Interval sequence	int_seq	Number	Visit sequence defined in visit schedule setup
Visit Interval ID	int_id	Number	Unique system ID for each visit within each cohort
Cohort ID	coh_id	Number	System cohort ID
Cohort Name	cohort	Text	Cohort Name
Target Visit Date	visit_interval_date	Date/time	Date defined in visit setup as the time “post treatment”
Visit window low date	low_window	Date/time	Low date boundary for the corresponding visit/subject
Visit window high date	high_window	Date/time	High date boundary for the corresponding visit/subject
Visit Status	status	Text	Complete/Incomplete based on the required forms in each visit being entered with a status of complete without errors or reviewed. This is automatically “Complete” for Hidden visits, or "Exited" for visits that are past the study Exit date (low window is after the exit date)
Number of Missing forms	number_missing	Number	Forms which are not entered, visit window is passed, and have not been flagged as Not missing via the action item report (scheduled visit forms only) If status is exited, then all the form counts will be 0 and the visit_started, visit_missed, and visit_missed columns will be false
Number of entered incomplete forms	number_incomplete	Number	Forms containing open queries - Only required forms within scheduled visits
Number of forms not yet entered	number_pending	Number	Forms which are both not yet entered and not yet due - Only required forms within scheduled visits
Visit Missed	visit_missed	Text	True/False - Visit window is passed, visit status is incomplete (at least one required form not entered in completion)
Visit In Window and awaiting data	visit_waiting	Text	True/False - Visit is currently in window with no forms entered. This is always false if the visit is hidden/not-applicable.
Visit In Window and started	visit_started	Text	True/False - Visit is currently in window with at least one required form entered, but visit status is not yet completed. This is always false if the visit is hidden/not-applicable.
Visit upcoming in 30 days or less	visit_upcoming	Text	True/False - Visit has an approaching low window date within the next 30 days. This includes hidden visits.
number expected	number_expected	Number	number of non hidden required forms for an interval
number complete	number_complete	Number	number of saved forms
percent complete	percent_complete	Number	Division of the previous two colums

 

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Data Entry

Data entry involves filling out a form either entirely or partially and tapping the Save button. 

During form completion, some fields may be inactive or hidden due to conditions designed by the study Administrator. If questions arise about data entry rules or form behavior, please contact your study Manager.

Form tabs/pages

Some forms may be designed with multiple pages or "tabs". This helps to visually break up different parts of the same form into smaller sections. If a form has errors and you don't see them on the current page, be sure to check other pages that might exist.

Tabbing across fields (Keyboard shortcuts)

On the web, the tab key on a keyboard can be used to move from one field to the next. The order is from left to right and then down the page.

The enter key will cause the for to get saved (for users that have edit permissions).

Saving Data

Web Browser:

The save button is located at both the top and the bottom of the form. Either can be used. The enter key will also save the form.

'Save Final' merely means that the date will be saved and edit checks will be run for any errors. You can always return later to correct the resulting errors or resave with changes.

 

Mobile App:

The Save button is accessible at the top of the form.

Viewing A Form's Errors

When a form gets saved, there is a popup window listing the errors. After closing the window, the errors can be seen on the form by red query icons next to the corresponding field(s).

For large forms where it is more difficult to locate the errors, the list of errors can be opened using the form's toolbar. Within the list, tapping any error will close the window and take you to that field on the form:

Web browser:

Mobile app:

Updating Data On A Form - Flagged Reasons For Change

When changing data and resaving, the system will prompt for reasons for changing data. It's best to provide this immediately. If not, the form will remain flagged until reasons are provided.

 

Web Browser:

Mobile App:

The flags will pop up directly on the form during data entry as shown below.

To provide reasons for multiple changes, tap the flag at the top of the form.

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