Navigating casebooks and accessing subjects' records
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 here to jump to the desired section:
Prerequisite: User has access to Subject Record Management permissions and access to view and edit forms.
Locate the Subject Manager under the Subject menu in the menu bar.
Once you selected the Subject Manager, a table will be shown with a list of information on subjects entered into the system. Here 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)
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.
The status icon to the left of each subject indicates the status of the Registration form for the the study. Tapping that will open the registration form itself. Tapping anywhere else on the row will open the entire casebook.
Tap and Hold! Tapping and holding for 1 second on any subject will open a popup of all the records saved. This works as a great shortcut to jump to a specific record under each subject.
Also take note, of the total CRF count on the right side of each card. This can be helpful in getting a quick view of progress.
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
Other things to know: (tap on each to learn more)
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 any icon to open the corresponding form within that visit.
- The icons displayed indicate the status of each record. Use the icon legend on the screen to help.
- As date windows lapse, the required forms in that visit will be counted as Missing.
- To quickly see what is missing or upcoming for all subjects at a given site, use the
Visit Summary Report described further down in this article.
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.
Using the Drop Dow View can be helpful on studies where a high volume of forms are collected on each subject. It allows records to load faster by only viewing one visit at a time.
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.
1. Tap the Unscheduled Visits tab at the top of the screen.
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.
Depending on the screen width, the top section can be scrolled to access the additional functions.
1. Tap the Log Forms option at the top.
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.
When saving log forms on the web, there are two options for saving:
- Normal Save will return the user back to the subject’s casebook to select another form - assuming no errors occurred when saving.
- “Save and New” will save the records and immediately open a new record - assuming no errors occurred when saving.
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.
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.
The "Starting" date listed in the info panel can have various meaning. This is defined by the Study Administrator. The Registration date is the date from the Registration form (the form that was filled out to create the subject). The Starting date is the date from some other defined form that dictates when the subject actually started or enrolled.
Opening the subject information window will display:
The subject’s pin - This is for ePRO studies only and is permission-dependent
The visit that the current record is part of
Starting date (this is the date from the registration form)
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 can be used to scroll through the sequence of forms.
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.
Visit Summary Report
The Visit Summary Report provides a single view of subjects visit status within a given site. This is helpful for Site users and Data Managers to see the following:
- Missing visits
- Visits in window where data entry has started but is not 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
Access to this report is based on permission to view the subject records page, and limits users to see only data for the sites they are a member of. It is accessible from the subject manager screen.
Once open, a series of counts display the number of visits in the categories described above.
Tapping on any of the numbers will expand the corresponding list below, where the subject schedule can be opened.
Data entry comprises of filling out a form either entirely or partially and tapping the Save button. On the web browser there is a Save button at both the top and the bottom of the form. Either can be used.
Data is not auto-saved. The save button must be used when adding or updating data on a 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.
The Save button is found at the top of the form.
Updating Data On A Form
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.
Mobile App: The flags will pop up directly on the form:
To provide reasons for multiple changes, tap the flag at the top of the form.