This article serves as a general single-source guide for Clinician users at the site/data entry and review levels who are new to Trialkit.
The objectives of this instruction include:
If you have been provided access to an existing study, you should have received an email from one of these addresses:
Be sure to check your inbox and spam/junk folder for this message and whitelist the addresses if necessary, as other notifications from the system may come from these.
That email contains a unique link to get signed in. Alternatively, you can find the website at trialkit.com or via the TrialKit mobile app on both the iOS app store and Google Play. From there use the Forgot Password link.
The Subject Manager is where subjects are registered in a study and where their records can be accessed. This is dependent upon your user permissions.
On the web:
Locate the Subject Manager under the Subject menu in the menu bar at the top of the screen.
On the app:
The Subject Manager is found in the bottom navigation panel, or by tapping "Access My Subjects" from the Home screen.
Once inside the Subject Manager, you will be able to register new subjects as shown below and access current subject casebooks by tapping on the subject ID.
Registering/Adding New Subjects
Depending on the study, subject IDs are either automatically generated or manually entered. This and the format of the profile ID will depend on how the study is configured. In this example, the system will auto-generate a new subject profile ID
Tap the button to add a new subject ID and open the registration form. The button may be titled differently for studies.
On the app:
Tap the add new subject button.
Once a new subject is created, The ID will display in the table. Tapping on the ID will open up the subject's casebook for entering additional forms.
If the registration form contains any errors, the subject's casebook cannot be opened. Errors must first be resolved on the registration form.
To re-open the initial registration form, tap the status icon on either the web browser or mobile app.
Read more here about navigating subject records.
Providing Access to Study Participants (Patients)
If the study is registering participants for accessing their own forms for data entry (ePRO), the registration form will contain a field on the form for collecting the Participant’s email address. When adding an email address, please make sure its an email owned by the Participant.
The system will run checks to verify the email address entered is NOT:
- Already another subject in the same study
- Already registered within TrialKit as a Clinician user
Collection of the patient/participant email address is necessary to give the Participant access to the system and send notifications on forms that become due.
TrialKit is HIPAA compliant and focuses heavily on data privacy. Email addresses entered are not attached to Participants' data and is blinded to other users in the study who do not need access. Each study should have its own privacy practices to properly enforce who is able to view the Participant email addresses.
Use of fictional or un-owned email addresses:
TrialKit's end user agreement requires that email addresses collected by the system have been given explicit consent by the address owner to be saved and used by Crucial Data Solutions solely for study related activities.
Crucial Data Solutions prohibits the use of fictional emails that are not owned by either the Participant or Sponsor. Email addresses that bounce or report spam will greatly impact the study’s ability to deliver email notifications effectively to all of its Participants.
Managing Your Queries
As data is entered on forms or as data is reviewed, queries may be opened. There are two types of queries: System queries and Manual queries. All of these can be seen and managed from the Queries Report - located in the Reports menu.
Once open, you will see a table like this containing links to the corresponding form where the query exists, options to view details, or comment on the query. Tap on the "Msg" column to open the query details and post comments or close the query, depending on user permissions.
Once open, you can choose between the different query types
The resulting list can be filtered further if needed via the filter icon at the upper right corner, or exported via the share link at the bottom right.
Tapping any row in the queries table will open the record where that query exists. Tapping the dialog icon on the right will open the query dialog for posting a message or closing the query (permission dependent).
Read more here to learn about query definitions and management
The Action Item report is helpful for Coordinators, Monitors, and Investigators to access a combined list of key action items that help drive the progress of data collection. It provides a listing of the following:
- Records missing - Visit window has passed
- Records with open queries or errors needing resolved
- Records where data was changed and reasons for change are pending
- Records awaiting review or eSignature
Users may see different items in this report depending on individual role and permissions
Access Action Items within the Reports menu on either the web browser or mobile app.
Within action items, select one of the available sections and then change to the desired site via the filter at tht top.
If using the Missing Forms section, like the example below, take note of the "Last Run" date indicated at the upper right. This will let you know if the report needs to be refreshed for an updated list, or if it's already been refreshed for the current day. This can take some time for higher-volume studies.