This article serves as a general single-source guide for users at the data entry and review levels. The objectives of this instruction include:
Signing In
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.
Subject Management
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’s 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 the study design. In this example, the system will auto-generate a new subject profile ID.
TrialKit Web (Browser)
Follow these steps for the desktop or mobile app:
Select the link to generate a new profile ID (desktop). The mobile app will create the profile ID automatically by tapping "Add New Subject". To manually enter a subject ID, simply type it in the text box. Different studies may have this configured differently to prevent manual entry or omit the auto-generated link altogether.
Select the button/link to open the enrollment form.
On the app:
After completing the enrollment form, you can choose to return to the previous page where the subject enrollment table is displayed and shows all subjects enrolled.
Opening up a subject's casebook after enrollment is dependent on first completing the subject registration form. Only then can a subject be opened up for further access.
Managing Your Queries
As you enter subjects described above, at some point the sponsor may start to conduct monitoring and data management queries of your data entered in the eCRFs. The report called "My Queries Report" is the report to keep you informed on queries to you as a site or your comments back to the sponsor from the query deployed to you. It is one central location to manage all manual and auto queries deployed to your role's web browser:
Once open, you will see a page similar to the one shown below. Reference the annotations below the image.
Descriptions for the above image:
Link to the Subject's Records page
Link to the record where the query resides
The user who created the query or "Auto" if it was generated by the system
The number of messages residing on the query. Select this to open the query window and post query messages or close queries.
Text field to search for a specific subject - Must match the subject profile ID exactly.
Display only open or closed queries
Display only Automatic or Manual queries. Automatic queries are generated by the system based on edit checks or missing data.
Further filter the query status by Open-ATTN: Site, Open-ATTN: Monitor Closed, or Re-opened. Queries to the ATTN of the site are those created either by an Admin level role or by the system (e.g. form error). Queries to the ATTN of the Monitor are those to which the site level user has posted a response.
Display only Field, Form, or Interval queries
Display a specific date range of records (Note: this is not the date of the query)
Not visible to all users, depending on permissions - This will display all queries across the entire study regardless of which site(s) you belong to.
Mobile App:
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 a row 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).
Action Items
The Action Item report provides a listing of the following:
Records missing - Visit window has past
Records with open queries or errors needing resolved
Records where data was changed and reasons need to be provided for the data changes
Records awaiting review or signoff - This is dependent on user permissions and role
This report is particularly helpful for Site users, Monitors, and Investigators
Read more about Action Items here
For more detailed articles or help on other topics, use the help icon on the web or app, or bookmark help.trialkit.com