Overview
Certain users (such as PIs) are exposed to subject Lab Test results via Study > Lab Data, Study > Data, and applicable reports. This creates issues with eliminating bias and meeting blinding requirements of certain trials, since some users may be able to gain insight into which subjects were dosed with the study drug based on certain test results. The Clinic requires a way to blind the results from everyone except specified user roles (for example, an unblinded physician).
Where are the Lab Results Blinded?
The Lab Results will be blinded in the following areas:
Study > Lab Data - this includes viewing, reviewing, comparing actions, review history, audits and export. The blinded users will not be able to perform the review action on the blinded results.
Study > Data - this includes viewing and exporting of this data.
Manage > Volunteers > Volunteer Profile > Studies tab > Lab Data - this includes viewing and export.
Where are the Lab Results not Blinded?
Lab > Orders > Specimens area
Study > Reports (requirement gathering and implementation in progress)
Dashboards (requirement gathering and implementation in progress)
What Setup is required to blind Lab Results?
Role Setup
If you wish to blind the Lab Tests, you will need to determine a User Role that can access the blinded Lab Results. This can be achieved in several ways, for example:
use one of your existing Roles
create a dedicated Role for unblinded users, for example “Unblinded User”, “Unblinded to Lab Results” or similar
create Roles that are blinded and Roles that are unblinded, for example, “Blinded PI” vs “Unblinded PI”
Assign the Role to the users who will be unblinded to the Lab Results and then use the unblinded Role in the next step.
Lab Test Setup
The second step is to use the created Roles to restrict the user access to the Lab Tests on a specific Study. You can do this when the desired Study is selected.
Go to the Lab > Configure module.
For each desired Test, select the Actions menu > Edit:
Then in the popup window, select the “unblinded” Role from the list and click “Save”:
The Role will become visible in the “Role” column:
The users with this unblinded Role will be able to view the blinded Lab Results and review them. All other users will be blinded to these Lab Results and will not be able to review them.
The rest of the setup remains the same - the blinded Tests within a Panel can be associated with Forms for Sample collection. The Forms can be collected by any authorized user. The Lab Orders can also be created as usual. The difference is visible once the Lab results come back from the Lab.
How does the blinded data look?
For blinded results, when an unblinded user is viewing them, they will appear as usual and they will be available for review.
Wherever a blinded user is able to view lab test data, the following information will be replaced with the text **blinded**:
Resulted Value
Alerts
Clinical Significance
Review Notes and History
Repeat
Updating the blinding settings
The blinding settings can be updated, even after the Study starts.
You can update the access to Test Results in the Lab > Configure area, but this will only affect the Lab Results that have not yet come back from the Lab.
If you need to update the access to Test Results that had already been resulted, you can do this via Labs > Orders > Specimen area.
If you wish to unblind all Lab Test Results once the Study had been completed, you may also chose the most convenient way of implementing that, for example:
use the above method to unblind Lab Results by removing the Role restriction from the Labs > Orders > Specimen area
assign the “unblinded” Role to all the relevant users
Does a Blinded User have to be Blinded for all Studies?
Using the Study > Configure > User Access option, a user can be defined as blinded or unblinded on a per Study basis.
For example, if a PI has both - “Blinded PI” and “Unblinded PI” - Roles assigned to them in their User Role list. The PI can be blinded for Study A, if they are added to it with their “blinded” Role and unblinded to Study B, if they are added with their “blinded” Role.