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).
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Lab > Orders > Specimens area
Study > Reports (Work In Progressrequirement gathering and implementation in progress)
Dashboards (Work In Progressrequirement 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,
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For example, you may consider creating two different PI Roles:
Blinded PI
Unblinded PI
The Role Actions for both Roles can be identical.
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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.
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If you need to update the access to Test Results that had already been resulted, you can do this via Labs > Orders > Specimen area. Additional details for after the study is finished
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.
This meansFor example, that if a PI can have has both - “Blinded PI” and “Unblinded PI” - Roles assigned to them in their User Role list. Then, if this user is The PI can be blinded for Study A, if they can be added in Study > Configure > User Access with their “Blinded PI” Role. If that same user is unblinded for are added to it with their “blinded” Role and unblinded to Study B, they can be setup for this Study if they are added with their “Unblinded PI” “blinded” Role.INSERT SCREENSHOT WITH PI ROLE SELECTED