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).

...

• Lab > Orders > Specimens area

• Study > Reports (Work In Progress)

• Dashboards (Work In Progress)

What Setup is required to blind Lab Results?

Role Setup

If you wish to blind the Lab Tests, you will need to create Roles that are blinded and Roles that are unblinded, in case the blind needs to be broken. Roles can be configured in Administration > Roles.

For example, you may consider creating two different PI Roles:

• Blinded PI

• Unblinded PI

The Role Actions for both Roles can be identical.

Assign the Roles to the relevant users.

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.

...

• 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.

Breaking the blind?Additional details for after the study is finished

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 means, that if a PI can have both - “Blinded PI” and “Unblinded PI” Roles assigned to them in their User Role list. Then, if this user is blinded for Study A, they can be added in Study > Configure > User Access with their “Blinded PI” Role. If that same user is unblinded for Study B, they can be setup for this Study with their “Unblinded PI” Role.

INSERT SCREENSHOT WITH PI ROLE SELECTED