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 > Specimen > Panel / Test Result Details areas

• 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 Test results, you will need to determine a User Role that can access the blinded tests. This can be achieved in several ways, for example:

• use an existing role

• create a dedicated Role for blinding purposes across all studies; for example “Unblinded User”, “Unblinded to Lab Results” or similar

• create and apply more specific Roles for blinded and unblinded users, for example, “Blinded PI” vs “Unblinded PI”. This may be useful when considering study specific controls to manage more discrete role assignment and study specific blinding needs.

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:

Open

Then in the popup window, select the “unblinded” Role from the list and click “Save”:

Open

The Role will become visible in the “Role” column:

The users with this unblinded Role will be able to view the Lab Test 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 role restrictions to view Test Results in the Lab > Configure area, but this change will only affect results that have not yet come back from the Lab.

If you need to update the role restrictions to view Test Results that had already been resulted, you can do this via Lab > Orders > Specimen > Panel / Test Result Details areas.

Unblinding at study completion

There may be a desire to unblind certain (or all) users to Lab Test Results once the study had been completed. This should be taken into consideration during study setup and when reviewing/assigning roles to users and study lab test configurations.

When using a single role definition for blinding purposes, qualified users can modify role restrictions on per-panel test results from the Lab > Orders > Specimen > Panel / Test Result Details areas. However for a large set of resulted lab data this is not an ideal method to unblind test results.

When using the User Access feature to manage study-specific roles, users can simply have their study role adjusted accordingly. For example, if blinded users were assigned a ‘Blinded’ role during the study, they could have their study specific role changed to ‘Unblinded’ after study completion and then access test results.

Alternately, it may be possible to achieve unblinded access to lab data through reports or dashboard components, while leaving existing role configurations in place. Customers are encouraged to confirm with Foundry Health support team members if this is achievable on a per-study basis.

Does a User have to be Blinded for all Studies?

Blinding rules through role restrictions can be applied per study. Customers can decide to use lab result blinding on a per-study basis as needed, or, determine feature use across all studies. It may be possible to achieve lab result blinding needs using singular role definitions and applying the same role restrictions across all applicable users and studies.

Alternately, users can take a more granular approach and use the Study > Configure > User Access feature. This will allow study specific role assignments and can help determine if users are 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.