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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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Where are the Lab Results not Blinded?

• Lab > Orders > Specimens area> 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 TestsTest results, you will need to determine a User Role that can access the blinded Lab Resultstests. This can be achieved in several ways, for example:

• use one of your an existing Rolesrole

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

• create Roles that are and apply more specific Roles for blinded and Roles that are unblinded users, for example, “Blinded PI” vs “Unblinded PI”

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• . 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.

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The users with this unblinded Role will be able to view the blinded Lab Test Results and review them. All other users will be blinded to these Lab Results and will not be able to review them.

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The blinding settings can be updated, even after the Study starts.

You can update the access role restrictions to view Test Results in the Lab > Configure area, but this change will only affect the Lab Results results that have not yet come back from the Lab.

If you need to update the access role restrictions to view Test Results that had already been resulted, you can do this via Labs Lab > Orders > Specimen area. If you wish to unblind all > 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 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

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. 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?

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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 option, a user can be 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.