New Subject Randomization Data Extract

Sponsor users can now extract cumulative data including randomization details, such as the subject ID along with its randomization number and associated treatment.

Details for sponsor users

A new data extract, Subject Randomization Data Extract, is available under Reports & Archives for Oracle Clinical One Platform studies in any mode. This report contains randomization-related information, including the following:

• Subject metadata
• Visit information for the visit when randomization occurred
• Details about the users who last updated a subject's randomization visit or stratification factors
• Randomization details
• Assigned treatment
• Stratification data

The stratification data included in this report corresponds to any form question defined as a stratum factor in the randomization design. Only records for randomized subjects are included, and only values that were used for a given subject as stratification factors at the time of randomization are populated for the subject. This means that, even if the site updates this data for a subject after randomization, the values that were actually used to determine randomization are retrieved. Conversely, if stratification factors are not specified, no stratification factors are listed.

You can find additional information in the Reporting Guide after the Release Assessment Environment (RAE) upgrade.

Details for user administrators

To support the creation of this new data extract, a new permission is introduced. Any user that's assigned the new Run the Subject Randomization Data Extract Report permission can generate this report. However, users can only see the data that they're allowed to, based on their access to classified data.

Similarly, the Subject Randomization Data Extract can contain blinded or unblinded data, depending on the user's permissions within the study. Having at least one of the following permissions makes unblinded data available in the generated extract:

WARNING:

Extracts generated by unblinded users must be managed carefully when sharing to protect other users blinding.

• Receive the Unblinded Dose Hold Notification
• Upload and Generate Inventory Lists
• View Dispensation Exceptions
• Create and Manage Dispensation Exceptions
• Edit Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies
• Manage Study Inventory for Unblinded Users
• Manage Randomization Lists
• Create and Manage Lots
• Create Shipments to Depots
• Upload and Generate Randomization Lists
• Receive the Unblinded Kit Misallocation Notification
• View Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies
• Run the Unblinded Randomization Report

You can find additional information in the Add Users Guide after the RAE upgrade.