Randomization List (Blinded) report

In this report, you view the current status as well as historical data for every randomization number in the study, as well as the subjects who were assigned each randomization number.

This report is especially useful at the end of a study because it shows you everything that's happened with your randomization list and who performed the action, from the creation of the list to the assignment of each number and whether any subjects were randomized in error.

Modes

Available in all 3 modes: Testing, Training, and Production

Permission required to run the report

Any user who's assigned the Run the Blinded Randomization Report permission can generate this report.

Filters

Filter	Description
Date Range	Choose a date range for the report. The report will include only randomization numbers with status changes during the date range.
Location	Choose one or more sites or depots to include only the randomization numbers that were assigned at that location, or leave the filter blank to include randomization numbers for all locations.
Randomization Status	Choose one or more statuses to include only the randomization numbers with that status, or leave the filter blank to include randomization numbers with all statuses.
File Type	Choose the output type for the report: CSV, HTML, PDF, or XLSX.
Historical Data	Click the radio button to view the latest records for randomization codes in the randomization list.
Audit Trail	Choose Yes to make the audit history available when selecting the date range, or choose No to only download the latest data.

Field descriptions

Note:

Fields that don't have any corresponding values are marked as N/A in the report.

Initial fields	Description
Customer Name	A customer's name used to purchase the cloud subscription.
Study Name	A study's ID as entered by the study manager when they created the study.
Mode	The mode in which you ran this report. For example, you may run a report in Testing mode to verify the data before going live with your study.
Location	The site or depot where the randomization numbers were assigned.
Date Range	Period of time you selected when running this report.
Report Generated By	Username of the user who generated this report.
Created Date	The date this report was run.
Randomization List	The name of the randomization list you selected to be included in the report.
Randomization Status	The status of the randomization numbers you selected to be included in the report.

Fields in this report	Description
Randomization Number	Unique number for the randomization.
Block Number	Indicates the block identifier. Randomization codes are created in blocks based on the design parameters to achieve balance.
Study Organization ID	Short name or code for the site or depot.
Study Organization Name	Long name of the site or depot.
Subject Number	If a randomization number is assigned to a subject, the subject number is included in the report.
Date	UTC time and date of the transaction.
Cohort	Cohort title per study design, used for Demography and Adaptive randomization.
Stratum	Stratum title per study design, used for all stratified designs excluding demography cohorts.
Status	Status of the randomization number, including Available, Assigned, Not Released, Not Approved, Randomized in Error.
Randomization List Name	Name of the randomization list.
User Name	User responsible for the transaction.
Reason for Change	Where applicable, user indicates a reason for change. Not all state changes require this additional comment.
Restricted to Available Kits	Indicates randomizations that skipped a code. The design provides the option if there is a shortage of supply at a site.
Blocked by	Displays the Site, Country, and Region when a study is blocked.