Randomization List (Unblinded) 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 Unblinded Randomization Report permission can generate this report.
Filters
Filter | Description |
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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 |
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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 |
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Randomization Number | Unique number for the randomization |
Block Number | 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 | Per study design, used for Demography and Adaptive |
Stratum | Per study design, used for all stratified designs excluding demography cohorts |
Treatment Arm ID | A treatment arm's ID as defined by the study designer |
Treatment Arm | Description of the treatment arm |
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 | Shows the Site, Country, and Region when a study is blocked. |
Parent topic: Report descriptions