Upload a randomization list

Create a randomization list for Testing mode when you're ready to test data entry and randomization. Create a randomization list for Production and Training mode when you're ready to make the study live.

Tip:

To prevent potential unblinding, create separate lists for each mode. If a statistician provides only the production list for a study, upload it in Production mode and generate lists for Testing and Training modes. We recommend you first create a randomization list in Testing mode before you create one in Training or Production mode.

You can generate a randomization list to see the format Oracle Clinical One Platform uses. For more guidelines on special characters and formatting of lists, see Guidelines for creating a kit or randomization list.

File requirements to upload a randomization list

  • The file name must not include any periods, other than the period that appears before the file extension.
  • Create a comma-separated values (CSV) file (up to 1 GB) that includes one row for each randomization number with the following corresponding columns:
    • Randomization number
    • Block number
    • Treatment ID
    • Stratum groups (required only if you use a stratified randomization design)
    • Sequence number (required only if you use randomization by sequence number)
  • We recommend using dynamic block assignments. However, if you are doing static block assignments, the list you upload must identify the site to associate with each block.
  1. Access the study version for a given mode as described in Open the design of a study version.
  2. Along the top, click Study Supplies.
  3. Below the study name, make sure the Randomizations tab is selected.
  4. From the Randomization List drop-down, select Upload.
  5. Select the randomization design that you want to upload a randomization list for, and click Next.
  6. Fill in the following fields:
    • Title
    • Description
    • Mode: Choose the mode that the randomization list is available in.
    • Columns in File Have Headings: Select if the CSV file you're uploading contains column headings.
  7. Click Choose File, select your CSV file, then click Next.
  8. On the Map Headers section of the wizard, from the Mapped to drop-down, select the corresponding column header that Oracle Clinical One Platform uses to map it to your CSV imported column headers. Then click Next.
    If you select the Sequence number in the List Settings the mapping is mandatory.
  9. On the Map Data Points section of the wizard, specify the treatment arms, stratum groups, or cohorts in your CSV file that are mapped to the treatment arms, stratum groups, and cohorts you created in Oracle Clinical One Platform, and click Upload.
  10. Click Finish once you complete the wizard.

You can generate or upload a new randomization list at any time, without creating a new version of a study.

Related Topics

Parent topic: Manage randomization