Upload a randomization list for minimization

Create a randomization list for minimization in 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.

Typically, minimization does not use a randomization list and the assignment of treatment arms is done dynamically based on the balance of subjects across the defined parameters. However, you can still upload (but not generate) a randomization list and her is how you can do it.

File requirements to upload a randomization list:

Create a comma-separated values (CSV) file (up to 1 GB) that includes one row for each randomization number with corresponding columns for:

• Randomization number
• Probability factor

The probability factor defines a probability score for each randomization number and must be a decimal value between 0 and 1, exclusive.

For guidelines on special characters and formatting of lists, see Guidelines for creating a kit or randomization list.

Note:

The file name must not include any periods, other than the period that appears before the file extension.

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 fields 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 headings.
7. Click Choose File and select your CSV file, then click Next.
8. On the third page of the wizard, specify the type of data in each column (Randomization Number and Probability Factor) of your CSV file by mapping it to the column headers that Oracle Clinical One Platform uses, and click Upload.

   Note:

   Make sure the Probability Factor is a decimal number between 0 and 1, exclusively.
9. Click Finish once you complete the wizard.