Summary

This article describes how to generate a randomization schedule.

Table of Contents

• Populate Strata
• Locate a Previously Used Seed Value
• Import Strata With Headers
• Import Strata Without Headers
• View the Randomization Schedule
• Export Randomization Schedule
• Add Individual Slots

If the trial is configured to use Stratification or Institutional Balancing, the randomization schedule must be randomly populated with open slots before you can randomize a subject. This can be done by either populating the strata within the system or by importing an existing strata file.

If the trial is configured to use Minimization, skip to the View Randomization Schedule section. There is no need to populate the schedule, because the Minimization schedule generates the schedule dynamically.

Populate Strata

If you want to import a strata file, skip this section.

1. On the Study Site homepage, select ‘Populate Strata’ in the Randomization actions menu under the Actions tab.
2. Enter the Sample Size for each stratum.
   • The Sample Size corresponds to the minimum number of each Stratum that should be created.
3. Based on the allocation ratios provided, enter a Block Size.
   • The Block Size enforces the ratio during randomization. It should be a multiple of the sum of the treatment allocation ratios shown on the form.
4. Leave the Seed blank unless you want to generate a previously created randomization schedule.
   • If you want to generate an exact match of a previously created randomization schedule, enter a previously used Seed value.
5. Select the Strata that you want to include in the randomization schedule.
   • Usually you will select the top check box to select all Strata.
6. Click the ‘Populate’ button to populate the strata.
   • The system will inform you that the strata was successfully populated.

Locate a Previously Used Seed Value

If you want to use a particular Seed Value for randomization that you’ve used before, you can locate the seed value in the Audits. With this seed value, you can create an exact match of a previously used randomization schedule. If you’re not using a particular Seed Value, you can skip this section.

1. On the Study Site homepage, select ‘Schedule’ from the navigation menu.
2. For a slot generated with the desired seed value, select ‘View’ under the ‘Audits’ column.
3. In the new window or tab that opens, locate the Seed value in the ‘Description’ column.
4. Enter this Seed value on the Populate Strata form.
   

Import Strata With Headers

If you already populated the strata or want to import strata without headers, you can skip this section.

Note: Fountayn does not recommend loading files without headers. Doing so can lead to fields being improperly imported.  When importing data, assure that there are no blank rows or extra information as this can cause errors. View the Import File Requirements for more information.

1. On the Study Site homepage, select ‘Import Strata’ in the Randomization actions menu.
2. Click the ‘Chose File’ button to select a file.
3. Indicate that the strata file has headers by selecting ‘true.’
4. Click the ‘Upload File’ button.
5. Review the Strata.
   • If red x’s appear in any of the columns, you may need to configure the import mapping or edit your file.
6. Click the ‘Import’ button.
7. If no errors occur, the system will notify you that the import was successful.

Import Strata Without Headers

If you already populated the strata or imported the strata with headers, you can skip this section.

Note: Fountayn does not recommend loading files without headers. Doing so can lead to fields being improperly imported.
When importing data, assure that there are no blank rows or extra information as this can cause errors. View the Import File Requirements for more information.

1. On the Study Site homepage, select ‘Import Strata’ in the Randomization actions menu.
2. Click the ‘Chose File’ button to select a file.
3. Indicate that the strata file does not have headers by selecting ‘false.’
4. Click the ‘Upload File’ button.
5. Review the Strata.
   • The columns will be filled with red x’s until you configure the import mapping.
6. Click the ‘Configure Import Mapping’ button.
7. Using the dropdown boxes, select the column numbers from the strata file that correspond to the different column names.
8. Click the ‘OK’ button.
9. Review the Strata.
   • If no errors occur, the columns should no longer be filled with red x’s.
10. Click the ‘Import’ button.
    • If no errors occur, the system will notify you that the import was successful.

View the Randomization Schedule

1. On the Study Site homepage, select ‘Schedule’ in the navigation menu.
2. In the Schedule tab, you can view the randomized slots that you just created.
   

Export Randomization Schedule

1. On the Study Site homepage, locate  the ‘Export Randomization Schedule’ option in the Randomization actions menu.
2. Select ‘Excel’ or ‘CSV’ depending on the type of file that you want to export.

Add Individual Slots

If you need to add slots to the Randomization Schedule individually for a certain stratum, you can do so by creating a slot.

Note: If the trial is configured to use the Minimization algorithm, skip this section. Slots manually added to the Schedule Manager will not be used.

1. On the Study Site homepage, select ‘Create Slot’ in the Randomization actions menu.
2. Complete the Create Slot form.

Note: The ‘Sequence Within Block’ and ‘Slot ID’ must be unique based on the current Strata in the Schedule tab.

3. Click the ‘OK’ button.
   • The system will display a summary of the changes about to be made.
4. To confirm the changes, click the ‘OK’ button.
   • You can view the change in the Schedule tab.

Note: The newly added slot will be the last slot on the newly appended schedule.

Need more help?

Please visit the Fountayn Contact Information page.