Sealed Envelope | Walkthrough - setting up the Simple + service with a randomisation list

We’re going to show you how to set up a simple randomisation system using the randomisation list option. This will allow us to name our treatment groups and stratify the randomisation using random permuted blocks.

Objective

For our trial to compare embryo transfer methods in IVF we want randomisation:

To either Delayed frozen transfer or Fresh transfer (1:1 ratio)
Stratification by age group and number of previous IVF cycles
Block sizes to be 4 and 6
120 women to be randomised

Step 1

Create a randomisation list using the tool on our website. Enter the following information:

Treatment groups: Delayed frozen transfer, Fresh transfer
Block sizes: 4, 6
List length: 480 (120 women ⨉ 4 strata)
Strata: Age group: ≤37, 38+
Strata: Number of previous IVF cycles: 0-2, 3 or more
Since the trial is unblinded do not check the Generate unique randomisation code? box

Click the Create list button and check the list appears as expected. All four combinations of the stratification variables should be represented. When you are happy with the list click the Download as CSV button. This is your randomisation list.

You must keep your randomisation list away from anyone who will be randomising patients in practice! This is to maintain allocation concealment

Creating a list — Creating an unblinded, stratified list

Step 2

Go to the simple service page and click the Create a new trial button.
Fill in the form and click the Show paid options link.
Under the Upload a randomisation list header click the Choose file button
Find the CSV file you created in step 1
Agree to the terms and conditions and click the Create trial button

Creating a trial using the list from step 1

Step 3

That’s it - your randomisation system is ready! Try it out by filling in the randomisation form. You should receive treatment allocations in the same order as your list from the rows matching the stratification values you enter.

We recommend you set up a dummy system first to test. When you are ready to start your trial create a new list with a different seed.