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Site | Patient | Strat1 | Strat2 | Randomization |
1 | 1 | 1 | 1 | 0 |
1 | 2 | 1 | 2 | 1 |
1 | 3 | 1 | 1 | 1 |
1 | 4 | 1 | 2 | 0 |
1 | 5 | 1 | 1 | 0 |
2 | 1 | 1 | 2 | 1 |
2 | 2 | 1 | 1 | 0 |
2 | 3 | 1 | 2 | 1 |
2 | 4 | 1 | 1 | 1 |
2 | 5 | 1 | 2 | 0 |
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Updating Randomization Schemas Mid-study
The randomization file can easily be updated if needed. Do this by exporting the existing schedule, modifying as needed, and re-uploading. The system will only update ‘slots’ that have not already been filled, so its okay if filled slots are part of the file when its re-imported. This helps the user in verifying proper spread of allocations, even if some have already been used.
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Randomization Conditions
For studies that use randomization, TrialKit allows study builders to dictate form logic according to where subjects are randomized. For example, each subject's randomization assignment can dictate if specific intervals, forms, or fields are displayed.
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There are two application rights you need to turn on permissions needed for the role you want to do that will be setting up randomization.
A) Randomization Configuration
Under the Study>Study Configuration menu click on the Role Security tab
Now select the role you want to grant access to randomization to
Check the setting called "Grant Access to Randomization"
Save Right (see below)
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B) Randomization View
Under the Study>Study Configuration menu click on the Role Security tab
Now select the role you want to grant access to randomization to
Check the settings for
Grant Access to Randomization View
Un-allocate Subject
Save Right (see below)
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| Info |
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The ability to view randomization should be considered as un-blinding. The person importing, viewing, and testing the schedule should be unblinded if the randomization requires blinding to most users. |
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View and decode the randomization allocations
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On the app, it can also be done in the randomization table by swiping left on any row (mobile app only) within the table. An “Unallocate” button will appear on the right side. Tap on the button to complete the action.
Removing allocations entirely
It’s usually advised to maintain the randomization schedule as it was designed and keep all slots, even if they aren’t needed anymore (e.g. A subject was randomized accidentally and the slot cannot be re-used). This can be done by filling the slot with a ‘placeholder’ subject, updating the subject’s ID to something that will not ever exist for a real subject, like “01-005ZZ” where “ZZ” is appended to the end of the ID. Then delete that subject. It will still fill the randomization slot and prevent a real subject from re-using it.
The alternative method is to un-allocate the subject from the slot that needs to be removed and then updating the randomization schedule by re-importing it (explained in sections above).
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Read here about how subject randomization is performed by the site
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