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Configure and test randomisation

Updated over a month ago

Randomisation in Datacapt ensures participants are assigned to treatment groups fairly and without bias. You can enable and configure it in Study settings, add a randomisation button in the eCRF, and test the process before going live.

Enable and configure randomisation

πŸ› οΈ Step-by-step guide:

How to configure randomisation

  1. Open your study and go to Settings β†’ Randomisation.

  2. Select Create New Randomisation.

  3. Define your allocation groups:

    • Name (mandatory)

    • Description (optional)

    • Weight (e.g., 1–1 for two equally balanced groups)

  4. Choose the method:

    • Block (Static) – Balanced allocation in fixed block sizes. Datacapt generates the list automatically.

    • Dynamic (Pocock & Simon) – Real-time allocation adjustment based on stratification factors and chosen distance method (Range, Variance, Max).

    • Import – Upload a predefined randomisation list (contact your CSM).

    • Double Blind Import – Import with blinded kit IDs (contact your CSM).

  5. (Optional) Configure stratification:

    • By centre – Maintains balance within each site.

    • By question – Uses a defined eCRF question for allocation (question must exist in the eCRF builder).

  6. Click Save.

πŸ’‘Tip : See our Randomisation Glossary for Block method, Dynamic method, Group weight, Stratification


Add the randomisation action to the eCRF

πŸ› οΈ Step-by-step guide:

How to add the randomisation action to the eCRF

  1. In the eCRF Builder, open the form where the randomisation action will be placed.

  2. Click Add question and choose # Randomisation.

  3. (Optional) Rename the button label.

  4. Save.


Test the allocation

πŸ› οΈ Step-by-step guide:

How to test the randomisation

  1. In your draft study, generate a new test eCRF.

  2. Click on the Randomise action button.

  3. Confirm the randomisation by selecting "Randomise".

  4. Repeat with multiple test subjects to verify allocation logic

  5. If changes are needed, update the configuration in Settings β†’ Randomisation.

πŸ’‘Tips :

  • Test with multiple subjects to ensure the allocation logic is functioning as intended.

  • If the configuration doesn’t meet your requirements, return to the Randomisation Settings, make the necessary adjustments, and save. Note that this will reset the randomisation to zero, so you’ll need to restart your tests.

  • Once the randomisation process is validated, avoid making further changes, and proceed to finalize your study for live deployment.


πŸ‘‰πŸ» Next Step: Run randomisation in a "Live" study

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