Using the CRF Builder after going live
Making changes to forms
You can make changes to forms after your system goes live. This will create a new version of the form and make the previous version obsolete.
Go to the form where you want make changes and click on the 'Edit' link.
A message will be shown warning that you are trying to edit a live form and asking for confirmation. Click on 'Edit' and edit the form as required.
The new version includes the changes made and shows a link to view previous versions
Clicking on the 'View' link shows the previous version of the form
If you delete the new form version, the previous version will be reinstated. Note you can only do this for form versions that have not been made live.
Making changes to randomisation configuration
✋ Randomisation configuration changes only apply to Red Pill version 32 and later.
After your system goes live, you will be able to make limited changes to the randomisation configuration.
Summary of changes allowed
| Change | Minimisation | Dynamic blocks | List |
|---|---|---|---|
| Add treatment group | ✅ ¹ | ✅ ¹ | ✅ ² |
| Remove treatment group | ✅ ¹ | ✅ ¹ | ✅ ² |
| Change allocation ratio | ✅ ¹ | ✅ ¹ | ✅ ² |
| Add stratification factor | ✅ | ✅ | ❌ |
| Remove stratification factor | ✅ | ✅ | ❌ |
| Add or remove categories from existing stratification factor | ✅ | ✅ | ✅ ² |
| Blinded/unblinded | ❌ | ❌ | ❌ |
| Code list management | ✅ | ✅ | ✅ |
| Code-break type | ✅ | ✅ | ✅ |
| Randomisation method | ❌ | ❌ | ❌ |
| Randomisation limit | ❌ | ❌ | ❌ |
(1) Changes to treatment groups or allocation ratios result in the previous minimisation scores or dynamic blocks being disregarded.
(2) List based methods can upload a new list to change treatment arms and allocation ratios.
Randomisation form
You will not be able to change
- the form that randomisation is associated with
- the treatment groups if using the randomisation list method (but note that the treatment groups can be changed by uploading a new list)
You will be able to change
- the treatment groups and allocation ratios if using minimisation or dynamic blocks
🔥 Warning! If you change the treatment groups (add, remove or rename) or the allocation ratios, the updated randomisation method will start again from baseline, ignoring any previous minimisation scores or permuted blocks.
Randomisation method
You will not be able to change
- the randomisation method
- the prognostic factors if using the randomisation list method
You will be able to change
- the prognostic factors and probability if using minimisation
- the prognostic factors and block sizes if using dynamic blocks
Blinding
You will not be able to change
- whether the randomisation is blinded or unblinded
You will be able to change
- whether code list management feature is enabled
- whether unblinding is enabled and the type of unblinding
Study size
You will not be able to change
- the randomisation limit
You will be able to change
- expected duration and number of sites
Randomisation and code lists
You will be unable to generate new randomisation or code lists in the CRF builder after your system goes live. However, you can upload a new randomisation or code list that you have created elsewhere.