Update randomization and kit types definitions during study conduct period
- Drop a treatment arm, add cohorts, or update randomization during the study conduct period
You can drop a treatment arm, add cohorts, and update randomization during the study conduct period. These procedures also apply to rollover studies. - Update a kit type during the study conduct period
Some fields for a kit type are editable, even during the study conduct period. If you need to update a read-only field, you must create a new kit type and use it to replace the kit type with the inaccurate field. These procedures also apply to rollover studies. - Update the way that subjects titrate during the study conduct period
Depending on the changes you need to make, you might be able to update the existing kit type titration, or you might need to create a new kit type titration and use it to replace the current kit type titration. These procedures also apply to rollover studies. - Update a randomization list that ran out of numbers during the study conduct period
You can upload or generate a new randomization list in an approved version of a study without creating a new version of a study. Consider assigning the new list to the study version before the current list runs out of numbers to avoid randomization errors at sites. This procedure also applies to rollover studies. - Update a kit list that ran out of numbers during the study conduct period
You can upload or generate a new kit list in an Approved version of a study. You do not need to create a new version of a study to perform this task. This procedure also applies to rollover studies.
Parent topic: Updates during the study conduct period