If you have previously configured Studies with the Study Has Arms setting, you should transition those Studies and any related Inbox Items and Cases so that they no longer use that setting.
About Deprecating the Study Has Arms Setting
To improve the efficiency and flexibility of working with Study Products, especially for complex studies involving numerous phases or products, Vault includes the multi-product selector for Inbox Items and Cases. This streamlined feature replaces the previous workflow that used the Study Has Arms setting on Studies. This setting required users to select a Study Arm on Inbox Items, which then auto-selected all the Products in the Study Arm. However, this restricted users from easily modifying the arm and products thereafter, which resulted in frustration. This behavior was also too restrictive for patient cases that spanned complex multi-part trials. As a result, Vault will sunset the Study Has Arms setting on Studies by the end of 2026.
Note: You can continue to include Study Arm details in the Study library for existing and new Studies. Sunsetting of the Study Has Arms setting will not change existing records on your configured Studies.
Transition Overview
To transition to the multi-product selector and deprecate the Study Has Arms setting in your Vault, complete the following procedures:
- Enable Multi-Product Selector for Study Products on Inbox Items
- Enable Multi-Product Selector for Study Products on Cases
- Update the Case object
- Update the Case Compare Followup layout
- Update open-label and blinded Studies
- Configure the Unblind Study Product action on Cases
- Configure complex Studies
No action is required for completed Studies with Study Arms.
Update the Case Object
On the Fields tab of the Case object, navigate to the Study Arm (unblinded) field and remove the reference constraint (study_product_group__v = ).
Update the Case Compare Followup Layout
To remove the Study Arm field on the Case Compare Followup layout:
- Navigate to Admin > Configuration > User Interface > Pages > Case Compare Page > Layouts > Case Compare Followup.
- In the Sections section, select Study.
- Select Edit.
- In the Fields field, remove the Study Arm and Study Arm (unblinded) fields.
- Select Save.
Note: When creating follow-ups to existing Inbox Items with Study Arms, Vault does not map Study Arms to follow-up Cases. On follow-up Cases, users can track Study Arms in the Study Arm field.
Update Open-Label and Blinded Studies
For all open-label and blinded Studies with Yes in the Study Has Arms field:
- Navigate to Business Admin > Objects > Studies and select the Study.
- Select Edit.
- In the Study Has Arms field, select No.
- Select Save.
Configure the Unblind Study Product Action on Cases
To configure the Unblind Study Product action, assign the action to the Case object and do one (1) of the following:
- Add the action as an entry action that will Always apply on the Unblinding state of the Case Lifecycle object lifecycle.
- Add the action as a user action to the Unblinding state of the Case Lifecycle object lifecycle.
Note: Update any process and Standard Operating Procedures (SOPs) to reflect the workflow change.
Configure Complex Studies
To support complex studies, for example studies with both open-label and blinded products, complete the following procedures:
Update Submission and Distribution Settings
Navigate to Admin > Settings > Submission and Distributions Settings and select the Display Unmasked Open-label Products on Blinded CIOMS and MedWatch 3500A checkbox.
Update the Case Object Lifecycle
For the Case Lifecycle object lifecycle, on the Unblinding state, add the following related object record condition to the Change related object lifecycle state asynchronously (no limit) entry action:
- Condition: Exclude related records in the following lifecycle states
- Related Record’s State: Open, Active, Unblinded