To reduce effort during Inbox Item and Case processing, you can use the Specify Study Products action to add multiple Study Products to the record. To use this action, the Inbox Item or Case must have a Report Type value of Study and the selected Study cannot have unspecified products. When you run the action, the Specify Study Products dialog appears and you can make selections on the following tabs:
- Open/Unblinded: Displays open-label and unblinded Study Products.
- Blinded: Displays Study Product Placeholder names for blinded Study Products. For Cases, this tab appears only if the Study is blinded and the Case Blinded field value is Yes or blank.
On each tab, you can enter a term in the Search bar and select the Search (
) icon to filter the list of Study Products and customize the records grid as needed. When the action completes, Vault generates Study Products with Drug Roles of Suspect for the products you selected in the Specify Study Products dialog. For Study Products selected from the Blinded tab, Vault sets the Study Product field to Blinded. For Study Products selected from the Open/Unblinded tab, Vault sets the Study Product field to Open Label or Unblinded. You can update this value, if needed.
Prerequisites
To add multiple Study Products, your Admin must enable the Specify Study Products action for Inbox Items and Cases.
Specify Inbox Item Study Products
Vault generates one placeholder Study Product for each Inbox Item generated manually, from email, and from non-E2B imported documents, which you can update as needed. If you do not update the placeholder before adding additional Study Products, Vault deletes it upon saving the Inbox Item. To add additional Study Products to an Inbox Item:
- In the Products section of the Inbox Item, select Specify Study Products from the Actions menu.
- In the Specify Study Products dialog, select up to nine Study Products.
- Select Confirm.
Vault generates Study Products for each of your selections and assigns the first selected record as primary (Rank of 1) or, if the Inbox Item already has a primary Study Product, Vault assigns it a Rank of 2. Upon saving the Inbox Item or promoting it to a Case, Vault validates the data.
Note: When you manually add Study Products to the Inbox Item, either by populating the Products section Study Product field or using the Specify Study Products action, Vault does not promote the Study Arm Products associated with the selected Study Arm.
Add Case Study Products
To add multiple Study Products to Cases:
- From the All Actions menu of the Case, select Specify Study Products.
- In the Specify Study Products dialog, select the applicable Study Products.
- You cannot select Study Products previously added to a Case.
- Select Confirm.
Vault generates Study Product types of Case Products for each of your selections. Vault does not populate the Rank field for any generated records. For open-label and unblinded Study Products, Vault maps information from the following record fields to the Case Product:
- Case Product Registration:
- MPID
- PhPID
- Case Product Dosage:
- Dose (including number and unit)
- Frequency (including number and unit)
- Dose Form
- RoA
For open-label and unblinded Study Products that are constituents of Combination Products, Vault also populates the Combination Product on the Case Product.