Code and Browse Study Products

To reduce effort during Inbox Item and Case processing, you can use the Specify Study Products action to add multiple Study Products. When you run the action, you make selections in the Specify Study Products dialog, which includes the following tabs:

• Open/Unblinded: Displays open-label and unblinded Study Products
• Blinded: Displays Study Product Placeholder names for blinded Study Products

For study Cases, if the Study is blinded and the Case Blinded field is set to Yes or is blank, both the Blinded and Open/Unblinded tabs appear. In all other instances, only the Open/Unblinded tab appears. You cannot select Study Products previously added to Cases.

When the action completes, Vault creates Study Products 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. For all generated Study Products, Vault sets the Drug Role to Suspect.

Prerequisites

Ensure the following prerequisites are met:

• Your Admin must enable the Specify Study Products action on Inbox Items and Cases.
• The Report Type of the Inbox Item or Case must be Study.
• The selected Study has a Study Has Unspecified Products value of No or is blank.

Add Multiple Study Products to an Inbox Item

You can add up to ten Study Products to manually created Inbox Items. Vault creates one placeholder Study Product. In the Specify Study Products dialog, you can select up to nine (9) Study Products.

To add multiple Study Products to an Inbox Item:

1. In the Products section, open the All Actions menu and select Specify Study Products.
2. In the Specify Study Products dialog, select up to nine Study Products.
   • 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.
3. Select Confirm.

Vault generates one placeholder Study Product and Study Products for each selected Study Product. Vault assigns the first Study Product as primary (Rank of 1). If the Inbox Item already has a primary Study Product, Vault assigns the first selected Study Product a Rank of 2.

Add Multiple Study Products to a Case

To add multiple Study Products to Cases:

1. From the Case’s All Actions menu and select Specify Study Products.
2. In the Specify Study Products dialog, select the applicable Study Products.
   • 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.
3. Select the checkbox for each Study Product you want to add.
4. Select Confirm.

Vault generates Case Products for each selected Study Product. 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.