Code and Browse Study Products

You can add multiple Study Products to Inbox Items and Cases for clinical trial studies in a single action.

About Adding Multiple Study Products

To reduce effort during Inbox Item and Case processing, you can select multiple Study Products and then add them in a single action. The Specify Study Products dialog includes the following tabs:

• Open/Unblinded: This tab lists open-label and unblinded Study Products.
• Blinded: This tab lists Study Product Placeholder names for blinded Study Products.

When adding Study Products to Inbox Items, you can toggle between the tabs. On Study Cases, only a single tab is available at a time. When both the Study and the Study Case are blinded, you can access the Blinded tab. In all other instances, you can access the Open/Unblinded tab. Study Products previously added to Cases cannot be selected from the Specify Study Products dialog.

Study Product Records

Vault creates Study Product records for products added through 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.

On all created Study Product records, 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 must meet the following criteria:
  • The Study Type must be Clinical Trial.
  • Study Has Unspecified Products must be No or blank.

Add Multiple Study Products to Inbox Items

On new manually created Inbox Items, you can add up to ten (10) Study Products. Vault creates one (1) placeholder Study Product record. In the Specify Study Products dialog, you can select up to nine (9) Study Products.

To add multiple Study Products to Inbox Items:

1. In the Products section, open the All Actions menu and select Specify Study Products.
2. In the Specify Study Products dialog, browse the Study Products available to add.
   • Select the Open/Unblinded tab to browse all Study Products for the selected Study.
   • Select the Blinded tab to browse all Blinded Names for the selected Study.
3. Select the checkbox for each Study Product you want to add.
4. Select Confirm.

Result

Vault creates a record in the Products section for each selected Study Product. If the Inbox Item does not contain a rank 1 Product yet, Vault assigns the first Study Product as the primary. If there is already a rank 1 Product, Vault sets the new Study Products to rank 2.

Add Multiple Study Products to Cases

To add multiple Study Products to Cases:

1. Open the Case’s All Actions menu and select Specify Study Products.
2. On the available tab, either Open/Unblinded or Blinded, browse the Study Products available to add.
3. Select the checkbox for each Study Product you want to add.
4. Select Confirm.

Result

Vault creates a record in the Case Products section for each Study Product you select. Vault does not populate the Rank field. For open label and unblinded Study Products, Vault maps information from the following objects and 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

Browsing Study Products

When the Specify Study Products dialog is open, you can enter a term in the Search bar and select the Search () icon to filter the list of Study Products. You can also sort the list in ascending or descending order by clicking on the column headers.

To customize the browser columns:

1. In the browser’s All Actions menu, select Edit Columns.
2. Use the right and left arrow buttons to move columns between the Available Columns and Selected Columns sections.
3. Select Save.