Details for clinical research associates (CRAs)

How do I perform source data verification (SDV) on the kits that subjects return to sites?

You have to perform SDV before marking the kits as Pending Destruction.

1. On the Inventory tab, select a kit that has been reconciled, and review details about the kit to the right under Inventory Management.
2. If reconciliation details are correct, click the gray checkbox in the new Verify column. The checkbox turns green.

   If reconciliation isn't correct, update the kit on the right in Inventory Management. After you save, the checkbox in the Verify column turns green.

If a site user updates a kit that you verified, the green verified checkbox is removed.

How do I mark kits that are ready for destruction?

1. On the Inventory tab, select the kits that are ready for destruction.
2. On the right below Inventory Management, click Update Kits, and change the status of the kits to Pending Destruction.

   If the site is drug destruction capable, the site can now destroy the kits.

   If the site isn't drug destruction capable, a shipment and packing list are created so either you or someone at the site can send the kits to the depot.

Usability improvements on the Subjects tab

See the following changes in Subject History, which is to the right of the Subjects table when you select a subject:

• You can now update the status of a kit.

  Kit numbers are now hyperlinks. Click a kit to change update the status of a kit.

• One click brings you to the Inventory tab, filtered for the selected subject.

  Click the arrow to the right of Dispensation History ( ) to see all kits dispensed to the subject on the Inventory tab.

Usability improvements on the Inventory tab

• New filtering options, including subject number and multi-select for kit statuses
  • The Subject Number filter is now available.
  • The Status filter moved to the left and now allows you to select multiple statuses.
  • There is a new Clear Filters option that appears after you select filtering criteria.
• New table columns, including a column for confirming site reconciliation

  The new columns appear only when kit reconciliation is required for the study.

  • The following columns are new:
    • Verify: This column is clickable if the site has reconciled the kit.
    • Last Modified
    • Units per Kit
    • Returned Units: Point to the talk bubble to see the reason for change.
    • Missing Units
    • Balance Units
  • Additional changes:
    • The icon for a kit type now appears in the Kit Number column.
    • The following columns were removed: Shipment Number and Comments.
• New details available on the right
  • Inventory Correction was renamed to Inventory Management

    This section now contains additional details about a kit, including the subject the kit was dispensed to (if the kit was dispensed) and the number of returned, missing, and balance units (if the kit has been reconciled).

  • New section on the right: Kit History

    This new section lists all status changes for the selected kit at the site, including when it was dispensed and who made the change.