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Perform site inventory reconciliation

An inventory reconciliation is a practice mostly performed by the clinical research associate (CRA) to ensure the quantity of items to be returned to the depot or destroyed at the site is valid according to the previously reported numbers by the clinical research coordinator (CRC).

For instance, after the subject treatment ended, they returned a vial of unused tablets which the site now has to dispose of. The CRC counts that there are 15 tablets left and marks those in the IWRS system as ready for destruction. Then, the CRA comes to the site to validate the calculations done by CRC on the leftover drug and verify that the amount of items to be destroyed is correct. This process of validation is called reconciliation.

Important

In IWRS, the reconciliation functionality can be enabled or disabled individually for each product unit upon configuration.

The site reconciliation list contains all the items for which the functionality is enabled and that were received by the site during their participation in a trial, except for the items that were resupplied to another site or returned to the depot, as those have never been used at the site and do not require to be handled in any way.

To perform the site inventory reconciliation

  1. In the IWRS application header, select the SITE tab.

  2. On the Site List page that opens, in the table, select the site code of your interest.

    Selecting site to open its details
    Figure 1. Selecting site to open its details

  3. On the page that opens, from the left pane, select Inventory.

  4. On the inventory page, from the contents panel, select Reconciliation.

    Accessing site inventory reconciliation
    Figure 2. Accessing site inventory reconciliation

    Tip

    Once you open the reconciliation page for a site, you can use the breadcrumbs navigation to switch between different sites' reconciliation lists without returning to the Site List page.

    Switching sites from reconciliation page
    Figure 3. Switching sites from reconciliation page

  5. In the Reconciliation table, review the items intended for reconciliation as interpreted in the following table.

    Reconciliation list for site
    Figure 4. Reconciliation list for site

    Column

    Details

    Item Unit

    Represents the unit (name) of items for reconciliation.

    Item Number

    Represents the unique number of the item.

    Disposition

    Represents the current status of the item in the site inventory, such as Available, To be Returned, or else.

    Lot Number

    Represents the unique identification number of the packaging lot to which the item belongs.

    Expiration Date

    Represents the expiration date of the item which is the same as the expiration date of its packaging lot.

    Subject ID

    Represents the unique identification number of the subject to whom the item is dispensed.

    Count by Site

    Represents the number of unnumbered items in a packaging intended for reconciliation as specified by the site representative, most commonly, CRC.

    For instance, if there is a vial with five tablets, then this value is 5.

    Monitor Count

    Represents the number of unnumbered items in a packaging that must be returned/destroyed out of the total number of items in a packaging as specified by the monitor upon reconciliation, most commonly, by CRA.

    For instance, if there is a vial with a total of eight tablets dispensed to the subject and five of them were returned to the site to be destroyed after the end of treatment, then this value is 5/8 (tablet).

    Monitor Comment

    Represents the comment added by the monitor upon reconciliation.

    Reconciliation Status

    Represents the current status of item reconciliation—Complete, With Exception, or Not Reconciled.

    Reconciled by

    Represents the name of the user who performed reconciliation for the item.

    Reconciled Time

    Represents the time when the reconciliation is performed for the item.

  6. Proceed to item reconciliation one by one or in bulk as follows.

Upon saving, the reconciliation for site items is complete. The reconciliation list must now be signed by the user in charge to enable item destruction at the site or shipment to the return depot—depending on the obtained reconciliation status.

In this section:

A person responsible for overseeing and monitoring a clinical trial to ensure it is conducted in compliance with regulatory standards and protocols. The CRA’s scope of work might include protocol review, site selection and initiation, monitoring, data entry control, and more.

In the eClinical system, the Clinical Research Associate (CRA) user role is assigned to a person who works with the sites, and in EDC, mainly has to make sure that the entered data is truthful to the source document. CRA checks the source document in a process called source data verification and ensures that everything entered by the clinical research coordinators is valid to avoid any discrepancies caused by human errors.

A person responsible for the successful planning, execution, and management of clinical trials. The CRC’s scope of work might include study preparation, site setup, patient recruitment, regulatory compliance control, data collection, and more.

In the eClinical system, the Clinical Research Coordinator (CRC) user role is granted to a person who works on a site with subjects and is responsible for entering data to EDC, ensuring the data is entered correctly according to all requirements, and answering queries from data managers on any questionable data pieces.

An investigational product that is used in a study. In eClinical, it can be viewed as an equivalent to a drug name to distinguish items at all stages of their lifecycle—manufacturing, shipment, dispensation to subjects, or else.

Another name for the product unit in the IWRS system is item unit.

A batch of items collected into one package for shipment or other logistic purposes. Using packaging lots with their unique lot numbers gives depots and sites the ability to differentiate between different batches of drugs to track, for instance, release and expiration dates or other useful information.