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Process request to release items from packaging lot

Releasing a lot is initiating its shipment to the selected depot or site. Typically, the items in the lot—product units or container units—are first released to the depot, and then the site requests a shipment from that depot, which delivers the drug to the site. However, some studies do not have a depot, so they may release the drug directly to the site.

In IWRS, lot release can be regulated by the review and approval process to further enhance the control of study item distribution. If lot release approval is enabled from the Study Information page, once the supply manager initiates the release request, the approver, such a a sponsor representative, can review the details of such a request and either approve, reject, or completely revoke it.

Important

You can process and amend lot release requests only if you have the following permission granted to your user role via the ADMIN application:

  • Approve Release: authorizes the user to edit, approve, or reject the requested item release from the packaging lot.

  • Edit Completed Release: authorizes the user to amend the released item details—add the attachments, change release date, or else.

  • Revoke Release: authorizes the user to discard the release and return its items to the Draft status.

To process the request to release items from the packaging lot

  1. In the IWRS application header, select the TREATMENT DESIGN tab.

  2. In the left pane, select the Lot subtab.

    Accessing lot subtab
    Figure 1. Accessing lot subtab

  3. On the page that opens, go to the Release tab. Then next to the release in the Requested status, from the Action(s) column, select Details info_icon.png.

    Accessing release request processing
    Figure 2. Accessing release request processing

  4. On the Lot Release page that opens, review and update the details of the item release request and then perform the needed action as explained in the following table.

    Processing lot release request
    Figure 3. Processing lot release request

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Release Number*

    Represents the unique identifier of the item release that helps track and distinguish releases made from the same lot. The value is read-only and cannot be changed upon the request processing.

    Destination*

    Select the depot or site to which your lot must be released. If the lot requires country release, only the sites of the selected country or region are displayed in the destination list.

    Comments*

    Enter the comment to follow the lot release.

    Release Date*

    Enter the actual date when the items have been released. The system autopopulates the current date but it can be changed to any previous date. This is helpful if you are recording the operation that has taken place on a different date from the current one.

    You cannot select the date past the current one to avoid registering future releases beforehand and only allow already performed operations to be recorded in IWRS.

    Attachment

    Select upload_icon.png to browse and select any auxiliary document from your computer according to your business scenario.

    If any document is uploaded by mistake, you can remove it by selecting the cross symbol x_icon.png and confirming the deletion in the resulting dialog.

    Items List

    Select the checkboxes next to the items—product units or container units—you want to include in the release and clear the checkboxes to exclude items from the release.

    Refresh

    Select refresh_icon.png to reload the item list and get the latest available items for release.

    Filter

    Select filter_icon.png to enable filtering and sort out the item list to help you locate the needed ones faster.

    History

    This block contains the complete operation log for the item release request.

    Operation

    Represents the action performed with this release request previously, such as Request Release, Revoke Release, or else.

    Operator

    Represents the name of the system user who performed the action.

    Operation Time

    Represents the exact date, time, and time zone indicator of when the action was performed.

    Comments

    Represents the comment added by the system user when requesting release, rejecting it, or performing any other action.

    Refresh

    Select refresh_icon.png to reload the history and get the latest available operation log.

    Processing options

    APROVE

    Select approve_button_red_white.png to validate the request and release the selected items from the lot to their destination.

    SAVE

    Select save_button_white_red.png to implement the changes you made to the item release request.

    REJECT

    Select reject_button_white_blue.png to decline the request. In such a case, the request obtains the Rejected status and the dedicated user can amend, reinitiate, or revoke it as required.

    To finalize the operation, in the resulting dialog, enter the reason for rejection and select SAVE.

    Rejecting item release request
    Figure 4. Rejecting item release request

    REVOKE

    Select revoke_button.png to discard the request and return all its items to the lot with the Draft status.

    To finalize the operation, in the resulting dialog, enter the reason for revoking and select SAVE.

    Revoking item release request
    Figure 5. Revoking item release request

Once processed, the release request is handled as follows:

  • The approved release obtains the Completed status and the items within are sent to their destination.

  • The rejected release obtains the Rejected status and has to be reviewed and taken care of by the dedicated user. The items within the rejected request remain in the Draft (Pending Approval) status and cannot be used in another release until the request is revoked.

  • The saved release remains in the Requested status and requires to be approved, rejected, or revoked.

  • The revoked release is discarded with the Revoked status and all its items return to the lot with the Draft status—available to be used in another release from the lot.

In this section:

A batch of items (drugs) that are produced at one time and have common characteristics, such as, for instance, expiration date. In IWRS, there are two types of item lots—packaging lot and manufacturing lot.

A warehouse that is used to store and distribute items (drugs) to another destination (other depots or sites).

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

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 hierarchical unit used to group and manage investigational products (IMPs) and placebos for shipping and inventory purposes. For example, large boxes and medium boxes.

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.