Add New Lot

Select this button to set up a new lot.

#

Select the link to Edit or Delete the lot in the row.

Lot Number

The unique identifier for the lot for each drug type.

REQUIRED.

Alphanumeric.

Maximum: 50 characters.

Unblinded Lot Number

The unique identifier that is used internally to track unblinded batch of drug units.

REQUIRED.

Alphanumeric.

Maximum: 50 characters.

Run Number

The identifier for the run number of the manufacturing lot. A manufacturing plant creates a run number to keep track of the drug units if it produces different batches of the drug units.

This number is used for tracking only.

Alphanumeric.

Maximum: 50 characters.

Expiration Date

The date the lot expires.

You can add new expiration dates when you edit the lot.

If you add a new expiration date, a message might ask whether you want to over-label all unused lots. Select at what level to apply the expiration date (all supplies, all sites, all depots, or all shipments).

If multiple manufacturing lots are included in the IRT lot, the earliest expiration date is used.

REQUIRED.

Must be in date format.

Do Not Ship Days

Acronym: DNS.

The number of days before the expiration date when drug units can no longer be shipped to sites. The purpose of this setting is to make sure drug units can be assigned at the site before the expiration date while avoiding shipments of nearly expiring drugs.

Important: The Do Not Ship value must be greater than the Do Not Count value. Otherwise, the site could run out of drug supplies.

Be sure to include the average lead time required for shipments from the depot to the site in your calculations.

Algorithm: If (Current Date < Lot Expiration Date - DND days), the drug order can be shipped.

Example: DNS is 10 days. The drug in this lot is not shipped out in a drug order if the drug lot is within 10 days of its expiration date.

REQUIRED.

Numeric.

0 - 9999

Do Not Count Days

Acronym: DNC.

The number of days before the expiration date when the drug units are no longer considered to be available (so drugs do not expire while at site or in the subject's possession). On this date, IRT automatically supplies sites from a lot with a later expiration date.

Important: The Do not Count value must be lower than the Do Not Ship value. Otherwise, the site could run out of drug supplies.

Algorithm: If (Current Date < Lot Expiration Date - DNC days), the unassigned drugs are included in site inventory (SAI)

Example: DNC is 10. If the drug list is within ten days of the expiration date, the drugs in the lot should not be counted as a part of site inventory for drug resupply purposes.

REQUIRED.

Number

0 - 9999

Lot Status

The lot status can be:

• In Use: All drug units associated with the finished lot are available for orders, shipments, and subject transactions.
• Not In Use: All units associated with the finished lot in site and depot inventories is no longer available for orders, shipments, or subject transactions.

  When you select this link, a popup appears where you switch the status from the current status (for example, from Not in Use to In Use). You must provide your user name and password to change the status. The status is changed when you click Submit.

Manufacturing Lots

An umbrella list of the manufacturing lots included in the IRT lot for tracking purposes. This list allows you to track the origin, expiration date, and other properties of the drug units within the lots.

If the lot contains more than one lot, choose the lot with the shortest expiration date.

Example: A lot from India expires in 2013, and a lot from China expires in 2014. You use the India lot for expiration purposes, but keep track of the China lot in case you need drug units that expire later.

Priority

Determines the order in which lots will be selected for shipments when expiry dates are the same.

Submit

Saves the changes to this page.

Cancel

Exits the page without saving the changes.