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A module of the eClinical administrative system that enables users to configure and maintain laboratory test assessment and unit conversion rules for the EDC application to follow.

Figure 1. Lab Admin module

In IWRS, an item number that is used to mark (label) a product unit or container unit for tracking and assistance purposes.

The item numbers in a lot (batch) of item units that are used for tracking and assistance purposes.

A set of numbers that are the high and low ends of the range in laboratory test results considered normal for a certain group of subjects and against which the actual results are measured and considered abnormal.

In pharmacovigilance, a formal authorization or approval granted by the regulatory authorities of a country or region that allows a pharmaceutical company or Marketing Authorization Holder (MAH) to market and sell a medicinal product within that jurisdiction. The product license indicates that the regulatory authorities have reviewed the safety, efficacy, and quality data for the product and have deemed it suitable for use by patients for the specified indications.

In eClinical, an environment that is designed to support a clinical trial development process, for instance, DEV for the development process, UAT for testing activities, and PROD for production.

A case report form that consists of multiple forms in which the data must be added sequentially. This is essential for accurate chronological monitoring of recorded data. Before the first log line is completed, you cannot proceed to enter data in the second log line. For instance, this can be an "Adverse event details" form that repeatedly records the AE progression.

See also: simple form and grid form

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 unique identification number assigned to each lot of items via the IWRS system.

The most specific level of MedDRA with more than 80,000 terms that parallel how information is communicated. These LLTs reflect how an observation might be reported in practice. This level directly supports assigning MedDRA terms within a user database.

See also: current LLT and retired LLT