Additional Information

In general, the variable labels specified in Sections 2.9.4 (Predefined Standard Variables for ADSL), 2.9.5 (Predefined Standard Variables for BDS), 2.9.6 (Predefined Standard Variables for OCCDS), and 2.9.7 (Predefined Standard Variables for REFERENCE) are required. There are only 2 exceptions to this rule:

1. Descriptive text is allowed at the end of the labels of variables whose names contain indexes "y" or "zz."
2. Variable labels containing a word or phrase in curly brackets, e.g., {Time} (the label for *TM variables), should be replaced by the producer with appropriate text. The label must contain the bracketed word or phrase somewhere in the text. For example, *STM must use the phrase "Start Time" in the label, so labels such as "Start Time of Rescue Med" or "Rescue Med Start Time" are both valid.

It is important to note that

• The standard variable labels by no means imply the use of standard derivation algorithms across studies and/or producers.
• When the CDISC Notes for a variable refer to another variable, it is understood that this means "on the same record or row." For example, "The numeric code for TRTP" is understood to mean "The numeric code for TRTP on the same record."

Controlled Terminology has been developed for the values of certain ADaM variables. The most current CDISC terminology sets can be accessed via the CDISC website (http://www.cdisc.org/terminology). In the tables in this section, the parenthesized external codelist name appears in the Codelist/Controlled Terms column, where relevant. Examples of controlled terms in this document should be considered examples only; the official source is the most current CDISC set available through the website.

Note that CDISC Controlled Terminology sets cannot represent null (absence of a value) in the list of valid terms because "null" is not a term. However, unless specified in the definition for a specific variable, null is allowed.

Additional variables not defined in this section may be necessary (e.g., to enable analysis, to support traceability, to facilitate presentation of the data), and may therefore be added to ADaM datasets, providing that they adhere to the ADaM naming conventions and rules as defined in this document.