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Product Impact on Individual Health only:

If multiple values are reported for an Intervention or Event general observations -observation class topic variable (e.g., --TRT in Intervention or ,  --TERM in Events), then the applicant will split the values into multiple records or otherwise resolve the multiplicity per the data management standard operating procedures (e.g., query the data for clarification).

• The Disposition (DS) dataset is an exception to the general rule of splitting multiple topic values into separate records. For DS, 1 record for each disposition or protocol milestone. For cases of multiple reasons for discontinuation, refer to the domain specifications for DS, .

If multiple result values (represented in --ORRES) are collected for a test, then multiple records will be represented for the test (represented in --TESTCD).

Multiple Values values for a Variable variable with Rolerole:

• Grouping Qualifier,qualifier
• Synonym Qualifier,qualifier
• Record Qualifier; orqualifier
• Variable Qualifierqualifier

Product Impact on Individual Health only:

For multiple values

(e.g., due to a "Check all that apply" instruction on a CRF)

:

• The variable will be populated with "MULTIPLE".
• The SUPP-- dataset will represent individual responses.
  • The value of -- values for QNAM will be sequential variable names, formed by appending a 1-digit integer, beginning with 1, to the name of the variable in the parent dataset appended with a number or letter.
  • In some cases, the standard variable name will be shortened to meet the 8-character variable name requirement, or it may be clearer to append a meaningful character string as shown in the second Adverse Events (AE) example below, where the first 3 characters of the drug name are appended. Likewise, the QLABEL value should be similar to the standard label. The values stored in QVAL should be consistent with the controlled terminology associated with the standard variable. See Section 8.4, Relating Non-standard Variable Values to a Parent Domain, for additional guidance on maintaining appropriately unique QNAM values.
  original domain variable name. In cases where the standard domain variable name is already 8 characters in length, applicants will replace the last character with a digit when creating values for QNAM.
  • The value for QLABEL should be the original domain variable label for all QNAM values.

If

f multiple values (--VAL)  are are reported for a for a parameter in a Trial Design or Study Reference dataset (e.g., TS, OI), multiple records should be submitted for that the --PARMCD.
For example,

• TSPARMCD = "TTYPE", TSPARM = "Trial Type", TSVAL = "EFFICACY"
• TSPARMCD = "TTYPE", TSPARM = "Trial Type", TSVAL = "SAFETY"

When a parameter can have multiple values, the key structure for the dataset must be adequate to distinguish between the multiple records. See Section 4.1.9, Assigning Natural Keys in the Metadata.

, unless the CDISC notes for the parameter indicate otherwise (e.g., TXPARMCD=LIGHT) 

Single concept

SEND

A single concepts represented by multiple values

Nonclinical only:

• A single value may represent a combination of multiple contributing items, delimited by slashes ("/"). In

• such cases, the combination is the collected value, the value analyzed, and so on—not the individual contributing items composing the value.

• When controlled terminology applies to the variable, the combination of concepts may already exist as a controlled terminology term. If this is not the case, then a new term will be constructed by combining existing controlled terms, when possible. 
• For example, DEGENERATION/REGENERATION is a microscopic finding that is a single concept represented by multiple values (which is different from having 2 separately collected findings of degeneration and regeneration, with 2 separate records respectively).

In these scenarios, when controlled terminology applies to the corresponding variable, the combination may already exist as a controlled terminology term; in the specimen list, this is the case for several commonly combined tissues. However, there do exist combinations that do not have a dedicated controlled term and whose rarity does not warrant creating an individual controlled term for the specific combination. In these cases, when constructing the combination term, each of the contributing items should abide by controlled terminology where possible, in order to keep the combination term consistent and easily interpretable. For example, in the TESTIS/EPIDIDYMIS case, TESTIS (the preferred term for this tissue) should be used instead of TESTES, Testis, testes, and so on, and EPIDIDYMIS should be used instead of EPIDIDYMIDES or other variations. As always, the SEND Controlled Terminology Team will evaluate feedback regarding potential new terms.

SEND

Multiple concepts represented by multiple valuesIn some cases, a

Nonclinical only:

• A variable value may

• represent multiple individual values. In

• such cases, each contributing value is a separately collected or analyzed item.

• When controlled terminology applies to the

• variable, controlled terms for each

• value

• will be represented delimited by semicolons.
• For example, multiple distinct values may be collected for directionality (--DIR), may be collected for a result. Values may be represented using controlled terminology as "VENTRAL;SURFACE".