Adhering to Dataset Record Structure

If multiple values are reported for an Intervention or Event general observations 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 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-TESTCD).

Multiple Values for a Variable with Role:

• Grouping Qualifier,
• Synonym Qualifier,
• Record Qualifier; or
• Variable Qualifier

• The SDTM permits 1 value for each qualifier variable per record.
• If multiple values exist (e.g., due to a "Check all that apply" instruction on a CRF), then:
  • The variable will be populated with "MULTIPLE".
  • The SUPP-- dataset will represent individual responses.
    • The value of -- QNAM will be 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.

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

SEND

A single concepts represented by multiple values

A single value may represent a combination of multiple contributing items, delimited by slashes ("/"). In these cases, the combination is the collected value, the value analyzed, and so on—not the individual contributing items composing the value.
A noteworthy example of this scenario is combined specimens, where a single specimen may consist of material from various tissues, and the combination is examined and analyzed together during an examination. For example, a specimen consisting of testis and epididymis tissues would be included as "TESTIS/EPIDIDYMIS". Another example is the DEGENERATION/REGENERATION microscopic finding: a single concept represented by multiple values (which is different from having 2 separately collected findings of degeneration and regeneration, 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 values

In some cases, a variable value may comprise multiple individual values. In these cases, each contributing value is a separately collected or analyzed item. This case is notably present in the directionality (--DIR), where often, multiple distinct values might be collected for a given record. In these scenarios, when controlled terminology applies to the corresponding variable, each contributing value must be included as its controlled terminology submission value, and delimited from other terms by a semicolon. For example, a finding with 2 directionality values of ventral and surface would be included as "VENTRAL;SURFACE."