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

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 values for QNAM will be sequential variable names, formed by appending a 1-digit integer, beginning with 1, to the 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 multiple values (--VAL) are reported for a parameter in a Trial Design dataset (e.g., TS), multiple records should be submitted for the --PARMCD. For example:

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

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."