Adhering to Dataset Record Structure

If multiple values are reported for an intervention or event topic variable (e.g., --TRT in an Interventions general observation-class dataset or --TERM in an Events general observation-class dataset), it is expected that the sponsor will split the values into multiple records or otherwise resolve the multiplicity per the sponsor's data management standard operating procedures. For example, if an adverse event term of "Headache and nausea" or a concomitant medication of "Tylenol and Benadryl" is reported, sponsors will often split the original report into separate records and/or query the site for clarification. By the time of submission, datasets should be in conformance with the record structures described in the SDTMIG.

Note: 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 is permitted according to the domain structure. For cases of multiple reasons for discontinuation see Section 6.2.4, Disposition, assumption 5 for additional information.

If multiple result values (--ORRES) are reported for a test in a Findings class dataset, multiple records should be submitted for that --TESTCD.
For example,

• EGTESTCD = "SPRTARRY", EGTEST = "Supraventricular Tachyarrhythmias", EGORRES = "ATRIAL FIBRILLATION"
• EGTESTCD = "SPRTARRY", EGTEST = "Supraventricular Tachyarrhythmias", EGORRES = "ATRIAL FLUTTER"

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 value for the qualifier variable should be "MULTIPLE" and SUPP-- should be used to store the individual responses. It is recommended that the SUPP-- QNAM value reference the corresponding standard domain variable with an appended 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.

If the sponsor has clearly documented that one response is of primary interest (e.g., in the CRF, protocol, or analysis plan), the standard domain variable may be populated with the primary response and SUPP-- may be used to store the secondary response(s).

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."