Introduction and Purpose: This document supplements SDTMIG V3.1.x, Section 6.3.5 Questionnaire – QS. Its purpose is two-fold:

  1. to provide sponsors with additional guidance around what clinical data as a whole belongs in the SDTMIGQuestionnaire (QS) domain
  2. to provide sponsors with guidance around the submission ofquestionnaire items that by definition might belong in other SDTM domains.

1.Determining SDTM Questionnaire Domain Content

a.What Data Belongs in the SDTMIGQuestionnaireDomain?

An SDTMIG Questionnaire is an instrument which is administered to a respondent and has all of the following characteristics:

Consists of conceptuallyrelated items that solicit responses that are scored*.

  • Each item contributes to the overall concept assessment. Together the items represent a cohesive group, where all are essential for assessing the concept and none is intended to be used outside of the constructs of the questionnaire.

Has as its primary purpose the generation of ascore to provide an assessment of a specific concept at a certain point in time or interval of time.

  • A score from a questionnaire likely has no relevant meaning outside the realm of the instrument itself andwill requiresupportive documentation for interpretation and analysis.

Has a defined and documented structure, format, and content for items and any pre-defined responses.

Has documented methods for administration and scoring, and typically methods for analysis and interpretation of results.

*Score: A number (or ordered categorical result) derived from a subject’s response. A score is computed based on a pre-specified scoring algorithm and is subsequently used in the collective analysis and interpretation of the responses. Scores can be computed for individual items, concepts, or sub-concepts, or as a summary of items, concepts, or sub-concepts.

Data from instruments meeting the above criteria should be submitted in the SDTMIG QS Domain unlessa CDISC foundational standard or Therapeutic Area standard specifies otherwise.

Sponsor-defined instruments that meet all of the criteria above should be submitted in the SDTM QS Domain.

Certain characteristics have no relevancein the determination of whether or not an instrument is an SDTM Questionnaire. These include the following:

  • the number of items within the instrument
  • the number of scores assigned or derived from the instrument
  • the number of times the instrument is administered to or completed by a subject
  • the person or persons who complete the instrument
  • whether the solicited responses are objective or subjective in nature
  • whether the solicited responses are quantitative or qualitative in nature
  • the method of administration for the instrument.

Here are some examples of instruments considered to be SDTMIG Questionnaires:

  • SF-36 Health Survey (SF-36)
  • Hamilton Rating Scale for Depression (HAM-D)
  • Karnofsky Performance Scale
  • Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
  • Current Opioid Misuse Measure (COMM)
  • Mini Mental State Examination (MMSE)
  • The Movement Disorder Society version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS).

b.What Data Does Not Belong in theSDTM Questionnaire Domain?

Data from instruments thatconsist of items that are not scored, including items that are direct quantitative measurements, should not be submitted in the SDTM QS Domain. Rather, sponsors should choose another appropriate Findings domain model.

Here are some examples of data that should not be submitted in the SDTM Questionnaire domain:

  • patient diary that collects the number of tablets of study medication taken per day
  • polysomnography study that measures the number of apnea and hypopnea events per hour.

c.What Data within a Questionnaire Belongs in the SDTMIG Questionnaire Domain?

A questionnairemay collect and assign a score to a data point with a topic that falls under another defined SDTM domain. For an instrument that has been determined to be an SDTM questionnaire per the criteria above, sponsors should submit all questionnaire-collected data elementstogether in the SDTM Questionnaire domain, regardless of the topic of the data element.

As an example, an instrument may collect a numeric systolic blood pressure measurement in mmHg and then assign a score to that measurement. Per SDTMIG, blood pressure measurements belong in the Vital Signs (VS) domain. However, because the blood pressure measurement here is defined as part of the instrument, collected within the constructs of the instrument, and used directly to assign a score, the blood pressure measurement should remain as an itemwithin the QS domain along with the assigned score.

Optionally, and/or based on specific submission needs, sponsors may wish to include suchdata values in the relevant topic-based SDTMIG domain in addition to being in QS. In these cases, sponsors should use the appropriate SDTM-basedmechanisms to unambiguously link these data valueswith the accompanying scores in the QS domain.

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