Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 QS 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 QS 2 DOMAIN Domain Abbreviation Char QS Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 QS 3 USUBJID Unique Subject Identifier Char Identifier Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Req
SDTMIG 3.3 QS 4 QSSEQ Sequence Number Num Identifier Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. Req
SDTMIG 3.3 QS 5 QSGRPID Group ID Char Identifier Used to tie together a block of related records in a single domain for a subject. Perm
SDTMIG 3.3 QS 6 QSSPID Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Question number on a questionnaire. Perm
SDTMIG 3.3 QS 7 QSTESTCD Question Short Name Char Topic Topic variable for QS. Short name for the value in QSTEST, which can be used as a column name when converting the dataset from a vertical format to a horizontal format. The value in QSTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). QSTESTCD cannot contain characters other than letters, numbers, or underscores. Controlled terminology for QSTESTCD is published in separate codelists for each questionnaire. See https://www.cdisc.org/standards/semantics/terminology for values for QSTESTCD. Examples: "ADCCMD01", "BPR0103". Req
SDTMIG 3.3 QS 8 QSTEST Question Name Char Synonym Qualifier Verbatim name of the question or group of questions used to obtain the measurement or finding. The value in QSTEST cannot be longer than 40 characters. Controlled terminology for QSTEST is published in separate codelists for each questionnaire. See https://www.cdisc.org/standards/semantics/terminology for vaues for QSTEST. Example: "BPR01 - Emotional Withdrawal". Req
SDTMIG 3.3 QS 9 QSCAT Category of Question Char (QSCAT) Grouping Qualifier Used to specify the questionnaire in which the question identified by QSTEST and QSTESTCD was included. Examples: "ADAS-COG", "MDS-UPDRS". Req
SDTMIG 3.3 QS 10 QSSCAT Subcategory for Question Char Grouping Qualifier A further categorization of the questions within the category. Examples: "MENTAL HEALTH" , "DEPRESSION", "WORD RECALL". Perm
SDTMIG 3.3 QS 11 QSORRES Finding in Original Units Char Result Qualifier Finding as originally received or collected (e.g., "RARELY", "SOMETIMES"). When sponsors apply codelist to indicate the code values are statistically meaningful standardized scores, which are defined by sponsors or by valid methodologies such as SF36 questionnaires, QSORRES will contain the decode format, and QSSTRESC and QSSTRESN may contain the standardized code values or scores. Exp
SDTMIG 3.3 QS 12 QSORRESU Original Units Char (UNIT) Variable Qualifier Original units in which the data were collected. The unit for QSORRES, such as minutes or seconds or the units associated with a visual analog scale. Perm
SDTMIG 3.3 QS 13 QSSTRESC Character Result/Finding in Std Format Char Result Qualifier Contains the finding for all questions or sub-scores, copied or derived from QSORRES in a standard format or standard units. QSSTRESC should store all findings in character format; if findings are numeric, they should also be stored in numeric format in QSSTRESN. If question scores are derived from the original finding, then the standard format is the score. Examples: "0", "1". When sponsors apply codelist to indicate the code values are statistically meaningful standardized scores, which are defined by sponsors or by valid methodologies such as SF36 questionnaires, QSORRES will contain the decode format, and QSSTRESC and QSSTRESN may contain the standardized code values or scores. Exp
SDTMIG 3.3 QS 14 QSSTRESN Numeric Finding in Standard Units Num Result Qualifier Used for continuous or numeric findings in standard format; copied in numeric format from QSSTRESC. QSSTRESN should store all numeric results or findings. Perm
SDTMIG 3.3 QS 15 QSSTRESU Standard Units Char (UNIT) Variable Qualifier Standardized unit used for QSSTRESC or QSSTRESN. Perm
SDTMIG 3.3 QS 16 QSSTAT Completion Status Char (ND) Record Qualifier Used to indicate that a question was not done or was not answered. Should be null if a result exists in QSORRES. Perm
SDTMIG 3.3 QS 17 QSREASND Reason Not Performed Char Record Qualifier Describes why a question was not answered. Used in conjunction with QSSTAT when value is "NOT DONE". Example: "SUBJECT REFUSED". Perm
SDTMIG 3.3 QS 18 QSLOBXFL Last Observation Before Exposure Flag Char (NY) Record Qualifier Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. Should be "Y" or null. Perm
SDTMIG 3.3 QS 19 QSBLFL Baseline Flag Char (NY) Record Qualifier Indicator used to identify a baseline value. Should be "Y" or null. Note that QSBLFL is retained for backward compatibility. The authoritative baseline for statistical analysis is in an ADaM dataset. Perm
SDTMIG 3.3 QS 20 QSDRVFL Derived Flag Char (NY) Record Qualifier Used to indicate a derived record. The value should be "Y" or null. Records that represent the average of other records or questionnaire sub-scores that do not come from the CRF are examples of records that would be derived for the submission datasets. If QSDRVFL = "Y", then QSORRES may be null with QSSTRESC and (if numeric) QSSTRESN having the derived value. Perm
SDTMIG 3.3 QS 21 QSEVAL Evaluator Char (EVAL) Record Qualifier Role of the person who provided the evaluation. Examples: "STUDY SUBJECT", "CAREGIVER", "INVESTIGATOR". Perm
SDTMIG 3.3 QS 22 VISITNUM Visit Number Num Timing 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting. Exp
SDTMIG 3.3 QS 23 VISIT Visit Name Char Timing 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY. Perm
SDTMIG 3.3 QS 24 VISITDY Planned Study Day of Visit Num Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm
SDTMIG 3.3 QS 25 TAETORD Planned Order of Element within Arm Num Timing Number that gives the planned order of the Element within the Arm for the Element in which the assessment was made. Perm
SDTMIG 3.3 QS 26 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the observation date/time of the physical exam finding. Perm
SDTMIG 3.3 QS 27 QSDTC Date/Time of Finding Char ISO 8601 Timing Date of questionnaire. Exp
SDTMIG 3.3 QS 28 QSDY Study Day of Finding Num Timing 1. Study day of finding collection, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. Perm
SDTMIG 3.3 QS 29 QSTPT Planned Time Point Name Char Timing 1. Text description of time when questionnaire should be administered. 2. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See QSTPTNUM and QSTPTREF. Perm
SDTMIG 3.3 QS 30 QSTPTNUM Planned Time Point Number Num Timing Numerical version of QSTPT to aid in sorting. Perm
SDTMIG 3.3 QS 31 QSELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Planned elapsed time (in ISO 8601) relative to a planned fixed reference (QSTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by QSTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by QSTPTREF. Perm
SDTMIG 3.3 QS 32 QSTPTREF Time Point Reference Char Timing Name of the fixed reference point referred to by QSELTM, QSTPTNUM, and QSTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL". Perm
SDTMIG 3.3 QS 33 QSRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Date/time of the reference time point, QSTPTREF. Perm
SDTMIG 3.3 QS 34 QSEVLINT Evaluation Interval Char ISO 8601 Timing Evaluation interval associated with a QSTEST question represented in ISO 8601 character format. Example: "-P2Y" to represent an interval of 2 years in the question "Have you experienced any episodes in the past 2 years?". Perm