SDTM.QS

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	QS	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	QS	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	QS	USUBJID	Unique Subject Identifier	Char		Identifier	Req	Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4	QS	QSSEQ	Sequence Number	Num		Identifier	Req	Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	QS	QSGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain for a subject.
6	QS	QSSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	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.
7	QS	QSTESTCD	Question Short Name	Char		Topic	Req	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".
8	QS	QSTEST	Question Name	Char		Synonym Qualifier	Req	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".
9	QS	QSCAT	Category of Question	Char	C100129	Grouping Qualifier	Req	Used to specify the questionnaire in which the question identified by QSTEST and QSTESTCD was included. Examples: "ADAS-COG", "MDS-UPDRS".
10	QS	QSSCAT	Subcategory for Question	Char		Grouping Qualifier	Perm	A further categorization of the questions within the category. Examples: "MENTAL HEALTH" , "DEPRESSION", "WORD RECALL".
11	QS	QSORRES	Finding in Original Units	Char		Result Qualifier	Exp	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.
12	QS	QSORRESU	Original Units	Char	C71620	Variable Qualifier	Perm	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.
13	QS	QSSTRESC	Character Result/Finding in Std Format	Char		Result Qualifier	Exp	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.
14	QS	QSSTRESN	Numeric Finding in Standard Units	Num		Result Qualifier	Perm	Used for continuous or numeric findings in standard format; copied in numeric format from QSSTRESC. QSSTRESN should store all numeric results or findings.
15	QS	QSSTRESU	Standard Units	Char	C71620	Variable Qualifier	Perm	Standardized unit used for QSSTRESC or QSSTRESN.
16	QS	QSSTAT	Completion Status	Char	C66789	Record Qualifier	Perm	Used to indicate that a question was not done or was not answered. Should be null if a result exists in QSORRES.
17	QS	QSREASND	Reason Not Performed	Char		Record Qualifier	Perm	Describes why a question was not answered. Used in conjunction with QSSTAT when value is "NOT DONE". Example: "SUBJECT REFUSED".
18	QS	QSLOBXFL	Last Observation Before Exposure Flag	Char	C66742	Record Qualifier	Perm	Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. Should be "Y" or null.
19	QS	QSBLFL	Baseline Flag	Char	C66742	Record Qualifier	Perm	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.
20	QS	QSDRVFL	Derived Flag	Char	C66742	Record Qualifier	Perm	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.
21	QS	QSEVAL	Evaluator	Char	C78735	Record Qualifier	Perm	Role of the person who provided the evaluation. Examples: "STUDY SUBJECT", "CAREGIVER", "INVESTIGATOR".
22	QS	VISITNUM	Visit Number	Num		Timing	Exp	1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
23	QS	VISIT	Visit Name	Char		Timing	Perm	1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
24	QS	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the visit based upon RFSTDTC in Demographics.
25	QS	TAETORD	Planned Order of Element within Arm	Num		Timing	Perm	Number that gives the planned order of the Element within the Arm for the Element in which the assessment was made.
26	QS	EPOCH	Epoch	Char	C99079	Timing	Perm	Epoch associated with the observation date/time of the physical exam finding.
27	QS	QSDTC	Date/Time of Finding	Char	ISO 8601	Timing	Exp	Date of questionnaire.
28	QS	QSDY	Study Day of Finding	Num		Timing	Perm	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.
29	QS	QSTPT	Planned Time Point Name	Char		Timing	Perm	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.
30	QS	QSTPTNUM	Planned Time Point Number	Num		Timing	Perm	Numerical version of QSTPT to aid in sorting.
31	QS	QSELTM	Planned Elapsed Time from Time Point Ref	Char	ISO 8601	Timing	Perm	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.
32	QS	QSTPTREF	Time Point Reference	Char		Timing	Perm	Name of the fixed reference point referred to by QSELTM, QSTPTNUM, and QSTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".
33	QS	QSRFTDTC	Date/Time of Reference Time Point	Char	ISO 8601	Timing	Perm	Date/time of the reference time point, QSTPTREF.
34	QS	QSEVLINT	Evaluation Interval	Char	ISO 8601	Timing	Perm	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?".