Questionnaires
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Unique identifier for a study. Controlled Terms or Format (if applicable): NA
text
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Two-character abbreviation for the domain. Controlled Terms or Format (if applicable): QS
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Controlled Terms or Format (if applicable): NA
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. Controlled Terms or Format (if applicable): NA
integer
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Used to tie together a block of related records in a single domain for a subject. Controlled Terms or Format (if applicable): NA
Role: Identifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Topic CDISC Notes (for domains) Description (for General Classes): 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". Controlled Terms or Format (if applicable): NA
Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): 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". Controlled Terms or Format (if applicable): NA
Role: Grouping Qualifier CDISC Notes (for domains) Description (for General Classes): Used to specify the questionnaire in which the question identified by QSTEST and QSTESTCD was included. Examples: "ADAS-COG", "MDS-UPDRS". Controlled Terms or Format (if applicable): (QSCAT), extensible
Role: Grouping Qualifier CDISC Notes (for domains) Description (for General Classes): A further categorization of the questions within the category. Examples: "MENTAL HEALTH" , "DEPRESSION", "WORD RECALL". Controlled Terms or Format (if applicable): NA
Role: Result Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): (UNIT), extensible
Role: Result Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Result Qualifier CDISC Notes (for domains) Description (for General Classes): Used for continuous or numeric findings in standard format; copied in numeric format from QSSTRESC. QSSTRESN should store all numeric results or findings. Controlled Terms or Format (if applicable): NA
float
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Standardized unit used for QSSTRESC or QSSTRESN. Controlled Terms or Format (if applicable): (UNIT), extensible
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Used to indicate that a question was not done or was not answered. Should be null if a result exists in QSORRES. Controlled Terms or Format (if applicable): (ND)
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Describes why a question was not answered. Used in conjunction with QSSTAT when value is "NOT DONE". Example: "SUBJECT REFUSED". Controlled Terms or Format (if applicable): NA
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. Should be "Y" or null. Controlled Terms or Format (if applicable): (NY), not extensible
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): (NY), not extensible
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): (NY), not extensible
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Role of the person who provided the evaluation. Examples: "STUDY SUBJECT", "CAREGIVER", "INVESTIGATOR". Controlled Terms or Format (if applicable): (EVAL), extensible
Role: Timing CDISC Notes (for domains) Description (for General Classes): 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): Planned study day of the visit based upon RFSTDTC in Demographics. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): Number that gives the planned order of the Element within the Arm for the Element in which the assessment was made. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): Epoch associated with the observation date/time of the physical exam finding. Controlled Terms or Format (if applicable): (EPOCH), extensible
Role: Timing CDISC Notes (for domains) Description (for General Classes): Date of questionnaire. Controlled Terms or Format (if applicable): ISO 8601
datetime
Role: Timing CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): Numerical version of QSTPT to aid in sorting. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): ISO 8601
durationDatetime
Role: Timing CDISC Notes (for domains) Description (for General Classes): Name of the fixed reference point referred to by QSELTM, QSTPTNUM, and QSTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL". Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): Date/time of the reference time point, QSTPTREF. Controlled Terms or Format (if applicable): ISO 8601
Role: Timing CDISC Notes (for domains) Description (for General Classes): 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?". Controlled Terms or Format (if applicable): ISO 8601