| STUDYID |
Study Identifier |
Char |
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviation |
Char |
Identifier |
Two-character abbreviation for the domain. |
Req |
| 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 |
| QSSEQ |
Sequence Number |
Num |
Identifier |
Sequence number given to ensure uniqueness of subject
records within a domain. May be any valid number. |
Req |
| QSGRPID |
Group ID |
Char |
Identifier |
Used to tie together a block of related records in a single
domain for a subject. |
Perm |
| 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 |
| 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 |
| 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 |
| QSCAT |
Category of Question |
Char |
Grouping Qualifier |
Used to specify the questionnaire in which the question
identified by QSTEST and QSTESTCD was included. Examples:
"ADAS-COG", "MDS-UPDRS". |
Req |
| QSSCAT |
Subcategory for Question |
Char |
Grouping Qualifier |
A further categorization of the questions within the
category. Examples: "MENTAL HEALTH" , "DEPRESSION", "WORD RECALL". |
Perm |
| 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 |
Exp |
| |
|
|
|
QSSTRESN may contain the standardized code values or scores.
|
|
| QSORRESU |
Original Units |
Char |
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 |
| 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 |
| 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 |
| QSSTRESU |
Standard Units |
Char |
Variable Qualifier |
Standardized unit used for QSSTRESC or QSSTRESN. |
Perm |
| QSSTAT |
Completion Status |
Char |
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 |
| 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 |
| QSLOBXFL |
Last Observation Before Exposure Flag |
Char |
Record Qualifier |
Operationally-derived indicator used to identify the last
non-missing value prior to RFXSTDTC. Should be "Y" or null. |
Perm |
| QSBLFL |
Baseline Flag |
Char |
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 |
| QSDRVFL |
Derived Flag |
Char |
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 |
| QSEVAL |
Evaluator |
Char |
Record Qualifier |
Role of the person who provided the evaluation. Examples:
"STUDY SUBJECT", "CAREGIVER", "INVESTIGATOR". |
Perm |
| VISITNUM |
Visit Number |
Num |
Timing |
Clinical encounter number. Numeric version of VISIT, used
for sorting. |
Exp |
| VISIT |
Visit Name |
Char |
Timing |
Protocol-defined description of clinical encounter. May be
used in addition to VISITNUM and/or VISITDY. |
Perm |
| VISITDY |
Planned Study Day of Visit |
Num |
Timing |
Planned study day of the visit based upon RFSTDTC in
Demographics. |
Perm |
| 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 |
| EPOCH |
Epoch |
Char |
Timing |
Epoch associated with the observation date/time of the
physical exam finding. |
Perm |
| QSDTC |
Date/Time of Finding |
Char |
Timing |
Date of questionnaire. |
Exp |
| QSDY |
Study Day of Finding |
Num |
Timing |
Study day of finding collection, measured as integer days.
Algorithm for calculations must be relative to the sponsor-defined
RFSTDTC variable in Demographics. |
Perm |
| QSTPT |
Planned Time Point Name |
Char |
Timing |
Text description of time when questionnaire should be
administered. 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 |
| QSTPTNUM |
Planned Time Point Number |
Num |
Timing |
Numerical version of QSTPT to aid in sorting. |
Perm |
| QSELTM |
Planned Elapsed Time from Time Point Ref |
Char |
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 |
| 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 |
| QSRFTDTC |
Date/Time of Reference Time Point |
Char |
Timing |
Date/time of the reference time point, QSTPTREF. |
Perm |
| QSEVLINT |
Evaluation Interval |
Char |
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 |