term
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⌀ | sources
listlengths 1
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stringclasses 48
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stringclasses 26
values | sheet
stringclasses 3
values | text
stringclasses 212
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|---|---|---|---|---|---|---|---|
Record
|
Describes the severity or intensity of a particular finding. Examples: MILD, MODERATE, SEVERE. --LLOQ
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Variable Qualifier of
|
--VAMT Units for the treatment vehicle. Examples: mL, puffs. --ADJ
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 14
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CDISC, © 2007. All rights reserved July 25, 2007
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[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
of --TERM
|
Dictionary or sponsor-defined derived text description of the topic variable, --TERM, or the modified topic variable (--MODIFY), if applicable. Equivalent to the Preferred Term (PT in MedDRA). --CAT
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
of
|
--TESTCD LOINC Code for the topic variable such as a lab test. --SPEC Specimen Material Type
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Qualifier
|
Value of TSPARM. Example: 'ASTHMA' when TSPARM value is 'Trial Indications'. TSVAL cannot be null – a value is required for the record to be valid. The first 200 characters of TSVAL will be in TSVAL, then next 200 in TSVAL1, and continuing as needed to TSVALn.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Qualifier of
|
--STRESN Indicates the lower limit of quantitation for an assay. Units will be those used for --STRESU. CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, © 2007. All rights reserved
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
and
|
--STRESN Standardized units used for --STRESC and --STRESN. Example: mmol/L. --BODSYS
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
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[
"SDTM.pdf"
] |
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|
pdf
|
glossary.json
| null | null |
Char
|
Since QVAL can represent a mixture of collected (on a CRF), derived, or assigned items, QORIG is used to indicate the origin of this data. Examples include CRF, ASSIGNED, or DERIVED. See Section 4.1.1.7.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Num
|
Identifier Sequence number given to ensure uniqueness within a dataset. Allows inclusion of multiple records for the same TSPARMCD, and can be used to join related records.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
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[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
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glossary.json
| null | null |
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[
"SDTM.pdf"
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pdf
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glossary.json
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|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Standard Format
|
3.1 STANDARD METADATA FOR DATASET CONTENTS AND
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
ATTRIBUTES
|
The SDTMIG provides standard descriptions of some of the most commonly used data domains, using the metadata attributes originally described in the CDISC Submission Metadata Model. The descriptive metadata attributes that should be included in a submission dataset definition file as applied in the domain models are: • The SDTMIG -standard variable name (standardized for all submissions, even though sponsors may be using other variable names internally in their operational database) • The SDTMIG -standard variable label • Expected data types (the SDTMIG uses character or numeric to conform to the data types consistent with SAS V5 transport file format, but Define.xml allows for more descriptive data types, such as integer or float) • The actual controlled terms and formats used by the sponsor (do not include the asterisk (*) included in the CDISC domain models to indicate when controlled terminology applies) • The origin or source of the data (e.g., CRF, derived - see definitions in Section 4.1.1.7) • The role of the variable in the dataset corresponding to the role in the SDTM if desired. Since these roles are predefined for all standard domains that follow the general observation classes, they do not need to be specified by sponsors in their Define data definition document for these domains.) • Any Comments provided by the sponsor that may be useful to the Reviewer in understanding the variable or the data in it. In addition to these metadata attributes, the CDISC domain models include three other shaded columns that are not sent to the FDA in order to assist sponsors in preparing their datasets — one column for notes relevant to the use of each variable, one to indicate how a variable is classified as a CDISC Core Variable (see Section 4.1.1.5), and one to provide references to relevant section of the SDTM or the SDTMIG. See the Define.xml specification for information about additional metadata attributes required in that standard. The domain models in Section 6 illustrate how to apply the SDTM when creating a specific domain dataset. In particular, these models illustrate the selection of a subset of the variables offered in one of the general observation classes along with applicable timing variables. The models also show how a standard variable from a general observation class should be adjusted to meet the specific content needs of a particular domain, including making the label more meaningful, specifying controlled terminology, and creating domain-specific notes and examples. Thus the domain models demonstrate not only how to apply the model for the most common domains, but also give insight on how to apply general model concepts to other domains not yet defined by CDISC. CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, © 2007. All rights reserved
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Demographics
|
dm.xpt One record per subject
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Subject Elements
|
se.xpt One record per actual Element
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Subject Visits
|
sv.xpt One record per actual visit per
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Medications
|
Interventions See Section 6.1.1.1, Assumption 1. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Exposure
|
Interventions See Section 6.1.2.1, Assumption 1. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Substance Use
|
Interventions See Section 6.1.3.1, Assumption 1 Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Adverse Events
|
ae.xpt One record per adverse event
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Disposition
|
ds.xpt One record per disposition status or protocol milestone per
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Medical History
|
mh.xpt One record per medical history
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Deviations
|
dv.xpt One record per protocol
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
DVSTDTC
|
CDISC SDTM Implementation Guide (Version 3.1.2)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Page 24
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[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Clinical Events
|
ce.xpt One record per event per
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
One record per ECG
|
observation per time point per
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Results
|
--VSORRESU, VSSTRESU Populated using a code value in the list of controlled terms, codelist VSRESU (C66770) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Tabulation
|
STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL,
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Examination
|
pe.xpt One record per body system or abnormality per visit per
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Questionnaires
|
qs.xpt One record per question per questionnaire per time point per
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Characteristics
|
sc.xpt One record per characteristic
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Vital Signs
|
vs.xpt One record per vital sign measurement per time point per
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Specimen
|
mb.xpt One record per microbiology specimen finding per time point
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Test
|
ms.xpt One record per microbiology susceptibility test (or other organism-related finding) per
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Concentrations
|
pc.xpt One record per time-point concentration or sample characteristic per analyte per
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
PCTPTREF
|
CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, © 2007. All rights reserved
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Parameters
|
pp.xpt One record per PK parameter per time-concentration profile per modeling method per
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Clinical Findings
|
cf.xpt One record per finding per subject per visit per time point
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Trial Arms
|
Trial Design See SDTM 3.2. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Trial Elements
|
Trial Design See SDTM 3.2. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Trial Visits
|
Trial Design See SDTM 3.2. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Exclusion Criteria
|
Trial Design See SDTM 3.4. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Trial Summary
|
Trial Design See SDTM 3.5. Included as a value in the list of controlled terms, codelist Domain Abbreviation (C66734) at http://www.cdisc.org/standards/terminology/index.html
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Related Records
|
relrec.xpt One record per related record, group of records or datasets
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Qualifiers for
|
[domain name] suppqual.xpt or supp--.xpt One record per IDVAR, IDVARVAL, and QNAM per
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
QNAM
|
†Separate Supplemental Qualifier tables of the form supp--.xpt are recommended. See Section 8.4. 3.2.1.1
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
PRIMARY KEYS
|
Table 3.2.1 above shows examples of what a sponsor might submit as variables that comprise the primary key for SDTM datasets. Since the purpose of this column is to aid reviewers in understanding the structure of a dataset, sponsors should list all of the natural keys (see definition below) for the dataset. These keys should define uniqueness for records within a dataset, and may define a record sort order. The naming of these keys should be consistent with the description of the structure in the Structure column. For all the general-observation-class domains (and for some special-purpose domains), the --SEQ variable was created so that a unique record could be identified consistently across all of these domains via its use, along with STUDYID, USUBJID, DOMAIN. In most domains, --SEQ will be a surrogate key (see definition below) for a set of variables which comprise the natural key. In certain instances, a Supplemental Qualifier (SUPP--) variable might also contribute to the natural key of a record for a particular domain. See assumption 4.1.1.8 for how this should be represented, and for additional information on keys. A natural key is a piece of data (one or more columns of an entity) that uniquely identify that entity, and distinguish it from any other row in the table. A natural key is controlled from outside the database environment. The advantage of natural keys is that they exist already, and one does not need to introduce a new “unnatural” value to the data schema. One of the difficulties in choosing a natural key is that just about any natural key one can think of has the potential to change. Because they have business meaning, natural keys are effectively coupled to the business, and they may need to be reworked when business requirements change. An example of such a change in clinical trials CDISC SDTM Implementation Guide (Version 3.1.2)
|
[
"SDTM.pdf"
] |
SDTM.pdf
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pdf
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glossary.json
| null | null |
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[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Topic variable
|
• Conforming to all business rules described in the CDISC Notes column and general and domain-specific assumptions. CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, © 2007. All rights reserved
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Models
|
4.1 GENERAL ASSUMPTIONS FOR ALL DOMAINS 4.1.1 GENERAL DOMAIN ASSUMPTIONS 4.1.1.1 REVIEW STUDY DATA TABULATION AND IMPLEMENTATION GUIDE Review the Study Data Tabulation Model as well as this Implementation Guide before attempting to use any of the individual domain models. See the Case Report Tabulation Data Definition Specification (define.xml), available on the CDISC website, for information about an xml representation of the Define data definition document. 4.1.1.2 RELATIONSHIP TO ANALYSIS DATASETS Specific guidance on preparing analysis datasets can be found in the CDISC Analysis Dataset Model General Considerations document, available at http://www.cdisc.org/models/adam/V2.0/index.html . 4.1.1.3 ADDITIONAL TIMING VARIABLES Additional Timing variables (Section 2.4.5) can be added as needed to a standard domain model based on the three general observation classes except where discouraged in Assumption 4.1.4.8 and specific domain assumptions. Timing variables can be added to special-purpose domains only where specified in the SDTMIG domain model assumptions. Timing variables cannot be added to SUPPQUAL datasets or to RELREC (described in Section 8). 4.1.1.4 ORDER OF THE VARIABLES The order of variables in the Define data definition document should reflect the order of variables in the dataset. The current order of variables in the CDISC domain models has been chosen to facilitate the review of the models and application of the models. Sponsors may thus wish to reorder Timing and Qualifier variables in order to place more emphasis on the most important variables, but are encouraged to apply a consistent variable-ordering scheme for all domains in a submission wherever possible. 4.1.1.5
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
CDISC CORE VARIABLES
|
The concept of core variable is used both as a measure of compliance, and to provide general guidance to sponsors Three categories of variables are specified in the 'Core' column in the domain models: • A Required variable is any variable that is basic to the identification of a data record (i.e., essential key variables and a topic variable) or is necessary to make the record meaningful. Required variables must always be included in the dataset and cannot be null for any record. • An Expected variable is any variable necessary to make a record useful in the context of a specific domain. Columns for Expected variables must be present in each submitted dataset even if all values are null. Expected variables may contain some null values, but in most cases will not contain null values for every record; however, when no data has been collected for an expected variable, a null column should still be included in the dataset, and a comment should be included in the Define data definition document to state that data was not collected. • A Permissible variable should be used in a domain as appropriate when collected or derived. Except where restricted by specific domain assumptions, any SDTM Timing and Identifier variables, and any Qualifier variables from the same general observation class are permissible for use in a domain based on that general observation class. The Sponsor can decide whether a Permissible variable should be included as a column when all values for that variable are null. CDISC SDTM Implementation Guide (Version 3.1.2)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
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] |
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pdf
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glossary.json
| null | null |
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[
"SDTM.pdf"
] |
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pdf
|
glossary.json
| null | null |
Rotation of the hand
|
• Method of measurement (X-ray / MRI) •
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Machine Make
|
CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, © 2007. All rights reserved
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Machine Model
|
Trying to encapsulate all of this information within a unique value of a --TESTCD results in the creation of a potentially large number of test codes, with the eight-character values of --TESTCD becoming less intuitively meaningful. Additionally, multiple test codes are essentially representing the same test or measurement simply to accommodate attributes of a test within the --TESTCD value itself (e.g., to represent a body location at which a measurement was taken). Here is an example of what a compound --TESTCD might look like, it represents the measurement of erosion in the left metacarpal using an ultrasound technique to make the measurement:
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
LMCP1EA2
|
This code breaks down as follows: LMCP1: represents the “Location” of the test - “Left Metacarpal 1” E: represents the “Test” – “Erosion” A: represents the evaluation machine “Make” – “Acme” 2: represents the evaluation machine “Model” – “u 2.1” A second approach for depicting a unique test would be to use a generic (or simple) test code that requires associated qualifier variables to fully express the test detail. Using this approach in the above example, a generic --TESTCD value might be “EROSION” and the additional components of the compound test codes discussed above would be represented in a number of distinct qualifier variables. These may include domain variables (--LOC, --METHOD, etc.) and Supplemental Qualifier variables (QNAM.MAKE, QNAM.MODEL, etc.). Expressing the natural key becomes very important in this situation in order to communicate the variables that contribute to the uniqueness of a test. If a generic --TESTCD was used the following variables would be used to fully describe the test. The test is “EROSION”, the location is “Left MCP I”, the method of measurement is “Ultrasound”, the make of the ultrasound machine is “ACME” and the model of the ultrasound machine is “u 2.1”. This domain includes both domain variables and Supplemental Qualifier variables that contribute to the natural key of each row and to describe the uniqueness of the test. --TESTCD --TEST --LOC --METHOD QNAM.MAKE QNAM.MODEL
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
ACME
|
U 2.1 CDISC SDTM Implementation Guide (Version 3.1.2)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
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[
"SDTM.pdf"
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pdf
|
glossary.json
| null | null |
CT1234-114-007
|
004 211 4.1.2.4 CASE USE OF TEXT IN SUBMITTED DATA It is recommended that text data be submitted in upper case text. Exceptions may include long text data (such as comment text); values of --TEST in Findings datasets (which may be more readable in mixed case if used as labels in transposed views); and certain controlled terminology (see Section 4.1.4.3) that are already in mixed case. The Sponsor’s Define data definition document may indicate as a general note or assumption whether case sensitivity applies to text data for any or all variables in the dataset. 4.1.2.5 CONVENTION FOR MISSING VALUES Missing values for individual data items should be represented by nulls. This is a change from previous versions of the SDTMIG, which allowed sponsors to define their conventions for missing values. Conventions for representing observations not done using the SDTM --STAT and --REASND variables are addressed in Section 4.1.5.1.1 and the individual domain models. 4.1.2.6 GROUPING VARIABLES AND CATEGORIZATION Grouping variables are Identifiers and Qualifiers that group records in the SDTM domains/datasets such as the --CAT and --SCAT variables assigned by sponsors to categorize data. For example, a lab record with LBTEST = 'SODIUM' might have LBCAT = 'CHEMISTRY' and LBSCAT = 'ELECTROLYTES'. Values for --CAT and --SCAT should not be redundant with the domain or dictionary classification provided by --DECOD and --BODSYS. 1. Hierarchy of Grouping Variables
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
USUBJID
|
Unique Subject Identifier Char Identifier Unique subject identifier within the submission.
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
For the subject
|
All records with the same USUBJID value are a group of records that describe that subject. b. Across subjects (records with different USUBJID values) 1. All records with the same STUDYID value are a group of records that describe that study 2. All records with the same DOMAIN value are a group of records that describe that domain 3. --CAT (Category) and --SCAT (Sub-category) values further subset groups within the domain. Generally, --CAT/--SCAT values have meaning within a particular domain. However, it is possible to use the same values for --CAT/--SCAT in related domains (e.g., MH and AE). When values are CDISC SDTM Implementation Guide (Version 3.1.2)
|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
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|
[
"SDTM.pdf"
] |
SDTM.pdf
|
pdf
|
glossary.json
| null | null |
Non-medical reason
|
_______________ The free text description should be stored in the SUPPEX dataset. • EXADJ=NONMEDICAL REASON • SUPPEX QNAM=EXADJOTH, QLABEL=Other Reason For Dose Adjustment, QVAL=PATIENT MISUNDERSTOOD INSTRUCTIONS Note that QNAM references the “parent” variable name with the addition of “OTH, ” one of the standard variable naming fragments for “Other” (see Appendix D). Likewise, the label is a modification of the parent variable label. When the CRF includes a list of values for a qualifier field that includes "Other" and the "Other" is supplemented with a "Specify" free text field, then the manner in which the free text "Specify" value is submitted will vary based on the sponsor's coding practice and analysis requirements. For example, consider a CRF that collects the anatomical location of administration (EXLOC) of a study drug given as an injection:
|
[
"SDTM.pdf"
] |
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pdf
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Left Thigh
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Other, Specify: _________________ CDISC SDTM Implementation Guide (Version 3.1.2)
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RIGHT ABDOMEN
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• Occasionally, the sponsor may wish to use controlled terminology for the specify field as well as the location field. Suppose “UPPER RIGHT ABDOMEN” is coded to “ABDOMEN.” If the sponsor wishes to submit both the controlled term as well as the original term, an additional record could be included in SUPPEX. In this case, the QNAM value might make use of the standard variable naming fragment for “Original.” EXLOC=OTHER SUPPEX QNAM=EXLOCOTH, QLABEL= Other Location Of Dose Administration, QVAL=ABDOMEN SUPPEX QNAM=EXLOCOR, QLABEL=Original Location Of Dose Administration, QVAL=UPPER RIGHT ABDOMEN 2) If the sponsor wishes to maintain controlled terminology for EXLOC but will expand the terminology based on values seen in the specify field, then the value of EXLOC will reflect the sponsor’s coding decision and SUPPEX could be used to store the verbatim text. • EXLOC=ABDOMEN • SUPPEX QNAM= EXLOCOTH, QVAL=UPPER RIGHT ABDOMEN Note that the sponsor might choose a different value for EXLOC (e.g., UPPER ABDOMEN, TORSO) depending on the sponsor's coding practice and analysis requirements. 3) If the sponsor does not require that controlled terminology be maintained and wishes for all responses to be stored in a single variable, then EXLOC will be used and SUPPEX is not required. In this case, the sponsor might have provided the pre-specified choices as a convenience to the investigator. • EXLOC= UPPER RIGHT ABDOMEN 4.1.2.7.2 “SPECIFY” VALUES FOR RESULT QUALIFIER VARIABLES: When the CRF includes a list of values for a result field that includes "Other" and the "Other" is supplemented with a "Specify" free text field, then the manner in which the free text "Specify" value is submitted will vary based on the sponsor's coding practice and analysis requirements. For example, consider a CRF where the sponsor requests the subject's eye color:
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Green
|
Other, specify: ________ An investigator has selected "OTHER" and specified "BLUEISH GRAY." As in the above discussion for non-result Qualifier values, the sponsor has several options for submission: 1) If the sponsor wishes to maintain controlled terminology in the standard result field and limit the terminology to the 5 pre-specified choices, then the free text is placed in --ORRES and the controlled terminology in --STRESC. • SCTEST=Eye Color, SCORRES=BLUEISH GRAY, SCSTRESC=OTHER 2) If the sponsor wishes to maintain controlled terminology in the standard result field, but will expand the terminology based on values seen in the specify field, then the free text is placed in --ORRES and the value of --STRESC will reflect the sponsor's coding decision. • SCTEST=Eye Color, SCORRES=BLUEISH GRAY, SCSTRESC=GRAY 3) If the sponsor does not require that controlled terminology be maintained, the verbatim value will be copied to --STRESC. • SCTEST=Eye Color, SCORRES=BLUEISH GRAY, SCSTRESC=BLUEISH GRAY CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, © 2007. All rights reserved
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Naproxen
|
Other: ______ If ibuprofen and diclofenac were reported, the CM dataset would include the following: • CMTRT=IBUPROFEN, CMPRESP=Y • CMTRT=DICLOFENAC, CMPRESP=N Events: “Other, Specify” for events may be handled similarly to interventions. --TERM should be populated with the description of the event found in the specified text and --PRESP could be used to distinguish between pre-specified and free text responses. Findings: “Other, Specify” for tests may be handled similarly to interventions. --TESTCD and --TEST should be populated with the code and description of the test found in the specified text. 4.1.2.8 MULTIPLE VALUES FOR A VARIABLE 4.1.2.8.1 MULTIPLE VALUES FOR AN INTERVENTION OR EVENT TOPIC VARIABLE If multiple values are reported for a topic variable (i.e., --TRT in an Interventions general-observation-class dataset or -- TERM in an Events general-observation-class dataset), it is assumed that the sponsor will split the values into multiple records or otherwise resolve the multiplicity as per the sponsor’s standard data management procedures. For example, if an adverse event term of “Headache and Nausea” or a concomitant medication of “Tylenol and Benadryl” is reported, sponsors will often split the original report into separate records and/or query the site for clarification. By the time of submission, the datasets should be in conformance with the record structures described in the SDTM IG. Note that the Disposition dataset (DS) should not have cases for splitting multiple topic values into separate records, since DS allows only one record per disposition status or protocol milestone per subject. See Section 6.2.2.1 for additional information. 4.1.2.8.2 MULTIPLE VALUES FOR A FINDING RESULT VARIABLE If multiple result values (--ORRES) are reported for a test in a Findings class dataset, multiple records should be submitted for that --TESTCD. Example: • EGTESTCD=RHYRATE, EGTEST=Rhythm and Rate, EGORRES=ATRIAL FIBRILLATION • EGTESTCD=RHYRATE, EGTEST=Rhythm and Rate, EGORRES=ATRIAL FLUTTER Note that in this case, the sponsor’s operational database may have a result-sequence variable as part of the natural key. Some sponsors may elect to keep this variable in a Supplemental Qualifier record, while others may decide to use --SPID or --SEQ to replace it. Dependent variables such as result Qualifiers should never be part of the natural key. CDISC SDTM Implementation Guide (Version 3.1.2)
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AELOC1
|
Location of the Reaction 1
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pdf
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glossary.json
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AELOC2
|
Location of the Reaction 2
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SDTM.pdf
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pdf
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glossary.json
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AELOC3
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Location of the Reaction 3
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CHEST
|
In some cases, values for QNAM and QLABEL more specific than those above may be needed. For example, a sponsor might conduct a study with two study drugs (e.g., open-label study of Abcicin + Xyzamin), and has the investigator assess causality and describe action taken for each drug for the rash:
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DOSE NOT CHANGED
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Note that in the latter case the label for standard variables AEREL and AEACN will have no indication that they pertain to Abcicin. This association must be clearly documented in the metadata and annotated CRF. CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, © 2007. All rights reserved
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VARIABLES
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• For events such as AEs and Medical History, populate --DECOD with the dictionary’s preferred term and populate --BODSYS with the preferred body system name. If a dictionary is multi-axial, the value in --BODSYS should represent the system organ class (SOC) used for the sponsor’s analysis and summary tables, which may not necessarily be the primary SOC. • For concomitant medications, populate CMDECOD with the drug's generic name and populate CMCLAS with the drug class used for the sponsor’s analysis and summary tables. If coding to multiple classes, follow assumption 4.1.2.8.1 or omit CMCLAS. In either case, no other intermediate levels or relationships should be stored in the dataset (although they may be provided in a Supplemental Qualifiers dataset). By knowing the dictionary and version used, the reviewer will be able to obtain intermediate levels in a hierarchy (as in MedDRA), or a drug’s ATC codes (as in WHO Drug). The dictionary version should be listed in the Comments column of the Define data Definition document. The sponsor may be required to submit the dictionary if it is not already available to the reviewer. CDISC SDTM Implementation Guide (Version 3.1.2)
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glossary.json
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PESTRESC
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Character Result/Finding in Std. Format
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pdf
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Precision
|
ISO 8601 Date/Time 1 December 15, 2003 13:14:17 Complete date/time 2003-12-15T13:14:17 2 December 15, 2003 13:14
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Unknown seconds
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2003-12-15T13:14 3 December 15, 2003 13 Unknown minutes and seconds 2003-12-15T13 4 December 15, 2003
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Unknown day and time
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2003-12 6 2003 Unknown month , day, and time 2003 This date and date/time model also provides for imprecise or estimated dates, such as those commonly seen in Medical History. To represent these intervals while applying the ISO 8601 standard, it is recommended that the sponsor concatenate the date/time values (using the most complete representation of the date/time known) that describe the beginning and the end of the interval of uncertainty and separate them with a solidus as shown in the table below: Interval of Uncertainty ISO 8601 Date/Time 1 Between 10:00 and 10:30 on the Morning of December 15, 2003 2003-12-15T10:00/2003-12-15T10:30 2 After the first of this year (2003) until "now" (February 15, 2003, noon) 2003-01-01/2003-02-15T12:00 3 Between the first and the tenth of December, 2003 2003-12-01/2003-12-10 4 Sometime in the first half of 2003 2003-01-01/2003-06-30 Other uncertainty intervals may be represented by the omission of components of the date when these components are unknown or missing. As mentioned above, ISO 8601 represents missing intermediate components through the use of a hyphen where the missing component would normally be represented. This may be used in addition to "appropriate right truncations" for incomplete date/time representations. When components are omitted, the expected delimiters must still be kept in place and only a single hyphen is to be used to indicate an omitted component. Examples of this method of omitted component representation are shown in the table below: Date and Time as Originally
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Level of Uncertainty
|
ISO 8601 Date/Time 1 December 15, 2003 13:15:17
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[
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pdf
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glossary.json
| null | null |
Complete date
|
2003-12-15T13:15:17 2 December 15, 2003 ??:15 Unknown hour with known minutes 2003-12-15T-:15 3 December 15, 2003 13:??:17 Unknown minutes with known date, hours,
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and seconds
|
2003-12-15T13:-:17 4 The 15th of some month in 2003, time
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pdf
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glossary.json
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not collected
|
Unknown month and time with known year
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pdf
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glossary.json
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and day
|
2003---15 5 December 15, but can't remember the year, time not collected Unknown year with known month and day --12-15 6 7:15 of some unknown date Unknown date with known hour and
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minute
|
-----T07:15 CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, © 2007. All rights reserved
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pdf
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glossary.json
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PnW
|
where: • [P] (duration designator): precedes the alphanumeric text string that represents the duration. NOTE: The use of the character P is based on the historical use of the term "period" for duration. • [n] represents a positive integer or zero • [W] is used as week designator, preceding a data Element that represents the number of calendar weeks within the calendar year (e.g., P6W represents 6 weeks of calendar time). The letter "P" must precede other values in the ISO 8601 representation of duration. The 'n' preceding each letter represents the number of Years, Months, Days, Hours, Minutes, Seconds, or the number of Weeks. As with the date/time format, 'T' is used to separate the date components from time components. Note that weeks cannot be mixed with any other date/time components such as days or months in duration expressions. As is the case with the date/time representation in --DTC, --STDTC or --ENDTC only the components of duration that are known or collected need to be represented. Also, as is the case with the date/time representation, if no time component is represented, the [T] time designator (in addition to the missing time) must be omitted in ISO 8601 representation. CDISC SDTM Implementation Guide (Version 3.1.2)
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P3D
|
6 Months 17 Days 3 Hours
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pdf
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glossary.json
| null | null |
P6M17DT3H
|
14 Days 7 Hours 57 Minutes
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One-half hour
|
PT0.5H 5 Days 12¼ Hours P5DT12.25H 4 ½ Weeks P4.5W Note that a leading zero is required with decimal values less than one. 4.1.4.3.2 INTERVAL WITH UNCERTAINTY When an interval of time is an amount of time (duration) following an event whose start date/time is recorded (with some level of precision, i.e. when one knows the start date/time and the duration following the start date/time), the correct ISO 8601 usage to represent this interval is as follows: YYYY-MM-DDThh:mm:ss/PnYnMnDTnHnMnS where the start date/time is represented before the solidus [/], the "Pn…", following the solidus, represents a “duration”, and the entire representation is known as an “interval”. NOTE: This is the recommended representation of elapsed time, given a start date/time and the duration elapsed. When an interval of time is an amount of time (duration) measured prior to an event whose start date/time is recorded (with some level of precision, i.e. where one knows the end date/time and the duration preceding that end date/time), the syntax is: PnYnMnDTnHnMnS/YYYY-MM-DDThh:mm:ss where the duration, "Pn…", is represented before the solidus [/], the end date/time is represented following the solidus, and the entire representation is known as an “interval”. 4.1.4.4 USE OF THE 'STUDY DAY' VARIABLES The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative day of the observation starting with the reference date as Day 1. They are determined by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC from the Demography domain). The Subject Reference Start Date (RFSTDTC) is designated as Study Day 1. The Study Day value is incremented by 1 for each date following RFSTDTC. Dates prior to RFSTDTC are decremented by 1, with the date preceding RFSTDTC designated as Study Day -1 (there is no Study Day 0). This algorithm for determining Study Day is consistent with how people typically describe sequential days relative to a fixed reference point, but creates problems if used for mathematical calculations because it does not allow for a Day 0. As such, Study Day is not CDISC SDTM Implementation Guide (Version 3.1.2) CDISC, © 2007. All rights reserved
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Week 2 Unscheduled
|
3.1 (Null) 17 4.1.4.6 REPRESENTING ADDITIONAL STUDY DAYS The SDTM allows for --DTC values to be represented as study days (--DY) relative to the RFSTDTC reference start date variable in the DM dataset, as described above in Section 4.1.4.4. The calculation of additional study days within subdivisions of time in a clinical trial may be based on one or more sponsor-defined reference dates not represented by RFSTDTC. In such cases, the Sponsor may define Supplemental Qualifier variables and the Define data definition document should reflect the reference dates used to calculate such study days. CDISC SDTM Implementation Guide (Version 3.1.2) 4.1.4.7 USE OF RELATIVE TIMING VARIABLES --STRF, --STTPT, --STRTPT, --ENRF, --ENTPT, AND --ENRTPT --STRF and --ENRF These variables --STRF and --ENRF were originally intended to represent timing of events and interventions relative to the study timeline when sponsors collected information such as 'PRIOR', 'ONGOING', or 'CONTINUING via check boxes on the CRF in lieu of collecting a date. However, it is acceptable to populate --STRF and --ENRF even if a date is collected. Some sponsors may automatically derive such information from collected dates for analysis or reporting purposes. --STRF is used to identify the start of an observation (Event, Intervention) or the time of collection (Finding) as being 'BEFORE', ‘BEFORE/DURING’, 'DURING', or 'AFTER' the sponsor-defined reference period. The sponsor- defined reference period is the continuous period of time defined by the discrete starting point (RFSTDTC) and the discrete ending point (RFENDTC) for each subject in Demographics. --ENRF is used to identify the end of the observation (Event, Intervention, or Finding) as being 'BEFORE', 'DURING', ‘DURING/AFTER' or 'AFTER' the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by the discrete starting point (RFSTDTC) and the discrete ending point (RFENDTC) in Demographics. Both --STRF and --ENRF should be set to ‘U’ if the underlying value (e.g., ‘PRIOR', 'ONGOING', or 'CONTINUING’) was not collected for a subject, and is therefore unknown. Figure 4.1.4.7 below illustrates how to populate these variables in a CM domain for the standard reference period represented by RFSTDTC and RFENDTC (defined in the DM domain). ` Figure 4.1.4.7 Example of --STRF and --ENRF Variables for Concomitant Medications
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