SDTM.RS

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	RS	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	RS	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	RS	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	RS	RSSEQ	Sequence Number	Num		Identifier	Req	Sequence number given to ensure uniqueness within a dataset for a subject. May be any valid number.
5	RS	RSGRPID	Group ID	Char		Identifier	Perm	Used to link together a block of related records within a subject in a domain.
6	RS	RSREFID	Reference ID	Char		Identifier	Perm	Internal or external identifier.
7	RS	RSSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	Sponsor-defined identifier.
8	RS	RSLNKID	Link ID	Char		Identifier	Perm	An identifier used to link the response assessment to the related measurement record in another domain which was used to determine the response result. LNKID values group records within USUBJID.
9	RS	RSLNKGRP	Link Group ID	Char		Identifier	Perm	A grouping identifier used to link the response assessment to a group of measurement/assessment records which were used in the assessment of the response. LNKGRP values group records within USUBJID.
10	RS	RSTESTCD	Assessment Short Name	Char	C96782	Topic	Req	Short name of the TEST in RSTEST. The value in RSTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). RSTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "TRGRESP", "NTRGRESP", "OVRLRESP", "SYMPTDTR", "CPS0102". \n There are separate codelists used for RSTESTCD where the choice depends on the value of RSCAT. Codelist "ONCRTSCD" is used for oncology response criteria (when RSCAT is a term in codelist "ONCRSCAT"). Examples: TRGRESP, "NTRGRESP, "OVRLRESP". For Clinical Classifications (when RSCAT is a term in codelist "CCCAT"), QRS Naming Rules apply. These instruments have individual dedicated terminology codelists.
11	RS	RSTEST	Assessment Name	Char	C96781	Synonym Qualifier	Req	Verbatim name of the response assessment. The value in RSTEST cannot be longer than 40 characters. \n There are separate codelists used for RSTEST where the choice depends on the value of RSCAT. Codelist "ONCRTS" is used for oncology response criteria (when RSCAT is a term in codelist "ONCRSCAT"). Examples: "Target Response", "Non-target Response", "Overall Response", "Symptomatic Deterioration". For Clinical Classifications (when RSCAT is a term in codelist "CCCAT"), QRS Naming Rules apply. These instruments have individual dedicated terminology codelists.
12	RS	RSCAT	Category for Assessment	Char	C124298 C118971	Grouping Qualifier	Exp	Used to define a category of related records across subjects. Examples: "RECIST 1.1", "CHILD-PUGH CLASSIFICATION". There are separate codelists used for RSCAT where the choice depends on whether the related records are about an oncology response criterion or another clinical classification. \n RSCAT is required for clinical classifications other than oncology response criteria.
13	RS	RSSCAT	Subcategory	Char		Grouping Qualifier	Perm	Used to define a further categorization of RSCAT values.
14	RS	RSORRES	Result or Finding in Original Units	Char		Result Qualifier	Exp	Result of the response assessment as originally received, collected, or calculated.
15	RS	RSORRESU	Original Units	Char	C71620	Variable Qualifier	Perm	Unit for RSORRES.
16	RS	RSSTRESC	Character Result/Finding in Std Format	Char	C96785	Result Qualifier	Exp	Contains the result value for the response assessment, copied, or derived from RSORRES in a standard format or standard units. RSSTRESC should store all results or findings in character format. \n For Clinical Classifications, this may be a score.
17	RS	RSSTRESN	Numeric Result/Finding in Standard Units	Num		Result Qualifier	Perm	Used for continuous or numeric results or findings in standard format; copied in numeric format from --STRESC. --STRESN should store all numeric test results or findings. For Clinical Classifications, this may be a score.
18	RS	RSSTRESU	Standard Units	Char	C71620	Variable Qualifier	Perm	Standardized units used for RSSTRESC and RSSTRESN.
19	RS	RSSTAT	Completion Status	Char	C66789	Record Qualifier	Perm	Used to indicate the response assessment was not performed. Should be null if a result exists in RSORRES.
20	RS	RSREASND	Reason Not Done	Char		Record Qualifier	Perm	Describes why a response assessment was not performed. Examples: "All target tumors not evaluated", "Subject does not have non-target tumors". Used in conjunction with RSSTAT when value is "NOT DONE".
21	RS	RSNAM	Vendor Name	Char		Record Qualifier	Perm	The name or identifier of the vendor that performed the response assessment. This column can be left null when the investigator provides the complete set of data in the domain.
22	RS	RSMETHOD	Method of Test or Examination	Char	C158113	Record Qualifier	Perm	Method of the test or examination.
23	RS	RSLOBXFL	Last Observation Before Exposure Flag	Char	C66742	Record Qualifier	Perm	Operationally derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null. \n When a clinical classification is assessed at multiple times, including baseline, RSLOBXFL should be included in the dataset.
24	RS	RSBLFL	Baseline Flag	Char	C66742	Record Qualifier	Perm	Indicator used to identify a baseline value. Should be "Y" or null. Note that --BLFL is retained for backward compatibility. The authoritative baseline for statistical analysis is in an ADaM dataset.
25	RS	RSDRVFL	Derived Flag	Char	C66742	Record Qualifier	Perm	Used to indicate a derived record (e.g., a record that represents the average of other records such as a computed baseline). Should be "Y" or null.
26	RS	RSEVAL	Evaluator	Char	C78735	Record Qualifier	Perm	Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Examples: "ADJUDICATION COMMITTEE", "INDEPENDENT ASSESSOR", "RADIOLOGIST". \n RSEVAL is expected for oncology response criteria. It can be left null when the investigator provides the complete set of data in the domain. However, the column should contain no null values when data from one or more independent assessors is included, meaning that the rows attributed to the investigator should contain a value of "INVESTIGATOR".
27	RS	RSEVALID	Evaluator Identifier	Char	C96777	Variable Qualifier	Perm	Used to distinguish multiple evaluators with the same role recorded in RSEVAL. Examples: "RADIOLOGIST1", "RADIOLOGIST2". See assumptions in Section 6.3.9.3.1, Disease Response Use Case.
28	RS	RSACPTFL	Accepted Record Flag	Char	C66742	Record Qualifier	Perm	In cases where more than 1 independent assessor (e.g., "RADIOLOGIST 1", "RADIOLOGIST 2", "ADJUDICATOR") provides an evaluation of response, this flag identifies the record that is considered to be the accepted evaluation.
29	RS	VISITNUM	Visit Number	Num		Timing	Exp	Clinical encounter number. Numeric version of VISIT, used for sorting.
30	RS	VISIT	Visit Name	Char		Timing	Perm	Protocol-defined description of a clinical encounter.
31	RS	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the visit based upon RFSTDTC in Demographics.
32	RS	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.
33	RS	EPOCH	Epoch	Char	C99079	Timing	Perm	Epoch associated with the date/time at which the assessment was made.
34	RS	RSDTC	Date/Time of Assessment	Char	ISO 8601 datetime or interval	Timing	Exp	Collection date and time of the assessment represented in ISO 8601 character format.
35	RS	RSDY	Study Day of Assessment	Num		Timing	Perm	Study day of the assessment, measured as integer days. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.
36	RS	RSTPT	Planned Time Point Name	Char		Timing	Perm	Text description of time when a measurement or observation should be taken as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See RSTPTNUM and RSTPTREF.
37	RS	RSTPTNUM	Planned Time Point Number	Num		Timing	Perm	Numeric version of planned time point used in sorting.
38	RS	RSELTM	Planned Elapsed Time from Time Point Ref	Char	ISO 8601 duration	Timing	Perm	Planned elapsed time in ISO 8601 character format relative to a planned fixed reference (RSTPTREF; e.g., "PREVIOUS DOSE", "PREVIOUS MEAL"). This variable is useful where there are repetitive measures. Not a clock time or a date/time variable, but an interval, represented as ISO duration.
39	RS	RSTPTREF	Time Point Reference	Char		Timing	Perm	Description of the fixed reference point referred to by RSELTM, RSTPTNUM, and RSTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".
40	RS	RSRFTDTC	Date/Time of Reference Time Point	Char	ISO 8601 datetime or interval	Timing	Perm	Date/time for a fixed reference time point defined by RSTPTREF in ISO 8601 character format.
41	RS	RSEVLINT	Evaluation Interval	Char	ISO 8601 duration or interval	Timing	Perm	Duration of interval associated with an observation such as a finding RSTESTCD, represented in ISO 8601 character format. Example: "-P2M" to represent a period of the past 2 months as the evaluation interval.
42	RS	RSEVINTX	Evaluation Interval Text	Char		Timing	Perm	Evaluation interval associated with an observation, where the interval is not able to be represented in ISO 8601 format. Examples: "LIFETIME", "LAST NIGHT", "RECENTLY", "OVER THE LAST FEW WEEKS".
43	RS	RSSTRTPT	Start Relative to Reference Time Point	Char	C66728	Timing	Perm	Identifies the start of the observation as being before or after the sponsor-defined reference time point defined by variable RSSTTPT. \n Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables.
44	RS	RSSTTPT	Start Reference Time Point	Char		Timing	Perm	Description or date/time in ISO 8601 character format of the sponsor-defined reference point referred to by RSSTRTPT. Examples: "2003-12-15", "VISIT 1".
45	RS	RSENRTPT	End Relative to Reference Time Point	Char	C66728	Timing	Perm	Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable RSENTPT. \n Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables.
46	RS	RSENTPT	End Reference Time Point	Char		Timing	Perm	Description or date/time in ISO 8601 character format of the sponsor-defined reference point referred to by RSENRTPT. Examples: "2003-12-25", "VISIT 2".