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	Used to link the response assessment to the appropriate measurement records (in TR) for same tumor that was used to determine the response result.
9	RS	RSLNKGRP	Link Group	Char		Identifier	Perm	Used to link the response assessment to the all of the measurement/assessment records in the TR domain which were used in the assessment of the response.
10	RS	RSTESTCD	Response Assessment Short Name	Char	C96782	Topic	Req	Short name of the TEST in RSTEST. RSTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: TRGRESP, NTRGRESP, OVRRESP, BESTRESP, NRADPROG
11	RS	RSTEST	Response Assessment Name	Char	C96781	Synonym Qualifier	Req	Verbatim name of the response assessment. The value in RSTEST cannot be longer than 40 characters. Examples: Target Response, Non-target Response, Overall Response, Best Overall Response, Non-radiological progression (i.e. Symptomatic deterioration)
12	RS	RSCAT	Category for Response Assessment	Char		Grouping Qualifier	Exp	RSCAT is used to identify the criteria used in the assessment of response and a version number if appropriate
13	RS	RSORRES	Response Assessment Original Result	Char		Result Qualifier	Exp	Result of the Response assessment as originally received, collected, or calculated.
14	RS	RSSTRESC	Response Assessment Result in Std Format	Char		Record 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;
15	RS	RSSTAT	Completion Status	Char	C66789	Result Qualifier	Perm	Used to indicate the response assessment was not performed. Should be Null if a result exists in RSORRES.
16	RS	RSREASND	Reason Response Assessment Not Performed	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 TRSTAT when value is NOT DONE.
17	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.
18	RS	RSEVAL	Evaluator	Char	C78735	Record Qualifier	Exp	Role of the person who provided the evaluation. Examples: INVESTIGATOR, INDEPENDENT ASSESSOR. This column 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.
19	RS	RSEVALID	Evaluator Identifier	Char	C96777	Variable Qualifier	Perm	The Evaluator Specified variable is used in conjunction with RSEVAL to provide an additional level of detail. When multiple assessors play the role identified in RSEVAL, values of RSEVALID will attribute a row of data to a particular assessor. RSEVALID should not contain the names of the assessors, or a code identifier for a specific assessor. The RSEVALID variable is subject to CDISC Controlled Terminology. Examples: RADIOLOGIST, RADIOLOGIST 1 or RADIOLOGIST 2. See Assumption 4
20	RS	RSACPTFL	Accepted Record Flag	Char	C66742	Record Qualifier	Perm	In cases where more than one 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.
21	RS	VISITNUM	Visit Number	Num		Timing	Exp	1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
22	RS	VISIT	Visit Name	Char		Timing	Perm	1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
23	RS	VISITDY	Planned Study Day of Visit	Num		Timing	Perm
24	RS	EPOCH	Epoch	Char		Timing	Perm	Epoch associated with the Element in the planned sequence of Elements for the ARM to which the subject was assigned
25	RS	RSDTC	Date/Time of Response Assessment	Char	ISO 8601	Timing	Exp	RSDTC may be derived from the dates of scans/images/physical exams which may be performed on different dates. However, if all assessments are performed on the same date, RSDTC may be consistent with the TUDTC and TRDTC. Note the physical exam date may correspond to the visit date.
26	RS	RSDY	Study Day of Response Assessment	Num		Timing	Perm	1. Study day of the response assessment, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.