Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 RS 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 RS 2 DOMAIN Domain Abbreviation Char RS Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 RS 3 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
SDTMIG 3.3 RS 4 RSSEQ Sequence Number Num Identifier Sequence number given to ensure uniqueness within a dataset for a subject. May be any valid number. Req
SDTMIG 3.3 RS 5 RSGRPID Group ID Char Identifier Used to link together a block of related records within a subject in a domain. Perm
SDTMIG 3.3 RS 6 RSREFID Reference ID Char Identifier Internal or external identifier. Perm
SDTMIG 3.3 RS 7 RSSPID Sponsor-Defined Identifier Char Identifier Sponsor-defined identifier. Perm
SDTMIG 3.3 RS 8 RSLNKID Link ID Char Identifier 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. Perm
SDTMIG 3.3 RS 9 RSLNKGRP Link Group ID Char Identifier 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. Perm
SDTMIG 3.3 RS 10 RSTESTCD Assessment Short Name Char (ONCRTSCD) Topic Short name of the TEST in RSTEST. RSTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "TRGRESP", "NTRGRESP", "OVRLRESP", "SYMPTDTR", "CPS0102". 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, "OVRLRESSP". For Clinical Classifications (when RSCAT is a term in codelist "CCCAT"), QRS Naming Rules apply. These instruments have individual dedicated terminology codelists. Req
SDTMIG 3.3 RS 11 RSTEST Assessment Name Char (ONCRTS) Synonym Qualifier Verbatim name of the response assessment. The value in RSTEST cannot be longer than 40 characters. 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", "CPS01-Ascites". For Clinical Classifications, QRS Naming Rules apply. These instruments have individual dedicated terminology codelists. Req
SDTMIG 3.3 RS 12 RSCAT Category for Assessment Char (ONCRSCAT), (CCCAT) Grouping Qualifier 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. RSCAT is required for clinical classifications other than oncology response criteria. Exp
SDTMIG 3.3 RS 13 RSSCAT Subcategory Char Grouping Qualifier Used to define a further categorization of RSCAT values. Perm
SDTMIG 3.3 RS 14 RSORRES Result or Finding in Original Units Char Result Qualifier Result of the response assessment as originally received, collected, or calculated. Exp
SDTMIG 3.3 RS 15 RSORRESU Original Units Char (UNIT) Variable Qualifier Unit for RSORRES. Perm
SDTMIG 3.3 RS 16 RSSTRESC Character Result/Finding in Std Format Char (ONCRSR) Result Qualifier 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. For Clinical Classifications, this may be a score. Exp
SDTMIG 3.3 RS 17 RSSTRESN Numeric Result/Finding in Standard Units Num Result Qualifier 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. Perm
SDTMIG 3.3 RS 18 RSSTRESU Standard Units Char (UNIT) Variable Qualifier Standardized units used for RSSTRESC and RSSTRESN. Perm
SDTMIG 3.3 RS 19 RSSTAT Completion Status Char (ND) Record Qualifier Used to indicate the response assessment was not performed. Should be null if a result exists in RSORRES. Perm
SDTMIG 3.3 RS 20 RSREASND Reason Not Done Char Record Qualifier 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". Perm
SDTMIG 3.3 RS 21 RSNAM Vendor Name Char Record Qualifier 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. Perm
SDTMIG 3.3 RS 22 RSLOBXFL Last Observation Before Exposure Flag Char (NY) Record Qualifier Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null. When a clinical classification is assessed at multiple times, including baseline, RSLOBXFL should be included in the dataset. Perm
SDTMIG 3.3 RS 23 RSBLFL Baseline Flag Char (NY) Record Qualifier 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. Perm
SDTMIG 3.3 RS 24 RSDRVFL Derived Flag Char (NY) Record Qualifier 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. Perm
SDTMIG 3.3 RS 25 RSEVAL Evaluator Char (EVAL) Record Qualifier 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". 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". Perm
SDTMIG 3.3 RS 26 RSEVALID Evaluator Identifier Char (MEDEVAL) Variable Qualifier Used to distinguish multiple evaluators with the same role recorded in RSEVAL. Examples: "RADIOLOGIST1", "RADIOLOGIST2". See RS Assumption 9. Perm
SDTMIG 3.3 RS 27 RSACPTFL Accepted Record Flag Char (NY) Record Qualifier 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. Perm
SDTMIG 3.3 RS 28 VISITNUM Visit Number Num Timing Clinical encounter number. Numeric version of VISIT, used for sorting. Exp
SDTMIG 3.3 RS 29 VISIT Visit Name Char Timing Protocol-defined description of a clinical encounter. Perm
SDTMIG 3.3 RS 30 VISITDY Planned Study Day of Visit Num Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm
SDTMIG 3.3 RS 31 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
SDTMIG 3.3 RS 32 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the date/time at which the assessment was made. Perm
SDTMIG 3.3 RS 33 RSDTC Date/Time of Assessment Char ISO 8601 Timing Collection date and time of the assessment represented in ISO 8601 character format. Exp
SDTMIG 3.3 RS 34 RSDY Study Day of Assessment Num Timing Study day of the assessment, measured as integer days. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. Perm
SDTMIG 3.3 RS 35 RSTPT Planned Time Point Name Char Timing 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. Perm
SDTMIG 3.3 RS 36 RSTPTNUM Planned Time Point Number Num Timing Numeric version of planned time point used in sorting. Perm
SDTMIG 3.3 RS 37 RSELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Planned elapsed time in ISO 8601 character format relative to a planned fixed reference (RSTPTREF) such as "Previous Dose" or "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. Perm
SDTMIG 3.3 RS 38 RSTPTREF Time Point Reference Char Timing Description of the fixed reference point referred to by RSELTM, RSTPTNUM, and RSTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL". Perm
SDTMIG 3.3 RS 39 RSRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Date/time for a fixed reference time point defined by RSTPTREF in ISO 8601 character format. Perm
SDTMIG 3.3 RS 40 RSEVLINT Evaluation Interval Char ISO 8601 Timing 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. Perm
SDTMIG 3.3 RS 41 RSEVINTX Evaluation Interval Text Char Timing 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". Perm
SDTMIG 3.3 RS 42 RSSTRTPT Start Relative to Reference Time Point Char (STENRF) Timing Identifies the start of the observation as being before or after the sponsor-defined reference time point defined by variable RSSTTPT. Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables. Perm
SDTMIG 3.3 RS 43 RSSTTPT Start Reference Time Point Char Timing Description or date/time in ISO 8601 character format of the sponsor-defined reference point referred to by RSSTRTPT. Examples: "2003-12-15" or "VISIT 1". Perm
SDTMIG 3.3 RS 44 RSENRTPT End Relative to Reference Time Point Char (STENRF) Timing Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable RSENTPT. Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables. Perm
SDTMIG 3.3 RS 45 RSENTPT End Reference Time Point Char Timing Description or date/time in ISO 8601 character format of the sponsor-defined reference point referred to by RSENRTPT. Examples: "2003-12-25" or "VISIT 2". Perm