SDTM Variable Definitions - 2017 Review

Observation Class	Variable	NCI C-code	SDTM v1.4/SDTMIG v3.2 Variable Label	SDTM v1.4/SDTMIG v3.2 Description/CDISC Notes	Final Definition	Order	Group
Demographics	STUDYID				See Identifiers	1	1
Demographics	DOMAIN				See Identifiers	2	2
Demographics	USUBJID				See Identifiers	3	3
Demographics	SUBJID	C83083 SDSVAR-1 - Getting issue details... STATUS	Subject Identifier for the Study	Subject identifier, which must be unique within the study. Often the ID of the subject as recorded on a CRF.	A sequence of characters used to uniquely identify a subject within a study. SDSVAR-2 - Getting issue details... STATUS	4	4
Demographics	RFSTDTC	C83395	Subject Reference Start Date/Time	Reference Start Date/time for the subject in ISO 8601 character format. Usually equivalent to date/time when subject was first exposed to study treatment. Required for all randomized subjects; will be null for all subjects who did not meet the milestone the date requires, such as screen failures or unassigned subjects.	The start date or date and time of the sponsor-defined study reference period, represented in a standardized character forma SDSVAR-3 - Getting issue details... STATUS t.	5	5
Demographics	RFENDTC	C83394	Subject Reference End Date/Time	Reference End Date/time for the subject in ISO 8601 character format. Usually equivalent to the date/time when subject was determined to have ended the trial, and often equivalent to date/time of last exposure to study treatment. Required for all randomized subjects; null for screen failures or unassigned subjects.	The end date or date and time of the sponsor-defined study reference period, represented in a standardized character format.	6	6
Demographics	RFXSTDTC	C117455	Date/Time of First Study Treatment	First date of exposure to any protocol-specified treatment or therapy, equal to the earliest value of EXSTDTC.	The start date or date and time of the first date of exposure to any protocol-specified treatment or therapy, represented in a standardized character format.	7	7
Demographics	RFXENDTC	C117454	Date/Time of Last Study Treatment	Last date of exposure to any protocol-specified treatment or therapy, equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not collected or is missing).	The end date or date and time of the last date of exposure to any protocol-specified treatment or therapy, represented in a standardized character format.	8	1
Demographics	RFICDTC	C117452	Date/Time of Informed Consent	Date/time of informed consent in ISO 8601 character format. This will be the same as the date of informed consent in the Disposition domain, if that protocol milestone is documented. Would be null only in studies not collecting the date of informed consent.	The date or date and time of informed consent, represented in a standardized character format.	9	2
Demographics	RFPENDTC	C117453	Date/Time of End of Participation	Date/time when subject ended participation or follow-up in a trial, as defined in the protocol, in ISO 8601 character format. Should correspond to the last known date of contact. Examples include completion date, withdrawal date, last follow-up, date recorded for lost to follow up, or death date.	The date or date and time of last contact with or information about a subject in a trial, represented in a standardized character format.	10	3
Demographics	DTHDTC	C117450	Date/Time of Death	Date/time of death for any subject who died, in ISO 8601 format. Should represent the date/time that is captured in the clinical-trial database.	The date or date and time of death, represented in a standardized character format..	11	4
Demographics	DTHFL	C117451	Subject Death Flag	Indicates the subject died. Should be Y or null. Should be populated even when the death date is unknown.	An indication that the subject died.	12	5
Demographics	SITEID	C83081	Study Site Identifier	Unique identifier for a site within a study.	A sequence of characters used to uniquely identify the facility associated with study-specific activities.	13	6
Demographics	INVID	C83078	Investigator Identifier	An identifier to describe the Investigator for the study. May be used in addition to SITEID. Not needed if SITEID is equivalent to INVID.	A sequence of characters used to uniquely identify the study investigator.	14	7
Demographics	INVNAM	C83302	Investigator Name	Name of the investigator for a site.	The name of the study investigator.	15	1
Demographics	BRTHDTC	C83217	Date/Time of Birth	Date/time of birth of the subject.	The date or date and time of birth, represented in a standardized character format.	16	2
Demographics	AGE	C25150	Age	Age expressed in AGEU. May be derived from RFSTDTC and BRTHDTC, but BRTHDTC may not be available in all cases (due to subject privacy concerns).	A numeric representation of the elapsed time since birth.	17	3
Demographics	AGETXT	C90352		e.g. infant, elderly, in their 20s	ON HOLD SDSVAR-5 - Getting issue details... STATUS	18	4
Demographics	AGEU	C50400	Age Units	Units associated with AGE.	The unit of time used to express the age, using standardized values.	19	5
Demographics	SEX	C28421	Sex	Sex of the subject.	ON HOLD - Biological sex of the subject. (HHS Guidance) CDASH - Sex of the subject as determined by the investigator. There needs to be a discussion about what this variable should contain or if other variables need to be defined to capture sex.	20	6
Demographics	RACE SDSVAR-6 - Getting issue details... STATUS	C17049	Race	Race of the subject. Sponsors should refer to “Collection of Race and Ethnicity Data in Clinical Trials” (FDA, September 2005) for guidance regarding the collection of race (http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm) See Assumption below regarding RACE.	ON HOLD	21	7
Demographics	ETHNIC	C16564	Ethnicity	The ethnicity of the subject. Sponsors should refer to “Collection of Race and Ethnicity Data in Clinical Trials” (FDA, September 2005) for guidance regarding the collection of ethnicity (http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm).	ON HOLD	22	1
Demographics	SPECIES	C45293			ON HOLD - SEND	23	2
Demographics	STRAIN	C14419			ON HOLD - SEND	24	3
Demographics	SBSTRAIN	C117456			ON HOLD - SEND	25	4
Demographics	ARMCD	C83216	Planned Arm Code	ARMCD is limited to 20 characters and does not have special character restrictions. The maximum length of ARMCD is longer than for other “short” variables to accommodate the kind of values that are likely to be needed for crossover trials. For example, if ARMCD values for a seven-period crossover were constructed using two-character abbreviations for each treatment and separating hyphens, the length of ARMCD values would be 20.	A short sequence of characters that represents the planned arm to which the subject was assigned.	26	5
Demographics	ARM	C15538	Description of Planned Arm	Name of the Arm to which the subject was assigned.	The name of the planned arm to which the subject was assigned.	27	6
Demographics	ACTARMCD	C117449	Actual Arm Code	Code of actual Arm. When an Arm is not planned (not in Trial Arms), ACTARMCD will be UNPLAN. Randomized subjects who were not treated will be given a value of NOTTRT. Values should be “SCRNFAIL” for screen failures and “NOTASSGN” for subjects not assigned to treatment. Restricted to values in Trial Arms in all other cases. ACTARMCD is limited to 20 characters and does not have special character restrictions. The maximum length of ACTARMCD is longer than for other short variables to accommodate the kind of values that are likely to be needed for crossover trials.	A short sequence of characters that represents the arm in which the subject actually participated.	28	7
Demographics	ACTARM	C117448	Description of Actual Arm	Description of actual Arm. When an Arm is not planned (not in Trial Arms), ACTARM will be “Unplanned Treatment”. Randomized subjects who were not treated will be given a value of “Not Treated”. Values should be “Screen Failure” for screen failures and “Not Assigned” for subjects not assigned to treatment. Restricted to values in Trial Arms in all other cases.	The name of the arm in which the subject actually participated.	29	1
Demographics	SETCD	C117457			ON HOLD - SEND	30	2
Demographics	COUNTRY	C25464	Country	Country of the investigational site in which the subject participated in the trial.	The country in which the investigational site is located.	31	3
Demographics	DMDTC	C83243	Date/Time of Collection	Date/time of demographic data collection.	The date or date and time of demographic data collection, represented in a standardized character format.	32	4
Demographics	DMDY	C83244	Study Day of Collection	Study day of collection measured as integer days.	The actual study day of demographic data collection derived relative to the sponsor-defined reference start date.	33	5
Demographics	RACEOTH	C104495			ON HOLD	34	6
Demographics	CRACE			CDASH Draft definition (CDASH v2.0): An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (U.S. Center for Disease Control).	ON HOLD	35	7
Events	--TERM	C82571	Reported Term	Topic variable for an event observation, which is the verbatim or pre-specified name of the event.	The reported name of the event.	1	1
Events	--MODIFY				See Findings	2	2
Events	--LLT	C71886	Lowest Level Term	MedDRA Lowest Level Term.	The lowest-level term assigned to the event from the MedDRA dictionary.	3	3
Events	--LLTCD	C117048	Lowest Level Term Code	MedDRA Lowest Level Term code.	The lowest-level term code assigned to the event from the MedDRA dictionary.	4	4
Events	--DECOD	C82977	Dictionary-Derived 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).	Standardized or dictionary derived text for the description of an event or intervention.	5	5
Events	--PTCD	C117056	Preferred Term Code	MedDRA Preferred Term code.	The preferred term code assigned to the event from the MedDRA dictionary.	6	6
Events	--HLT	C71880	High Level Term	MedDRA High Level Term from the primary path.	The high-level term from the primary hierarchy assigned to the event from the MedDRA dictionary.	7	7
Events	--HLTCD	C117047	High Level Term Code	MedDRA High Level Term code from the primary path.	The high-level term code from the primary hierarchy assigned to the event from the MedDRA dictionary.	8	1
Events	--HLGT	C71889	High Level Group Term	MedDRA High Level Group Term from the primary path.	The high-level group term from the primary hierarchy assigned to the event from the MedDRA dictionary.	9	2
Events	--HLGTCD	C117046	High Level Group Term Code	MedDRA High Level Group Term code from the primary path.	The high-level group term code from the primary hierarchy assigned to the event from the MedDRA dictionary.	10	3
Events	--CAT				See Findings	11	4
Events	--SCAT				See Findings	12	5
Events	--PRESP				See Interventions	13	6
Events	--OCCUR				See Interventions	14	7
Events	--STAT				ON HOLD Definition: An indication as to whether a pre-specified event or intervention occurred. SDSVAR-7 - Getting issue details... STATUS (Note: The definition for Findings is different.)	15	1
Events	--REASND				See Findings	16	2
Events	--BODSYS	C12919	Body System or Organ Class	Body system or system organ class assigned for analysis from a standard hierarchy (e.g. MedDRA) associated with an event. Example: GASTROINTESTINAL DISORDERS.	A standardized or dictionary derived name for the body system or organ class	17	3
Events	--BDSYCD	C117040	Body System or Organ Class Code	MedDRA System Organ Class code corresponding to --BODSYS assigned for analysis.	A standardized or dictionary derived short sequence of characters used to represent the body system or organ class.	18	4
Events	--SOC	C71888	Primary System Organ Class	MedDRA primary System Organ Class associated with the event.	The system organ class from the primary hierarchy assigned in the MedDRA dictionary.	19	5
Events	--SOCCD	C117059	Primary System Organ Class Code	MedDRA primary System Organ Class code.	The system organ class code from the primary hierarchy assigned in the MedDRA dictionary.	20	6
Events	--LOC				See Findings	21	7
Events	--LAT				See Findings	22	1
Events	--DIR				See Findings	23	2
Events	--PORTOT				See Findings	24	3
Events	--PARTY	C117052	Accountable Party	Party accountable for the transferable object (e.g. device, specimen) as a result of the activity performed in the associated --TERM variable. The party could be an individual (e.g., subject), an organization (e.g., sponsor), or a location that is a proxy for an individual or organization (e.g., site). It is usually a somewhat general term that is further identified in the --PRTYID variable.	The role of the individual or entity responsible for the receipt of the transferred object (e.g. device, specimen).	25	4
Events	--PRTYID	C117054	Identification of Accountable Party	Identification of the specific party accountable for the transferable object (e.g. device, specimen) after the action in --TERM is taken. Used in conjunction with --PARTY.	A sequence of characters used to uniquely identify the individual or entity responsible for the receipt of the transferred object (e.g. device, specimen).	26	5
Events	--SEV				See Findings	27	6
Events	--SER	C82578	Serious Event	Is this is a serious event? Valid values are “Y” and “N”.	An indication as to whether an event meets regulatory criteria for seriousness.	28	7
Events	--ACN	C49499	Action Taken with Study Treatment	Describes changes made to the study treatment as a result of the event. Examples: DOSE INCREASED, DOSE NOT CHANGED.	An action taken to study treatment as the result of the event.	29	1
Events	--ACNOTH	C82509	Other Action Taken	Describes other actions taken as a result of the event that are unrelated to dose adjustments of study treatment.	An action taken, unrelated to study treatment, as the result of the event. SDSVAR-36 - Getting issue details... STATUS	30	2
Events	--ACNDEV	C117037	Action Taken with Device	Action taken with respect to a device in a study, which may or may not be the device under study	An action taken to a device as the result of the event.	31	3
Events	--REL	C82552	Causality	Records the investigator's opinion as to the causality of the event to the treatment. ICH E2A and E2B examples include NOT RELATED, UNLIKELY RELATED, POSSIBLY RELATED, RELATED.	The investigator's assessment of the likelihood that the study treatment was the cause of the event.	32	4
Events	--RELNST	C82564	Relationship to Non-Study Treatment	An opinion as to whether the event may have been due to a treatment other than study drug. Example: "MORE LIKELY RELATED TO ASPIRIN USE."	The investigator's assessment of the causal relationship of the event to a non-study treatment.	33	5
Events	--PATT	C82550	Pattern of Event	Used to indicate the pattern of the event over time. Examples: INTERMITTENT, CONTINUOUS, SINGLE EVENT.	A characterization of the temporal pattern of occurrences of the event.	34	6
Events	--OUT	C20200	Outcome of Event	Description of the outcome of an event. Examples: RECOVERED/RESOLVED, FATAL.	The status associated with the result or conclusion of the event.	35	7
Events	--SCAN	C82561	Involves Cancer	Was the event associated with the development of cancer? Valid values are “Y” and “N”.	An indication as to whether the reason an event was serious was because the event was associated with cancer.	36	1
Events	--SCONG	C2849	Congenital Anomaly or Birth Defect	Was the event associated with congenital anomaly or birth defect? Valid values are “Y” and “N”.	An indication as to whether the reason an event is serious is because the event is associated with congenital anomaly or birth defect in an offspring of the subject.	37	2
Events	--SDISAB	C68606	Persist or Signif Disability/Incapacity	Did the event result in persistent or significant disability/incapacity? Valid values are “Y” and “N”.	An indication as to whether the reason an event is serious is because the event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the subject's body function/structure, physical activities and/or quality of life.	38	3
Events	--SDTH	C82549	Results in Death	Did the event result in death? Valid values are “Y” and “N”.	An indication as to whether the reason an event is serious is because the event resulted in death.	39	4
Events	--SHOSP	C68605	Requires or Prolongs Hospitalization	Did the event require or prolong hospitalization? Valid values are “Y” and “N”.	An indication as to whether the reason an event is serious is because the event resulted in or prolonged hospitalization.	40	5
Events	--SLIFE	C82508	Is Life Threatening	Was the event life threatening? Valid values are “Y” and “N”.	An indication as to whether the reason an event is serious is because the event resulted in a substantial risk of dying.	41	6
Events	--SOD	C82548	Occurred with Overdose	Did the event occur with an overdose? Valid values are “Y” and “N”.	An indication as to whether the reason an event is serious is because the event is associated with overdose.	42	7
Events	--SMIE	C82521	Other Medically Important Serious Event	Do additional categories for seriousness apply? Valid values are “Y” and “N”.	An indication as to whether the reason an event is serious is because the event may jeopardize the subject and may require intervention to prevent one of the other outcomes associated with serious adverse events.	43	1
Events	--CONTRT	C53630	Concomitant or Additional Trtmnt Given	Was another treatment given because of the occurrence of the event? Valid values are “Y” and “N”. SDSVAR-31 - Getting issue details... STATUS	An indication as to whether a non-study treatment was given because of the occurrence of the event.	44	2
Events	--TOX				See Findings	45	3
Events	--TOXGR				See Findings	46	4
Findings	--TESTCD	C82503	Short Name of Measurement, Test or Examination	Short character value for --TEST used as a column name when converting a dataset from a vertical format to a horizontal format. The short value can be up to 8 characters. Examples: PLAT, SYSBP, RRMIN, EYEEXAM.	The standardized or dictionary derived short sequence of characters used to represent the assessment.	1	5
Findings	--TEST	C82541	Name of Measurement, Test or Examination	Long name For --TESTCD. Examples: Platelet, Systolic Blood Pressure, Summary (Min) RR Duration, Eye Examination.	The standardized or dictionary derived name of the assessment.	2	6
Findings	--MODIFY	C25446	Modified Term	If the value of --ORRES is modified for coding purposes, then the modified text is placed here.	A value which represents an alteration to a collected value for coding purposes.	3	7
Findings	--TSTDTL	C117062	Measurement, Test or Examination Detail	Further description of --TESTCD and --TEST. Example: “The percentage of cells with +1 intensity of staining” when MITESTCD = TTF1.	ON HOLD	4	1
Findings	--CAT	C25372	Category	Used to define a category of topic-variable values. Examples: HEMATOLOGY, URINALYSIS, CHEMISTRY, HAMILTON DEPRESSION SCALE, SF36, MICRO ARRAY, EGFR MUTATION ANALYSIS	A grouping or classification of the topic of the finding, event, or intervention.	5	2
Findings	--SCAT	C25692	Subcategory	Used to define a further categorization of --CAT values. Example: DIFFERENTIAL.	A further grouping or classification of the category for the topic of the finding, event, or intervention.	6	3
Findings	--POS	C62164	Position of Subject During Observation	Position of the subject during a measurement or examination. Examples: SUPINE, STANDING, SITTING.	The particular way that a subject's body is placed or situated during an assessment.	7	4
Findings	--ORRES	C117221	Result or Finding in Original Units	Result of the measurement or finding as originally received or collected. Examples: 120, <1, POS.	The outcome of the assessment as originally received or collected.	9	5
Findings	--ORRESU	C82586	Original Units	Unit for --ORRES. Examples: IN, LB, kg/L.	The unit of measure for the original outcome of the assessment, using standardized values.	10	6
Findings	--ORNRLO	C82580	Normal Range Lower Limit-Original Units	Lower end of normal range or reference range for results stored in --ORRES.	The lowest value in a normal or reference result range, as originally received or collected.	11	7
Findings	--ORNRHI	C70933	Normal Range Upper Limit-Original Units	Upper end of normal range or reference range for results stored in --ORRES.	The highest value in a normal or reference result range, as originally received or collected.	12	1
Findings	--STRESC	C117222	Result or Finding in Standard Format	Contains the result value for all findings, copied or derived from --ORRES in a standard format or in standard units. --STRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in --STRESN. For example, if various tests have results “NONE”, “NEG”, and “NEGATIVE” in --ORRES and these results effectively have the same meaning, they could be represented in standard format in --STRESC as "NEGATIVE".	The standardized outcome of the assessment as reported in character format.	13	2
Findings	--STRESN	C70952	Numeric Result/Finding in Standard Units	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.	The standardized outcome of the assessment as reported in numeric format.	14	3
Findings	--STRESU	C82587	Standard Units	Standardized units used for --STRESC and --STRESN. Example: mol/L.	The unit of measure for the standardized outcome of the assessment, using standardized values.	15	4
Findings	--STNRLO	C25555	Normal Range Lower Limit-Standard Units	Lower end of normal range or reference range for standardized results (e.g., --STRESC, --STRESN) represented in standardized units (--STRESU).	The standardized lowest value in a normal or reference result range.	16	5
Findings	--STNRHI	C25706	Normal Range Upper Limit-Standard Units	Upper end of normal range or reference range for standardized results (e.g., --STRESC, --STRESN) represented in standardized units (--STRESU).	The standardized highest value in a normal or reference result range.	17	6
Findings	--STNRC	C78727	Normal Range for Character Results	Normal range or reference range for results stored in --STRESC that are character in ordinal or categorical scale. Example: Negative to Trace.	A reference set of values identifying the normal range for character results in an ordinal scale or categorical grouping.	18	7
Findings	--NRIND	C82532	Normal/Reference Range Indicator	Used to indicate the value is outside the normal range or reference range. May be defined by --ORNRLO and --ORNRHI or other objective criteria. Examples: Y, N; HIGH, LOW; NORMAL; ABNORMAL.	A classification of the result as it relates to a normal or reference result range.	19	1
Findings	--RESCAT	C82498	Result Category	Used to categorize the result of a finding. Example: MALIGNANT or BENIGN for tumor findings. RESISTANCE VARIANT for genetic variation.	A grouping or classification of the results of an assessment.	20	2
Findings	--STAT	C41202	Completion Status	Used to indicate that a question was not asked or a test was not done, or a test was attempted but did not generate a result. Should be null or have a value of NOT DONE.	ON HOLD Definition: An indication as to whether a requested result was obtained. The definition for Events and Interventions is different.	21	3
Findings	--REASND	C82556	Reason Not Done	Reason not done. Used in conjunction with --STAT when value is NOT DONE.	The explanation for why requested information was not available.	22	4
Findings	--XFN	C82536	External File Path	Filename for an external file, such as one for an ECG waveform or a medical image.	The filename and/or path to external data not stored in the same format and possibly not the same location as the other data for a study.	23	5
Findings	--NAM	C117200	Laboratory/Vendor Name	Name or identifier of the vendor (e.g., laboratory) that provided the test results.	The name of the vendor that performs an assessment.	24	6
Findings	--LOINC	C82502	LOINC Code	Logical Observation Identifiers Names and Codes (LOINC) code for the topic variable such as a lab test.	A short sequence of characters used to represent laboratory and clinical tests within the Logical Observation Identifiers Names and Codes (LOINC) database.	25	7
Findings	--SPEC	C70713	Specimen Material Type	Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, URINE, DNA, RNA.	The type of sample material taken from a biological entity for testing, diagnostic, propagation, treatment or research purposes.	26	1
Findings	--ANTREG	C12680	Anatomical Region	Defines the specific anatomical or biological region of a tissue, organ specimen or the region from which the specimen is obtained, as defined in the protocol, such as a section or part of what is described in the --SPEC variable. Examples: CORTEX, MEDULLA, MUCOSA	ON HOLD	27	2
Findings	--SPCCND	C70714	Specimen Condition	Defines the condition of the specimen. Example: CLOUDY.	The physical state or quality of a sample for assessment.	28	3
Findings	--SPCUFL	C105758	Specimen Usability for the Test	Describes the usability of the specimen for the test. The value will be N if the specimen is not usable, and null if the specimen is usable.	An indication as to whether a sample is suitable for testing.	29	4
Findings	--LOC	C25341	Location Used for the Measurement	Anatomical location of the subject relevant to the collection of the measurement. Examples: RECTAL for temperature, ARM for blood pressure.	ON HOLD	30	5
Findings	--LAT	C25185	Laterality	Qualifier for anatomical location or specimen further detailing laterality. Examples: RIGHT, LEFT, BILATERAL	ON HOLD	31	6
Findings	--DIR	C54215	Directionality	Qualifier for anatomical location or specimen further detailing directionality. Examples: ANTERIOR, LOWER, PROXIMAL	ON HOLD	32	7
Findings	--PORTOT	C103166	Portion or Totality	Qualifier for anatomical location or specimen further detailing the distribution, which means arrangement of, apportioning of. . Examples: ENTIRE, SINGLE, SEGMENT, MANY.	ON HOLD	33	1
Findings	--METHOD	C82535	Method of Test or Examination	Method of the test or examination. Examples: EIA (Enzyme Immunoassay), ELECTROPHORESIS, DIPSTICK	ON HOLD	34	2
Findings	--RUNID	C117058	Run ID	A unique identifier for a particular run of a test on a particular batch of samples.	A sequence of characters used to uniquely identify a particular run of a test on a particular batch of samples.	35	3
Findings	--ANMETH	C117039	Analysis Method	Analysis method applied to obtain a summarized result. Analysis method describes the method of secondary processing applied to a complex observation result (e.g. an image or a genetic sequence).	ON HOLD	36	4
Findings	--LEAD	C50282	Lead Identified to Collect Measurements	Lead or leads identified to capture the measurement for a test from an instrument. Examples: LEAD I, LEAD V2, LEAD CM5.	An electrical recording from some region of the body that represents the voltage difference between two electrodes.	37	5
Findings	--CSTATE	C88429	Consciousness State	The consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS	The subject's level of consciousness.	38	6
Findings	--BLFL	C82526	Baseline Flag	Indicator used to identify a baseline value. Should be Y or null.	An indication that the record is the baseline assessment.	39	7
Findings	--FAST	C93566	Fasting Status	Indicator used to identify fasting status. Valid values include Y, N, U or null if not relevant.	An indication as to whether a subject has abstained from food and liquid for a prescribed amount of time.	40	1
Findings	--DRVFL	C81197	Derived Flag	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.	An indication that the measurement or finding is not a collected value but is processed or computed by the sponsor from collected data.	41	2
Findings	--EVAL	C51824	Evaluator	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.	The role of the person(s) providing an evaluation, appraisal, or interpretation.	42	3
Findings	--EVALID	C117043	Evaluator Identifier	Used to distinguish multiple evaluators with the same role recorded in --EVAL. Examples: RADIOLOGIST1 or RADIOLOGIST2	A sequence of characters used to uniquely identify the evaluator(s).	43	4
Findings	--ACPTFL	C117038	Accepted Record Flag	In cases where more than one assessor provides an evaluation of a result or response, this flag identifies the record that is considered, by an independent assessor, to be the accepted evaluation. Expected to be Y or null.	An indication that one record out of multiple records is the final, endorsed assessment.	44	5
Findings	--TOX	C27990	Toxicity	Description of toxicity quantified by --TOXGR such as NCI CTCAE Short Name. Examples: HYPERCALCEMIA, HYPOCALCEMIA. Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define-XML document.	A standardized or dictionary derived name for an untoward event or finding.	45	6
Findings	--TOXGR	C82528	Toxicity Grade	Records toxicity grade using a standard toxicity scale (such as the NCI CTCAE). Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define data definition document. Example: 2.	A standardized categorical classification of the severity of an event or finding.	46	7
Findings	--SEV	C25676	Severity	Describes the severity or intensity of a particular finding. Examples: MILD, MODERATE, SEVERE.	The quality or degree of harm associated with a finding or event.	47	1
Findings	--DTHREL	C82563	Relationship to Death	Describes the relationship of a particular finding to the death of a subject. Examples: Y, N or U.	ON HOLD	48	2
Findings	--LLOQ	C82589	Lower Limit of Quantitation	Indicates the lower limit of quantitation for an assay. Units will be those used for --STRESU.	The lowest threshold for reliably detecting the result of a specific test in standardized units.	49	3
Findings	--ULOQ	C85533	Upper Limit of Quantitation	Indicates the upper limit of quantitation for an assay. Units will be those used for --STRESU.	The highest threshold for reliably detecting the result of a specific test in standardized units.	50	4
Findings	--EXCLFL	C117045	Exclude from Statistics	Indicates whether the values in the result variables for this record should be excluded from summary statistical calculations such as Mean, Standard Deviation, and Count (and others). Expected to be Y or null. --EXCLFL should not be used when --STAT is NOT DONE. Not to be used with human clinical trials.	An indication that the result is to be excluded from a result set used for a statistical calculation.	51	5
Findings	--REASEX	C117057	Reason for Exclusion from Statistics	Reason excluded from statistics. Used in conjunction with --EXCLFL when its value is Y. Not to be used with human clinical trials	The explanation for why a result is excluded from a result set used for a statistical calculation.	52	6
Identifiers	STUDYID	C83082	Study Identifier	Unique identifier for a study.	A sequence of characters used by the sponsor to uniquely identify the study.	1	7
Identifiers	DOMAIN	C49556	Domain Abbreviation	Two-character abbreviation for the domain most relevant to the observation. The Domain abbreviation is also used as a prefix for variables to ensure uniqueness when datasets are merged.	An abbreviation for a collection of observations, with a topic-specific commonality.	2	1
Identifiers	USUBJID	C70731	Unique Subject Identifier	Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.	A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.	3	2
Identifiers	POOLID	C117053	Pool Identifier	An identifier used to identify a result from a group of subjects that is not assignable to a specific subject.	A sequence of characters used to uniquely identify a group of subjects that have been pooled together.	4	3
Identifiers	SPDEVID	C117060	Sponsor Device Identifier	Sponsor-defined identifier for a device	A sequence of characters used by the sponsor to uniquely identify a specific device. SDSVAR-8 - Getting issue details... STATUS	5	4
Identifiers	--SEQ	C70710	Sequence Number	Sequence number to ensure uniqueness of records within a dataset for a subject (or within a parameter, in the case of the Trial Summary domain). May be any valid number (including decimals) and does not have to start at 1.	A number used to identify records within a dataset.	6	5
Identifiers	--GRPID	C82529	Group ID	Optional group identifier, used to link together a block of related records within a subject in a domain. Also used to link together a block of related records in the Trial Summary dataset (Section 3.4).	A sequence of characters used to uniquely identify related records for a subject within a domain, or related parameters in the Trial Summary dataset.	7	6
Identifiers	--REFID	C82531	Reference ID	Optional internal or external identifier such as lab specimen ID, or UUID for an ECG waveform or a medical image.	A sequence of characters used to uniquely identify a source of information.	8	7
Identifiers	--SPID	C82530	Sponsor-Defined Identifier	Sponsor-defined identifier. Example: pre-printed line identifier on a Concomitant Medications page.	A sponsor-defined sequence of characters used to identify an instance of an observation.	9	1
Identifiers	--LNKID	C117050	Link ID	Identifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship. For Example: A single tumor may have multiple measurements/assessments performed at each study visit.	A sequence of characters used to uniquely identify a record in one domain and link it to one or more records in another domain.	10	2
Identifiers	--LNKGRP	C117049	Link Group ID	Identifier used to link related records across domains. This will usually be a many-to-one relationship. For example: Multiple tumor measurements/assessments will contribute to a single response to therapy determination record.	A sequence of characters used to uniquely identify a group of records in one domain and link it to one or more records in another domain. .	11	3
Interventions	--TRT	C82542	Name of Treatment	The topic for the intervention observation, usually the verbatim name of the treatment, drug, medicine, or therapy given during the dosing interval for the observation.	The reported name of the drug, procedure, or therapy.	1	4
Interventions	--MODIFY				See Findings	2	5
Interventions	--DECOD				See Events	3	6
Interventions	--MOOD	C117051	Mood	Mode or condition of the record (e.g., SCHEDULED, PERFORMED).	The state that may be applied to a record to indicate its phase in a life cycle or business process, e.g., scheduled, performed.	4	7
Interventions	--CAT				See Findings	5	1
Interventions	--SCAT				See Findings	6	2
Interventions	--PRESP	C82510	Pre-specified	Used when a specific intervention is pre-specified on a CRF. Values should be “Y” or null.	An indication that the event or intervention was prospectively stated or detailed on the CRF.	7	3
Interventions	--OCCUR	C25275	Occurrence	Used to record whether a pre-specified intervention occurred when information about the occurrence of a specific intervention is solicited.	An indication as to whether a pre-specified event or intervention has occurred.	8	4
Interventions	--STAT				See Findings	9	5
Interventions	--REASND				See Findings	10	6
Interventions	--INDC	C41184	Indication	Denotes the indication for the intervention (e.g., why the therapy was taken or administered).	The sign, symptom or condition that is the basis for initiation of a treatment.	11	7
Interventions	--CLAS	C25346	Class	Class for a medication or treatment, often obtained from a coding dictionary.	A standardized or dictionary derived grouping of drugs, procedures, or therapies.	12	1
Interventions	--CLASCD	C82501	Class Code	Used to represent code for --CLAS.	A standardized or dictionary derived short sequence of characters used to represent a grouping of drugs, procedures, or therapies..	13	2
Interventions	--DOSE	C25488	Dose	Amount of --TRT given. Not populated when --DOSTXT is populated.	The quantity of an agent (such as a drug, substance or radiation) taken or absorbed at a single administration.	14	3
Interventions	--DOSTXT	C70961	Dose Description	Dosing information collected in text form. Examples: <1 per day, 200-400. Not populated when --DOSE is populated.	A textual description of the quantity of an agent (such as a drug, substance or radiation) taken or absorbed at a single administration.	15	4
Interventions	--DOSU	C73558	Dose Units	Units for --DOSE, --DOSTOT, or --DOSTXT (Examples: ng, mg, mg/kg).	The unit of measure for the agent (such as a drug, substance or radiation), using standardized values.	16	5
Interventions	--DOSFRM	C42636	Dose Form	Dose form for the treatment. Examples: TABLET, CAPSULE.	The shape or configuration in which an agent (such as a drug, substance or radiation) is physically presented.	17	6
Interventions	--DOSFRQ	C15682	Dosing Frequency per Interval	Usually expressed as the number of doses given per a specific interval. Examples: Q2H, QD, PRN.	The number of times that an agent (such as a drug, substance or radiation) is administered per unit of time.	18	7
Interventions	--DOSTOT	C70888	Total Daily Dose	Total daily dose of --TRT using the units in --DOSU. Used when dosing is collected as Total Daily Dose.	The quantity of an agent (such as a drug, substance or radiation) taken or absorbed on a single day.	19	1
Interventions	--DOSRGM	C71137	Intended Dose Regimen	Text description of the (intended) schedule or regimen for the Intervention. Example: TWO WEEKS ON, TWO WEEKS OFF.	The planned schedule for the administration of an agent (such as a drug, substance or radiation).	20	2
Interventions	--ROUTE	C38114	Route of Administration	Route of administration for the intervention. Examples: ORAL, INTRAVENOUS.	Designation of the part of the body through which or into which, or the way in which, a substance is introduced.	21	3
Interventions	--LOT	C70848	Lot Number	Lot number for the intervention described in --TRT.	An identifier assigned by the manufacturer or distributor to a specific quantity of manufactured material or product within a batch.	22	4
Interventions	--LOC				See Findings	23	5
Interventions	--LAT				See Findings	24	6
Interventions	--DIR				See Findings	25	7
Interventions	--PORTOT				See Findings	26	1
Interventions	--FAST				See Findings	27	2
Interventions	--PSTRG	C53294	Pharmaceutical Strength	Amount of an active ingredient expressed quantitatively per dosage unit, per unit of volume, or per unit of weight, according to the pharmaceutical dose form. Example: 50 mg/TABLET, 300 mg/L	The amount of active ingredient per unit of pharmaceutical dosage form.	28	3
Interventions	--PSTRGU	C117055	Pharmaceutical Strength Units	Unit for --PSTRG. Example: mg/TABLET, mg/mL	The unit of measure for the amount of active ingredient per unit of pharmaceutical dosage form, using standardized values.	29	4
Interventions	--TRTV	C927	Treatment Vehicle	Vehicle for administration of treatment, such as a liquid in which the treatment drug is dissolved. Example: SALINE.	A carrier or inert medium in which a medicinally active agent is administered.	30	5
Interventions	--VAMT	C82553	Treatment Vehicle Amount	Amount of the prepared product (treatment + vehicle) administered or given. Note: should not be diluent amount alone.	Amount of the prepared product (treatment plus vehicle) administered.	31	6
Interventions	--VAMTU	C82583	Treatment Vehicle Amount Units	Units for the prepared product (treatment + vehicle). Examples: mL, mg.	The unit of measure for the prepared product (treatment plus vehicle) using standardized values.	32	7
Interventions	--ADJ	C82555	Reason for Dose Adjustment	Describes reason or explanation of why a dose is adjusted. Examples ADVERSE EVENT, INSUFFICIENT RESPONSE, NON-MEDICAL REASON.	The explanation given for why a dose was changed as compared to a previous dose.	33	1
Timing	VISIT	C83093	Visit Name	Protocol-defined description of a clinical encounter.	The protocol-defined label for a clinical encounter.	2	2
Timing	VISITDY	C83450	Planned Study Day of Visit	Planned study day of VISIT. Should be an integer.	The planned study day of a clinical encounter relative to the sponsor-defined reference start date.	3	3
Timing	VISITNUM	C83101	Visit Number	Clinical encounter number. Numeric version of VISIT, used for sorting.	An assigned numeric identifier that aligns to the chronological order of a clinical encounter.	3	4
Timing	TAETORD	C83438	Planned Order of Element within Arm	Number that gives the planned order of the Element within the Arm (see Trial Arms, Section 3.2.2 ).	An assigned numeric identifier that gives the planned order of the element within the trial arm of the study.	4	5
Timing	EPOCH	C71738	Epoch	Epoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected. (See Section 3.2.2).	A time period in a study with a specific purpose.	5	6
Timing	--DTC	C82515	Date/Time of Collection	Collection date and time of an observation represented in IS0 8601 character format.	The date or date and time of specimen or data collection from the subject, represented in a standardized character format.	6	7
Timing	--STDTC	C82517	Start Date/Time of Observation	Start date/time of an observation represented in IS0 8601 character format.	The start date or date and time of an intervention or event, represented in a standardized character format.	7	1
Timing	--ENDTC	C82516	End Date/Time of Observation	End date/time of the observation represented in IS0 8601 character format.	The end date or date and time of an intervention, event, or finding represented in a standardized character format.	8	2
Timing	--DY	C82437	Study Day of Visit/Collection/Exam	Actual study day of visit/collection/exam expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.	The actual study day of an intervention, event, or finding, derived relative to the sponsor-defined reference start date.	9	3
Timing	--STDY	C82570	Study Day of Start of Observation	Actual study day of start of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.	The actual study day of the start of an intervention or event, derived relative to the sponsor-defined reference start date.	10	4
Timing	--ENDY	C82569	Study Day of End of Observation	Actual study day of end of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.	The actual study day of the end of an intervention or event, derived relative to the sponsor-defined reference start date.	11	5
Timing	--DUR	C25330	Duration	Collected duration of an event, intervention, or finding represented in ISO 8601 character format. Used only if collected on the CRF and not derived.	The collected length of time during which an observation continues, represented in a standardized character format.	12	6
Timing	--TPT	C82539	Planned Time Point Name	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 --TPTNUM and --TPTREF.	The description of when an observation is planned to occur.	13	7
Timing	--TPTNUM	C82545	Planned Time Point Number	Numeric version of planned time point used in sorting.	The numeric identifier of when an observation is planned to occur.	14	1
Timing	--ELTM	C82572	Planned Elapsed Time from Time Point Ref	Planned Elapsed time in ISO 8601 character format relative to a planned fixed reference (--TPTREF) 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.	The interval of time between a planned time point and a fixed reference point, represented in a standardized character format.	15	2
Timing	--TPTREF	C82576	Time Point Reference	Description of the fixed reference point referred to by --ELTM, --TPTNUM, and --TPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL.	The description of a time point that acts as a fixed reference for a series of planned time points.	16	3
Timing	--RFTDTC	C82518	Date/Time of Reference Time Point	Date/time for a fixed reference time point defined by --TPTREF in ISO 8601 character format.	The actual date or date and time of a time point that acts as a fixed reference for a series of planned time points, represented in a standardized character format..	17	4
Timing	--STRF	C82559	Start Relative to Reference Period	Identifies the start of the observation as being before, during, or after the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point represented by RFSTDTC and RFENDTC in Demographics. Note: This variable will be deprecated (phased out) in a future (post SDTM v1.4) release. The functionality of this variable can be replaced by the use of --STRTPT with --STTPT = RFSTDTC.	The characterization of the start of an observation relative to the study reference period.	18	5
Timing	--ENRF	C82557	End Relative to Reference Period	Identifies the end of the observation as being before, during or after the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point represented by RFSTDTC and RFENDTC in Demographics. Note: This variable will be deprecated (phased out) in a future (post SDTM v1.4) release. The functionality of this variable can be replaced by the use of --ENRTPT with --ENTPT = RFENDTC.	The characterization of the end of an observation relative to the study reference period.	19	6
Timing	--EVLINT	C82534	Evaluation Interval	Duration of interval associated with an observation such as a finding --TESTCD, represented in ISO 8601 character format. Example: -P2M to represent a period of the past 2 months as the evaluation interval for a question from a questionnaire such as SF-36.	The planned time interval for which an observation is assessed, represented in a standardized character format.	20	7
Timing	--EVINTX	C117044	Evaluation Interval Text	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.	A textual description of the planned time interval for which an observation is assessed, where the interval is not able to be represented in a standardized character format.	21	1
Timing	--STRTPT	C82560	Start Relative to Reference Time Point	Identifies the start of the observation as being before or after the sponsor-defined reference time point defined by variable --STTPT.	The characterization of the start of an observation relative to a reference time point.	22	2
Timing	--STTPT	C82575	Start Reference Time Point	Description or date/time in ISO 8601 or other character format of the sponsor-defined reference point referred to by --STRTPT. Examples: "2003-12-15" or "VISIT 1".	The description or date and/or time of a time point that acts as a fixed reference for characterizing the start of an observation.	23	3
Timing	--ENRTPT	C82558	End Relative to Reference Time Point	Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable --ENTPT.	The characterization of the end of an observation relative to a reference time point.	24	4
Timing	--ENTPT	C82574	End Reference Time Point	Description or date/time in ISO 8601 or other character format of the sponsor-defined reference point referred to by --ENRTPT. Examples: "2003-12-25" or "VISIT 2".	The description or date and/or time of a time point that acts as a fixed reference for characterizing the end of an observation.	25	5
Timing	--STINT	C117061	Planned Start of Assessment Interval	The start of a planned evaluation or assessment interval in ISO 8601 character format relative to the Time Point Reference (--TPTREF).	The start of a planned assessment interval relative to a reference time point, represented in a standardized character format.	26	6
Timing	--ENINT	C117042	Planned End of Assessment Interval	The end of a planned evaluation or assessment interval in ISO 8601 character format relative to the Time Point Reference (--TPTREF).	The end of a planned assessment interval relative to a reference time point, represented in a standardized character format..	27	7
Timing	--DETECT	C117041	Time in Days to Detection	The number of days from the start of dosing to the earliest detection of a condition or pathogen.	ON HOLD	28	1
Timing	--CDUR				ON HOLD	29	2
Timing	--CDURU				ON HOLD	30	3

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Vineet Sharma

Carey Smoak

Sterling Hardy