| Source Page | SDTM2DOT0:General Observation Variables |
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| Valid Tables | 7 |
| Destination | Library |
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| Scrape Errors |
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| Output Format | Table |
| Variable Name | Variable Label | Type | Format | Role | Variable(s) Qualified | Usage Restrictions | Variable C-code | Definition | Notes | Examples | Seq. for Order |
|---|---|---|---|---|---|---|---|---|---|---|---|
| --TRT | Name of Treatment | Char | Topic | C82542 | The reported name of the drug, procedure, or therapy. | 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. | 1 | ||||
| --MODIFY | Modified Treatment Name | Char | Synonym Qualifier | --TRT | C170998 | A value which represents an alteration to a collected value for coding purposes. | If the value for --TRT is modified for coding purposes, then the modified text is placed here. | 2 | |||
| --DECOD | Standardized Treatment Name | Char | Synonym Qualifier | --TRT | C170991 | Standardized or dictionary-derived text for the description of an event or intervention. | Equivalent to the generic drug name in WHODrug, or a term in SNOMED, ICD-9, or other published or sponsor-defined dictionaries. | 3 | |||
| --MOOD | Mood | Char | Record Qualifier | C117051 | The state that may be applied to a record to indicate its phase in a life cycle or business process (e.g., scheduled, performed). | "SCHEDULED", "PERFORMED" | 4 | ||||
| --CAT | Category | Char | Grouping Qualifier | C25372 | A grouping or classification of the topic of the finding, event, or intervention. | 5 | |||||
| --SCAT | Subcategory | Char | Grouping Qualifier | A further grouping or classification of the category for the topic of the finding, event, or intervention. | The category is in --CAT. | 6 | |||||
| --PRESP | Pre-Specified | Char | Variable Qualifier | --TRT | Not in nonclinical trials | C82510 | An indication that the event or intervention was prospectively stated or detailed on the CRF. | Values should be "Y" or null. | 7 | ||
| --OCCUR | Occurrence Indicator | Char | Record Qualifier | C171000 | An indication as to whether a prespecified event or intervention has occurred. | 8 | |||||
| --REASOC | Reason for Occur Value | Char | Record Qualifier | --REASOC is the reason the intervention did or did not occur, according to the value in --OCCUR. This does not replace --INDC. | 9 | ||||||
| --STAT | Completion Status | Char | Record Qualifier | Used to indicate when a question about the occurrence of a prespecified intervention was not answered. Should be null or have a value of "NOT DONE". | 10 | ||||||
| --REASND | Reason Not Done | Char | Record Qualifier | C82556 | The explanation for why requested information was not available. | Used in conjunction with --STAT when value is "NOT DONE". | 11 | ||||
| --CNTMOD | Contact Mode | Char | Record Qualifier | The way in which the event, visit, or contact was conducted. | 12 | ||||||
| --EPCHGI | Epi/Pandemic Related Change Indicator | Char | Record Qualifier | Indicates whether the intervention was changed due to an epidemic or pandemic. | 13 | ||||||
| --INDC | Indication | Char | Record Qualifier | C41184 | The sign, symptom, or condition that is the basis for initiation of a treatment. | 14 | |||||
| --CLAS | Class | Char | Variable Qualifier | --TRT | C170987 | A standardized or dictionary-derived name for a grouping of drugs, procedures, or therapies. | 15 | ||||
| --CLASCD | Class Code | Char | Variable Qualifier | --TRT | C170988 | A standardized or dictionary-derived short sequence of characters used to represent a grouping of drugs, procedures, or therapies. | Used to represent code for --CLAS. | 16 | |||
| --DOSE | Dose | Num | Record Qualifier | C25488 | The quantity of an agent (e.g., drug, substance, radiation) taken or absorbed at a single administration. | Not populated when --DOSTXT is populated. | 17 | ||||
| --DOSTXT | Dose Description | Char | Record Qualifier | C70961 | A textual description of the quantity of an agent (e.g., drug, substance, radiation) taken or absorbed at a single administration. | Not populated when --DOSE is populated. | "200-400" | 18 | |||
| --DOSU | Dose Units | Char | Variable Qualifier | --DOSE; --DOSTXT; --DOSTOT | C73558 | The unit of measure for the administered agent (e.g., drug, substance, radiation), using standardized values. | Units for --DOSE, --DOSTOT, or --DOSTXT. | "ng", "mg", "mg/kg" | 19 | ||
| --TDOSD | Toxic/Physiologic Dose Descr | Char | Record Qualifier | A description of a statistically derived estimate of a dose with a certain toxicological or physiological effect in a population, based on data from a dose-response study. | "LD50", "ED90" | 20 | |||||
| --FTDOSD | Factor for Toxic/Physiologic Dose Descr | Num | Variable Qualifier | --TDOSD | The quantity given for the multiplier of --TDOSD. | If --TDOSD="LD50" and --FTDOSD="5", then the value represented by --DOSE and --DOSU is 5 times the LD50. | 21 | ||||
| --DOSFRM | Dose Form | Char | Variable Qualifier | --TRT | C42636 | Physical characteristics of a drug product, (e.g., tablet, capsule, or solution) that contains a drug substance, generally (but not necessarily) in association with one or more other ingredients. | "TABLET", "CAPSULE" | 22 | |||
| --DOSFRQ | Dosing Frequency per Interval | Char | Record Qualifier | C15682 | The number of times that an agent (e.g., drug, substance, radiation) is administered per unit of time. | "Q2H", "QD", "PRN" | 23 | ||||
| --DOSTOT | Total Daily Dose | Num | Record Qualifier | C70888 | The quantity of an agent (e.g., drug, substance, radiation) taken or absorbed on a single day. | Uses the units in --DOSU. | 24 | ||||
| --DOSRGM | Intended Dose Regimen | Char | Record Qualifier | C71137 | The planned schedule for the administration of an agent (e.g., drug, substance, radiation). | "TWO WEEKS ON, TWO WEEKS OFF" | 25 | ||||
| --ROUTE | Route of Administration | Char | Record Qualifier | C38114 | Designation of the part of the body through which or into which, or the way in which, a substance is introduced. | "ORAL", "INTRAVENOUS" | 26 | ||||
| --LOT | Lot Number | Char | Record Qualifier | C70848 | An identifier assigned by the manufacturer or distributor to a specific quantity of manufactured material or product. | Although the identifier for a lot is generally called a lot number, it may contain characters other than digits (e.g., letters). | 27 | ||||
| --LOC | Location of Administration | Char | Record Qualifier | Anatomical location of an intervention, such as an injection site. | "ARM" for an injection | 28 | |||||
| --METHOD | Method of Administration | Char | Record Qualifier | Not in human clinical trials; EX domain only | Method of administration of the treatment. | "INFUSION" when ROUTE is "INTRAVENOUS" \n | 29 | ||||
| --LAT | Laterality | Char | Variable Qualifier | --LOC | Qualifier for anatomical location further detailing laterality of intervention administration. | "RIGHT", "LEFT", "BILATERAL" | 30 | ||||
| --DIR | Directionality | Char | Variable Qualifier | --LOC | Qualifier for anatomical location further detailing directionality of intervention administration. | "ANTERIOR", "LOWER", "PROXIMAL" | 31 | ||||
| --PORTOT | Portion or Totality | Char | Variable Qualifier | --LOC | Qualifier for anatomical location further detailing the distribution, which means arrangement of or apportioning of the intervention administration. | "ENTIRE", "SINGLE", "SEGMENT", "MANY" | 32 | ||||
| --FAST | Fasting Status | Char | Record Qualifier | C93566 | An indication as to whether a subject has abstained from food and liquid for a prescribed amount of time. | Valid values include "Y", "N", "U", or null if not relevant. | 33 | ||||
| --PSTRG | Pharmaceutical Strength | Num | Record Qualifier | C53294 | The amount of active ingredient per unit of pharmaceutical dosage form. | "50", "300" | 34 | ||||
| --PSTRGU | Pharmaceutical Strength Units | Char | Variable Qualifier | --PSTRG | C117055 | The unit of measure for the amount of active ingredient per unit of pharmaceutical dosage form, using standardized values. | Unit for --PSTRG. | "mg/TABLET", "mg/mL" | 35 | ||
| --TRTV | Treatment Vehicle | Char | Record Qualifier | C927 | A carrier or inert medium in which a medicinally active agent is administered. | "SALINE" | 36 | ||||
| --VAMT | Treatment Vehicle Amount | Num | Record Qualifier | C82553 | Amount of the prepared product (treatment plus vehicle) administered. | Note: Should not be diluent amount alone. | 37 | ||||
| --VAMTU | Treatment Vehicle Amount Units | Char | Variable Qualifier | --VAMT | C82583 | The unit of measure for the prepared product (treatment plus vehicle) using standardized values. | "mL", "mg" | 38 | |||
| --ADJ | Reason for Dose Adjustment | Char | Record Qualifier | C82555 | The explanation given for why a dose was changed as compared to a previous dose. | "ADVERSE EVENT", "INSUFFICIENT RESPONSE", "NON-MEDICAL REASON" | 39 | ||||
| --RSDISC | Reason for Treatment Discontinuation | Char | Record Qualifier | Reason the treatment was discontinued. | 40 | ||||||
| --USCHFL | Unscheduled Flag | Char | Record Qualifier | Not in human clinical trials | C170510 | An indication that the performed test or observation was done at a time that was not planned. | If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are "Y" or null. This variable would not be needed when information on planned assessments is provided, such as when the Trial Visits (TV) and Subject Visits (SV) domains are used. | 41 | |||
| --RSTIND | Restraint Indicator | Char | Record Qualifier | Not in human clinical trials | An indicator as to whether the animal subject was restrained during the intervention period. Expected values are "Y" or null. | 42 | |||||
| --RSTMOD | Restraint Mode | Char | Record Qualifier | Not in human clinical trials | A description of whether the restraint was physical and/or chemical. | 43 | |||||
| --TERM | Reported Term | Char | Topic | C82571 | The collected name for an event observation. | The verbatim or prespecified name of the event. | 1 | ||||
| --MODIFY | Modified Reported Term | Char | Synonym Qualifier | --TERM | C170998 | A value which represents an alteration to a collected value for coding. | If the value for --TERM is modified for coding purposes, then the modified text is placed here. | 2 | |||
| --LLT | Lowest Level Term | Char | Variable Qualifier | --TERM | Not in nonclinical trials | C71886 | The lowest-level term assigned to the event from MedDRA. | 3 | |||
| --LLTCD | Lowest Level Term Code | Num | Variable Qualifier | --LLT | Not in nonclinical trials | C117048 | The lowest-level term code assigned to the event from MedDRA. | 4 | |||
| --DECOD | Dictionary-Derived Term | Char | Synonym Qualifier | --TERM | C170991 | Standardized or dictionary-derived text for the description of an event or intervention. | Equivalent to the Preferred Term ("PT" in MedDRA). | 5 | |||
| --EVDTYP | Medical History Event Date Type | Char | Variable Qualifier | --STDTC; --ENDTC | MH domain only | Specifies the aspect of the medical condition or event by which MHSTDTC and/or the MHENDTC is defined. | "DIAGNOSIS", "SYMPTOM ONSET", "DISEASE RELAPSE" | 6 | |||
| --PTCD | Preferred Term Code | Num | Variable Qualifier | --DECOD | Not in nonclinical trials | C117056 | The preferred term code assigned to the event from the MedDRA dictionary. | 7 | |||
| --HLT | High Level Term | Char | Variable Qualifier | --TERM | Not in nonclinical trials | C71880 | The high-level term from the primary hierarchy assigned to the event from MedDRA. | 8 | |||
| --HLTCD | High Level Term Code | Num | Variable Qualifier | --HLT | Not in nonclinical trials | C117047 | The high-level term code from the primary hierarchy assigned to the event from MedDRA. | 9 | |||
| --HLGT | High Level Group Term | Char | Variable Qualifier | --TERM | Not in nonclinical trials | C71889 | The high-level group term from the primary hierarchy assigned to the event from MedDRA. | 10 | |||
| --HLGTCD | High Level Group Term Code | Num | Variable Qualifier | --HLGT | Not in nonclinical trials | C117046 | The high-level group term code from the primary hierarchy assigned to the event from MedDRA. | 11 | |||
| --CAT | Category | Char | Grouping Qualifier | C25372 | A grouping or classification of the topic of the finding, event, or intervention. | 12 | |||||
| --SCAT | Subcategory | Char | Grouping Qualifier | A further grouping or classification of the category for the topic of the finding, event, or intervention. | The category is in --CAT. | 13 | |||||
| --PRESP | Pre-Specified | Char | Variable Qualifier | --TERM | C82510 | An indication that the event or intervention was prospectively stated or detailed on the CRF. | Value is "Y" for prespecified events, null for spontaneously reported events. | 14 | |||
| --OCCUR | Occurrence Indicator | Char | Record Qualifier | Not in AE domain | C171000 | An indication as to whether a prespecified event or intervention has occurred. | 15 | ||||
| --REASOC | Reason for Occur Value | Char | Record Qualifier | Not in AE domain | --REASOC is the reason the event did or did not occur, according to the value in --OCCUR. | 16 | |||||
| --STAT | Completion Status | Char | Record Qualifier | Not in AE domain \n | Used to indicate when a question about the occurrence of a prespecified event was not answered. Should be null or have a value of "NOT DONE". | 17 | |||||
| --REASND | Reason Not Done | Char | Record Qualifier | Not in AE domain | C82556 | The explanation for why requested information was not available. | Used in conjunction with --STAT when its value is "NOT DONE". | 18 | |||
| --BODSYS | Body System or Organ Class | Char | Record Qualifier | C170986 | A standardized or dictionary-derived name for the 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. | "GASTROINTESTINAL DISORDERS" | 19 | |||
| --BDSYCD | Body System or Organ Class Code | Num | Variable Qualifier | --BODSYS | Not in nonclinical trials | C170985 | A standardized or dictionary-derived short sequence of characters used to represent the body system or organ class. | MedDRA System Organ Class code corresponding to --BODSYS assigned for analysis. | 20 | ||
| --SOC | Primary System Organ Class | Char | Variable Qualifier | --TERM | Not in nonclinical trials | C71888 | The system organ class from the primary hierarchy assigned in the MedDRA dictionary. | 21 | |||
| --SOCCD | Primary System Organ Class Code | Num | Variable Qualifier | --SOC | Not in nonclinical trials | C117059 | The system organ class code from the primary hierarchy assigned in the MedDRA dictionary. | 22 | |||
| --CNTMOD | Contact Mode | Char | Record Qualifier | The way in which the event, visit, or contact was conducted. | "IN PERSON", "TELEPHONE", "IVRS" | 23 | |||||
| --EPCHGI | Epi/Pandemic Related Change Indicator | Char | Record Qualifier | Indicates whether the event was changed due to an epidemic or pandemic. Not the same as whether a medical condition was caused by an epidemic or pandemic. | 24 | ||||||
| --LOC | Location of Event | Char | Record Qualifier | Describes anatomical location relevant for the event. | "ARM" for skin rash | 25 | |||||
| --LAT | Laterality | Char | Variable Qualifier | --LOC | Qualifier for anatomical location, further detailing laterality. | "RIGHT", "LEFT", "BILATERAL" | 26 | ||||
| --DIR | Directionality | Char | Variable Qualifier | --LOC | Qualifier for anatomical location, further detailing directionality. | "ANTERIOR", "LOWER", "PROXIMAL" | 27 | ||||
| --PORTOT | Portion or Totality | Char | Variable Qualifier | --LOC | Qualifier for anatomical location, further detailing the distribution (i.e., arrangement of, apportioning of). | "ENTIRE", "SINGLE", "SEGMENT", "MANY" | 28 | ||||
| --PARTY | Accountable Party | Char | Record Qualifier | Not in nonclinical trials | C117052 | The role of the individual or entity responsible for the receipt of the transferred object (e.g., device, specimen). | 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. | 29 | |||
| --PRTYID | Identification of Accountable Party | Char | Variable Qualifier | --PARTY | Not in nonclinical trials | C117054 | A sequence of characters used to uniquely identify the individual or entity responsible for the receipt of the transferred object (e.g., device, specimen). | Used in conjunction with --PARTY. | 30 | ||
| --SEV | Severity/Intensity | Char | Record Qualifier | C25676 | The quality or degree of harm associated with a finding or event, as collected. | "MILD", "MODERATE", "SEVERE" | 31 | ||||
| --SER | Serious Event | Char | Record Qualifier | C82578 | A collected indication as to whether an event meets regulatory criteria for seriousness. | Valid values are "Y" and "N". | 32 | ||||
| --ACN | Action Taken with Study Treatment | Char | Record Qualifier | C49499 | An action taken with study treatment as the result of the event. | "DOSE INCREASED", "DOSE NOT CHANGED" | 33 | ||||
| --ACNOTH | Other Action Taken | Char | Record Qualifier | C82509 | An action taken unrelated to study treatment, as the result of the event. | 34 | |||||
| --ACNDEV | Action Taken with Device | Char | Record Qualifier | C117037 | An action taken with a device as the result of the event. | The device may or may not be the device under study. | 35 | ||||
| --REL | Causality | Char | Record Qualifier | C103163 | The investigator's assessment of the likelihood that the study treatment was the cause of the event. | "NOT RELATED", "UNLIKELY RELATED", "POSSIBLY RELATED", "RELATED" | 36 | ||||
| --RLDEV | Relationship of Event to Device | Char | Record Qualifier | A judgement as to the likelihood that the device caused the event. | The device may or may not be the device under study. Controlled terminology from EC Directive MEDDEV 2.7/3 March 2015 is required in EU but not US. | "CAUSAL", "UNLIKELY" | 37 | ||||
| --RELNST | Relationship to Non-Study Treatment | Char | Record Qualifier | C82564 | The investigator's assessment of the causal relationship of the event to a non-study treatment. | "MORE LIKELY RELATED TO ASPIRIN USE" | 38 | ||||
| --PATT | Pattern of Event | Char | Record Qualifier | C82550 | A characterization of the temporal pattern of occurrences of the event. | "INTERMITTENT", "CONTINUOUS", "SINGLE EVENT" | 39 | ||||
| --OUT | Outcome of Event | Char | Record Qualifier | C171001 | The status associated with the result or conclusion of the event. | "RECOVERED/RESOLVED", "FATAL" | 40 | ||||
| --SCAN | Involves Cancer | Char | Record Qualifier | Not in nonclinical trials | C82561 | An indication as to whether the reason an event was serious was because the event was associated with cancer. | Valid values are "Y", "N", and null. | 41 | |||
| --SCONG | Congenital Anomaly or Birth Defect | Char | Record Qualifier | Not in nonclinical trials | C2849 | 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. | Valid values are "Y", "N", and null. | 42 | |||
| --SDISAB | Persist or Signif Disability/Incapacity | Char | Record Qualifier | Not in nonclinical trials | C68606 | 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. | Valid values are "Y", "N", and null. | 43 | |||
| --SDTH | Results in Death | Char | Record Qualifier | Not in nonclinical trials | C82549 | An indication as to whether the reason an event is serious is because the event resulted in death. | Valid values are "Y", "N", and null. | 44 | |||
| --SHOSP | Requires or Prolongs Hospitalization | Char | Record Qualifier | Not in nonclinical trials | C68605 | An indication as to whether the reason an event is serious is because the event resulted in or prolonged hospitalization. | Valid values are "Y", "N", and null. | 45 | |||
| --SLIFE | Is Life Threatening | Char | Record Qualifier | Not in nonclinical trials | C82508 | An indication as to whether the reason an event is serious is because the event resulted in a substantial risk of dying. | Valid values are "Y", "N", and null. | 46 | |||
| --SOD | Occurred with Overdose | Char | Record Qualifier | Not in nonclinical trials | C82548 | An indication as to whether the reason an event is serious is because the event is associated with overdose. | Valid values are "Y", "N", and null. | 47 | |||
| --SMIE | Other Medically Important Serious Event | Char | Record Qualifier | Not in nonclinical trials | C82521 | 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. | Valid values are "Y", "N", and null. | 48 | |||
| --SINTV | Needs Intervention to Prevent Impairment | Char | Record Qualifier | AE domain only | Valid values are "Y", "N", and null. Expected use is in medical device-related trials. It is part of the definition of a serious AE as represented in 21 CFR Part 803.3(w)(3). \n Records whether medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, with either situation suspected to be due to the use of a medical product. | 49 | |||||
| --UNANT | Unanticipated Adverse Device Effect | Char | Record Qualifier | AE domain only | The assessment is about a device identified in the data (i.e., which has an SPDEVID). The device may be ancillary or under study. \n Any serious adverse effect on health or safety or any life-threatening problem or death caused by or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. (21 CFR 812.3(s)). | 50 | |||||
| --RLPRT | Rel of AE to Device-Related Procedure | Char | Record Qualifier | AE domain only | The investigator's opinion as to the likelihood that the device-related study procedure caused the AE (e.g., implant/insertion, revision/adjustment, explant/removal) \n The relationship is to a device-related procedure where the device is identified in the data (i.e., which has an SPDEVID). The device may be ancillary or under study. | "CAUSAL", "UNLIKELY" | 51 | ||||
| --RLPRC | Rel of AE to Non-Dev-Rel Study Activity | Char | Record Qualifier | AE domain only | The investigator's opinion as to the causality of the event as related to other protocol-required activities, actions or assessments (e.g., medication changes, tests/assessments, other procedures). \n The relationship is to a protocol-specified non-device-related activity where the device is identified in the data (i.e., which has an SPDEVID). The device may be ancillary or under study. | "CAUSAL", "UNLIKELY" | 52 | ||||
| --CONTRT | Concomitant or Additional Trtmnt Given | Char | Record Qualifier | C170989 | An indication as to whether a non-study treatment was given because of the occurrence of the event. | Valid values are "Y", "N", and null. | 53 | ||||
| --TOX | Toxicity | Char | Variable Qualifier | --TOXGR | C27990 | The standardized or dictionary-derived name for an untoward event or finding. | Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define-XML document. | An NCI CTCAE Short Name, "HYPERCALCEMIA", "HYPOCALCEMIA" | 54 | ||
| --TOXGR | Toxicity Grade | Char | Record Qualifier | C82528 | A categorical classification of the severity of an event or finding, based on a standard scale, used in study data tabulation. | Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define-XML document. | A toxicity grade from the NCI CTCAE. | 55 | |||
| --USCHFL | Unscheduled Flag | Char | Record Qualifier | Not in human clinical trials | C170510 | An indication that the performed test or observation was done at a time that was not planned. | If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are "Y" or null. This variable would not be needed when information on planned assessments is provided, such as when the Trial Visits (TV) and Subject Visits (SV) domains are used. | 56 | |||
| --TESTCD | Short Name of Measurement, Test, or Exam | Char | Topic | C82503 | The standardized or dictionary-derived short sequence of characters used to represent the measurement, test, or examination. | 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. | "PLAT", "SYSBP", "RRMIN", "EYEEXAM" | 1 | |||
| --TEST | Name of Measurement, Test, or Exam | Char | Synonym Qualifier | --TESTCD | C82541 | The standardized or dictionary-derived name of the measurement, test, or examination. | "Platelets", "Systolic Blood Pressure", "Summary (Min) RR Duration", "Eye Examination" | 2 | |||
| --SBMRKS | Sublineage Marker String | Char | Variable Qualifier | --TESTCD | CP domain only | Used to further subset the cell population identified in CPTEST based on the use of additional marker(s) that define a sublineage. The value in CPSBMRKS is used in combination with values in CPTEST and CPCELSTA to fully describe the cell population being measured. As such, it is an essential component of the full test name. | Three unnamed sublineages of monocytes have been identified: CCR2+CD16-; CCR2-CD16+; and CCR2+CD16+. Whereas the entire monocyte cell population can be defined as CD14+ cells, the additional CCR2 and CD16 markers are used to differentiate one sublineage from another, none of which has yet been given a name by the scientific community. By combining the CPTEST value of "Monocyte Subset" with the value of "CCR2+CD16-" in CPSBMRKS, the full test is defined to be the CCR2+CD16- monocyte subpopulation. | 3 | |||
| --CELSTA | Cell State | Char | Variable Qualifier | --TESTCD | CP domain only | A textual description of a subset of the cell population identified in CPTEST based on a particular functional and/or biological state (e.g., primed, activated, proliferating, senescent, G2-arrested). When populated, the values in CPCELSTA and CPSMRKS, in combination with values in CPTEST and CPSBMRKS, fully describe the cell population being measured. | 4 | ||||
| --CSMRKS | Cell State Marker String | Char | Variable Qualifier | --TESTCD | CP domain only | Identifies the marker(s) or indicator(s) used to define the cell state (i.e., the value in CPCELSTA). | When Ki67 expression is used to determine that a cell population is in a proliferating state (i.e., CPCELSTA value = "PROLIFERATING"), the value "Ki67+" in CPCSMRKS indicates that positive expression of Ki67 was used to define the population as proliferating. Similarly, a value of "Ki67-" in CPCSMRKS would indicate that lack of expression of Ki67 defined the "NON-PROLIFERATING" cell state in CPCELSTA. The CPCSMRKS value is useful for quickly determining which marker(s) were used to classify (i.e., operationally define) a cell population based on a functional/biological state. | 5 | |||
| --CNTMOD | Contact Mode | Char | Record Qualifier | The way in which the measurement, test, or examination was conducted. | 6 | ||||||
| --EPCHGI | Epi/Pandemic Related Change Indicator | Char | Record Qualifier | Indicates whether the measurement, test, or examination was changed due to an epidemic or pandemic. | 7 | ||||||
| --TSTCND | Test Condition | Char | Variable Qualifier | --TESTCD | CP, IS, and LB domains only | Identifies any planned condition imposed by the assay system on the specimen at the time the test is performed. | Stimulating or activating agents, assay temperature, incubation time \n "STIMULATED", "NON-STIMULATED", "25 C", "37 C". | 8 | |||
| --CNDAGT | Test Condition Agent | Char | Record Qualifier | CP, IS, and LB domains only | The textual description of the agent used to impose a test condition identified in CPTSTCND. For example, records might be produced for the same test run under stimulating (CPTSTCND value = "STIMULATED") conditions produced by different stimulating agents. | "Phorbol myristate acetate", "Concanavalin A, PHA-P", "TNF-alpha, Ionomycin", "Candida antigen" | 9 | ||||
| --BDAGNT | Binding Agent | Char | Variable Qualifier | --TESTCD | CP, IS, and LB domains only | The textual description of the agent that's binding to the entity in the --TEST variable. The --BDAGNT variable is used to indicate that there is a binding relationship between the entities in the --TEST and --BDAGNT variables, regardless of direction.--BDAGNT is not a method qualifier. It should only be used when the actual interest of the measurement is the binding interaction between the two entities in --TEST and --BDAGNT. In other words, the combination of --TEST and --BDAGNT should describe the thing, the entity, or the analyte being measured, without the need for additional variables. \n The binding agent may be, but is not limited to, a test article, a portion of the test article, a related compound, an endogenous molecule, an allergen, or an infectious agent. | 10 | ||||
| --ABCLID | Antibody Clone Identifier | Char | Record Qualifier | CP domain only | Identifies the antibody clone (e.g., supplier-provided catalog name) used to confer specificity for the binding agent specified in CPBDAGNT. | 11 | |||||
| --MRKSTR | Marker String | Char | Record Qualifier | CP domain only | The text string identifying the full set of markers/indicators used by the laboratory to operationally define the complete test. Because laboratories often use different markers/indicators to identify a cell population, the relationship between a named cell population in CPTEST (as combined with CPSBMRKS and CPCELSTA values) and the set of markers used to identify that population is many-to-one. To ensure nuances important for accurately interpreting the data are accounted for and which arise from the use of different sets of markers, it is necessary to operationally define the test in terms of the markers/indicators used to perform that test. | 12 | |||||
| --GATE | Gate | Char | Record Qualifier | CP domain only | The sponsor-defined name assigned to a gate. Gates are electronic (device setting or software-defined) boundaries set by a user to virtually parse a specimen into discrete populations based on a set of defined characteristics (e.g., presence, absence, or intensity of expression of various markers; physical size; internal complexity or granularity). Gates are used to constrain data collection or analysis to a specific cell population or region of interest within the specimen. | 13 | |||||
| --GATDEF | Gate Definition | Char | Record Qualifier | CP domain only | The text string identifying the set of parameters and the order in which they are applied to define the gating strategy. In practice, a series of 2-dimensional subgates based on 2 different cell characteristics (i.e., markers/indicators/physical properties) are most often combined until the cell population of interest is sufficiently resolved (i.e., electronically isolated) from other cell populations contained within the specimen. \n For complex analyses, differences in gating strategies can produce subtle differences in results obtained for a test. To ensure nuances important for accurately interpreting the data are accounted for and which arise from the use of different gating strategies, it is often necessary to qualify the test in terms of the gating strategy. For some purposes, however, and at the discretion of the sponsor, only the ultimate or penultimate gate is identified. When specifying the gating strategy in CPGATDEF, each subgate should be listed in the order it was applied and separated from the next sub-gate using the vertical line or pipe character ("|"). | 14 | |||||
| --TSTOPO | Test Operational Objective | Char | Variable Qualifier | --TESTCD | The textual description of the high-level purpose of the test at the operational level. | "SCREEN", "CONFIRM", "QUANTIFY" | 15 | ||||
| --MSCBCE | Molecule Secreted by Cells | Char | Variable Qualifier | --TESTCD | IS domain only | The textual description of the entity secreted by the cells represented in --TEST. The combination of --TEST and --MSBCE should describe the thing, the entity, or the analyte being measured, without the need for additional variables. | 16 | ||||
| --AGENT | Agent Name | Char | Record Qualifier | MS Domain only | The name of the drug or other material for which resistance is tested. The agent may be used for in vitro testing or may be used in tests for genetic markers or in direct phenotypic drug-sensitivity testing. | 17 | |||||
| --CONC | Agent Concentration | Num | Variable Qualifier | --AGENT | MS Domain only | The amount of drug or other material listed in MSAGENT per unit volume or weight. Used when the agent is part of the prespecified test. Not to be used when the concentration is a result of a test such as minimal inhibitory concentration, IC50, or EC50. | 18 | ||||
| --CONCU | Agent Concentration Units | Char | Variable Qualifier | --CONC | MS Domain only | Unit of measure for MSCONC. | 19 | ||||
| --MODIFY | Modified Result Term | Char | Synonym Qualifier | --ORRES | C170998 | A value which represents an alteration to a collected value for coding purposes. | 20 | ||||
| --TSTDTL | Measurement, Test, or Examination Detail | Char | Variable Qualifier | --TESTCD | Further description of --TESTCD and --TEST. | "STAINING INTENSITY" when MITEST="Human Epidermal Growth Factor Receptor 2" | 21 | ||||
| --SPTSTD | Sponsor Test Description | Char | Record Qualifier | CP domain only | Sponsor's description of a test. This variable is particularly valuable for identifying the cell population on which certain tests are conducted when it is not identified in the Test Name (CPTEST; e.g., tests for quantitative expression of a particular marker). | 22 | |||||
| --CAT | Category | Char | Grouping Qualifier | C25372 | A grouping or classification of the topic of the finding, event, or intervention. | "HEMATOLOGY", "URINALYSIS", "CHEMISTRY", "HAMD 17", "SF36 V2.0 ACUTE", "EGFR MUTATION ANALYSIS" | 23 | ||||
| --SCAT | Subcategory | Char | Grouping Qualifier | A further grouping or classification of the category for the topic of the finding, event, or intervention. | The category is in --CAT. | "WBC DIFFERENTIAL" | 24 | ||||
| --TSTPNL | Test Panel | Char | Grouping Qualifier | CP domain only | Sponsor-defined textual description used to group tests run together as part of a test panel. Can be used with --GRPID to ensure that relationships between associated tests are accurately identified. | 25 | |||||
| --POS | Position of Subject During Observation | Char | Record Qualifier | C171002 | The particular way that a subject's body is placed or situated during an assessment. | "SUPINE", "STANDING", "SITTING" | 26 | ||||
| --BODSYS | Body System or Organ Class | Char | Record Qualifier | C170986 | A standardized or dictionary-derived name for the body system or organ class. | MedDRA SOC | 27 | ||||
| --ORRES | Result or Finding in Original Units | Char | Result Qualifier | C117221 | The result of the measurement, test, or examination, as originally received or collected. | "120", "<1", "POS" | 28 | ||||
| --ORRESU | Original Units | Char | Variable Qualifier | --ORRES; --ORNRLO; --ORNRHI; --ORREF | C82586 | The unit of measure for the result (as originally received or collected) of the measurement, test, or examination. | Unit for --ORRES and --ORREF. | "in", "LB", "kg/L" | 29 | ||
| --RESSCL | Result Scale | Char | Record Qualifier | Classifies the scale of the original result value with respect to whether the result is, for example, ordinal, nominal, quantitative, or narrative. | "NARRATIVE", "NOMINAL", "ORDINAL", "QUANTITATIVE" | 30 | |||||
| --RESTYP | Result Type | Char | Record Qualifier | Classifies the kind of result (i.e., property type) originally reported for the test. | "SUBSTANCE CONCENTRATION", "MASS RATE", "ARBITRARY CONCENTRATION" | 31 | |||||
| --COLSRT | Collected Summary Result Type | Char | Variable Qualifier | --TESTCD | Used to indicate the type of a collected summary result. This is used for summary results collected on a CRF or provided by an external vendor (e.g., central lab). \n If the summary result is derived by the sponsor using individual source data records, the summary result is represented in ADaM. If a sponsor has both a collected or vendor-provided summary result and a derived summary result, the collected or vendor-provided summary result is represented in SDTM and the derived summary result is represented in ADaM. | "MAXIMUM", "MINIMUM", "MEAN", "MEDIAN", "NADIR" | 32 | ||||
| --ORNRLO | Normal Range Lower Limit-Original Units | Char | Variable Qualifier | --ORRES | C82580 | The lowest value in a normal or reference range for the result (as originally received or collected) of the measurement, test, or examination. | 33 | ||||
| --ORNRHI | Normal Range Upper Limit-Original Units | Char | Variable Qualifier | --ORRES | C70933 | The highest value in a normal or reference range for the result (as originally received or collected) of the measurement, test, or examination. | 34 | ||||
| --ORREF | Reference Result in Original Units | Char | Variable Qualifier | --ORRES | Reference value for the result or finding as originally received or collected. --ORREF uses the same units as --ORRES, if applicable. | Value from predicted normal value in spirometry tests. | 35 | ||||
| --LLOD | Lower Limit of Detection | Char | Variable Qualifier | --TESTCD | The lowest threshold (as originally received or collected) for reliably detecting the presence or absence of substance measured by a specific test. The value for the field will be as described in documentation from the instrument or lab vendor. | 36 | |||||
| --STRESC | Result or Finding in Standard Format | Char | Result Qualifier | C117222 | The standardized result of the measurement, test, or examination, in character format. | --STRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in --STRESN. | 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". | 37 | |||
| --IMPLBL | Implantation Site Label | Char | Record Qualifier | Not in human clinical trials; IC Domain only | Label or identifier that describes the location or position of a fetal implantation site in the uterus (or uterine horn) when classifying implantations during a uterine examination in a reproductive toxicology study. | 38 | |||||
| --STRESN | Numeric Result/Finding in Standard Units | Num | Result Qualifier | C171009 | The standardized result of the measurement, test, or examination in numeric format. | Copied in numeric format from --STRESC. --STRESN should store all numeric test results or findings. | 39 | ||||
| --STRESU | Standard Units | Char | Variable Qualifier | --STRESC; --STRESN; --STNRLO; --STNRHI; --STREFC; --STREFN; --LLOQ; --ULOQ | C82587 | The unit of measure for the standardized result of the measurement, test, or examination. | "mol/L" | 40 | |||
| --STNRLO | Normal Range Lower Limit-Standard Units | Num | Variable Qualifier | --STRESC; --STRESN | C171008 | The lowest value in a normal or reference range for the standardized result of the measurement, test, or examination. | 41 | ||||
| --STNRHI | Normal Range Upper Limit-Standard Units | Num | Variable Qualifier | --STRESC; --STRESN | C171007 | The highest value in a normal or reference range for the standardized result of the measurement, test, or examination. | 42 | ||||
| --STNRC | Normal Range for Character Results | Char | Variable Qualifier | --STRESC | C171006 | A set of normal or reference values for the standardized character result, in an ordinal scale or categorical grouping. | "Negative to Trace" | 43 | |||
| --STREFC | Reference Result in Standard Format | Char | Variable Qualifier | --STRESC | Reference value for the result or finding copied or derived from --ORREF in a standard format. | 44 | |||||
| --STREFN | Numeric Reference Result in Std Units | Num | Variable Qualifier | --STRESN | Reference value for continuous or numeric results or findings in standard format or in standard units. --STREFN uses the same units as --STRESN, if applicable. | 45 | |||||
| --NRIND | Normal/Reference Range Indicator | Char | Variable Qualifier | --ORRES; --STRESC; --STRESN | C170999 | A classification of the original or standardized result as it relates to a normal or reference result range. | May be defined by --ORNRLO and --ORNRHI or other objective criteria. | "Y", "N"; "HIGH", "LOW"; "NORMAL", "ABNORMAL" | 46 | ||
| --RESCAT | Result Category | Char | Variable Qualifier | --ORRES; --STRESC; --STRESN | C82498 | A grouping or classification of the results of an assessment. | The result is in --STRESC. | "MALIGNANT" or "BENIGN" for tumor findings | 47 | ||
| --INHERT | Inheritability | Char | Variable Qualifier | --ORRES; --STRESC; --STRESN | GF domain only | Identifies whether the variation can be passed to the next generation. | 48 | ||||
| --GENREF | Genome Reference | Char | Variable Qualifier | --METHOD | GF domain only | An identifier for the genome reference used to generate the reported result. | For example, Genome Reference Consortium Human Build 38 patch release 13 may be represented as GRCh38.p13. | 49 | |||
| --CHROM | Chromosome Identifier | Char | Variable Qualifier | --ORRES; --STRESC; --STRESN | GF domain only | The designation (name or number) of the chromosome or contig on which the variant or other feature appears. | "17", "X" | 50 | |||
| --SYM | Genomic Symbol | Char | Variable Qualifier | --ORRES; --STRESC; --STRESN | GF domain only | A published symbol for the portion of the genome serving as a locus for the experiment/test. | 51 | ||||
| --SYMTYP | Genomic Symbol Type | Char | Variable Qualifier | --SYM | GF domain only | A description of the type of genomic entity that is represented by the published symbol in --SYM. | 52 | ||||
| --GENLOC | Genetic Location | Char | Variable Qualifier | --ORRES; --STRESC; --STRESN | GF domain only | Specifies the location within a sequence for the observed value in --ORRES. | 53 | ||||
| --GENSR | Genetic Sub-Region | Char | Variable Qualifier | --ORRES; --STRESC; --STRESN | GF domain only | The portion of the locus in which the variation was found. | "Exon 15", "Kinase domain" | 54 | |||
| --SEQID | Sequence Identifier | Char | Variable Qualifier | --ORRES; --STRESC; --STRESN | GF domain only | A unique identifier for the sequence used as the reference to identify the genetic variation in the result. | "NM_001234", "ENSG00000182533", "ENST00000343849.2" | 55 | |||
| --PVRID | Published Variant Identifier | Char | Variable Qualifier | --ORRES; --STRESC; --STRESN | GF domain only | A unique identifier for the variation that has been publicly characterized in an external database. | "rs2231142", "COSM41596" | 56 | |||
| --COPYID | Copy Identifier | Char | Variable Qualifier | --ORRES; --STRESC; --STRESN | GF domain only | An arbitrary identifier used to differentiate between copies of a genetic target of interest present on homologous chromosomes. | 57 | ||||
| --CHRON | Chronicity of Finding | Char | Variable Qualifier | --STRESC | Characterization of the duration of a biological process resulting in a particular finding. | "ACUTE", "CHRONIC", "SUBACUTE" | 58 | ||||
| --DISTR | Distribution Pattern of Finding | Char | Variable Qualifier | --STRESC | Description of the distribution pattern of a finding within the examined area. | "FOCAL", "MULTIFOCAL", "DIFFUSE" | 59 | ||||
| --RESLOC | Result Location of Finding | Char | Record Qualifier | Not in human clinical trials | C170500 | Anatomical location where the result was observed. | Location where the result was observed (as opposed to the location specified for examination). This location may have a higher degree of specificity than the location specified for examination. | "PINNA" when --LOC is "EAR" \n "LUNG, LEFT LOWER LOBE" where --LOC is "CHEST" \n "CORTEX" when --SPEC is "KIDNEY" | 60 | ||
| --STAT | Completion Status | Char | Record Qualifier | 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". | 61 | ||||||
| --REASND | Reason Not Done | Char | Record Qualifier | C82556 | The explanation for why requested information was not available. | Used in conjunction with --STAT when value is "NOT DONE". | 62 | ||||
| --XFN | External File Path | Char | Record Qualifier | C82536 | 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. | A filename and/or path for an ECG waveform or a medical image. | 63 | ||||
| --NAM | Laboratory/Vendor Name | Char | Record Qualifier | C117200 | The name of the vendor performing an assessment. | A laboratory name. | 64 | ||||
| --LOINC | LOINC Code | Char | Record Qualifier | C82502 | A short sequence of characters used to represent laboratory and clinical tests within the Logical Observation Identifiers Names and Codes (LOINC) database. | 65 | |||||
| --SPEC | Specimen Material Type | Char | Record Qualifier | C70713 | The type of sample material taken from a biological entity. | "SERUM", "PLASMA", "URINE", "DNA", "RNA" | 66 | ||||
| --ANTREG | Anatomical Region | Char | Variable Qualifier | --SPEC | C170983 | The specific anatomical or biological region of a tissue or organ specimen. | As defined in the protocol. | A section or part of what is described in the --SPEC variable \n "CORTEX", "MEDULLA", "MUCOSA" | 67 | ||
| --SPCCND | Specimen Condition | Char | Record Qualifier | C70714 | The physical state or quality of a sample for assessment. | "CLOUDY" | 68 | ||||
| --SPCUFL | Specimen Usability for the Test | Char | Record Qualifier | C171004 | An indication as to whether a sample is suitable for testing. | The value will be "N" if the specimen is not usable, and null if the specimen is usable. | 69 | ||||
| --LOC | Location Used for the Measurement | Char | Record Qualifier | Anatomical location of the subject relevant to the collection of the measurement. | "RECTUM" for temperature, "ARM" for blood pressure | 70 | |||||
| --LAT | Laterality | Char | Variable Qualifier | --LOC; --SPEC | Qualifier for anatomical location or specimen further detailing laterality. | "RIGHT", "LEFT", "BILATERAL" | 71 | ||||
| --DIR | Directionality | Char | Variable Qualifier | --LOC; --SPEC | Qualifier for anatomical location or specimen further detailing directionality. | "ANTERIOR", "LOWER", "PROXIMAL" | 72 | ||||
| --PORTOT | Portion or Totality | Char | Variable Qualifier | --LOC; --SPEC | Qualifier for anatomical location or specimen further detailing the distribution (i.e., arrangement or apportioning of). | "ENTIRE", "SINGLE", "SEGMENT", "MANY" | 73 | ||||
| --METHOD | Method of Test or Examination | Char | Record Qualifier | Method of the test or examination. | "EIA" (enzyme immunoassay), "ELECTROPHORESIS", "DIPSTICK" | 74 | |||||
| --RUNID | Run ID | Char | Record Qualifier | C117058 | A sequence of characters used to uniquely identify a particular run of a test on a particular batch of samples. | 75 | |||||
| --ANMETH | Analysis Method | Char | Record Qualifier | 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, a genetic sequence). | 76 | ||||||
| --TMTHSN | Test Method Sensitivity | Char | Record Qualifier | The sensitivity of the test methodology with respect to observation, detection, or quantification. | "LOW SENSITIVITY", "HIGH SENSITIVITY", "ULTRA-HIGH SENSITIVITY" | 77 | |||||
| --LEAD | Lead Identified to Collect Measurements | Char | Record Qualifier | C170997 | An electrical recording from some region of the body that represents the voltage difference between 2 electrodes. | "LEAD I", "LEAD V2", "LEAD CM5" | 78 | ||||
| --CSTATE | Consciousness State | Char | Record Qualifier | C88429 | The subject's level of consciousness. | "CONSCIOUS", "SEMI-CONSCIOUS", "UNCONSCIOUS" | 79 | ||||
| --LOBXFL | Last Observation Before Exposure Flag | Char | Record Qualifier | Operationally derived indicator used to identify the last non-missing value prior to RFXSTDTC. Result value is in --STRESC. Should be "Y" or null. | 80 | ||||||
| --BLFL | Baseline Flag | Char | Record Qualifier | C82526 | An indication that the record is the sponsor-defined baseline assessment, used in study data tabulation. | Result value is in --STRESC. Should be "Y" or null. | 81 | ||||
| --FAST | Fasting Status | Char | Record Qualifier | C93566 | An indication as to whether a subject has abstained from food and liquid for a prescribed amount of time. | Valid values include "Y", "N", "U", or null if not relevant. | 82 | ||||
| --DRVFL | Derived Flag | Char | Record Qualifier | C81197 | An indication that the measurement or finding is not a collected value but is processed or computed by the sponsor from collected data. | Should be "Y" or null. | The average of other records used as a computed baseline. | 83 | |||
| --EVAL | Evaluator | Char | Record Qualifier | Not in QS, FT, and clinical classifications use case of RS | C51824 | The role of the person(s) providing an evaluation, appraisal, or interpretation. | Used only for results that are subjective (e.g., assigned by a person or a group). | "ADJUDICATION COMMITTEE", "INDEPENDENT ASSESSOR" | 84 | ||
| --EVALID | Evaluator Identifier | Char | Variable Qualifier | --EVAL | Not in QS, FT, and clinical classifications use case of RS | C117043 | A sequence of characters used to uniquely identify the evaluator(s). | Used to distinguish multiple evaluators with the same role recorded in --EVAL. | "RADIOLOGIST1", "RADIOLOGIST2" | 85 | |
| --ACPTFL | Accepted Record Flag | Char | Record Qualifier | C117038 | An indication that a record is the endorsed assessment. | Expected values can include "Y", "N", or null. This is not intended to be an analysis flag to indicate acceptability for a given analysis. | 86 | ||||
| --TOX | Toxicity | Char | Variable Qualifier | --TOXGR | C27990 | The standardized or dictionary-derived name for an untoward event or finding. | Sponsors should specify which scale and version is used in the Sponsor Comments column of the Define-XML document. | An NCI CTCAE Short Name. \n "HYPERCALCEMIA", "HYPOCALCEMIA" | 87 | ||
| --TOXGR | Toxicity Grade | Char | Record Qualifier | C82528 | A categorical classification of the severity of an event or finding, based on a standard scale, used in study data tabulation. | Sponsors should specify which scale and version is used in the Sponsor Comments column of the Define-XML document. | A grade from the NCI CTCAE. \n "2" | 88 | |||
| --SEV | Severity/Intensity | Char | Record Qualifier | C25676 | The quality or degree of harm associated with a finding or event, as collected. | "MILD", "MODERATE", "SEVERE" | 89 | ||||
| --CLSIG | Clinically Significant, Collected | Char | Record Qualifier | C93532 | An indication as to whether an observation is clinically significant based on judgment. | For collected assessments of clinical significance of a result. | "Y", "N" | 90 | |||
| --DTHREL | Relationship to Death | Char | Record Qualifier | Not in human clinical trials | C82563 | An indication that a particular finding is related to the cause of death. | "Y", "N", or "U" | 91 | |||
| --LLOQ | Lower Limit of Quantitation | Num | Variable Qualifier | --STRESC; --STRESN | C82589 | The lowest threshold for reliably quantifying the amount of substance measured by a specific test, in standardized units. | Units will be those used for --STRESU. | 92 | |||
| --ULOQ | Upper Limit of Quantitation | Num | Variable Qualifier | --STRESC; --STRESN | C85533 | The highest threshold for reliably detecting the result of a specific test in standardized units. | Units will be those used for --STRESU. | 93 | |||
| --REASPF | Reason Test Performed | Char | Record Qualifier | C171003 | The explanation for why a test, measurement, or assessment is executed. | 94 | |||||
| --EXCLFL | Exclude from Statistics | Char | Record Qualifier | Not in human clinical trials | C117045 | An indication that the result is to be excluded from all calculations. | Expected to be "Y" or null. --EXCLFL should be null when --STAT is "NOT DONE". | 95 | |||
| --REASEX | Reason for Exclusion from Statistics | Char | Record Qualifier | Not in human clinical trials | C117057 | The explanation for why a result is excluded from all calculations. | Used in conjunction with --EXCLFL when its value is "Y". | 96 | |||
| --USCHFL | Unscheduled Flag | Char | Record Qualifier | Not in human clinical trials | C170510 | An indication that the performed test or observation was done at a time that was not planned. | If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are "Y" or null. This variable would not be needed when information on planned assessments is provided, such as when the Trial Visits (TV) and Subject Visits (SV) domains are used. | 97 | |||
| --REPNUM | Repetition Number | Num | Record Qualifier | The instance number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a time point or within a visit). | Multiple measurements of blood pressure or multiple analyses of a sample. | 98 | |||||
| --RSTIND | Restraint Indicator | Char | Record Qualifier | Not in human clinical trials | An indicator as to whether the animal was restrained during the observation period. Expected values are "Y" or null. | 99 | |||||
| --RSTMOD | Restraint Mode | Char | Record Qualifier | Not in human clinical trials | A description of whether the restraint was physical and/or chemical. | 100 | |||||
| --OBJ | Object of the Observation | Char | Record Qualifier | Used in domains modeled as Findings About Events or Findings About Interventions. Describes the event or intervention whose property is being measured in --TESTCD/--TEST. | An event of vomiting which has findings, where --OBJ="VOMIT" and the volume of VOMIT is being measured where --TESTCD="VOLUME". | 1 | |||||
| STUDYID | Study Identifier | Char | Identifier | C83082 | A sequence of characters used by the sponsor to uniquely identify the study. | 1 | |||||
| DOMAIN | Domain Abbreviation | Char | Identifier | C49558 | An abbreviation for a collection of observations, with a topic-specific commonality. | 2-character abbreviation. The domain abbreviation is also used as a prefix for variables to ensure uniqueness when datasets are merged. | 2 | ||||
| USUBJID | Unique Subject Identifier | Char | Identifier | C69256 | A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product. | 3 | |||||
| POOLID | Pool Identifier | Char | Identifier | C117053 | A sequence of characters used to uniquely identify a group of subjects that have been pooled together. | Used for results that are not assignable to a specific subject. | 4 | ||||
| SPDEVID | Sponsor Device Identifier | Char | Identifier | C117060 | A sequence of characters used by the sponsor to uniquely identify a specific device. | 5 | |||||
| NHOID | Non-Host Organism Identifier | Char | Identifier | Sponsor-defined identifier for a non-host organism. This variable should be populated with an intuitive name based on the identity of the non-host organism as reported by the lab. | "A/California/7/2009 (H1N1)" | 6 | |||||
| FETUSID | Fetus Identifier | Char | Identifier | Not in human clinical trials | C170497 | A sequence of characters used to uniquely identify a fetus associated with a maternal subject, for a particular prenatal evaluation. | 7 | ||||
| FOCID | Focus of Study-Specific Interest | Char | Identifier | Identification of a focus of study-specific interest on or within a subject or specimen as called out in the protocol for which a measurement, test, or examination was performed. The value in this variable should have inherent semantic meaning. | A drug application site (e.g., "Injection site 1", "Biopsy site 1", "Treated site 1"), or a more specific focus (e.g., "OD" (right eye), "Upper left quadrant of the back") | 8 | |||||
| --SEQ | Sequence Number | Num | Identifier | C70710 | A number used in combination with the identifier of the subject of the observation to uniquely identify a record within a domain. | May be any valid number (including decimals) and does not have to start at 1. Datasets that do not contain subject data, such as the Trial Summary (TS) domain and the Device Tracking (DT) domains, use --SEQ as a sequence number to ensure uniqueness within the dataset. | 9 | ||||
| --GRPID | Group ID | Char | Identifier | C170996 | A sequence of characters used to uniquely identify related records for a subject within a domain, or related parameters in the Trial Summary (TS) dataset. | See also Section 5.1.6, Trial Summary Information and Section 5.1.7, Challenge Agent Characterization. | 10 | ||||
| --REFID | Reference ID | Char | Identifier | C82531 | A sequence of characters used to uniquely identify a source of information. | A lab specimen ID, the UUID for an ECG waveform or a medical image. | 11 | ||||
| --RECID | Invariant Record Identifier | Char | Identifier | Identifier for a record that is unique within a domain for a study and that remains invariant through subsequent versions of the dataset, even if the content of the record is modified. When a record is deleted, this value must not be reused to identify another record in either the current or future versions of the domain. | 12 | ||||||
| --SPID | Sponsor-Defined Identifier | Char | Identifier | C82530 | A sponsor-defined sequence of characters used to identify an instance of an observation. | A preprinted line identifier on a Concomitant Medications form. | 13 | ||||
| --LNKID | Link ID | Char | Identifier | C117050 | A sequence of characters used to uniquely identify a record, for a subject, in one domain and link it to 1 or more records for that subject in another domain. | This may be a one-to-one or a one-to-many relationship. | A value that links a single tumor to multiple measurements/assessments performed at different times. | 14 | |||
| --LNKGRP | Link Group ID | Char | Identifier | C117049 | A sequence of characters used to uniquely identify a group of records, for a subject, in one domain and link it to 1 or more records for that subject in another domain. | This will usually be a many-to-one relationship. | A value that links multiple tumor measurement/assessments to a single response to therapy. | 15 | |||
| --BEATNO | ECG Beat Number | Num | Identifier | EG Domain only | A sequence number that identifies the beat within an ECG. | 16 | |||||
| APID | Associated Persons Identifier | Char | Identifier | Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person (see Section 6.3, Pool Definition Dataset, and Section 4, Associated Persons Data). | 1 | ||||||
| RSUBJID | Related Subject or Pool Identifier | Char | Identifier | Identifier for a related subject or pool of subjects. RSUBJID may be populated with the USUBJID of the related subject or the POOLID of the related pool. \n RSUBJID will be null for data about associated persons who are related to the study but not to any study subjects. | 2 | ||||||
| RDEVID | Related Device Identifier | Char | Identifier | Identifier for a related device. RDEVID will be populated with the SPDEVID of the related device. | 3 | ||||||
| SREL | Subject, Device, or Study Relationship | Char | Identifier | If RSUBJID is populated, describes the relationship of the associated person(s) identified in APID to the subject or pool identified in RSUBJID. \n If RDEVID is populated, describes the relationship of the associated person(s) identified in APID to the device identified in RDEVID. \n If RSUBJID and RDEVID are null, SREL describes the relationship of the associated person(s) identified in APID to the study identified in STUDYID. | 4 | ||||||
| VISITNUM | Visit Number | Num | Timing | C83101 | An assigned numeric identifier that aligns to the chronological order of a clinical encounter. | Numeric version of VISIT, used for sorting. VISITNUM does not have to be an integer value. | 1, 1.1, 503.75 | 1 | |||
| VISIT | Visit Name | Char | Timing | C171010 | The label for a protocol-defined clinical encounter. | 2 | |||||
| VISITDY | Planned Study Day of Visit | Num | Timing | C171011 | The planned study day of a clinical encounter relative to the sponsor-defined reference start date. | Should be an integer. | 3 | ||||
| TAETORD | Planned Order of Element Within Arm | Num | Timing | C83438 | An assigned numeric identifier that gives the planned order of the element within the trial arm of the study. | See Section 5.1.1.2, Trial Arms. | 4 | ||||
| EPOCH | Epoch | Char | Timing | C71738 | A time period defined in the protocol with a study-specific purpose. | The epoch associated with an observation is determined by the start date or start date and time of the observation, or the date/time of collection if start date/time is not collected (see Section 5.1.1.2, Trial Arms). | 5 | ||||
| RPHASE | Repro Phase | Char | Timing | Not in human clinical trials | Reproductive phase with which the reproductive stage of the reproductive path is associated. Defined in Trial Paths domain. The RPHASE variable is Required when any Reproductive Phase Day variable is used. | 6 | |||||
| RPPLDY | Planned Repro Phase Day of Observation | Num | Timing | Not in human clinical trials | C170506 | The day within the reproductive phase on which the test or observation was scheduled to occur. | Expressed as an integer. | 7 | |||
| RPPLSTDY | Planned Repro Phase Day of Obs Start | Num | Timing | Not in human clinical trials | C170508 | The day within the reproductive phase on which the test or observation was scheduled to begin. | Expressed as an integer. | 8 | |||
| RPPLENDY | Planned Repro Phase Day of Obs End | Num | Timing | Not in human clinical trials | C170507 | The day within the reproductive phase on which the test or observation was scheduled to end. | Expressed as an integer. | 9 | |||
| --DTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | C82515 | The date or date and time of the assessment or the specimen or data collection from the subject, represented in a standardized character format. | 10 | ||||
| --STDTC | Start Date/Time of Observation | Char | ISO 8601 datetime or interval | Timing | Not in Findings class domains | C82517 | The start date or date and time of an intervention or event, represented in a standardized character format. | The start date of a Findings class record is stored in the --DTC variable. | 11 | ||
| --ENDTC | End Date/Time of Observation | Char | ISO 8601 datetime or interval | Timing | C82516 | The end date or date and time of an intervention, event, or finding, represented in a standardized character format. | 12 | ||||
| --DY | Study Day of Visit/Collection/Exam | Num | Timing | C170993 | The number of days from the sponsor-defined reference start date to the date of collection (--DTC), used in study data tabulation. | The sponsor-defined reference start date is RFSTDTC in Demographics. | 13 | ||||
| --STDY | Study Day of Start of Observation | Num | Timing | Not in Findings class domains | C171005 | The number of days from the sponsor-defined reference start date to the start of an intervention or event (--STDTC), used for study data tabulation. | The sponsor-defined reference start date is RFSTDTC in Demographics. | 14 | |||
| --ENDY | Study Day of End of Observation | Num | Timing | C170995 | The number of days from the sponsor-defined reference start date to the end of an intervention, event, or finding (--ENDTC), used for study data tabulation. | The sponsor-defined reference start date is RFSTDTC in Demographics. | 15 | ||||
| --NOMDY | Nominal Study Day for Tabulations | Num | Timing | Not in human clinical trials | C170498 | The nominal study day, relative to the sponsor-defined reference start date, used by data collection and reporting systems for grouping records for observations that may be scheduled to occur on different days into a single study day (e.g., for output on a tabulation report). | 16 | ||||
| --NOMLBL | Label for Nominal Study Day | Char | Timing | Not in human clinical trials | C170499 | The name for a protocol-defined nominal study day. | As presented in the study report. | 17 | |||
| --RPDY | Actual Repro Phase Day of Observation | Num | Timing | Not in human clinical trials | C170504 | The day within the reproductive phase on which the test or observation occurred. | Expressed as an integer. | 18 | |||
| --RPSTDY | Actual Repro Phase Day of Obs Start | Num | Timing | Not in human clinical trials | C170509 | The day within the reproductive phase on which the test or observation began. | Expressed as an integer. | 19 | |||
| --RPENDY | Actual Repro Phase Day of Obs End | Num | Timing | Not in human clinical trials | C170505 | The day within the reproductive phase on which the test or observation ended. | Expressed as an integer. | 20 | |||
| --XDY | Day of Obs Relative to Exposure | Num | Timing | The actual study day of an intervention, event, or finding, derived relative to the first exposure to any protocol-specified treatment. Expressed in integer days relative to RFXSTDTC in Demographics. | 21 | ||||||
| --XSTDY | Start Day of Obs Relative to Exposure | Num | Timing | Not in Findings class domains | The actual study day of the start of an intervention or event, derived relative to the first exposure to any protocol-specified treatment. Expressed in integer days relative to RFXSTDTC in Demographics. | 22 | |||||
| --XENDY | End Day of Obs Relative to Exposure | Num | Timing | The actual study day of the end of an intervention, event, or finding, derived relative to the first exposure to any protocol-specified treatment. Expressed in integer days relative to RFXSTDTC in Demographics. | 23 | ||||||
| --CHDY | Day of Obs Rel to Challenge Agent | Num | Timing | The actual study day of an intervention, event, or finding, derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics. | 24 | ||||||
| --CHSTDY | Start Day of Obs Rel to Challenge Agent | Num | Timing | Not in Findings class domains | The actual study day of the start of an intervention or event derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to c ure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics. | 25 | |||||
| --CHENDY | End Day of Obs Rel to Challenge Agent | Num | Timing | The actual study day of the end of an intervention, event, or finding derived relative to the first exposure to the challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent. Expressed in integer days relative to RFCSTDTC in Demographics. | 26 | ||||||
| --DUR | Collected Duration | Char | ISO 8601 duration | Timing | C170992 | The collected length of time during which an observation continues, represented in a standardized character format. | Used only if collected on the CRF and not derived. | 27 | |||
| --TPT | Planned Time Point Name | Char | Timing | C171029 | The description of the time when a protocol-defined activity is planned to occur, used for study data tabulation. | This may be represented as an elapsed time relative to a fixed reference point (e.g., time since last dose). See --TPTNUM and --TPTREF. | "PREDOSE", "1 HOUR POST-DOSE" | 28 | |||
| --TPTNUM | Planned Time Point Number | Num | Timing | C82545 | The numeric identifier of when an observation is planned to occur. | Used in sorting. | 29 | ||||
| --ELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | C170994 | The interval of time between a planned time point and a fixed reference point, represented in a standardized character format. | The fixed reference point is in --TPTREF. This variable is useful where there are repetitive measures. Not a clock time or a date/time variable, but an interval. | 30 | |||
| --TPTREF | Time Point Reference | Char | Timing | C171030 | The description of a time point that acts as a fixed reference for a series of planned time points, used for study data tabulation. | Description of the fixed reference point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. | "PREVIOUS DOSE", "PREVIOUS MEAL" | 31 | |||
| --RFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | C82518 | 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. | The fixed reference point is in --TPTREF. | 32 | |||
| --STRF | Start Relative to Reference Period | Char | Timing | C82559 | The characterization of the start of an observation relative to the study 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. | 33 | ||||
| --ENRF | End Relative to Reference Period | Char | Timing | C82557 | The characterization of the end of an observation relative to the study 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. | 34 | ||||
| --EVLINT | Evaluation Interval | Char | ISO 8601 duration or interval | Timing | C82534 | The planned time interval for which an observation is assessed, represented in a standardized character format. | Usually used with --DTC to describe an interval of this duration that ended at the time represented in --DTC. | "-P2M" to represent a period of the past 2 months as the evaluation interval for a question from a questionnaire. | 35 | ||
| --EVINTX | Evaluation Interval Text | Char | Timing | C117044 | 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. | A value that cannot be represented in ISO 8601 format. | "LIFETIME", "LAST NIGHT", "RECENTLY", "OVER THE LAST FEW WEEKS" | 36 | |||
| --STRTPT | Start Relative to Reference Time Point | Char | Timing | C82560 | The characterization of the start of an observation relative to a reference time point. | The sponsor-defined reference time point is in --STTPT. | 37 | ||||
| --STTPT | Start Reference Time Point | Char | Timing | C82575 | The description or date and/or time of a time point that acts as a fixed reference for characterizing the start of an observation. | This is the sponsor-defined reference point referred to by --STRTPT. | "2003-12-15", "VISIT 1" | 38 | |||
| --ENRTPT | End Relative to Reference Time Point | Char | Timing | C82558 | The characterization of the end of an observation relative to a reference time point. | The sponsor-defined reference time point is in --ENTPT. | 39 | ||||
| --ENTPT | End Reference Time Point | Char | Timing | C82574 | The description or date and/or time of a time point that acts as a fixed reference for characterizing the end of an observation. | This is the sponsor-defined reference point referred to by --ENRTPT. | "2003-12-25", "VISIT 2" | 40 | |||
| MIDS | Disease Milestone Instance Name | Char | Timing | The name of a specific instance of a Disease Milestone Type (MIDSTYPE) described in the Trial Disease Milestones dataset (see Section 5.1.4.3, Trial Disease Milestones). This should be unique within a subject. Used only in conjunction with RELMIDS and MIDSDTC. | 41 | ||||||
| RELMIDS | Temporal Relation to Milestone Instance | Char | Timing | The temporal relationship of the observation to the Disease Milestone Instance Name in MIDS. | "IMMEDIATELY BEFORE", "AT TIME OF", "AFTER" | 42 | |||||
| MIDSDTC | Disease Milestone Instance Date/Time | Char | ISO 8601 datetime or interval | Timing | The start date/time of the Disease Milestone Instance Name in MIDS. | 43 | |||||
| --STINT | Planned Start of Assessment Interval | Char | ISO 8601 duration | Timing | C117061 | The start of a planned assessment interval relative to a reference time point, represented in a standardized character format. | The reference time point is in --TPTREF. As this variable describes planned timing of an assessment, caution should be exercised when using outside of the Findings class of domains. In an Events or Interventions domain, it may refer to the interval over which --OCCUR is assessed. | 44 | |||
| --ENINT | Planned End of Assessment Interval | Char | ISO 8601 duration | Timing | C117042 | The end of a planned assessment interval relative to a reference time point, represented in a standardized character format. | The reference time point is in --TPTREF. As this variable describes planned timing of an assessment, caution should be exercised when using outside of the Findings class of domains. In an Events or Interventions domain, it may refer to the interval over which --OCCUR is assessed. | 45 | |||
| --DETECT | Time in Days to Detection | Num | Timing | Not in human clinical trials | C117041 | The number of days from the start of dosing to the earliest detection of a condition or pathogen. | 46 | ||||
| --PTFL | Point in Time Flag | Char | Timing | Only in Findings class specimen-based domains: BS, CP, GF, IS, LB, MB, MS, MI, PC, PP | An indication that the specimen was collected at a single point in time. The value is "Y" or null. | 47 | |||||
| --PDUR | Planned Duration | Char | ISO 8601 duration | Timing | Only in Findings class specimen-based domains: BS, CP, GF, IS, LB, MB, MS, MI, PC, PP | Planned duration of a finding. For a sample-based finding, this could apply to the planned duration of specimen collection. | 48 |
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