SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. Release Notes
| # | Variable Name | Variable Label | Type | Format | Role | Variable(s) Qualified | Usage Restrictions | Variable C-code | Definition | Notes | Examples |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | --TERM | Reported Term | Char | Topic | C82571 | The collected name for an event observation. | The verbatim or prespecified name of the event. | ||||
| 2 | --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. | |||
| 3 | --LLT | Lowest Level Term | Char | Variable Qualifier | --TERM | Not in nonclinical trials | C71886 | The lowest-level term assigned to the event from MedDRA. | |||
| 4 | --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. | |||
| 5 | --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). | |||
| 6 | --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" | |||
| 7 | --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. | |||
| 8 | --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. | |||
| 9 | --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. | |||
| 10 | --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. | |||
| 11 | --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. | |||
| 12 | --CAT | Category | Char | Grouping Qualifier | C25372 | A grouping or classification of the topic of the finding, event, or intervention. | |||||
| 13 | --SCAT | Subcategory | Char | Grouping Qualifier | C25692 | A further grouping or classification of the category for the topic of the finding, event, or intervention. | The category is in --CAT. | ||||
| 14 | --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. | |||
| 15 | --OCCUR | Occurrence Indicator | Char | Record Qualifier | Not in AE domain | C171000 | An indication as to whether a prespecified event or intervention has occurred. | ||||
| 16 | --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. | |||||
| 17 | --STAT | Completion Status | Char | Record Qualifier | Not in AE domain | 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". | |||||
| 18 | --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". | |||
| 19 | --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" | |||
| 20 | --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. | ||
| 21 | --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. | |||
| 22 | --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. | |||
| 23 | --CNTMOD | Contact Mode | Char | Record Qualifier | The way in which the event, visit, or contact was conducted. | "IN PERSON", "TELEPHONE", "IVRS" | |||||
| 24 | --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. | ||||||
| 25 | --LOC | Location of Event | Char | Record Qualifier | Describes anatomical location relevant for the event. | "ARM" for skin rash | |||||
| 26 | --LAT | Laterality | Char | Variable Qualifier | --LOC | Qualifier for anatomical location, further detailing laterality. | "RIGHT", "LEFT", "BILATERAL" | ||||
| 27 | --DIR | Directionality | Char | Variable Qualifier | --LOC | Qualifier for anatomical location, further detailing directionality. | "ANTERIOR", "LOWER", "PROXIMAL" | ||||
| 28 | --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" | ||||
| 29 | --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. | |||
| 30 | --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. | ||
| 31 | --SEV | Severity/Intensity | Char | Record Qualifier | C25676 | The quality or degree of harm associated with a finding or event, as collected. | "MILD", "MODERATE", "SEVERE" | ||||
| 32 | --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". | ||||
| 33 | --ACN | Action Taken w/Investigational Product | Char | Record Qualifier | C49499 | An action taken with study treatment or investigational product, as the result of the event. | "DOSE INCREASED", "DOSE NOT CHANGED" | ||||
| 34 | --ACNOTH | Other Action Taken | Char | Record Qualifier | C82509 | An action taken unrelated to study treatment or product, as the result of the event. | |||||
| 35 | --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. | ||||
| 36 | --REL | Causality | Char | Record Qualifier | C103163 | The investigator's assessment of the likelihood that the study treatment or product was the cause of the event. | "NOT RELATED", "UNLIKELY RELATED", "POSSIBLY RELATED", "RELATED" | ||||
| 37 | --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" | ||||
| 38 | --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" | ||||
| 39 | --PATT | Pattern of Event | Char | Record Qualifier | C82550 | A characterization of the temporal pattern of occurrences of the event. | "INTERMITTENT", "CONTINUOUS", "SINGLE EVENT" | ||||
| 40 | --OUT | Outcome of Event | Char | Record Qualifier | C171001 | The status associated with the result or conclusion of the event. | "RECOVERED/RESOLVED", "FATAL" | ||||
| 41 | --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. | |||
| 42 | --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. | |||
| 43 | --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. | |||
| 44 | --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. | |||
| 45 | --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. | |||
| 46 | --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. | |||
| 47 | --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. | |||
| 48 | --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. | |||
| 49 | --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). 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. | |||||
| 50 | --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. 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)). | |||||
| 51 | --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) 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" | ||||
| 52 | --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). 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" | ||||
| 53 | --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. | ||||
| 54 | --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" | ||
| 55 | --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. | |||
| 56 | --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. |
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