SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
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| # | Variable Name | Variable Label | Type | Format | Role | Variable(s) Qualified | Usage Restrictions | Variable C-code | Definition | Notes | Examples |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | --TRT | Name of Treatment or Product | Char | Topic | C82542 | The reported name of the drug, procedure, therapy, or product. SDTM-748 - Getting issue details... STATUS | The topic for the intervention observation, usually the verbatim name of the treatment, drug, medicine, therapy, or product given during the dosing interval for the observation. | ||||
| 2 | --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. | |||
| 3 | --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. | |||
| 4 | --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" | ||||
| 5 | --CAT | Category | Char | Grouping Qualifier | C25372 | A grouping or classification of the topic of the finding, event, or intervention. | |||||
| 6 | --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. | ||||
| 7 | --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. | ||
| 8 | --OCCUR | Occurrence Indicator | Char | Record Qualifier | C171000 | An indication as to whether a prespecified event or intervention has occurred. | |||||
| 9 | --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. | ||||||
| 10 | --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". | ||||||
| 11 | --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". | ||||
| 12 | --CNTMOD | Contact Mode | Char | Record Qualifier | The way in which the event, visit, or contact was conducted. | ||||||
| 13 | --EPCHGI | Epi/Pandemic Related Change Indicator | Char | Record Qualifier | Indicates whether the intervention was changed due to an epidemic or pandemic. | ||||||
| 14 | --INDC | Indication | Char | Record Qualifier | C41184 | The sign, symptom, or condition that is the basis for initiation of a treatment. | |||||
| 15 | --CLAS | Class | Char | Variable Qualifier | --TRT | C170987 | A standardized or dictionary-derived name for a grouping of drugs, procedures, or therapies. | ||||
| 16 | --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. | |||
| 17 | --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. | ||||
| 18 | --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" | |||
| 19 | --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" | ||
| 20 | --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" | |||||
| 21 | --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. | ||||
| 22 | --DOSFRM | Dose Form | Char | Variable Qualifier | --TRT | C42636 | Physical characteristics of a product, (e.g., tablet, capsule, solution) that contains a substance, generally (but not necessarily) in association with 1 or more other ingredients. | "TABLET", "CAPSULE" | |||
| 23 | --DOSFRQ | Dosing Frequency per Interval | Char | Record Qualifier | C15682 | The number of times that an agent (e.g., drug, product, substance, radiation) is administered per unit of time. | "Q2H", "QD", "PRN" | ||||
| 24 | --DOSTOT | Total Daily Dose | Num | Record Qualifier | C70888 | The quantity of an agent (e.g., drug, product, substance, radiation) taken or absorbed on a single day. | Uses the units in --DOSU. | ||||
| 25 | --DOSRGM | Intended Dose Regimen | Char | Record Qualifier | C71137 | The planned schedule for the administration of an agent (e.g., drug, product, substance, radiation). | "TWO WEEKS ON, TWO WEEKS OFF" | ||||
| 26 | --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" | ||||
| 27 | --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). | ||||
| 28 | --LOC | Location of Administration | Char | Record Qualifier | Anatomical location of an intervention, such as an injection site. | "ARM" for an injection | |||||
| 29 | --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" | ||||
| 30 | --LAT | Laterality | Char | Variable Qualifier | --LOC | Qualifier for anatomical location further detailing laterality of intervention administration. | "RIGHT", "LEFT", "BILATERAL" | ||||
| 31 | --DIR | Directionality | Char | Variable Qualifier | --LOC | Qualifier for anatomical location further detailing directionality of intervention administration. | "ANTERIOR", "LOWER", "PROXIMAL" | ||||
| 32 | --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" | ||||
| 33 | --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. | ||||
| 34 | --PSTRG | Pharmaceutical Strength | Num | Record Qualifier | C53294 | The amount of active ingredient per unit of pharmaceutical dosage form. | "50", "300" | ||||
| 35 | --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" | ||
| 36 | --TRTV | Treatment Vehicle | Char | Record Qualifier | C927 | A carrier or inert medium in which a medicinally active agent is administered. | "SALINE" | ||||
| 37 | --VAMT | Treatment Vehicle Amount | Num | Record Qualifier | C82553 | Amount of the prepared product (treatment plus vehicle) administered. | Note: Should not be diluent amount alone. | ||||
| 38 | --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" | |||
| 39 | --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" | ||||
| 40 | --RSDISC | Reason Treatment or Product Discontinued | Char | Record Qualifier | Reason the treatment or product was discontinued. | ||||||
| 41 | --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. | |||
| 42 | --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. | |||||
| 43 | --RSTMOD | Restraint Mode | Char | Record Qualifier | Not in human clinical trials | A description of whether the restraint was physical and/or chemical. |
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