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SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1

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#Variable NameVariable LabelTypeFormatRoleVariable(s) QualifiedUsage RestrictionsVariable C-codeDefinitionNotesExamples
1--TRTName of Treatment or ProductChar
Topic

C82542The reported name of the drug, procedure, or therapy, or product. SDTM-748 - Getting issue details... STATUS The topic for the intervention observation, usually the verbatim name of the treatment, drug, medicine, or therapy, or product given during the dosing interval for the observation.
2--MODIFYModified Treatment NameChar

Synonym Qualifier

--TRT
C170998A 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--DECODStandardized Treatment NameChar
Synonym Qualifier--TRT
C170991Standardized 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--MOODMoodChar
Record Qualifier

C117051The 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--CATCategoryChar
Grouping Qualifier

C25372A grouping or classification of the topic of the finding, event, or intervention.

6--SCATSubcategoryChar
Grouping Qualifier

C25692A further grouping or classification of the category for the topic of the finding, event, or intervention.

The category is in --CAT.


7--PRESPPre-SpecifiedChar
Variable Qualifier--TRTNot in nonclinical trialsC82510An indication that the event or intervention was prospectively stated or detailed on the CRF.Values should be "Y" or null.
8--OCCUROccurrence IndicatorChar
Record Qualifier

C171000An indication as to whether a prespecified event or intervention has occurred.

9--REASOCReason for Occur ValueChar
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--STATCompletion StatusChar
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--REASNDReason Not DoneChar
Record Qualifier

C82556The explanation for why requested information was not available.

Used in conjunction with --STAT when value is "NOT DONE".


12--CNTMODContact ModeChar
Record Qualifier



The way in which the event, visit, or contact was conducted.


13--EPCHGIEpi/Pandemic Related Change IndicatorChar
Record Qualifier



Indicates whether the intervention was changed due to an epidemic or pandemic.


14--INDCIndicationChar
Record Qualifier

C41184The sign, symptom, or condition that is the basis for initiation of a treatment.

15--CLASClassChar
Variable Qualifier--TRT
C170987A standardized or dictionary-derived name for a grouping of drugs, procedures, or therapies.

16--CLASCDClass CodeChar
Variable Qualifier--TRT
C170988A 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--DOSEDoseNum
Record Qualifier

C25488The quantity of an agent (e.g., drug, substance, radiation) taken or absorbed at a single administration.Not populated when --DOSTXT is populated.
18--DOSTXTDose DescriptionChar
Record Qualifier

C70961A 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--DOSUDose UnitsChar
Variable Qualifier--DOSE; --DOSTXT; --DOSTOT
C73558The 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--DOSFRMDose FormChar
Variable Qualifier--TRT
C42636Physical 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--DOSFRQDosing Frequency per IntervalChar
Record Qualifier

C15682The number of times that an agent (e.g., drug, product, substance, radiation) is administered per unit of time.
"Q2H", "QD", "PRN"
24--DOSTOTTotal Daily DoseNum
Record Qualifier

C70888The quantity of an agent (e.g., drug, product, substance, radiation) taken or absorbed on a single day.Uses the units in --DOSU.
25--DOSRGMIntended Dose RegimenChar
Record Qualifier

C71137The planned schedule for the administration of an agent (e.g., drug, product, substance, radiation).
"TWO WEEKS ON, TWO WEEKS OFF"
26--ROUTERoute of AdministrationChar
Record Qualifier

C38114Designation 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--METHODMethod of AdministrationChar
Record Qualifier

Not in human clinical trials; EX domain only


Method of administration of the treatment.


"INFUSION" when ROUTE is "INTRAVENOUS"

30--LATLateralityChar
Variable Qualifier--LOC


Qualifier for anatomical location further detailing laterality of intervention administration."RIGHT", "LEFT", "BILATERAL"
31--DIRDirectionalityChar
Variable Qualifier--LOC


Qualifier for anatomical location further detailing directionality of intervention administration."ANTERIOR", "LOWER", "PROXIMAL"
32--PORTOTPortion or TotalityChar
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--FASTFasting StatusChar
Record Qualifier

C93566An 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--PSTRGPharmaceutical StrengthNum
Record Qualifier

C53294The amount of active ingredient per unit of pharmaceutical dosage form.
"50", "300"
35--PSTRGUPharmaceutical Strength UnitsChar
Variable Qualifier--PSTRG
C117055The 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--TRTVTreatment VehicleChar
Record Qualifier

C927A carrier or inert medium in which a medicinally active agent is administered.
"SALINE"
37--VAMTTreatment Vehicle AmountNum
Record Qualifier

C82553Amount of the prepared product (treatment plus vehicle) administered.Note: Should not be diluent amount alone.
38--VAMTUTreatment Vehicle Amount UnitsChar
Variable Qualifier--VAMT
C82583The unit of measure for the prepared product (treatment plus vehicle) using standardized values.
"mL", "mg"
39--ADJReason for Dose AdjustmentChar
Record Qualifier

C82555The explanation given for why a dose was changed as compared to a previous dose.
"ADVERSE EVENT", "INSUFFICIENT RESPONSE", "NON-MEDICAL REASON"
40--RSDISCReason Treatment or Product DiscontinuedChar
Record Qualifier



Reason the treatment or product was discontinued.
41--USCHFLUnscheduled FlagChar
Record Qualifier
Not in human clinical trialsC170510An 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--RSTINDRestraint IndicatorChar
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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