CDISC Sdtm ec/ex Domain Learning Note-1



"Finishing translation from Sdtm IG 3.2:www.cdisc.org/sdtm"

EX (Exposure exposure)

Exgrpid (Group ID): Associating all records of a subject

Exrefid (Reference ID): internal or external identification such as kit number, bottle label, vial identifier

Exspid (sponsor-defined Identifier): The reference number defined by Sponsor.

Exlnkid (Link ID): An identifier used to correlate related records between multiple domain

EXLNKGRP (Link group ID): an identifier used to correlate related group records between multiple domain

EXTRT (Name of treatment): study the name of the drug

Excat (category of treatment): Defining categories for EXTRT

Exscat (Subcategory of treatment): sub-class

Exdose (Dose): Dosage of EXTRT

Exdostxt (Dose Description): Dosage or text in the form of a range such as 200-400. Exdose Exdostxt can only export one

Exdosu (Dose Units): unit

Exdosfrm (Dose Form): extrt dosage forms, such as pill lotion

Exdosfrq (dosing Frequency per Interval): usually expressed as the number of repeated medications for a specific period. such as Q2H (once every 2 hours), QD (once per day)

EXDOSRGM (intended Dose regimen): A text description of the medication plan or scheme, as in the case of a WEEKS on (two weeks of medication), and a WEEKS OFF (two weeks of withdrawal)

Exroute (Route of Administration): interference pathways such as oral intravenous injection

Exlot (Lot number): Number of drugs for interfering with drugs

Exloc (Location of Dose adminstration): Specific position of medication such as arm (arm) lip (LIP)

Exlat (laterality): Specific emphasis on anatomical positions such as left (partial right)

Exdir (direactionality): Specific direction information of anatomical positions such as anterior (front) LOWER (lower) proximal (near body Central)

Exfast (Fasting status): Identifies the status of dieting y/n

Exadj (Reason for Dose adjustment): Describe or explain the cause of dose adjustment

Epoch: An experimental period in which drug disclosure is recorded.

EXSTDTC (start date/time of treatment): EXTRT and Exdose indicated treatment start date time

EXENDTC (end date/time of treament): EXTRT and Exdose indicate the treatment end date time. For medications that occur at a point in time, there is only one time to love your phone, so EXSTDTC should be copied to EXENDTC

Exstdy/exendy (Study Day of Start/end of treatment): Rfstdtc Day relative to Study

Exdur (Duration of Treatment): duration of medication. Collected on the CRF, cannot be derive

EXTPT (Planned time Point Name): 1. A textual description of the timing of the drug occurrence; 2. Can be expressed as a duration relative to a fixed reference point, such as the last time of use. Refer to Extptnum and extptref

Extptnum (Planned time point number): The numeric value of EXTPT is used to sort

Exeltm (Planned Elapsed time from Hour point Ref): The duration of the medication relative to the scheduled fixed reference time (EXTPTREF). This variable has meaning when there are repeated measurements. Non-clock time. ISO 8601 format

Extptref (Time point Reference): The name of the fixed reference dot, used for Exeltm, Extptnum, extpt for reference. such as PREVIOUS DOSE (before medication), PREVIOUS MEAL (pre-meal)

EXRFTDTC (Date/time of Reference time point): Fixed reference points defined by Extptref

Note:

1. Ex Definition

A. Ex reflects detailed information on subject treatment. Treatment is an intervention that is defined in the study as a test material and is often not provided to subject. such as placebo, active contrast drugs, drug subjects. Non-specified treatment information should be stored in cm or other suitable domain.

B. Ex is, in most cases, an exported data set in which Exdosu reflects the unit of the test-specific drug. The collected data (number of pills, dosage of injections) with additional inputs (randomization files, concentrations, dosage intensities, drug descriptions) are used to export records in Ex.

C. EX domain is required for trials containing designated drugs. The record of exposure may be determined directly or indirectly; Metadata should describe how records are exported. The general methods of determining exposure include (by the most direct to least direct order):

1. Drug use actually observed by the researcher

2. Use of drugs recorded by automatic dispensing devices

3. Subject records such as diaries

4. The collection of data from the distribution of drugs, such as the count of pills

5. Export from protocol

Ex does not want to be exported when the study is still in an open state and protocol specifies that the drug cannot be reflected by the specified unit because of the blind state.

D. EX domain structure interval one record per constant-dosing per subject. "Constant-dosing interval" is defined by Sponsor and can contain any period of time, which can be described by known medications, frequency, and drip rate. For example, for one trial, one week of medication for 6 weeks, the exposure information can be expressed as follows:

1. If the information for each drug is not collected, there is only one record for each subject, covering the entire 6-week period.

2. If sponsor regulates each treatment, there are up to 6 records (each corresponding to the weekly medication).

2. Description of exposure treatment

A. EXTRT collects the name of the study drug, which is the topic variable. Required, must have a value. EXTRT must contain only the name of the medication and cannot contain dosage, dosage forms or other qualifying information. For example, "Aspirin MG TABLET" is not a valid EXTRT value. This situation should be expressed as extrt= "aspirin", exdose=100, exdosu= "mg", exdosfrm= "TABLET".

B. The dose of the placebo should be expressed as extrt= "placebo", exdose=0 (indicating that 0 mg of active ingredient is used)

3. Classification and Grouping

A. Excat and Exscat are used to differentiate between classes and subclasses. For example, if the experiment contains multiple active comparison drugs, the excat can be set to "active COMPARATOR". The classification method does not necessarily use all the tests, so these variables are perm

4. Time variables

A. The exposure time of the test drug is collected at the start/end date and time of each medication interval. If subject is used only for outpatient use (e.g. in outpatient injections), Visitnum can be added to domain as an additional time variable. Vsiitdy and visit are limited variables of perm. However, if the start and end of the range are not limited to outpatient time (such as subject taking the pills home), then visitnum should not be added to ex domain. The reason for this is that ex is the time information used for mobile phone exposure treatment, not the distribution information of the treatment drug. Also, Visitnum cannot be used to indicate that treatment begins with a particular visit and lasts for some time. Sdtm does not have the definition of "start visit" and "End Visit View".

B. For timed medications (e.g. oral tablets, pre-filled notes), if only time is collected, then EXSTDTC need to copy to EXENDTC

5. The collected exposure data is expressed in the EC. When the relationship between EC and ex can be described in Relrec, it needs to be defined. The export of ex must be described in Define.xml

6. Additional Interference Qualifiers

A.--presp,--occur,--stat,--reasnd from the general category of interference, are not used for ex domain. Ex contains drug receiving; Including not administered, not administered, missing to be evaluated

B.--dostot is under evaluation for potential deprecation and replacement with a mechanism to describe total dose over any Interval of time (e.g., day, week, month). Sponsors considering use of Exdostot could want to consider using other dose amount variables (exdose or exdostxt) in Combin ation with frequency (EXDOSFRQ) and timing variables to represent the data.

C. When the EC and ex co-export, Exvamt and EXVAMTU cannot be used in ex; The data collected should be represented in Ecdose and Ecdosu.

D. Qualifiers in other SDTM interference classes may be added to the domain.



CDISC Sdtm ec/ex Domain Learning Note-1