CDISC Sdtm SU Domain Learning Notes



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

SU (Substance use drugs)

Sugrpid: A related record used to correlate a subject

The reference number defined by the suspid:sponsor. Can be pre-printed information on the CRF

SUTRT (reported name of substance): Drug name: cigarettes, coffee

Sumodify (Modified substance name): If SUTRT has a modification, this variable uses the modified name

Sudecod (Standardized substance Name): Standardized or dictionary-derived text, used to describe SURTR or sumodify if sponsor chooses to encode the drug usage. It is recommended that sponsor provide a dictionary name and version for map terms

Sucat (category for substance use): The categories used to define related records, such as tobacco, alcohol, and caffeine.

Suscat (Subcategory for substance use): subclass, such as: Cigar cigarette, beer liquor

Supresp (SU pre-specified): Indicates whether the drug use information (y/null) is pre-specified in the CRF

Suoccur (SU occurrence): When use is specified beforehand, use Suoccur to indicate whether the prescribed drug (y/n) is used. If the drug is not pre-specified, the value of suoccur is null

Sustat (Completion status): When the medication is pre-specified, the completion status indicates that there is no answer to the specified drug. When the CRF does not collect the drug information in advance, the completion status indicates that subject has not received the medicine

SUREASND (Reason substance use not collected): Describes why the drug was not collected. Common use with Sustat.

Suclas (Substance use Class): drug classification. Can be obtained from the code. The value of the exported category when encoded as a single category. If you use a dictionary and encode multiple categories, refer to section 4:4.1.2.8.3 or omit Suclas

SUCLASCD (Substance use Class code): Suclas corresponding encoding

Sudose (Substance use Class Code): The amount of sutrt used. If Sudostxt is already exported, you do not need to export sudose

Sudostxt (Substance use consumption text): The amount of medication used or the scope of the information used, text form

Sudosu (consumption Units): unit

Sudosfrm (Dose Form): Dosage forms (Injection body powder)

Sudosfrq (use Frequency per Interval): Number of uses of sudose within a specified time period, such as q24h (once per day)

Sudostot (total Daily consumption): daily usage of SUTRT. If sponsor requires a period of time (not daily) of the data and can be exported in supp

Suroute (Route of Administration): Methods of use of SUTRT such as oral injections

SUSTDTC/SUENDTC (start/end date/time of substance use)

Sustdy/suendy study day with respect to RFSTDTC

Sudur (Duration of substance Use): The duration of drug usage collected is expressed in ISO 8601. Used only on CRF and cannot be exported by other information

SUSTRF/SUENRF (start/end Relative to Reference Period): Describes the drug use start/end time point, relative to the sponsor defined reference period. The reference period defined by Sponsor is a continuous time, defined by a discrete start point and end time Point (Rfstdtc rfendtc). If there is information collection similar to PRIOR ongoing continuing, this can be used with SUSTRF

SUSTRTPT (Start Relative to Reference time point): Indicates that the start of the drug is before or after the reference time (SUSTTPT)

SUSTTPT (Start Reference time point): Description of reference points referenced by SUSTRTPT or datetime in ISO 8601 format, such as "2003-12-15" or "VISIT 1"

Note:

1. The domain is used to collect information on drug use, which can be used to analyze the effectiveness and safety of long-term treatment, and also as a write variable for other effectiveness and safety analysis

2. Su definition

A. This information may be independent of the planned research assessment, or a key outcome of clinical trials

B. In many clinical trials, detailed drug use information is not required for that or not as necessary to collect information. In this case, many of the qualifying variables are not committed

C. Su may contain answers to questions about pre-developed drugs, as well as the collection of free text

3. Su Description and coding

A. SUTRT collects the text information of the specified medication, is SU's topic variable, required, must have the value

B. sumodify is a perm variable, if the sponsor program allows modification of the drug using a name term used for encoding, the modified names are stored in the sumodify. The variable can be exported according to the sponsor program

C. sudecod is a preferred term that is exported by sponsor from a coded dictionary. The perm variable. If sponsor believes it is necessary to encode the name SUTRT using a standard dictionary, you need to specify the dictionary and version to use for the encoding.

4. Supplementary classifications and groupings

A. Sucat and Suscat are not redundant, although they have been encoded and categorized using SUDECOD code and dictionaries. That is, Sucat and Suscat provide different methods for defining or classifying SU information. For example, sponsor may be interested in defining all medications, and researchers are interested in using information about opium, so this information is collected as a separate page on the CRF, which may differ from the categories exported from a standard encoding dictionary

B. Sugrpid can be used to associate a subject with multiple information records in a chunk, referring to section 4:4.1.2.6. You need to be careful not to use it instead of Sucat or Suscat.

5. Time variables

A. Sustdtc and SUENDTC can be exported as required

B. If the drug usage information is collected multiple times in the CRF, then visitnum needs to join domain as an additional time variable. Visitdy and visit as perm variables

6. Supplementary perm interference limit variables

A. Any additional modifier variables in the interference class can be added to the domain.

CDISC Sdtm SU Domain Learning Notes