Guidance is in this section will be used with domain-specific guidance in Section x.x, Metadata for Individual Health and is organized by general observation class.
The following should be used when the observation class for a domain is Interventionsguidance will be followed for Interventions class domains.
| Metadataspec |
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| Num | Collection Variable(s) | Implementation |
|---|
| 1 | --YN | - Variables with the question text "Were there any interventions?" (e.g., “Were there any procedures?”, “Were there any concomitant medications?") are intended to assist in the cleaning of data and in confirming that there are no missing values. Values collected for these fields are not represented in subsequent tabulation datasets.
| | 2 | --CAT, --SCAT | - Values are generally not entered on the CRF. Implementers may pre-populate and display these category values to help individuals involved in data collection understand what data should be recorded on the CRF. Implementers may also prepopulate hidden variables with the values assigned within their operational database. Categories and subcategories are determined per protocol design and can be populated during tabulation dataset creation.
| | 3 | Date and Time | - Date variables (e.g., --DAT, --STDAT, --ENDAT) are concatenated with CDASH time variables (e.g., --TIM, --STTIM, --ENTIM, if time is applicable) into the appropriate
SDTM - tabulation --DTC variables (e.g., --DTC, --STDTC, --ENDTC) using ISO 8601 format.
- Collecting the time an intervention was started is only appropriate if it can be realistically determined and if there is a scientific reason for needing to know this level of detail.
| | 4 | -- REASND | SDTM - tabulation variable --STAT only. The value "NOT DONE" in --STAT indicates that the subject was not questioned about the intervention or that data were not collected; it does not mean that the subject had no interventions.
| | 5 | --SPID | variable - --SPID may be populated by the
sponsor- applicant's data collection system. If collected, it can be beneficial to use an identifier in a data query to communicate clearly to
the site - individuals involved in data collection the specific record in question. This field may be populated by the
sponsor- applicant's data collection system.
| | 6 | Coding | - When free-text intervention treatments are recorded, the location may be included in the --TRT variable to facilitate coding (e.g.,
liver - lung biopsy). Location may be collected when the
sponsor - applicant needs to identify the specific anatomical location of the intervention. This location information does not need to be removed from the verbatim --TRT when creating
SDTMIG submission non-standard (or SUPPQUAL) variables - nonstandard variables --ATC1 through --ATC5 and --ATC1CD through --ATC5CD are used only when the intervention is coded using the World Health Organization's Anatomical Therapeutic Chemical (ATC) classification system (https://www.who.int/medicines/regulation/): 1 = the anatomical main group, 2 = the therapeutic main group, 3 = the therapeutic/pharmacological subgroup, 4 = chemical/therapeutic/pharmacological subgroup, 5 = chemical substance.
- The implementer may also add MedDRA coding elements as NSVs to the Interventions domain if this dictionary is used for coding.
| | 7 | Location (--LOC) and related variables (--LAT, --DIR, -- PORTOT) | - Because the complete lists of controlled terminology for these variables may be too extensive to be relevant for a particular study CRF, sponsors may choose to include only subsets of the controlled terminology on the CRF.
- --LOC could be a defaulted or hidden field on the CRF for prespecified [--TRT]/Intervention Topic].
| | 8 | Relative Timing Variables | sponsor - applicant defines the study reference period in the Demographics (DM) domain using SDTMIG
variables RFSTDTC - variables RFSTDTC and RFENDTC. Other
sponsor- applicant-specified reference time points can be defined for other data collection situations. The CDASH variables --PRIOR and --ONGO may be collected in lieu of start date or end date.
- The CDASH variable --PRIOR is used to indicate if the --TRT (the topic item) started prior to either the study reference period or another
sponsor- applicant-defined reference time point. When the study reference period is used as the anchor, --PRIOR may be used to derive a value (from the Controlled Terminology codelist STENRF) into the SDTM relative timing variable --STRF. When populating --STRF, if the value of --PRIOR is "Y", the value of “BEFORE” may be mapped to --STRF. The value in DM.RFSTDTC serves as the anchor for --STRF.
- When a reference time point is used instead of the study reference period, --PRIOR may be used to derive a value into the SDTM relative timing variable --STRTPT. If the value of --PRIOR is "Y", the value of "BEFORE" may be derived into --STRTPT.
Note: -
- --STRTPT must refer to the "time point anchor" as described in --STTPT. The value in --STTPT can be either text (e.g., "VISIT 1") or a date (in ISO 8601 format).
- The CDASH variable --ONGO is used to indicate if the value in --TRT is continuing beyond the study reference period or beyond another sponsor-defined reference time point. When the study reference period is used as the anchor, --ONGO may be used to derive a value into the SDTM relative timing variable --ENRF. If the value of --ONGO = "Y", the value of "AFTER" may be mapped to --ENRF.
- When a reference time point is used instead of the study reference period, --ONGO may be used to derive a value into the SDTM relative timing variable --ENRTPT. If the value of --ONGO is "Y", the value of "ONGOING" may be mapped to --ENRTPT.
Note: -
- --ENRTPT must refer to the “time point anchor” as described in --ENTPT. The value in --ENTPT can be either text (e.g., "TRIAL EXIT") or a date (in ISO 8601 format).
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The following should be used when the observation class for fields in a domain are Events.
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