General Guidance for Metadata

The SDTM class for a data collection field is specified in the Observation Class column in the metadata table for the domain. General guidance for data collection fields by class are provided in the tables below and will be

The following should be used when the observation class for fields in a domain are Interventions.

1	Data Collection Field(s)	Guidance
	--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. These variables are not included as part of the SDTM Intervention domains for submission and are annotated as NOT SUBMITTED on the CRF.
	--CAT and/or --SCAT	are generally not entered on the CRF by the sites. Implementers may pre-populate and display these category values to help the site 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 could be populated during SDTM submission dataset creation.
	Date and Time Variables	CDASH 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 --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. An example is where the subject is under the direct care of the site at the time the intervention was started, and the study design is such that it is important to know the intervention start time with respect to dosing.
	The CDASH variable -- REASND	is used with SDTM 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.
	--SPID	variable may be populated by the sponsor's data collection system. If collected, it can be beneficial to use an identifier in a data query to communicate clearly to the site the specific record in question. This field may be populated by the sponsor's data collection system.
	Coding	When free-text intervention treatments are recorded, the location may be included in the --TRT variable to facilitate coding (e.g., liver biopsy). Location may be collected when the sponsor 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 datasets. The non-standard (or SUPPQUAL) 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.
	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].
	Relative Timing Variables (see the SDTMIG for more information and details)	For each study, the sponsor defines the study reference period in the Demographics (DM) domain using SDTMIG variables RFSTDTC and RFENDTC. Other sponsor-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-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).

The following should be used when the observation class for fields in a domain are Findings.

Num	Data Collection Field(s)	Guidance

The following should be used when the observation class for fields in a domain are Events.

Num	Field or Variable	Guidance
1	--YN	Variables with the question text "Were there any <events>?" (e.g., “Were there any adverse events?”, “Were there any healthcare encounters?”) are intended to assist in the cleaning of data and in confirming there are no missing values. These questions can be added to any CRF in order to capture this information.
2	--CAT and/or --SCAT	Variables are generally not entered on the CRF by sites. Implementers may prepopulate and display these category values to help site personnel 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 typically evident from the protocol design, and could be populated during SDTM dataset creation.
3	Date and Time Variables	CDASH date variables (e.g., --DAT, --STDAT,--ENDAT) are concatenated with CDASH time variables (e.g., --TIM, --STTIM, --ENTIM, if time is collected) into the appropriate SDTM --DTC variables (e.g., --DTC, --STDTC, --ENDTC) using ISO 8601 format. Collecting the time of an event is only appropriate if it can be easily obtained and if there is a scientific reason, such as the need to know the order of events (e.g., the adverse event started after dosing). An example of this would be a study where the subject is confined to a phase 1 unit and under the direct care of the unit staff at the time that the event started or using time to tie together dosing and pharmacokinetic (PK) sample collection.
	--COCCUR variable	(see Section 3.4, How to Collect New Data Collection Fields When No CDASHIG Field Has Been Defined, category 3) may be used when a specific event is solicited (preprinted) on the CRF and the CRF uses a sponsor-defined codelist. For example, a sponsor may combine the concepts of the CDASH OCCUR variable while also allowing for a "NOT DONE" response. Because the SDTM Controlled Terminology for --OCCUR only includes "N", "Y", and "UNKNOWN" responses, if the CDASH variable --OCCUR is used, the CRF would require a second question to indicate that the data were not collected. The CDASH variable --COCCUR is only used when events are prespecified.
	--REASND	variable is used in conjunction with SDTM variable --STAT. The value "NOT DONE" in --STAT indicates that the subject was not questioned about the event or that data was not collected; it does not mean that the subject had no events.
	The CDASH --SPID	variable may be populated by the sponsor's data collection system. If collected, it can be beneficial to use an identifier in a data query to communicate clearly to the site the specific record in question. This field may be populated by the sponsor's data collection system
	Coding	The CDASH variables used for coding are not data collection fields that will appear on the CRF itself. Sponsors will populate these through the coding process. When free-text event terms are entered, the location may be included in --TERM to facilitate coding and further clarify the event. This location information does not need to be removed from the verbatim term when creating SDTM submission datasets. The CDASH variables --LLT, --LLTCD, --PTCD, --HLT, --HLTCD, --HLGT, --HLGTCD, --SOC, and --SOCCD are only applicable to events coded in MedDRA.
	Location (--LOC, --LAT, --DIR, --PORTOT)	Location is collected when the sponsor needs to identify the specific anatomical location of the event. Implementers may collect the location information using a subset list of controlled terminology on the CRF. Location variables can be prepopulated as needed. There is currently some overlap across the LOC, LAT, and DIR variables for controlled terminology. While the overlap exists, ensure that this overlap for these variables is not part of database design.

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General Guidance for Metadata