General Guidance for Data Collection Fields

1. 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.
2. 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.

1. 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.
2. 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.
3. The implementer may also add MedDRA coding elements as NSVs to the Interventions domain if this dictionary is used for coding.

1. 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.
2. --LOC could be a defaulted or hidden field on the CRF for prespecified [--TRT]/Intervention Topic].

1. 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.
2. 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. 
3. 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).
4. 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. 
5. 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).

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.

• 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.

1. 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.
2. 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.
3. The CDASH variables --LLT, --LLTCD, --PTCD, --HLT, --HLTCD, --HLGT, --HLGTCD, --SOC, and --SOCCD are only applicable to events coded in MedDRA.

1. Location is collected when the sponsor needs to identify the specific anatomical location of the event.
2. 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.