I NTERVENTIONS
DRAFT CDASH Definition Question Text Prompt Data
SDTM Target Mapping Instructions Controlled
Interventions N/A 1 YN Any [Intervention] An indication whether or not any data was collected for the intervention topic
Has the subject had any [intervention topic(s)] (after/before) [study-specific time frame] (after/before [study-specific time frame] )?; [Was/Were] (there) any [intervention topic(s)]
[taken/performed/used/collected] (after/before) [study-specific time frame]?
Any [Intervention Topic] Char N/A Does not map to an SDTM variable The SDTM Annotated CRF is annotated to indicate that this field is NOT SUBMITTED
The general prompt question in New York serves as a tool for monitoring and data cleaning, ensuring that all other fields on the Case Report Form (CRF) are intentionally left blank This field can be utilized across various intervention CRFs to signify the presence or absence of data to record.
The topic for the intervention observation, usually the reported name of the treatment, drug, medicine, or therapy given during the dosing interval for the observation
What [is/was] the (type of) [treatment/investigational product/ intervention topic]?; [If other is selected], [explain/specify/provide more details]
[Treatment/Investigational Product/Intervention Name]; [Specify Other/Explain/Specify Details]
[Treatment/Investigational Product/Intervention Name]
Char TRT Maps directly to the SDTM variable listed in the column with the heading
N/A If TRT is preprinted/pre-specified, the value should also be mapped into the TRT variable E.g., if Oral Steroid is preprinted on a CM CRF,
"Oral Steroid" must be stored in CMTRT, while the CDASH field TRT can capture any free text values associated with the sponsor's standardized value in the CDASH field DECOD For instance, if DECOD is labeled as "OTHER," the corresponding free text intervention topic can be recorded in TRT, using the prompt "Specify Other." This ensures that interventions are accurately documented and standardized.
The dictionary or sponsor-defined standardized text description of the topic variable, TRT, or the modified topic variable ( MODIFY), if applicable
What [is/ was] the [treatment/intervention topic]? [Intervention Topic] Char DECOD Maps directly to the SDTM variable listed in the column with the heading
When utilizing coding dictionaries such as WHO Drug or MedDRA, the Question Text and Prompt fields are not applicable WHO Drug is specifically designed for coding treatment names, while MedDRA is used for coding procedures In this context, the CDASH field DECOD corresponds to the Preferred Term from these dictionaries Additionally, the DECOD field can be employed to gather standardized, pre-specified values from CDISC Controlled Terminology or sponsor-defined terms on a Case Report Form (CRF) Meanwhile, the TRT field allows for the collection of any free text values associated with the standardized sponsor value.
"OTHER" and the associated free text intervention topic is collected in CDASH field TRT
Interventions N/A 4 MOOD Mood The mode or condition of the record that specifies whether the intervention (activity) is intended to happen or has happened
Does this record describe scheduled treatment or performed treatment?
[Scheduled/Performed] Char MOOD Maps directly to the SDTM variable listed in the column with the heading
In clinical research, "SCHEDULED" refers to the collection of intended dose records at the subject level, while "PERFORMED" pertains to the gathering of actual dose records These terms are typically used as headings on the Case Report Form (CRF).
Class Number Variable Label Type Terminology
The Codelist Name should not be framed as a question that the site would answer When capturing both scheduled and performed dosing in a single horizontal record, the sponsor has the option to append additional information.
"_SCHEDULED" to the variable name to capture the scheduled dose Interventions N/A 5 CAT Category A grouping of topic-variable values based on user-defined characteristics
What [is/was] the category (of the [intervention])? [Category/Category Value]; NULL Char CAT Maps directly to the SDTM variable listed in the column with the heading
Terminology is typically presented as a heading on the Case Report Form (CRF) or screen rather than as a question requiring an answer from the site The Standardized Clinical Assessment and Management Plan (SCAT) is applicable only when there is a corresponding Clinical Assessment Tool (CAT) For reference, examples can be found in the CDASHIG Metadata Table or the SDTMIG When a question is posed, the response generally corresponds to a sponsor-defined codelist In cases where the form is organized as a grid, terms like "category" may be used as column headers, with further examples available in the CDASHIG Metadata Table or the SDTMIG.
Interventions N/A 6 SCAT Subcategory A sub-division of the CAT values based on user-defined characteristics
What [is/was] the subcategory (of the [intervention])? [Subcategory/Subcategory Value]; NULL Char SCAT Maps directly to the SDTM variable listed in the column with the heading
In clinical research data collection, terminology is typically displayed as a heading on the Case Report Form (CRF) or screen rather than as a question requiring an answer from the site SCAT can only be utilized in conjunction with a corresponding CAT, with examples available in the CDASHIG Metadata Table or SDTMIG When a question is posed, the response will generally adhere to a sponsor-defined codelist If the form is organized in a grid format, terms like "subcategory" may be used as column headers, while interventions are marked as N/A and PRESP indicates pre-specified parameters.
An indication that a specific intervention or a group of interventions is pre-specified on a CRF
N/A N/A Char PRESP Maps directly to the SDTM variable listed in the column with the heading
In clinical research, for pre-specified interventions, a hidden field on a Case Report Form (CRF) is set to "Y" by default or added during the creation of the Study Data Tabulation Model (SDTM) dataset When a study collects both pre-specified and free-text interventions, the value of PRESP should be "Y" for all pre-specified interventions, while it should be null for those reported as free-text Additionally, the OCCUR field indicates whether the pre-specified intervention was administered when information regarding its occurrence is requested.
[taken/performed/administered/consumed] (after/before [study-specific time frame])?;Has the subject [had/taken/performed/administered/consumed] the [ TRT/ intervention]?
[Had/Taken/Performed/Administered/Consum ed]
Char OCCUR Maps directly to the SDTM variable listed in the column with the heading
In accordance with the protocol, specific interventions must be documented accurately If a term is preprinted or pre-specified, it should be recorded in the TRT variable; for instance, if "Oral Steroid" appears on a CM CRF, it should be entered as "Oral Steroid" in CMTRT The CDASH field OCCUR is not applicable for spontaneously reported free text TRT and should not be used to indicate that data was not collected This field is intended solely for instances where the value can be reliably captured.
DRAFT CDASH Definition Question Text Prompt Data
SDTM Target Mapping Instructions Controlled
In the implementation of CDISC CT values, the OCCUR variable is defined as a Yes/No indicator within SDTM submission datasets It is populated when PRESP is marked as "Y" and remains null if PRESP is also null Note that interventions are not applicable in this context, as indicated by PERF [Observation].
The variable used to indicate whether data are available by having the site recording the value as "Yes" or "No"
(Were/Was) (the) [intervention topic]
[answered/done/assessed/evaluated/available]?
([intervention topic]) [Answered/Done/Assessed/Evaluated/Availab le]
The Char STAT field does not directly correspond to an SDTM variable, but it can be utilized to populate the SDTM variable STAT to indicate instances when a pre-specified intervention was not assessed If the CDASH variable PERF is set to "N", then the value for the SDTM variable STAT will reflect this status.
"NOT DONE" If PERF"Y", STAT is null
(NY) Using PERF, a negative response can be collected as "N" and mapped to the STAT variable in SDTM as
PERF can be used instead of STAT when a YN response list is needed for implementation Examples: Were prior medications assessed? Were medications of interest assessed?
Interventions N/A 10 STAT Completion Status The variable used to indicate that data are not available by having the site recording the value as "Not Done"
Was the [intervention topic] not [answered/done/assessed/evaluated/available]?; Indicate if ([intervention topic] was) not
[answered/done/assessed/evaluated/available]
Not [Answered/Done/Assessed/Evaluated/Availab le]
Char STAT Maps directly to the SDTM variable listed in the column with the heading
"SDTM Target" If collected, the Origin (column in the Define-XML)
= "CRF", if populated from other sources such as a free text or sponsor-defined listing for REASND, the Origin ="DERIVED"
The "Not Done" (ND) value signifies that data is either unavailable or the relevant question was not posed This CDASH field should not be utilized when determining whether a pre-specified intervention was conducted; instead, such information should be recorded using the OCCUR field in CDASH.
Reason Not Done An explanation of why the data are not available
What [is/was] the reason that the [Interventions topic/data/information/sponsor-defined phrase] was not [collected/answered/done/assessed/evaluated/available]?
Reason Not [Collected/Answered/Done/Assessed/Evaluat ed/Available]
Char REASND Maps directly to the SDTM variable listed in the column with the heading
In the SDTM dataset, when utilizing the REASND terminology to indicate the reason for data unavailability, it is essential to also populate the STAT field The reasons for data absence can be selected from a sponsor-defined codelist, such as broken equipment or subject refusal, or can be entered as free text.
Interventions N/A 12 INDC Indication The condition, disease, symptom or disorder that the intervention was used to address or investigate (e.g., why the therapy was taken or administered or the procedure performed)
For what indication was the [ TRT]
Indication Char INDC Maps directly to the SDTM variable listed in the column with the heading
Additional information is gathered on the Case Report Form (CRF) when a sponsor aims to document the indications or medical issues that led a subject to receive an intervention This data is essential for coding, analysis, and reconciling interventions during the data clean-up and monitoring process Furthermore, it includes details such as the dose, which refers to the specific amount of the substance administered.
TRT) given at one time represented as a numeric value
What [is/ was] the (individual) (intended) [dose/amount] (of [ TRT] [taken/performed/administered/consumed/per administration])?
(Intended) [Dose/Amount] (per Administration) Num DOSE Maps directly to the SDTM variable listed in the column with the heading
N/A Used when the dose/amount taken/administered/consumed has only numeric entries If non-numeric entries are possible, use the CDASH field DSTXT
Interventions N/A 14 DSTXT Dose Description The amount of substance ( e.g.,
TRT) given at one time represented in text format
What [is/was] the (individual) (intended) [dose/amount] (of [ TRT] [taken/performed/administered/consumed/per administration])?
(Intended) [Dose/Amount] (per Administration) Char DOSE;
Does not directly map to SDTM Maps to either DOSE or DOSTXT
N/A Defining this data collection field as a dose text field allows for flexibility in capturing dose entries as numbers, text or ranges
Class Number Variable Label Type Terminology
Interventions N/A 15 DOSU Dose Units The unit for DOSE, DOSTOT, or -
What [is/was] the unit (for the dose/amount of [ TRT])? ([Dose/Amount]) Unit Char DOSU Maps directly to the SDTM variable listed in the column with the heading
(UNIT) When possible, is pre-printed on the
The Case Report Form (CRF) includes a section for documenting the treatment dose unit, which can be obtained through various methods such as protocols or data analysis When this information is collected, it is either pre-printed on the CRF or provided in a designated field for accurate capture.
Dose Form The form in which the TRT is physically presented
What [is/was] the dose form (of the [ TRT])? Dose Form Char DOSFRM Maps directly to the SDTM variable listed in the column with the heading
The number of doses given/administered/taken during a specific interval
What [is/was] the frequency (of the [ TRT])? Frequency Char DOSFRQ Maps directly to the SDTM variable listed in the column with the heading
E VENTS
DRAFT CDASH Definition Question Text Prompt Data
Events N/A 1 YN Any [Event] An indication whether or not any data was collected for the event topic
Has the subject had any [event topic(s)/term/name]
([study specific time frame])?; [Was/Were] (there) any [event topic(s)] (reported) ([study specific time frame])?
Any [Event Topic] ([study specific time frame]) Char N/A Does not map to an SDTM variable
The SDTM Annotated CRF is annotated to indicate that this field is NOT SUBMITTED
The CRF field serves as a crucial tool for indicating the presence or absence of data during events, primarily for data cleaning purposes It ensures that all other fields on the CRF are intentionally left blank If the intention is to submit a YES/NO response in the SDTM datasets, this CDASH variable should be avoided in favor of the appropriate CDASH variable, such as OCCUR.
Events N/A 2 TERM Reported Term The topic variable for an event observation, which is the reported or pre-specified name of the event
What [is/was] the [event topic/term/name]?; If DECOD (is selected), [explain/specify/provide (more) detail(s)]?
[Event Topic]; [Specify/Specify Other/Explain/Provide Details (for [Event Topic])]
Char TERM Maps directly to the SDTM variable listed in the column with the heading
Typically, the TERM variable is used to collect verbatim text for an event If the term is preprinted on an Adverse Event Case Report Form (AE CRF), such as "Headache," this value should be stored in the AETERM variable Additionally, the CDASH field TERM can capture any free text values associated with the standardized value in the DECOD field For instance, if DECOD is labeled "OTHER," the corresponding free text event topic can be recorded in TERM, often using the item prompt "Specify Other."
The dictionary or sponsor-defined standardized text description of the topic variable, TERM, or the modified topic variable ( MODIFY), if applicable
What [is/was] the [event/event topic] (at the EPOCH/study specific time frame)?
(Standardized) [Event/Event Topic] (at the EPOCH/Study Specific Time Frame)
Char DECOD Maps directly to the SDTM variable listed in the column with the heading
When utilizing a dictionary to code the TERM for SDTM Target, sponsors must specify the dictionary name and version in the Define-XML external codelist attributes Additionally, it is essential for sponsors to incorporate an Origin column in the define metadata document to denote that the data has been "ASSIGNED."
When using a coding dictionary like MedDRA, the Question Text and Prompt may not apply, as they correspond to the Preferred Term (PT) in MedDRA Additionally, the CDISC Controlled terminology (NCOMPLT) is utilized for standardized coding.
The CDASH field DECOD is utilized to gather standardized pre-specified values, either from CDISC Controlled Terminology or Sponsor-defined Terminology, on a Case Report Form (CRF) In conjunction with this, the CDASH field TERM captures any free text values associated with the standardized value For instance, if the DECOD field contains the value "OTHER," the related free text event topic would be recorded in the TERM field Additionally, the Events N/A 4 CAT field serves as a category that groups topic-variable values based on user-defined characteristics.
What [is/was] the category (of the [ TERM/event topic])?
[Category/Category Value]; NULL Char CAT Maps directly to the SDTM variable listed in the column with the heading
The heading on the CRF or screen typically does not represent a question that the site would answer SCAT is applicable only when there is a corresponding CAT, as illustrated in the CDASHIG Metadata Table or the SDTMIG When a question is posed, the response usually corresponds to a sponsor-defined codelist, depending on how the form is structured.
Class Number Variable Label Type Target Terminology
To create a grid, start by naming it and using terms like "category" as column headers You can find examples in the CDASHIG Metadata Table and the SDTMIG Additionally, the SCAT subcategory represents a subdivision of the CAT values, tailored to specific user-defined characteristics.
What [is/was] the subcategory (of the [ TERM/event topic])?
[Subcategory/Subcategory Value]; NULL Char SCAT Maps directly to the SDTM variable listed in the column with the heading
The SCAT can only be utilized in the presence of a CAT, as indicated in the CDASHIG Metadata Table or the SDTMIG, and this information is typically presented as a heading on the CRF or screen rather than as a question requiring a response from the site.
Events N/A 6 PRESP Pre-Specified An indication that a specific event, or group of events, is pre-specified on a CRF
N/A N/A Char PRESP Maps directly to the SDTM variable listed in the column with the heading
In clinical studies, pre-specified events are indicated by a hidden field on a Case Report Form (CRF) that defaults to 'Y' or is added during the creation of the SDTM dataset When a study collects both pre-specified and free-text events, the value of PRESP should be set to 'Y' for all pre-specified events, while remaining null for free-text reported events Additionally, the OCCUR field indicates whether the pre-specified event or a group of events occurred when solicited.
[Did/Does] the subject have [ TERM] (after/before [study-specific time frame])?; Is the [pre-specified medical occurring]?
[ TERM] Char OCCUR Maps directly to the SDTM variable listed in the column with the heading
In New York, when a term is preprinted or pre-specified, its value is assigned to the TERM variable For instance, if "Headache" appears on an Adverse Event Case Report Form (AE CRF), it should be recorded as "Headache" in the AETERM field.
The variable used to indicate whether data are available by having the site recording the value as "Yes" or "No"
(Were/Was) (the) [event topic]
[answered/done/assessed/evaluated/available]?
([event topic]) [Answered/Done/Assessed/Evaluated/Available]
Char STAT This field does not map directly to an
SDTM variable May be used to populate a value into the SDTM variable STAT to indicate when a pre-specified Event was not assessed
For use with prespecified events, when the CDASH variable PERF="N", the value of the STDM variable STAT is
"NOT DONE" If PERF= "Y", STAT is null
In the context of SDTM implementation, the PERF variable can capture binary responses of "Y" or "N," where a "N" response is recorded as "NOT DONE" in the STAT variable This allows for the collection of yes/no responses, such as whether medical history conditions were assessed, providing a clear framework for data representation.
The variable used to indicate that data are not available by having the site recording the value as "Not Done"
Was the [event topic] not [answered/done/assessed/evaluated]?; Indicate if ([event topic] was) not
Not Done Char STAT Maps directly to the SDTM variable listed in the column with the heading
The "SDTM Target" specifies that if data is collected, the Origin in the Define-XML should indicate "CRF." However, if the data is sourced from free text or a sponsor-defined listing for REASND, the Origin should be marked as "DERIVED."
The "Not Done" checkbox signifies that data is unavailable or the question was not posed, with one checkbox typically assigned to each pre-defined event This feature is particularly valuable when multiple questions are presented, ensuring that a blank result field is intentionally left blank.
Reason Not Done An explanation of why the assessment/evaluation/question was not answered/collected/done, etc
What [is/was] the reason that the ([data/information/sponsor-defined phrase]) was not [answered/collected/done/evaluated/assessed]?
Reason Not [Answered/Collected/Done/Evaluated/
Char REASND Maps directly to the SDTM variable listed in the column with the heading
N/A Sponsor-defined Controlled Terminology can be utilized, allowing users to select reasons for data not being collected from a predefined list, such as broken equipment or subject refusal, or to input a custom reason in free text It is essential to populate STAT in the SDTM dataset whenever REASND is applied.
Events N/A 11 LOC Location of Event A description of the anatomical location relevant for the event
What [is/was] the anatomical location (of the [ TERM/event topic])?
Anatomical Location Char LOC Maps directly to the SDTM variable listed in the column with the heading
(LOC) This may be pre-printed or collected
LOC is used only to specify the anatomical location LAT, DIR, PORTOT are used to further describe the anatomical location
Events N/A 12 LAT Laterality Qualifier for anatomical location further detailing the side of the body relevant for the event
What [is/was] the side (of the anatomical location of the event)?
Side Char LAT Maps directly to the SDTM variable listed in the column with the heading
The laterality of the location of the TERM is further specified, which can be either pre-printed or gathered Sponsors have the option to collect this data using a specific subset list of CT on the CRF.
DRAFT CDASH Definition Question Text Prompt Data
Events N/A 13 DIR Directionality Qualifier further detailing the position of the anatomical location relative to the center of the body, organ, or specimen
What [is/was] the directionality (of the anatomical location)?
Directionality Char DIR Maps directly to the SDTM variable listed in the column with the heading