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Assumptions in this section are appliable section are applicable to Interventions, Events, and Findings class domains and domains and will be used with detailed assumptions for applicable domains.

The following assumptions will be implemented for Interventions class domains.

domain-specific assumptions as appropriate.

Hidden variables are variables in an operational database that are used to collect values assigned by the applicant that are not entered via a CRF. Such values are pre-determined, fixed, and may or may not be displayed on the CRF as noneditable fields.

The following assumptions will be implemented for Interventions class domains.

Metadataspec

Num	Collection Variable Use	Implementation
1	--YN

Variables with the question text "Were there any interventions?" (e.

--YN ("Yes/No") questions are used to provide a definite answer. The absence of a response is ambiguous as it can mean "no," "none," or that the response is missing.
Variables with the question text "Were there any interventions?" (e.g., “Were there any concomitant medications?") support the cleaning of data and confirmation that

there are no missing values.

entry of collected data is complete.
Values collected

Values collected

for these fields will not be represented in subsequent tabulation datasets.
2	--CAT, --SCAT	Categories and subcategories are determined per protocol design and values are generally not entered via CRF. Implementers may:

Pre-populate

- Prepopulate and display category values to help individuals involved in data collection understand what data should be recorded on the CRF.

Pre-populate

Prepopulate hidden variables with the values assigned within their operational database. Populate values directly in the tabulation dataset during dataset creation.
3	Variables for

Date

date and

Time

time

Collecting the

The time an intervention started

is only appropriate if it can be realistically determined and

will be collected if there is a scientific or regulatory reason

for

to collect this level of detail and the time can be realistically determined.

Date

Collection variables for date (e.g., --DAT, --STDAT, --ENDAT)

are

will be concatenated with

CDASH

collection variables for time

variables

(e.g., --TIM, --STTIM, --ENTIM

, if time is applicable) into the appropriate tabulation --DTC variables

) as applicable to populate tabulation variables for dates (e.g., --DTC, --STDTC, --ENDTC) using ISO 8601 format.
4	-- REASND	--REASND is used with 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	--SPID may be populated by the

applicant

implementer's data collection system.
If collected, --SPID it can be

beneficial to use

used as an identifier in a data query to communicate clearly to individuals involved in data collection the

specific

record in question.

This field may be populated by the applicant's data collection system.


6	Coding	When free-text

intervention

interventions/treatments are recorded, the location may be included in the --TRT variable to facilitate coding (e.g., lung biopsy). Location may be collected when the

applicant

implementer 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 tabulation datasets.
The

nonstandard

non-standard 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

Implementers may

also

add MedDRA coding elements as NSVs to the Interventions domain if

this

that 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

Applicants may collect location data using a subset list of controlled terminology on the CRF.

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

8

Relative Timing

Applicants will define the study reference period in the Demographics (DM) domain using TIG tabulation variables RFSTDTC and RFENDTC. Other applicant-specified reference time points can be defined for other data collection situations. The TIG Collection or CDASH Model 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 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.
- --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 applicant-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.
- --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 assumptions will be implemented for Events class domains.

...

Applicants may prepopulate hidden variables with values assigned within their operational database.

The following assumptions will be implemented for Events class domains.

Metadataspec

Num	Field or Variable	Guidance
1	--YN	--YN ("Yes/No") questions are used to provide a definite answer. The absence of a response is ambiguous as it can mean "no," "none," or that the response is missing. Variables with the question text "Were there any <events>?" (e.g., “Were there any adverse events?”) support the cleaning of data and confirmation that entry of collected data is complete. These questions can be used on any CRF. Values collected for these fields will not be represented in subsequent tabulation datasets.
2	--CAT, --SCAT	Categories and subcategories are determined per protocol design and values are generally not entered via CRF. Implementers may: Prepopulate and display category values to help individuals involved in data collection understand what data should be recorded on the CRF. Prepopulate hidden variables with the values assigned within their operational database. Populate values directly in the tabulation dataset during dataset creation.
3	Variables for date and time	The time of an event will be collected if there is a scientific or regulatory reason to collect this level of detail and the time can be realistically determined. Collection variables for date (e.g., --DAT, --STDAT, --ENDAT) will be concatenated with collection variables for time (e.g., --TIM, --STTIM, --ENTIM) as applicable to populate tabulation variables for dates (e.g., --DTC, --STDTC, --ENDTC) using ISO 8601 format.
4	--OCCUR	--OCCUR may be used when a specific event is solicited (preprinted) on the CRF and the CRF uses an applicant-defined codelist. --OCCUR = "N" indicates the pre-specified event did not occur. --OCCUR may be implemented while also allowing for a "NOT DONE" response.
5	--REASND	--REASND is used with tabulation variable --STAT. The value "NOT DONE" in --STAT indicates that the subject was not questioned about the event or that data were not collected; it does not mean that the subject had no events.
6	--SPID	--SPID may be populated by the applicant's data collection system. If collected, --SPID it can be used as an identifier in a data query to communicate clearly to individuals involved in data collection the record in question.
7	Coding	The collection variables used for coding are not data collection fields that will appear on the CRF. Applicants will populate values 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 tabulation datasets. The CDASH variables --LLT, --LLTCD, --PTCD, --HLT, --HLTCD, --HLGT, --HLGTCD, --SOC, and --SOCCD are only applicable to events coded in MedDRA.
8	Location (--LOC, --LAT, --DIR, --PORTOT)	Location is collected when the applicant needs to identify the specific anatomical location of the event. Implementers may collect location data using a subset list of controlled terminology on the CRF. Implementers may prepopulate hidden variables with values assigned within their operational database.

The following assumptions will be implemented for Findings class domains.

Metadataspec

Num	Field or Variable	Guidance
1	--CAT, --SCAT	Categories and subcategories are determined per protocol design and values are generally not entered via CRF. Implementers may: Prepopulate and display category values to help individuals involved in data collection understand what data should be recorded on the CRF. Prepopulate hidden variables with the values assigned within their operational database. Populate values directly in the tabulation dataset during dataset creation.
2	--PERF, --STAT, --REASND	--PERF defines - variables to record whether an assessment has been performed/collected. --REASND is used to collect a reason why an assessment was not done. --PERF has the Question Text "[Were any/Was the] [--TEST/ topic] [measurement(s)/test(s) /examinations (s)/specimen(s) /sample(s) ] [performed/collected]?" are intended to assist in the cleaning of data and in confirming that entry of collected data is complete. --PERF may be used

...

Variables with the question text "Were there any <events>?" (e.g., “Were there any adverse events?”) support the cleaning of data and confirmation that there are no missing values.
These questions can be used on any CRF.
Values collected for these fields will not be represented in subsequent tabulation datasets.

...

Categories and subcategories are determined per protocol design and values are generally not entered via CRF.
Implementers may:
- Pre-populate and display category values to help individuals involved in data collection understand what data should be recorded on the CRF.
- Pre-populate hidden variables with the values assigned within their operational database.
- Populate values directly in the tabulation dataset during dataset creation.

...

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.

...

--COCCUR may be used when a specific event is solicited (preprinted) on the CRF and the CRF uses an applicant-defined codelist.
An applicant 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 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.

...

--SPID may be populated by the 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 the specific record in question.
This field may be populated by the applicant's data collection system.

...

The CDASH variables used for coding are not data collection fields that will appear on the CRF itself. Applicants 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 tabulation datasets.
The CDASH variables --LLT, --LLTCD, --PTCD, --HLT, --HLTCD, --HLGT, --HLGTCD, --SOC, and --SOCCD are only applicable to events coded in MedDRA.

...

Location is collected when the applicant 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.

The following assumptions will be implemented for Findings class domains.

--PERF defines - variables to record whether an assessment has been performed/collected. --REASND is used to collect a reason why an assessment was not done.

--PERF has the Question Text "[Were any/Was the] [--TEST/ topic] [measurement(s)/test(s) /examinations (s)/specimen(s) /sample(s) ] [performed/collected]?" are intended to assist in the cleaning of data and in confirming that there are no missing values.

--PERF may be used at the page, panel, or question level.

--PERF may be used during the creation of tabulaton datasets to derive a value into the SDTM variable --STAT. The implementer can use a combination of --CAT, --SCAT, with the --TESTCD= "--ALL" and --TEST= "<Name of the CRF module>" to represent what tests were not performed.

Applicants must decide how to model each test not performed (e.g., to denote that all tests were not performed using TESTCD = "–ALL").

--STAT has the Question Text "Was the [--TEST] not [completed/answered/done/assessed/evaluated]?; Indicate if (the [--TEST] was) not [answered/assessed/done/evaluated/performed]." This is intended to be used to collect a simple "NOT DONE" check box

Metadataspec

Num	Field or Variable	Guidance
1	--CAT, --SCAT	Categories and subcategories are determined per protocol design and values are generally not entered via CRF. Implementers may: Pre-populate and display category values to help individuals involved in data collection understand what data should be recorded on the CRF. Pre-populate hidden variables with the values assigned within their operational database. Populate values directly in the tabulation dataset during dataset creation.
2	--PERF, --STAT, --REASND

at the page, panel, or question level.
--

REASND is used with

PERF may be used during the creation of tabulaton datasets to derive a value into the SDTM variable --STAT

only. The value NOT DONE in --STAT indicates that the findings test was not performed. 3--SPID

--SPID may be populated by the 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 the specific record in question.
This field may be populated by the applicant's data collection system.

4Date and Time

CDASH variables (--DAT, --TIM) are used in Findings domains to collect the date or date and time that the test was done or performed. The SDTM --DTC variable contains either a date or date and time when a specimen is collected or the start date or start date and time when a specimen is collected over time.
Collecting the time is only appropriate if it can be realistically determined and if there is a scientific reason for needing to know this level of detail.
Implementers must not use these elements to record a date that is the result of a test.
The date of collection of a test may be derived from the date of visit. If so, a separate date of observation field is not required to be present on the CRF.

5Horizontal (Denormalized) and Vertical Data Structures (Normalized)

In metadata tables, many of the Findings class domains are presented in a normalized structure (1 record for each test) that is similar to the SDTM, even though many data management systems hold the data in a denormalized structure (1 variable for each test).
When implementing CDASH in a denormalized structure, create variable names for the Findings --TEST and/or --TESTCD values. To do this, define the denormalized variable names using available CDISC Controlled Terminology for --TESTCD. Alternatively, CDASH variable names for data management systems allowing more than 8-character variable names can use CDASH variables using the following naming convention: <--TESTCD>_<-- SDTM variable name> where --TESTCD is the appropriate CT for the test code (e.g., DIABP_VSORRES, DIABP_VSLOC).
In the horizontal (denormalized) setting, SDTM variables such as --PERF, --LOC , --STAT may be collected once for the whole horizontal record and applying the value to all of the observations on that record, or they can be collected per test using the CDASH variable such as <--TESTCD>_--PERF. When tabulation datasets are created, any variables collected for the entire horizontal record must be mapped to each vertical record (as appropriate).
In the horizontal (denormalized) setting, an identifier (e.g., --GRPID) may be used to identify all --TESTCD collected on the same record. This facilitates transformation from the CDASH horizontal setting to the SDTM vertical setting and creation of RELRECs.

6Tests and Original Results

The value in --TEST cannot be longer than 40 characters. The corresponding codelist value for the short test name (at most 8 characters) must also be populated in the SDTM variable --TESTCD.
--TESTCD should be used to create a variable name and --TEST be used as the Prompt on the CRF. Both --TESTCD and --TEST are recommended for use in the operational database.
--ORRES is used to collect test results or findings in the original units in character format.
If the results are modified for coding, the --MODIFY variable contains any modified text.
If normal or reference ranges are collected for results, the --ORNRLO and --ORNRHI and --NRIND are used.
CDASH does not define the SDTM variable used to standardize the findings results (e.g., --STRESC, --STRESN) or to standardize the normal/reference ranges (--STNRLO,--STNRHI, --STNRC). The standardization of the original findings results and normal/reference ranges is expected to be performed during the creation of tabulation datasets.

7Location Variables (--LOC, --LAT, --DIR, --PORTOT)

These variables are used to collect the location of the test. The SDTM acknowledges that the results themselves may not be at the same location as the test. This is a known issue with the SDTM.
Sponsors may collect the data using a subset list of controlled terminology on the CRF.
--LOC could be a defaulted or hidden field on the CRF.

8–ORRES, --RES, --DESC, and --RESOTH

. The implementer can use a combination of --CAT, --SCAT, with the --TESTCD= "--ALL" and --TEST= "<Name of the CRF module>" to represent what tests were not performed.
Implementers must decide how to model each test not performed (e.g., to denote that all tests were not performed using TESTCD = "–ALL").
--STAT has the Question Text "Was the [--TEST] not [completed/answered/done/assessed/evaluated]?; Indicate if (the [--TEST] was) not [answered/assessed/done/evaluated/performed]." This is intended to be used to collect a simple "NOT DONE" check box at the page, panel, or question level.
--REASND is used with SDTM variable --STAT only. The value NOT DONE in --STAT indicates that a question was not asked or a test was not done, or a test was attempted but did not generate a result.

3

--SPID

--SPID may be populated by the 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 the specific record in question.
This field may be populated by the applicant's data collection system.

4

Variables for date and time

Time will be collected if there is a scientific or regulatory reason to collect this level of detail and the time can be realistically determined.
- Metadata tables generally include --DAT and --TIM will be added from the CDASH Model as appropriate.
Collection variables for date and time (e.g., --DAT, --TIM) will be used to collect the date or date and time that the test was performed, or the specimen was collected. The start and end dates and times (e.g., for specimen collection) will be collected as appropriate.
The date of collection of a test can be derived from the date of visit. In such cases, a separate date of observation field is not required to be present on the CRF.
Date and time variables will not be used to collect dates that are the result of a tests. Test results will be collected using --ORRES.

5

Horizontal (denormalized) and vertical data structures (normalized)

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In metadata specifications, many of the Findings class domains are presented in a normalized structure (1 record for each test) similar to a tabulation dataset, even though many data management systems hold the data in a denormalized structure (1 variable for each test).
When implementing collection standards in a denormalized structure, create variable names for the Findings --TEST and/or --TESTCD values. To do this:
- Define the denormalized variable names using available CDISC Controlled Terminology for --TESTCD; or
- When a system allows more than 8-character variable names, the value of variable --TESTCD can be concatenated with the tabulation variable name separated by an underscore (e.g., DIABP_VSORRES, DIABP_VSLOC).
In the horizontal (denormalized) setting, collection variables such as --PERF, --LOC , and --STAT can be collected once for the whole horizontal record and applied to all of the observations on that record, or collected per test using collection variables, such as <--TESTCD>_--PERF. When tabulation datasets are created, any variables collected for the entire horizontal record will be mapped to each vertical record per tabulation guidance.
In the horizontal (denormalized) setting, an identifier can be used to identify all --TESTCD for the same collection record. This supports mapping of data collected in a horizontal setting to tabulation datasets and creation of RELRECs.

6

Tests and original results

The value in --TEST will be 40 characters or less.
The corresponding codelist value for the short test name, 8 characters or less, will be populated in the tabulation variable --TESTCD.
Variable --TESTCD should be used to create a variable name and --TEST be used as the Prompt on the CRF.
Both --TESTCD and --TEST are recommended for use in the operational database.
Variable --ORRES is used to collect test results or findings in the original units as received or collected in character format.
If results are modified for coding, the --MODIFY variable contains the modified text.
Variables --ORNRLO and --ORNRHI and --NRIND are used when normal or reference ranges are collected for results.
Standardization of the original results and/or normal/reference ranges will be performed during the creation of tabulation datasets.

7

Location variables (--LOC, --LAT, --DIR, --PORTOT)

Location variables are used to collect the location of the test.
Applicants may collect location data using a subset list of controlled terminology on the CRF.
Applicants may prepopulate hidden variables with values assigned within their operational database.

8

–ORRES, --RES, --DESC, and --RESOTH

Variables --ORRES, --RES, --DESC, and --RESOTH are used to collect results.

–ORRES, --RES, --DESC, and --RESOTH collect results for the observation class findings. The variable pairs --RES/--DESC, and --RES/--RESOTH are often used when a finding result is collected using 2 CRF questions but is combined into a single row in the tabulation dataset.

--ORRES is used when the finding result is based on a single question and is mapped directly to a single row the tabulation dataset.

It is recommended that:
- --ORRES is used when the

finding

- result is collected using a single question. The result

should

- will map directly to the

SDTM

- tabulation variable --ORRES.
- --RES and --DESC are used when a

question is asked

- pair of questions are asked to collect the result; a question to collect the

finding

- result

,

- with a follow-up question for a description of the

finding

- result.

Typically

- For example, the question

would be

- “Is the <condition> [

normal/abnormal] or [

- absent/present]?"

,

- with a follow-up question

such as “What is the abnormality?” or

- “What is the finding that was observed?

”

- " where --RES is used to collect whether the finding is normal/abnormal or absent/present and --DESC is used to collect the description of the finding.

Typically, this data is modeled in the SDTM as described in the Physical Examination (PE) domain:

- --

--ORRES result is normal/absent, --ORRES is the actual abnormality/observed finding and the collected value abnormal/present are not represented.

--

- RES and --RESOTH are used when a question is asked that allows the selection of a

pre-specified

- prespecified finding, with a follow-up question to ask about the pre-specified response "OTHER".

Typically

- For example, the question

would be

- "What is the result?" with a set of prespecified responses, including the choice “OTHER” with the follow-up question “Specify

, Other”. --RES is used to collect the finding with pre-specified responses, and --RESOTH is used to collect "Specify, Other". Typically, --RESOTH data is modeled in SDTM as --ORRES (instead of the response "OTHER")

, Other”.
9	Root variables	The Findings About Events and Intervention domains use the same root variables as the Findings domain, with the addition of the --OBJ variable.

10Adding variablesIt is assumed that implementers will add other data variables as needed to meet protocol-specific and other data collection requirements (e.g., as required per protocol, business practice, or operating procedures) to Findings and Findings About domains.

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