Respiratory System Findings (RE)+

TIG v1.0 Metadata Check for CDASH Domain Specification Table Beta 2

Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. Release Notes

Observation Class	Domain	Data Collection Scenario	Implementation Options	Order Number	Collection Variable	Collection Variable Label	DRAFT Collection Definition	Question Text	Prompt	Data Type	Collection Core	Case Report Form Completion Instructions	Tabulation Target	Mapping Instructions	Controlled Terminology Codelist Name	Subset Controlled Terminology/CDASH Codelist Name	Implementation Notes
Findings	RE	N/A	N/A	1	STUDYID	Study Identifier	A unique identifier for a study.	What is the study identifier?	[Protocol/Study]	Char	HR	N/A	STUDYID	Maps directly to the tabulation variable listed in the Tabulation Target column .	N/A	N/A	Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.
Findings	RE	N/A	N/A	2	SITEID	Study Site Identifier	A unique identifier for a site within a study.	What is the site identifier?	Site (Identifier)	Char	HR	N/A	DM.SITEID	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. EDC: This should be pre-populated.
Findings	RE	N/A	N/A	3	SUBJID	Subject Identifier for the Study	A unique subject identifier within a site and a study.	What is the subject identifier?	Subject	Char	HR	Record the identifier for the subject.	DM.SUBJID	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be provided to the site using a pre-populated list in the system. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.
Findings	RE	N/A	N/A	4	VISIT	Visit Name	The name of an encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.	What is the visit name?	[Visit]	Char	R/C	N/A	VISIT	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	The name of the clinical encounter is typically pre-printed on the CRF or displayed in the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.
Findings	RE	N/A	N/A	5	VISDAT	Visit Date	Date the encounter occurred (or started).	What [is/was] the date of the visit?	(Visit) Date	Char	R/C	Record the [date/start date] of the visit using this format (DD-MON-YYYY).	N/A	This field is not an tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable VSDTC in ISO 8601 format.	N/A	N/A	The date the RE measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the RE CRF using the Respiratory Assessments (REDAT) field.
Findings	RE	N/A	N/A	6	REPERF	Respiratory Assessment Performed	An indication of whether a planned measurement, test, observation or specimen was performed/collected.	Was a respiratory assessment performed?	Respiratory Assessment Performed	Char	HR	Indicate whether or not a respiratory assessment was done.	RESTAT	This field does not map directly to an tabulation variable. May be used to populate a value into the tabulation variable RESTAT. If the collection variable REPERF="N", the value of the tabulation variable RESTAT is "NOT DONE". If REPERF= "Y", RESTAT is null. A combination of tabulation variables (e.g., RECAT and RESCAT, RETPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable RETESTCD would be populated with REALL and an appropriate test name (RETEST) provided.	(NY)	N/A	This field is used to capture a response to whether or not a planned measurement, test or observation was performed. A negative response can be collected as "N" and mapped to the -STAT variable in SDTM as " NOT DONE".
Findings	RE	N/A	N/A	7	REDAT	Respiratory Assessment Date	The date the respiratory measurement was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY).	What was the date the respiratory measurement was taken?	Date	Char	R/C	Record date of measurements using this format (DD-MON-YYYY).	REDTC	This field does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable REDTC in ISO 8601 format.	N/A	N/A	The date the RE measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the RE CRF using the Date of Collection (REDAT) field.
Findings	RE	N/A	N/A	8	RETIM	Respiratory Assessment Time	The time of measurement, represented in an unambiguous time format (e.g., hh:mm:ss).	What was the time of the respiratory system measurement?	Time	Char	R/C	Record time of measurement (as complete as possible).	REDTC	This field does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable REDTC in ISO 8601 format.	N/A	N/A	A single collection time (e.g., RETIM) may be collected for all the measurements when they are performed at the same time. The time of each measurement can also be collected using a collection variable [RETESTCD]_RETIM.
Findings	RE	N/A	N/A	9	RETPT	RE Assessment Planned Time Point Name	A text description of planned time points when measurements should be taken, as defined in the protocol.	What is the planned time point for this respiratory assessment measurement?	[Planned Time Point Name]	Char	R/C	Record the planned time-point labels for respiratory assessment, if not pre-printed on the CRF.	RETPT	Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation time-point anchors RETPTREF (text description) and RERFTDTC (date/time) may be needed, as well as tabulation variables RETPTNUM, REELTM.	N/A	N/A	Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then terms such as "Planned Time Point" can be included in the column heading.
Findings	RE	N/A	N/A	10	RETEST	Respiratory Test Name	Descriptive name of the test or examination used to obtain the measurement or finding.	What is the respiratory test name?	[Respiratory Test Name]	Char	HR	Record the name of the respiratory test, if not pre-printed on the CRF.	RETEST; RETESTCD	Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable RETESTCD may be determined from the value collected in RETEST using the Controlled Terminology List RETESTCD.	(RETEST)	N/A	The test name will usually be pre-printed on the CRF, and not solicited as a question. If the form is laid out as a grid, then "Test" or "Test Name" can be included in the column heading. RETEST is most useful as the PROMPT on the field in which the RESULT for that test is collected.
Findings	RE	N/A	N/A	11	RECAT	Category for Respiratory Test	A grouping of topic-variable values based on user-defined characteristics.	What is the category of the respiratory test?	[Respiratory Test Category]; NULL	Char	R/C	Record the respiratory assessment category, if not pre-printed on the CRF.	RECAT	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	Applicant-defined controlled terminology. This would most commonly be a heading on the CRF or screen, not a question to which the site would provide an answer. RESCAT can only be used if there is a RECAT. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as "Category" can be included in the column heading.
Findings	RE	N/A	N/A	12	RESCAT	Subcategory for Respiratory Test	A sub-division of the RECAT values based on user-defined characteristics.	What was the subcategory of the respiratory assessment?	[Respiratory Assessment Subcategory]; NULL	Char	O	Record the respiratory assessment subcategory, if not pre-printed on the CRF.	RESCAT	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as "Subcategory" can be included in the column heading. RESCAT can only be used if there is a RECAT, and it must be a subcategorization of RECAT.
Findings	RE	N/A	N/A	13	REORRES	RE Test Result in Original Units	Result of the measurement or finding as originally received or collected.	What was the result of the measurement?	[RETEST] Result	Char	HR	Record the respiratory test result.	REORRES	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	Both quantitative results and interpretive findings or summaries may be recorded here.
Findings	RE	N/A	N/A	14	REORRESU	Respiratory Test Original Unit	The unit of the result as originally received or collected.	What was the unit of the result?	Unit	Char	R/C	Record or select the original unit in which these data were collected, if not pre-printed on CRF.	REORRESU	Maps directly to the tabulation variable listed in the Tabulation Target column.	(UNIT)	N/A	Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field. Should be included if applicable and not available elsewhere.
Findings	RE	N/A	N/A	15	RERES	Respiratory Test Result or Finding	The result of the measurement or finding as originally received or collected.	Was the result (normal/abnormal/absent/present/ [applicant defined response])?	(Result)	Char	O	Indicate the overall assessment for [RETEST].	REORRES	This does not map directly to an tabulation variable. The mapping instructions depend on the implementation; for example: RERES is used to collect Normal, Abnormal or similar type classifications (e.g., Absent/Present) with a description of the abnormal result using the collection field REDESC. For tabulation datasets, If the collection field RERES = "NORMAL", populate the tabulation variables REORRES and RESTRESC with the value of the collection field RERES. If the collection field RERES is "ABNORMAL", populate the tabulation variable REORRES with the collection field REDESC. If the reported findings in REDESC are coded using a dictionary, then the tabulation variable RESTRESC is populated with the dictionary preferred term and REMODIFY is populated with the modified text used for coding. If the reported findings in REDESC are not coded, then the tabulation variable RESTRESC is populated with the collection REDESC field. The tabulation variable RENRIND may be populated with "NORMAL" or "ABNORMAL" if appropriate. Where RERES is used to collect standardized values (e.g. a codelist) on the CRF and the value of "OTHER" is included, the collection field RERESOTH can be used to collect free-text values for "Specify Other". When using this field, the "OTHER" value recorded in the collect field RERES field is mapped to the tabulation variable RESTRESC and the value in the collection field RERESOTH is mapped to the tabulation variable REORRES.	N/A	N/A	The collection field RERES is used when the collected results are not mapped directly to the tabulation variable REORRES and must be transformed. For example, RERES is used to collect standardized values on the CRF and the value of "OTHER" is included and "Specify Other" is collected. REORES is collected using Normal, Abnormal and a description of the abnormality is collected.
Findings	RE	N/A	N/A	16	REDESC	Description of Respiratory Test Finding	Text description of respiratory test findings.	What was the description of the (abnormality/observed finding/[Applicant-defined])?	(Abnormal) Findings	Char	O	Record all abnormal findings for the respiratory test in the space provided.	REORRES	This does not map directly to an tabulation variable. May be used to populate a value into the tabulation variable REORRES. If RERES="Normal", populate REORRES with the value of RERES. If RERES="Abnormal", populate REORRES with the value of REDESC.	N/A	N/A	RERES and REDESC are used when a question is asked to collect the finding result, with a follow-up question for a description of the finding.
Findings	RE	N/A	N/A	17	RERESOTH	Respiratory Test Result Other	A free-text result which provides further information about the original received or collected result.	If other is selected, [explain/specify/provide more detail].	[Specify Other/Explain/Specify Details]	Char	O	Provide more detail for the "Other" result.	REORRES	When using this collection field, the "OTHER" value collected in the collection field RERES is mapped to the tabulation variable RESTRESC and the value in the collection field RERESOTH is mapped to the tabulation variable REORRES.	N/A	N/A	In cases where RERES is used to collect standardized values on the CRF and the value of "OTHER" is included, the collection field RERESOTH can be used to collect free-text values for "Specify Other".
Findings	RE	N/A	N/A	18	REORNRLO	RE Ref Range Lower Limit- Original Unit	The lower end of normal range or reference range for continuous results stored in REORRES.	What was the lower limit of the reference range?	Normal Range Lower Limit	Char	O	Record the lower limit of the reference range of the respiratory test.	REORNRLO	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	REORNRLO should be populated only for continuous findings. The tabulation variable RESTNRC should be populated only for noncontinuous results. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site or lab specific set of normal ranges stored in a look-up table.
Findings	RE	N/A	N/A	19	REORNRHI	RE Ref Range Upper Limit- Original Unit	The upper end of normal range or reference range for continuous results stored in REORRES.	What was the upper limit of the reference range?	Normal Range Upper Limit	Char	O	Record the upper limit of the reference range of the respiratory test.	REORNRHI	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	REORNRHI should be populated only for continuous findings. The tabulation variable RESTNRC should be populated only for noncontinuous results. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site or lab specific set of normal ranges stored in a look-up table.
Findings	RE	N/A	N/A	20	RENRIND	RE Reference Range Indicator	An indication or description about how the value compares to the normal range or reference range.	How do the reported values compare within the [reference/normal/expected] range?	Comparison to [Reference/Expected/Normal] Range	Char	O	Record where the test result fell with respect to the reference range.	RENRIND	Maps directly to the tabulation variable listed in the Tabulation Target column.	(NRIND)	N/A	Reference ranges may be defined by REORNRLO, REORNRHI, RESTNRC or other objective criteria. Reference Range Indicator (e.g., Y, N; HIGH, LOW; NORMAL, ABNORMAL) may be included if not derived or determined programmatically after data collection. Should not be used to indicate clinical significance.
Findings	RE	N/A	N/A	21	RESTAT	Completion Status	This variable is used to indicate that data are not available, by having the site recording the value as "Not Done".	Indicate if the [RETEST] was not [answered/assessed/done/evaluated/performed].	Not Done	Char	O	Indicate if the respiratory assessment or measurement was not done.	RESTAT	Maps directly to the tabulation variable listed in the Tabulation Target column.	(ND)	N/A	Used only when the response value is collected as NOT DONE or NULL in lieu of or in addition to the collection REPERF field. Typically a checkbox which indicates the test was NOT DONE. This field can be useful when multiple questions are asked to confirm that a blank result field is meant to be blank.
Findings	RE	N/A	N/A	22	REREASND	Reason Not Done	An explanation for why the data are not available.	Was the was the reason that the respiratory (assessment/[RETEST]) was not [collected / answered / done / assessed / evaluated]?	Reason Not [Answered/Collected/Done/Evaluated/Assessed/Available]	Char	O	Provide the reason the measurement or test was not done.	REREASND	Maps directly to the tabulation variable listed in the Tabulation Target column.	N/A	N/A	Applicant-defined controlled terminology may be used. The reason the data are not available may be chosen from an applicant-defined codelist (e.g., broken equipment, subject refused) or entered as free text. When REREASND is used, RESTAT should also be populated in the SDTM-based dataset.
Findings	RE	N/A	N/A	23	REPOS	Position of Subject During Observation	The position of the subject during a measurement or examination.	What was the position of the subject during the assessment?	Position	Char	O	Record the position of subject at time of test.	REPOS	Maps directly to the tabulation variable listed in the Tabulation Target column.	(POSITION)	N/A	Results may be affected by whether conditions for respiratory test, as specified in the protocol, were properly met. One common condition is the subject's position. If the protocol requires this type of information, then a collection variable [RETESTCD]_REPOS may be created for each RETESTCD and added to the CRF, if needed.
Findings	RE	N/A	N/A	24	RELOC	Location	Location used for the measurement.	What was the anatomical location where the measurement was taken?	Anatomical Location	Char	O	Record or select location on body where the measurement was performed.	RELOC	Maps directly to the tabulation variable listed in the Tabulation Target column.	(LOC)	N/A	Collected or pre-printed when the applicant needs to identify the specific anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF.LAT, DIR, and PORTOT are used to further describe the anatomical location.
Findings	RE	N/A	N/A	25	RELAT	Laterality	Qualifier for anatomical location, further detailing the side of the body.	What was the side of the anatomical location of the [measurement/test/examination])?	Side	Char	O	Record the side of the anatomical location of the respiratory test or measurement.	RELAT	Maps directly to the tabulation variable listed in the Tabulation Target column.	(LAT)	N/A	May be pre-printed or collected when the applicant needs to identify the specific side of the anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF.
Findings	RE	N/A	N/A	26	REDIR	Directionality	Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.	What was the directionality of the anatomical location of the respiratory test?	Directionality	Char	O	Record the directionality of the anatomical location of the respiratory test.	REDIR	Maps directly to the tabulation variable listed in the Tabulation Target column.	(DIR)	N/A	May be pre-printed or collected when the applicant needs to identify the directionality of the anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF.
Findings	RE	N/A	N/A	27	REMETHOD	Method of Respiratory Test	The method of the test or examination.	What was the method (used for the [measurement/test/examination])?	Method	Char	O	Record the method used for the respiratory test.	REMETHOD	Maps directly to the tabulation variable listed in the Tabulation Target column.	(METHOD)	N/A	This information may be collected when more than 1 method is possible, and collecting the method used is necessary.
Findings	RE	N/A	N/A	28	REEVAL	Respiratory Test Evaluator	The role of the person who provided the evaluation.	Who was the evaluator?	Evaluator	Char	O	Select the role of the person who provided the evaluation.	REEVAL	Maps directly to the tabulation variable listed in the Tabulation Target column.	(EVAL)	N/A	Used only for results that are subjective (e.g., assigned by a person or a group). May be a pre-printed or collected. Applicants may collect the data using a subset list of controlled terminology on the CRF.
Findings	RE	N/A	N/A	29	REEVALID	Respiratory Test Evaluator Identifier	An identifier used to distinguish multiple evaluators with the same role recorded in REEVAL.	What is the identifier of the evaluator?	Evaluator Identifier	Char	O	Record the unique identifier assigned to the person making the evaluation.	REEVALID	Maps directly to the tabulation variable listed in the Tabulation Target column.	(MEDEVAL)	N/A	Collect if multiple evaluators are used in the study (may be omitted if multiple evaluators are not used); values should follow controlled terminology.
Findings	RE	N/A	N/A	30	REACPTFL	Accepted Record Flag	An indication that the evaluation is considered, by an independent assessor, to be the accepted or final evaluation.	Was this record considered to be the accepted evaluation?	Accepted Evaluation	Char	O	Indicate whether or not the evaluation is considered, by an independent assessor, to be the accepted or final evaluation.	REACPTFL	Maps directly to the tabulation variable listed in the Tabulation Target column.	(NY)	N/A	Use where more than one assessor provides an evaluation of a result or response. Typically a checkbox with the value of "Y" or "NULL", which indicates the evaluation was accepted.
Findings	RE	N/A	N/A	31	REREPNUM	Respiratory Test Repetition Number	The instance number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a time point, within a visit).	What was the repetition number within the time point for this measurement?	Repetition Number	Char	O	Record the repetition number of the measurement within the time point.	SUPPRE.QVAL	This does not map directly to an tabulation variable. This information could be represented in a SUPPRE dataset as the value of SUPPRE.QVAL where SUPPRE.QNAM = "REREPNUM" and SUPPRE.QLABEL= "Repetition Number within Time Point".	N/A	N/A	The repetition number of the test/measurement within the time point may be pre-printed on the CRF.
Findings	RE	N/A	N/A	32	RECLSIG	Clinical Significance	An indication of whether the test results were clinically significant.	Was this result clinically significant? TOBA-196 - Getting issue details... STATUS	Clinically Significant	Char	O	Record whether respiratory test results were clinically significant.	SUPPRE.QVAL	This does not map directly to a tabulation variable. This information could be represented in a SUPPRE dataset as the value of SUPPRE.QVAL when SUPPRE.QNAM = "CLSIG" and SUPPRE.QLABEL = "Clinical Significance".	(NY)	N/A	Could apply to specific measurements or to overall interpretation, as required by the protocol.

Metadata Checks Findings

Metadata Check User Macros FAQ

For variable N/A / N/A / REORNRLO, REORNRLO is a not a recognized tabulation variable in Tabulation Target
For variable N/A / N/A / REORNRHI, REORNRHI is a not a recognized tabulation variable in Tabulation Target
For variable N/A / N/A / RENRIND, RENRIND is a not a recognized tabulation variable in Tabulation Target
For variable N/A / N/A / REACPTFL, REACPTFL is a not a recognized tabulation variable in Tabulation Target

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Respiratory System Findings (RE)+