| 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 |
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| 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.
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| 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? | Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-196 |
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| 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. |