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| Events | EM | 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 the EDC system. This field can be included into the database or populated during tabulation dataset creation. |
| Events | EM | 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 for the CRFs that are shipped to each site. EDC: This should be pre-populated. |
| Events | EM | N/A | N/A | 3 | SUBJID | Subject Identifier for the Study | A unique subject identifier within a site and a study. | What [is/was] the (study) [subject/participant] identifier? | [Subject/Participant] (Identifier) | Char | R/C | 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 system generated. This collection variable is typically collected for all domains. However, this collection variable is populated only in the tabulation DM dataset. R/C rather than HR because events may happen to or with a device that do not involved subjects, and may even be before the device was in contact with a subject. |
| Events | EM | N/A | N/A | 4 | SPTOBID | Applicant-Defined Tobacco Product ID | Applicant-Defined Tobacco Product ID | [Applicant-defined question] | [Applicant-Defined Tobacco Product ID] | Char | HR | Record the identifier for the study device. | SPTOBID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | 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-354 |
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| Identifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. |
| Events | EM | N/A | N/A | 5 | EMYN | Any Tobacco Device Event | An indication of whether any tobacco device events were experienced during the study. | Were any tobacco device events experienced? | Any Tobacco Device Events | Char | O | Indicate if the subject experienced any tobacco device events. If Yes, include the appropriate details where indicated on the CRF. | N/A | Does not map to an tabulation variable. | (NY) | N/A | The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank. |
| Events | EM | N/A | N/A | 6 | EMCAT | Category for Device Event | A grouping of topic-variable values based on user-defined characteristics. | What is the category of the device Event? | [Device Event Category]; NULL | Char | O | Record the device event category, if not pre-printed on the CRF. | EMCAT | 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, and 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 "Category" can be included as the column heading. |
| Events | EM | N/A | N/A | 7 | EMSCAT | Subcategory for Device Event | A sub-division of the EMCAT values based on user-defined characteristics. | What is the subcategory of the device event? | [Device Event Subcategory]; NULL | Char | O | Record the device event subcategory, if not pre-printed on the CRF. | EMSCAT | 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 pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. EMSCAT can only be used if there is an EMCAT and it must be a subcategorization of EMCAT. |
| Events | EM | N/A | N/A | 8 | EMSPID | EM Applicant Defined Identifier | An applicant-defined identifier. This is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined identifier field. | [Applicant-defined question] | [Applicant defined] | Char | O | If collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier. | EMSPID | Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain. | N/A | N/A | Because SPID is an applicant-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile concomitant medications, procedures and/or medical history records with AEs or device events. If CMAENO or PRAENO is used, this is the identifier to which CMAENO or PRAENO refers. May be used to record pre-printed number (e.g., line number, record number) on the CRF. This field may be populated by the applicant's data collection system. |
| Events | EM | N/A | N/A | 9 | EMTERM | Reported Term for the Device Event | The reported or pre-specified name of the device event. | What is the device event term? | Device Event | Char | HR | Record only 1 device event. Use accepted terminology. | EMTERM | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Can be represented either as an open-entry field to capture verbatim terms reported by subjects or pre-printed, in the situation where solicited device events of interest are captured. In most cases, the verbatim term (i.e. investigator-reported term) will be coded to a a standard dictionary. |
| Events | EM | N/A | N/A | 10 | EMOCCUR | Device Event Occurrence | An indication of whether a pre-specified device event or a group of device events occurred when information about the occurrence of a specific event is solicited. | Did the subject have [pre-specified device event/group of device events]? | [Specific Device Event] | Char | O | Indicate if [specific Device Event] has occurred/is occurring, by checking Yes or No. | EMOCCUR | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | The collection variable EMOCCUR is used to indicate the occurrence of pre-specified device events (e.g. "Did the the device batteries malfunction? EMOCCUR should not be used for spontaneously reported device events. The site should be able to indicate that the response was not asked or answered. |
| Events | EM | N/A | N/A | 11 | EMPRESP | Pre-specified Device Event | An indication that a specific event or group of events are pre-specified on a CRF. | N/A | N/A | Char | O | N/A | EMPRESP | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | A hidden field on a CRF defaulted to "Y", or added during tabulation dataset creation, when the EMis pre-specified. Null for spontaneously reported events. If a study collects both pre-specified and free-text device events, the value of EMPRESP should be "Y" for all pre-specified events and null for events reported as free-text. EMPRESP is a permissible field. and may be omitted from the tabulation dataset if all events were collected as free text. |
| Events | EM | N/A | N/A | 12 | EMSTDAT | Device Event Start Date | The start date of the device event, represented in an unambiguous date format (e.g., DD-MON-YYYY). | What is the device event start date? | Start Date | Char | HR | Record the start date of the device event using this format (DD-MON-YYYY). | EMSTDTC | This does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable EMSTDTC in ISO 8601 format. | N/A | N/A | N/A |
| Events | EM | N/A | N/A | 13 | EMSTTIM | Start Time of Device Event | The start time of the device event, represented in an unambiguous time format (e.g., hh:mm:ss). | What is the device event start time? | Start Time | Char | R/C | Record the start time (as complete as possible) of the device event. | EMSTDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable EMSTDTC in ISO 8601 format. | N/A | N/A | Collecting the time an event resolved is only appropriate if it can be realistically determined and if there is a scientific reason for needing to know this level of detail. |
| Events | EM | N/A | N/A | 14 | EMONGO | Ongoing Device Event | Indication that an device event is ongoing when no end date is provided. | Is the device event ongoing (as of [the study-specific time point or period])? | Ongoing (as of [the study-specific time point or period]) | Char | O | Indicate if the device event has not resolved at the time of data collection; leave the End Date blank. | EMENRTPT; EMENRF | This does not map directly to an tabulation variable. May be used to populate a value into a tabulation relative timing variable such as EMENRF or EMENRTPT. When populating EMENRF, if the value of EMONGO is "Y", the value of "DURING", "AFTER" or "DURING/AFTER" may be used. When populating EMENRTPT, if the value of EMONGO is "Y", the value of "ONGOING" may be used. When EMONGO refers to the Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the tabulation variable EMENRF should be populated. When EMONGO is compared to another time point, the tabulation variables EMENRTPT and EMENTPT should be used. Note: EMENRTPT must refer to a time-point anchor described in EMENTPT. | (NY) | N/A | Completed to indicate that the event has not resolved at the time of data collection, when no end date is collected. In some cases the ongoing status may be determined from Outcome. The purpose of collecting this field is to help with data cleaning and monitoring; this field provides further confirmation that End Date was deliberately left blank. Often used as a tick/checkbox. |
| Events | EM | N/A | N/A | 15 | EMENDAT | Device Event End Date | The date when the device event resolved/ended, represented in an unambiguous date format (e.g., DD-MON-YYYY). | What was the device event end date? | End Date | Char | R/C | Record the date that the device event. resolved using this format (DD-MON-YYYY). If the EMis ongoing, leave the field blank. | EMENDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable EMENDTC in ISO 8601 format. | N/A | N/A | The definition of resolved is applicant-specific. The preferred method is to collect a complete end date (if applicable). Partial dates (e.g., providing year only, month and year only) may be acceptable. |
| Events | EM | N/A | N/A | 16 | EMENTIM | End Time of Device Event | The time when the Device Event ended/resolved, represented in an unambiguous time format (e.g., hh:mm:ss). | What was the Device Event end time? | End Time | Char | R/C | Record the time (as complete as possible) that the Device Event resolved. | EMENDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable EMENDTC in ISO 8601 format. | N/A | N/A | Collecting the time an event resolved is only appropriate if it can be realistically determined and if there is a scientific reason for needing to know this level of detail. |
| Events | EM | N/A | N/A | 17 | EMSEV | EM Severity/Intensity | The severity or intensity of the event. | What is the severity of the device event? | Severity | Char | R/C | The reporting physician/healthcare professional will assess the severity of the event using the applicant-defined categories. This assessment is subjective and the reporting physician/ healthcare professional should use judgment to compare the reported device event to similar type events observed. Severity is not equivalent to seriousness. | EMSEV | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | N/A |
| Events | EM | N/A | N/A | 18 | EMACNDEV | Actions Taken with Device | A description of the action taken, with respect to a device used in a study (which may or may not be the device under study), as a result of the event. | What action was taken with a device used in the study? | Action Taken with Device | Char | O | Record actions taken resulting from the device event that are related to a study or non-study device. | EMACNDEV | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-defined controlled terminology for actions that are related to the device. Action Taken may include device replacement, battery replacement, etc. |
| Events | EM | N/A | N/A | 19 | EMSI | Device Event of Special Interest | An device event of special interest (serious or non-serious) is one of scientific and medical concern specific to the applicant's product or program, for which ongoing monitoring and rapid communication by the investigator to the applicant can be appropriate. Such an event might warrant further investigation in order to characterize and understand it. Depending on the nature of the event, rapid communication by the study applicant to other parties (e.g., regulators) might also be warranted. | Is this event of special interest? | Device Event of Special Interest | Char | O | Record the investigator's opinion as to whether the event is an device event of special interest by the applicant. | N/A | Does not map to a tabulation variable. | (NY) | N/A | This collection field may be used just to trigger other CRF pages, or populate a value in EMCAT or EMSCAT. This information could be represented in a SUPPEM dataset where SUPPEM.QNAM = "EMSI" and SUPPEM.QLABEL = "Device Event of Special Interest. |
| Events | EM | N/A | N/A | 20 | EMPATT | Pattern of Device Event | Used to indicate the pattern of the event over time. | What is the device event pattern? | Pattern | Char | O | For each device event, check the pattern of the device event, If a single event, choose Single. | EMPATT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Used to report the pattern of the EM (e.g.,"INTERMITTENT", "CONTINUOUS", "SINGLE EVENT"). For crossover studies, it is NOT recommended to capture this field for intermittent events. Instead, the corresponding start and stop dates should be captured. |
| Events | EM | N/A | N/A | 21 | EMMODIFY | EM Modified Reported Term | If the value for EMTERM is modified to facilitate coding, then EMMODIFY will contain the modified text. | N/A | N/A | Char | R/C | N/A | EMMODIFY | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This is not a data collection field that would appear on the CRF. applicants will populate this through the coding process. |
| Events | EM | N/A | N/A | 22 | EMDECOD | EM Dictionary-Derived Term | The dictionary or standardized text description of EMTERM or the modified topic variable (EMMODIFY), if applicable. | N/A | N/A | Char | O | N/A | EMDECOD | Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. | N/A | N/A | This is typically not a data collection field that would appear on the CRF. applicants will populate this through the coding process. |