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Description

Exposure (EX) is an interventions domain used for the details of a subject's exposure to a study product TOBA-145 - Getting issue details... STATUS . Exposure as Collected (EC) is an interventions domain used for information about a subject's exposure to an investigational product, as collected. For collection, the EC domain is used to represent data as collected on the CRF, and is used in a study when the tabulation EX domain cannot be directly populated with the data collected on the CRF.

EC is used for collection when:

  1. An alias for the actual product name is used rather than the actual product name.
  2. Exposure data are collected in non-protocol-specified units.
  3. Scheduled and/or missed exposures are collected.
  4. Planned exposures are collected in addition to actual exposures.

An applicant may choose to always collect exposure data using the EC domain.


Specifications

Exposure (EX)

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 ClassDomainData Collection ScenarioImplementation OptionsOrder NumberCollection VariableCollection Variable Label

DRAFT Collection Definition

Question TextPromptData TypeCollection CoreCase Report Form Completion InstructionsTabulation TargetMapping InstructionsControlled Terminology Codelist NameSubset Controlled Terminology/CDASH Codelist NameImplementation Notes
InterventionsEXN/AN/A1STUDYIDStudy IdentifierA unique identifier for a study.What is the study identifier?[Protocol/Study]CharHRN/ASTUDYIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AAlthough 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 into the database or populated during tabulation dataset creation.
InterventionsEXN/AN/A2SITEIDStudy Site IdentifierA unique identifier for a site within a study.What is the site identifier?Site (Identifier)CharHRN/ADM.SITEIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/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.

InterventionsEXN/AN/A3SUBJIDSubject Identifier for the StudyA unique subject identifier within a site and a study.What [is/was] the (study) [subject/participant] identifier?[Subject/Participant] (Identifier)CharHRRecord the identifier for the subject.DM.SUBJIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/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 in all domains. However, this collection variable is populated only in the tabulation DM domain.

InterventionsEXN/AN/A4EPOCHEpochName of the trial epoch with which this element of the arm is associated.What is the trial epoch?

[Epoch](Period/Phase/Applicant-defined phrase)

CharR/C[protocol specific]EPOCHMaps directly to the tabulation variable listed in the Tabulation Target column.(EPOCH)N/AIf the same information is collected more than once in different periods/parts of a study (e.g., Disposition), EPOCH may be needed to differentiate them. Typically, the trial epoch will be pre-printed on the CRF as the title of the page.
InterventionsEXN/AN/A5EXYNAny Study Product TakenAn indication of whether the subject used study product.Were any [study product/dose] taken?Any Study ProductsCharOIndicate if the subject used any study products. If Yes, include the appropriate details where indicated.N/ADoes not map to a tabulation variable.(NY)N/AThe 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. The EXYN variable is a cleaning or EDC convention meant to indicate that the exposure form should be completed or inserted into the case book.
InterventionsEXN/AN/A6EXCATCategory of ProductA grouping of topic-variable values based on user-defined characteristics.What is the category of the [study product/dose] ?[Study Product Category]; NULLCharORecord the study product category, if not pre-printed on the CRF.EXCATMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AApplicant-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 header.
InterventionsEXN/AN/A7EXSCATSubcategory of ProductA sub-division of the EXCAT values based on user-defined characteristics.What is the subcategory of the [study product/dose] ?[Study Product Subcategory]; NULLCharORecord the study product subcategory, if not pre-printed on the CRF.EXSCATMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AApplicant-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. EXSCAT can only be used if there is an EXCAT and it must be a subcategorization of EXCAT.
InterventionsEXN/AN/A8EXTRTName of ProductName of the study product given for the observation.

What was the study product name?

[Study Product Name]CharR/CRecord the name of study product.EXTRTMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AEXTRT captures the name of the study product. This is typically collected for open label studies and populated for blinded studies during the tabulation dataset creation.
InterventionsEXN/AN/A9EXREFIDExposure Reference IDAn internal or external identifier.What is the [study product/dose] label identifier?Product Label IdentifierCharR/CRecord product label identifier.EXREFIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis packaging identifier may be collected in different ways.
InterventionsEXN/AN/A10EXLOTLot NumberLot number of the EXTRT product.What was the lot number of the [study product/dose] used?Lot NumberCharR/CRecord the lot number that appears on the container holding the study product.EXLOTMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThe lot number identifies the manufacturing batch of the study product. In open-label studies, the reference number on the study product container may represent an actual lot number and is represented using EXLOT. This variable may be populated during the process of creating the tabulation datasets. Do not collect other identification variables in this field.
InterventionsEXN/AN/A12EXDOSFRMExposure Dose FormThe dosage form in which the EXTRT is physically presented.What was the dose form of the [study product/dose]?Dose FormCharR/CRecord the dose form or enter the appropriate code from the code list.EXDOSFRMMaps directly to the tabulation variable listed in the Tabulation Target column.(FRM)(EXDOSFRM)This must be collected if it cannot be determined from other sources or if there are multiple options.
InterventionsEXN/AN/A13EXSTDATExposure Start DateThe start date of study product, represented in an unambiguous date format (e.g., DD-MON-YYYY).What was the ([intended/planned/actual]) ([study product/dose]) (start) date?(Start) DateCharHRRecord the start date of the study product administration using this format (DD-MON-YYYY).EXSTDTCThis 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 EXSTDTC in ISO 8601 format.N/AN/ADate when the constant interval of the study product use started, or single use occurred. When collecting the date for an individual dose, the word "start" may be omitted from the question text and prompt.
InterventionsEXN/AN/A14EXSTTIMExposure Start TimeThe start time of the study product use, represented in an unambiguous time format (e.g., hh:mm:ss).What was the ([intended/planned/actual]) ([study product/dose]) (start) time?(Start) TimeCharR/CRecord the start time (as complete as possible) when administration of study product started.EXSTDTCThis 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 EXSTDTC in ISO 8601 format.N/AN/ARecommend collecting the time a product was started only when a protocol or data collection scenario requires it.
InterventionsEXN/AN/A15EXENDATExposure End DateThe end date of study product use represented in an unambiguous date format (e.g., DD-MON-YYYY).What was the ([intended/planned/actual]) ([study product/dose]) (end) date?(End) DateCharR/CRecord the end date or last date of administration of study product using this format (DD-MON-YYYY).EXENDTCThis 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 EXENDTC in ISO 8601 format.N/AN/AIf start date and end date are not expected to be on the same date, the end date is required. If the study design indicates that the start and end date are on the same day, the end date is not required because it can be assigned to be equal to the start date.
InterventionsEXN/AN/A16EXENTIMExposure End TimeThe end time of study product use, represented in an unambiguous time format (e.g., hh:mm:ss).What was the ([intended/planned/actual]) ([study product/dose]) (end) time?(End) TimeCharR/CRecord the time, (as complete as possible) when study product administration stopped.EXENDTCThis 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 EXENDTC in ISO 8601 format.N/AN/ARecommend collecting the time a product was ended when a protocol or data collection scenario requires it. For infusions, the end time of the infusion is typically needed.
InterventionsEXN/AN/A17EXDSTXTExposure Dose DescriptionDose (per administration).What was the dose [per administration] (of [study product/dose]) ?DoseCharR/CRecord the dose or amount of study product that was used by the subject in the period recorded; from the start date/time to the end date/time inclusive.EXDOSTXT; EXDOSEThis does not map directly to a tabulation variable. Numeric values map to tabulation variable EXDOSE. Non-numeric values (e.g., 200-400) map to tabulation variable EXDOSTXT.N/AN/ADose or amount taken for single administration of study product or per constant dosing interval recorded. Dose must be collected if it cannot be determined via other methods (e.g., from diary data, product accountability data, protocol). The data collected in this dose text-format field should be mapped to either tabulation variable EXDOSE (if numeric) or EXDOSTXT (if text).
InterventionsEXN/AN/A18EXDOSUExposure Dose UnitThe unit for intended dose (per administration) for EXDOSE, EXDOSTOT, or EXDOSTXT.What was the unit for the dose?UnitCharR/CRecord the unit of dose or amount taken per period recorded (e.g., ng, mg, mg/kg).EXDOSUMaps directly to the tabulation variable listed in the Tabulation Target column.(UNIT)N/AUnit of dose or amount taken per constant dosing interval recorded. Dose unit must be collected if it cannot be determined via other methods (e.g., from protocol). The unit should be pre-printed on the CRF or a field provided on the CRF to capture it. A CDASH Subset Controlled Terminology Codelist Name is available for general dose and volume units.
InterventionsEXN/AN/A19EXDOSFRQExposure Dosing Frequency per IntervalThe number of doses given/administered/taken during a specific interval.What was the frequency of [study product/dose] dosing?FrequencyCharR/CRecord the frequency the study product was administered for a defined period of time.EXDOSFRQMaps directly to the tabulation variable listed in the Tabulation Target column.(FREQ)N/AThis may be collected if it cannot be determined from other sources or if there are multiple options. When possible, the options for dose/amount frequency are pre-printed on the CRF. When collected, the recommendation is to collect dosing information in separate fields (e.g., ECDOSE, ECDOSEU, ECDOSFRQ) for specific and consistent data collection and to enable programmatically using these data.
InterventionsEXN/AN/A20EXROUTEExposure Route of AdministrationThe route of administration of the study product.What was the route of administration (of the [study product/dose] )?RouteCharR/CRecord the route of administration (e.g., ORAL) or enter the appropriate code from the code list.EXROUTEMaps directly to the tabulation variable listed in the Tabulation Target column.(ROUTE)(EXROUTE)This may be collected if it cannot be determined via other methods (e.g., from protocol) or if there are multiple options.
InterventionsEXN/AN/A22EXDOSADJDose AdjustedAn indication of whether the dose was adjusted.Was the dose adjusted?(Dose) AdjustedCharOSelect either Yes or No to indicate whether there was a change in dosing.N/AWhen EXADJ is collected, does not map to a tabulation variable. When EXADJ is not collected, the applicant may represent this variable as a SUPPQ.(NY)N/ATypically, the intent/purpose of collecting this field is to help with data cleaning and monitoring, as it provides a definitive response regarding any dose changes. It provides verification that the associate field on the CRF (EXADJ) was deliberately left blank. However, the applicant may collect whether the dose was adjusted, without collecting the reason for the change.
InterventionsEXN/AN/A23EXADJReason for Dose AdjustmentDescription of or explanation for why a dose of the study product was adjusted.What was the reason the dose was adjusted (from planned)?Reason AdjustedCharOIf there was a change in dosing, record the reason for change.EXADJMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/ACaptures the reason the dose was changed or modified. The reason may be chosen from an applicant-defined list (e.g., adverse event) or entered as free text. May be used for variations from protocol-specified doses or changes from expected doses.
InterventionsEXN/AN/A24EXITRPYNEX Exposure InterruptedAn indication of whether the exposure was interrupted.Was the [(study) product/dose] interrupted?[(Study) Product / Dose] InterruptedCharORecord if there was an interruption in the study product use or dosing.N/ADoes not map to a tabulation variable.(NY)N/AThe intent/purpose of collecting this field is to help with data cleaning and monitoring when the actual duration of the exposure is collected using the collection field EXCINTD. In some situations, if the actual duration of the interruption is not collected, or not derived, this information could be represented in a SUPPEX.QVAL dataset where SUPPEX.QNAM = "EXITRPYN" and SUPPEX.QLABEL = "Exposure Interrupted".
InterventionsEXN/AN/A25EXCINTDExposure Interruption DurationThe collected duration of the product interruption.If the dose was interrupted, how long was the interruption?(Interruption) DurationCharORecord the duration of product use interruption.SUPPEX.QVALThis does not map directly to a tabulation variable. This information could be represented in a SUPPEX dataset as the value of SUPPEX.QVAL where SUPPEX.QNAM="EXITRPD" and SUPPEX.QLABEL= "Interruption Duration". Concatenate the collected product interruption duration and the duration unit components and create EXITRPD using ISO 8601 Period format.N/AN/AIn some situations, the duration of the interruption may be calculated from the administration start and end times recorded elsewhere in the CRF.
InterventionsEXN/AN/A26EXCINTDUExposure Interruption Duration UnitsThe unit for the collected duration of product interruption.If the dose was interrupted, what were the units for the interruption duration?(Interruption Duration) UnitCharORecord the unit (e.g., MINUTES, HOURS, DAYS) for the duration of product use interruption.SUPPEX.QVALThis does not map directly to a tabulation variable. This information could be represented in a SUPPEX dataset as the value of SUPPEX.QVAL where SUPPEX.QNAM = "EXITRPD" and SUPPEX.QLABEL= "Interruption Duration". Concatenate the collected interruption duration and the duration unit components and create EXITRPD using ISO 8601 Period format.(UNIT)

(EXINTPU) TOBA-348 - Getting issue details... STATUS

The unit should be collected and converted into ISO 8601 period format.
InterventionsEXN/AN/A27EXLOCExposure Location of Dose AdministrationA description of the anatomical location of administration.What was the anatomical location of the ([study product/dose] ) administration?Anatomical LocationCharORecord the body location where the study product was administered (e.g., SHOULDER, HIP, ARM).EXLOCMaps directly to the tabulation variable listed in the Tabulation Target column.(LOC)N/ACollected or pre-printed when the applicant needs to identify the specific anatomical location where the study product was administered. LAT, DIR, PORTOT are used to further describe the anatomical location.
InterventionsEXN/AN/A28EXVAMTExposure Vehicle AmountThe amount of the prepared product (product + vehicle) administered or given.What was the total amount (product + vehicle)(of [study product/dose] ) administered?Total AmountNumORecord the total amount (product +vehicle) that was administered/given to the subject.EXVAMTMaps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable ECTRTV may also be populated during the process of creating the tabulation datasets.N/AN/AAdministration amount that was given to the subject. Note: should not be the diluent amount alone. The ECTRTV field may be collected if it cannot be determined from other sources.
InterventionsEXN/AN/A29EXVAMTUExposure Vehicle Amount UnitsThe unit of measure for the prepared product (product + vehicle).What was the unit for the amount (of [study product/dose] ) administered?UnitCharORecord the unit of total amount (product +vehicle) administered/given to the subject (e.g., mL).EXVAMTUMaps directly to the tabulation variable listed in the Tabulation Target column.(UNIT)(EXVOLTU)Unit of the administration amount. A CDASH Subset Controlled Terminology Codelist Name is available for dose and volume units.
InterventionsEXN/AN/A32EXTPTExposure Planned Time Point NameA text description of the planned time point when measurements should be taken, as defined in the protocol.What was the planned time point for [study product/dose] ?[Planned Time Point Name]CharR/CRecord the planned time point of study product administration if not pre-printed on the CRF.EXTPTMaps directly to the tabulation variable listed in the Tabulation Target column. The tabulation time-point anchors EXTPTREF (text description) and EXRFTDTC (date/time) may be needed, as well as tabulation variables EXTPTNUM, EXELTM.N/AN/APlanned 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 field that requires the site to enter text. If the form is laid out as a grid, then words such as "Planned Time Point" can be included in the column heading.
InterventionsEXN/AN/A34EXLATExposure LateralityQualifier for anatomical location, further detailing side of the body for the study product administration.What was the side of the anatomical location of the ([study product/dose]) administration?SideCharORecord the side of the body location where the study product was administered (e.g., Left, Right).EXLATMaps directly to the tabulation variable listed in the Tabulation Target column.(LAT)N/AFurther details the laterality of the location where the study product was administered. This may be pre-printed or collected. Applicants may collect the data using a subset list of controlled terminology on the CRF.
InterventionsEXN/AN/A35EXDIRExposure DirectionalityQualifier 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 ([study product/dose]) administration?DirectionalityCharORecord the directionality of the body location where the study product was administered (e.g., Anterior, Lower, Proximal, Upper).EXDIRMaps directly to the tabulation variable listed in the Tabulation Target column.(DIR)N/AMay 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.

Metadata Checks Findings

Metadata Check User Macros FAQ
  • Content: For variable N/A / N/A / EXVAMT, it is not a numeric variable in CDASH Model
  • For variable N/A / N/A / EXVAMT, EXVAMT is a not a recognized tabulation variable in Tabulation Target
  • For variable N/A / N/A / EXVAMTU, EXVAMTU is a not a recognized tabulation variable in Tabulation Target

Exposure as Collected (EC)

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 ClassDomainData Collection ScenarioImplementation OptionsOrder NumberCollection VariableCollection Variable LabelDRAFT Collection DefinitionQuestion TextPromptData TypeCollection CoreCase Report Form Completion InstructionsTabulation TargetMapping InstructionsControlled Terminology Codelist NameSubset Controlled Terminology/CDASH Codelist NameImplementation Notes
InterventionsECN/AN/A1STUDYIDStudy IdentifierA unique identifier for a study.What is the study identifier?[Protocol/Study]CharHRN/ASTUDYIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AAlthough 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.
InterventionsECN/AN/A2SITEIDStudy Site IdentifierA unique identifier for a site within a study.What is the site identifier?Site (Identifier)CharHRN/ADM.SITEIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/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.

InterventionsECN/AN/A3SUBJIDSubject Identifier for the StudyA unique subject identifier within a site and a study.What [is/was] the (study) [subject/participant] identifier?[Subject/Participant] (Identifier)CharHRRecord the identifier for the subject.DM.SUBJIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/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 in all domains. However, this collection variable is populated only in the tabulation DM domain.

InterventionsECN/AN/A4EPOCHEpochName of the trial epoch with which this element of the arm is associated.What is the trial epoch?

[Epoch](Period/Phase/Applicant-defined phrase)

CharR/C[protocol specific]EPOCHMaps directly to the tabulation variable listed in the Tabulation Target column.(EPOCH)N/AIf the same information is collected more than once in different periods/parts of a study (e.g., Disposition), EPOCH may be needed to differentiate them. Typically, the trial epoch will be pre-printed on the CRF as the title of the page.
InterventionsECN/AN/A5ECYN

Any Study Product Taken

An indication of whether the subject used the study product. SDTM-755 - Getting issue details... STATUS Were any[study product/dose] taken?Any Study ProductsCharOIndicate if the subject used any study products. If Yes, include the appropriate details where indicated.N/ADoes not map to a tabulation variable.(NY)N/AThe 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. The ECYN is meant to indicate that the exposure as collected form should be completed or inserted into the case book. ECOCCUR would be used when the actual product name is pre-printed on the CRF. While these might be equivalent in a single-product study, there are differences in how they would be used in most trials. Therefore, it does not map into the tabulation variable ECOCCUR; ECOCCUR indicates whether the subject actually used study product. If actual data is available (ECYN ="Y"), ECOCCUR may be populated based on whether subject was actually used study product.
InterventionsECN/AN/A6ECCATCategory of ProductA grouping of topic-variable values based on user-defined characteristics.What is the category of the [study product/dose]?[Study Product Category]; NULLCharORecord the study product category, if not pre-printed on the CRF.ECCATMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AApplicant-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.
InterventionsECN/AN/A7ECSCATSubcategory of ProductA sub-division of the ECCAT values based on user-defined characteristics.What is the subcategory of the [study product/dose]?[Study Product Subcategory]; NULLCharORecord the study product subcategory, if not pre-printed on the CRF.ECSCATMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AApplicant-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. ECSCAT can only be used if there is an ECCAT and it must be a subcategorization of ECCAT.
InterventionsECN/AN/A8ECTRTProductName of the study product.What was the [study product] name?[Study Product Name]CharR/CRecord the name of study product.ECTRTMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AECTRT is the name of the product.
InterventionsECN/AN/A9ECPRESPExposure as Collected Pre-SpecifiedAn indication that a specific intervention or a group of interventions is pre-specified on a CRF.N/AN/ACharON/AECPRESPMaps directly to the tabulation variable listed in the Tabulation Target column.(NY)N/AFor pre-specified interventions, a hidden field on a CRF defaulted to "Y", or added during the tabulation dataset creation. If a study collects both pre-specified and free-text interventions, the value of ECPRESP should be "Y" for all pre-specified interventions and null for interventions reported as free text.
InterventionsECN/AN/A10ECOCCURExposure as Collected OccurrenceAn indication whether the study product was used when information about the occurrence of a specific intervention was solicited.Was [study product/dose] used?; Has the subject taken [study product/dose]?[Study Product]CharOIndicate if the subject used study product. If Yes, include the appropriate details where indicated.ECOCCURMaps directly to the tabulation variable listed in the Tabulation Target column. Not applicable when ECMOOD is "Scheduled".(NY)N/AECOCCUR is used to indicate whether the subject actually used study product. ECOCCUR should not be used to indicate that the question was not asked or answered.
InterventionsECN/AN/A11ECREASOCExposure Reason for Occur ValueAn explanation for why a scheduled study product administration did or did not occur.What was the reason that the [study product/dose] was (not) used?Reason (Not) TakenCharOIndicate why the study product was or was not used.SUPPEC.QVALThis information could be represented in a SUPPEC dataset as the value of SUPPEC.QVAL where SUPPEC.QNAM="ECREASOC" and SUPPEC.QLABEL ="Reason for Occur Value".N/AN/AThe reason the study product was or was not taken may be chosen from an applicant-defined codelist or entered as free text. When --REASOC is used, --OCCUR must also be populated in the tabulation dataset with a value of "Y" or "N".
InterventionsECN/AN/A12ECMOODExposure as Collected MoodMode or condition of the record specifying whether the intervention (activity) is intended to happen or has happened.Does this record describe scheduled [study product/dose] or used [study product/dose]?Scheduled/PerformedCharOIndicate if this record has happened or is intended to happen.ECMOODMaps directly to the tabulation variable listed in the Tabulation Target column. When implemented, ECMOOD must be populated for all records.(BRDGMOOD)N/A"SCHEDULED" is for collected subject-level intended dose records. "PERFORMED" is for collected subject-level actual dose records. "Planned" or "Scheduled" can be pre-printed as the CRF name or section header, as applicable. If collecting both the scheduled and performed dosing in the same horizontal record, the applicant may choose to append "_SCHEDULED" to the ECDOSE/ECDOSTXT variable name to delineate the scheduled dose from the performed dose. The performed dose would just be collected with ECDOSE/ECDOSTXT and ECDOSU.
InterventionsECN/AN/A13ECREFIDExposure as Collected Reference IDAn internal or external identifier (e.g., kit number, bottle label, vial identifier).What is the [study product/dose] label identifier?[Study Product] Label IdentifierCharORecord product label identifier.ECREFIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis packaging identifier (e.g., kit number, bottle label, vial identifier) may be collected in different ways (e.g., affixing label onto CRF, scanning a bar code). For some study dosing regimens that require greater granularity for product identifiers, applicants may need to use additional variables.
InterventionsECN/AN/A14ECLOTLot NumberLot number of the ECTRT product.What was the lot number of the [study product/dose] used?Lot NumberCharR/CRecord the lot number that appears on the container holding the study product.ECLOTMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThe lot number identifies the manufacturing batch of the study product. In open-label studies, the reference number on the study product container may represent an actual lot number and should be represented using ECLOT. This variable may be populated during the process of creating the tabulation datasets. Do not collect other identification variables in this field.
InterventionsECN/AN/A15ECDOSFRMExposure as Collected Dose FormThe dosage form in which the ECTRT is physically presented.What was the dose form of the [studyproduct /dose]?Dose FormCharR/CRecord the dose form (e.g., SOLUTION, TABLET, LOTION) or enter the appropriate code from the code list.ECDOSFRMMaps directly to the tabulation variable listed in the Tabulation Target column.(FRM)(EXDOSFRM)This must be collected if it cannot be determined from other sources or if there are multiple options for the same study product.
InterventionsECN/AN/A16ECSTDATExposure as Collected Start DateThe start date of study product, intended or actual, represented in an unambiguous date format (e.g., DD-MON-YYYY).What was the ([intended/planned/actual]) ([study product/dose]) (start) date?(Start) DateCharHRRecord the start date of the study product administration using this format (DD-MON-YYYY).ECSTDTCThis 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 ECSTDTC in ISO 8601 format.N/AN/ADate when constant dosing interval of the study product started or single administration occurred. When collecting the date for an individual dose, the word "start" may be omitted from the Question Text and Prompt. When ECMOOD is collected and ECMOOD is "SCHEDULED", use "intended" in the question text and prompt. When ECMOOD is collected and ECMOOD is "PERFORMED", use "actual" in the question text and prompt.
InterventionsECN/AN/A17ECSTTIMExposure as Collected Start TimeThe start time of study product, represented in an unambiguous time format (e.g., hh:mm:ss).What was the ([intended/planned/actual]) ([study product/dose]) (start) time?(Start) TimeCharR/CRecord the start time (as complete as possible) when administration of study product started.ECSTDTCThis 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 ECSTDTC in ISO 8601 format.N/AN/ARecommend collecting the time a product was started only when a protocol or data collection scenarios requires it. When collecting the time for an individual dose, the word "start" may be omitted from the question text and prompt.
InterventionsECN/AN/A18ECENDATExposure as Collected End DateThe end date of study product, represented in an unambiguous date format (e.g., DD-MON-YYYY).What was the ([intended/planned/actual]) ([study product/dose]) (end) date?(End) DateCharR/CRecord the end date of the study product use using this format (DD-MON-YYYY).ECENDTCThis 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 ECENDTC in ISO 8601 format.N/AN/ADate when study product period stopped. If start date and end date are not expected to be the same date, the collection of the end date is required. If the study design indicates that the start and end are on the same day, the collection of the end date is not required because it can be assigned to be equal to the start date.
InterventionsECN/AN/A19ECENTIMExposure as Collected End TimeThe end time of study product use, represented in an unambiguous time format (e.g., hh:mm:ss).What was the ([intended/planned/actual]) ([study product/dose]) (end) time?(End) TimeCharR/CRecord the time, (as complete as possible) when study product use stopped (e.g., for infusions this is the time when the infusion ended).ECENDTCThis 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 ECENDTC in ISO 8601 format.N/AN/ARecommend collecting the time a medwas ended when a protocol or data collection scenarios requires it. For infusions, the end time of the infusion is typically needed.
InterventionsECN/AN/A20ECDSTXTExposure as Collected Dose DescriptionThe dose of study product taken (per administration).What was the dose (per administration) (of [study product/dose])?DoseCharR/CRecord the dose or amount of study product that was used to/taken by the subject in the period recorded; from the start date/time to the end date/time inclusive.ECDOSTXT; ECDOSEThis does not map directly to a tabulation variable. The data collected in this dose text-format field should be mapped to either ECDOSE if numeric or ECDOSTXT if text.N/AN/ADose or amount taken for single use of study product or per constant use interval recorded. Dose must be collected if it cannot be determined via other methods (e.g., from diary data, procuct accountability data, protocol). Care should be taken when mapping ECDSTXT. The data collected in this dose text-format field should be separated or mapped to either ECDOSE if numeric or ECDOSTXT if text.
InterventionsECN/AN/A21ECDOSUExposure as Collected Dose UnitsThe unit for intended dose (per administration) for ECDOSE, ECDOSTOT, or ECDOSTXT.What were the units for the dose?UnitsCharR/CRecord the unit of dose or amount taken per period recorded (e.g., ng, mg, mg/kg).ECDOSUMaps directly to the tabulation variable listed in the Tabulation Target column.(UNIT)(EXDOSU)Unit of dose or amount taken per constant dosing interval recorded. Dose unit must be collected if it cannot be determined via other methods (e.g., from protocol, randomization data). The unit should be pre-printed on the CRF or a field provided on the CRF to capture it. A CDASH Subset Controlled Terminology Codelist Name is available for dose and volume units. In blinded trials, the collected unit may be tablet, capsule, etc., since the actual unit is also blinded.
InterventionsECN/AN/A22ECDOSFRQEC Dosing Frequency per IntervalThe number of doses taken during a specific interval.What was the frequency of [study product/dose] dosing?FrequencyCharR/CRecord the frequency the study product was used for a defined period of time (e.g., BID, QID, TID).ECDOSFRQMaps directly to the tabulation variable listed in the Tabulation Target column.(FREQ)(EXDOSFRQ)This may be collected if it cannot be determined from other sources or if there are multiple options. When possible, the options for dose/amount frequency are pre-printed on the CRF. When collected, the recommendation is to collect dosing information in separate fields (e.g., ECDOSE, ECDOSEU, ECDOSFRQ) for specific and consistent data collection and to enable programmatically using these data.
InterventionsECN/AN/A23ECROUTEEC Route of AdministrationThe route of administration of the study productWhat was the route of use (of the [study product/dose])?RouteCharR/CRecord the route of administration (e.g., IV, ORAL, TRANSDERMAL) or enter the appropriate code from the code list.ECROUTEMaps directly to the tabulation variable listed in the Tabulation Target column.(ROUTE)(EXROUTE)This may be collected if it cannot be determined via other methods (e.g., from protocol) or if there are multiple options.
InterventionsECN/AN/A24ECDOSADJDose AdjustedAn indication of whether the dose was adjusted.Was the dose adjusted?(Dose) AdjustedCharOSelect either Yes or No to indicate whether there was a change in dosing.N/AWhen ECADJ is collected, does not map to a tabulation variable. When ECADJ is not collected, applicant may represent this variable in SUPPEC.(NY)N/ATypically, the intent/purpose of collecting this field is to help with data cleaning and monitoring, as it provides a definitive response regarding any dose changes. It provides verification that the associated field on the CRF (ECADJ) was deliberately left blank. However, the applicant may collect whether the dose was adjusted, without collecting the reason for the change. When using ECMOOD, this field should not be used.
InterventionsECN/AN/A25ECADJReason for Dose AdjustmentDescription of or explanation for why a dose of the study product was adjusted.What was the reason the dose was adjusted?Reason AdjustedCharOIf there was a change in dosing, record the reason for change.ECADJMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/ACaptures the reason the dose was changed or modified. The reason may be chosen from an applicant-defined list (e.g., adverse event, insufficient response) or entered as free text. May be used for variations from protocol-specified doses, or changes from expected doses. Used only when an adjustment is represented in EX dataset.
InterventionsECN/AN/A26ECITRPYNEC Exposure InterruptedAn indication of whether the exposure was interrupted.Was the [(study) product/dose] interrupted?[(Study) Product / Dose] InterruptedCharORecord if there was an interruption in the study product use or dosing.N/ADoes not map to a tabulation variable.(NY)N/AThe intent/purpose of collecting this field is to help with data cleaning and monitoring when the actual duration of the exposure is collected using the collection field ECCINTD. In some situations, if the actual duration of the interruption is not collected or not derived, this information could be represented in a SUPPEC.QVAL dataset where SUPPEC.QNAM = "ECITRPYN" and SUPPEC.QLABEL = "Exposure Interrupted".
InterventionsECN/AN/A27

ECCINTD

EC Interruption DurationThe collected duration of the study product use interruption.What was the duration of the interruption in product use?(Interruption) DurationCharORecord the duration of the interruption in project use.SUPPEC.QVALThis does not map directly to a tabulation variable. This information could be represented in a SUPPEC dataset as the value of SUPPEC.QVAL where SUPPEC.QNAM="ECITRPD" and SUPPEC.QLABEL= "Interruption Duration". Concatenate the collected interruption duration and the duration unit components and create ECITRPD using ISO 8601 Period format.N/AN/AThis field is used to collect the duration of the interruption. In some situations, the duration of the interruption may not be collected but calculated from the product start and end times recorded elsewhere in the CRF.
InterventionsECN/AN/A28

ECCINTDU

EC Interruption Duration UnitsThe unit for the collected duration of the interruption in product use.What was the interruption duration unit?(Interruption Duration) UnitCharORecord the unit (e.g., MINUTES, HOURS, DAYS) for the duration of interruption in product use.SUPPEC.QVALThis does not map directly to a tabulation variable. This information could be represented in a SUPPEC dataset as the value of SUPPEC.QVAL where SUPPEC.QNAM = "ECITRPD" and SUPPEC.QLABEL= "Interruption Duration". Concatenate the interruption duration and the duration unit components and create ECITRPD using ISO 8601 Period format.(UNIT)(EXINTPU)The unit should be collected as a qualifier to the number for duration.
InterventionsECN/AN/A29ECLOCEC Location of Dose AdministrationA description of the anatomical location of administration.What was the anatomical location of the ([study product/dose]) administration?Anatomical LocationCharORecord the body location where the study product was administered (e.g., SHOULDER, HIP, ARM).ECLOCMaps directly to the tabulation variable listed in the Tabulation Target column.(LOC)N/ACollected or pre-printed when the applicant needs to identify the specific anatomical location where the study product was administered. LAT, DIR, PORTOT are used to further describe the anatomical location.
InterventionsECN/AN/A30ECLATExposure as Collected LateralityQualifier for anatomical location, further detailing side of the body for the study product administration.What was the side of the anatomical location of the ([study product/dose]) administration?SideCharORecord the side of the body location where the study product was administered (e.g., Left, Right).ECLATMaps directly to the tabulation variable listed in the Tabulation Target column.(LAT)N/AFurther details the laterality of the location where the study product was administered. This may be pre-printed or collected. Applicants may collect the data using a subset list of controlled terminology on the CRF.
InterventionsECN/AN/A31ECDIRExposure as Collected DirectionalityQualifier 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 ([study product/dose]) administration?DirectionalityCharORecord the directionality of the body location where the study product was administered (e.g., Anterior, Lower, Proximal, Upper).ECDIRMaps directly to the tabulation variable listed in the Tabulation Target column.(DIR)N/AMay 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.
InterventionsECN/AN/A32

ECVAMT

EC Vehicle AmountThe amount of the prepared product (product + vehicle) used.What was the total amount (Product + Vehicle) (of [study product/dose]) used?Total Amount (Product + Vehicle)NumORecord the total amount (product +vehicle) that was administered/given to the subject.ECVAMTMaps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable ECTRTV may also be populated during the process of creating the tabulation datasets.N/AN/A

Administration amount that was used by the subject.

Note: Should not be the diluent amount alone. The ECTRTV field may be collected if it cannot be determined from other sources.

InterventionsECN/AN/A33ECVAMTUEC Vehicle Amount UnitsThe unit of measurement for the prepared product (product + vehicle).What was the unit for the amount (of [study product/dose] used)?UnitCharORecord the unit of total amount (product +vehicle) used by the subject (e.g., mL).ECVAMTUMaps directly to the tabulation variable listed in the Tabulation Target column.(UNIT)N/AUnit of the used amount
InterventionsECN/AN/A34ECTPTEC Planned Time Point NameA text description of the planned time point when measurements should be taken, as defined in the protocol.What was the planned time point for [product study /dose] use?[Planned Time Point Name]CharR/CRecord the planned time point of study product use if not pre-printed on the CRF.ECTPTMaps directly to the tabulation variable listed in the Tabulation Target column. The tabulation time-point anchors ECTPTREF (text description) and ECRFTDTC (date/time) may be needed, as well as tabulation variables ECTPTNUM, ECELTM.N/AN/APlanned 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 field that requires the site to enter text. If the form is laid out as a grid, then words such as Planned Time Point can be included as the column heading.

Metadata Checks Findings

Metadata Check User Macros FAQ
  • Content: For variable N/A / N/A / ECVAMT, it is not a numeric variable in CDASH Model
  • For variable N/A / N/A / ECVAMT, ECVAMT is a not a recognized tabulation variable in Tabulation Target
  • For variable N/A / N/A / ECVAMTU, ECVAMTU is a not a recognized tabulation variable in Tabulation Target


Assumptions

  1. If the tabulation EC dataset would be an exact duplicate of the tabulation EX dataset, then the applicant may choose to collect data using either the collection EC or EX domain. 
  2. If an exposure is such that start and stop times are not required, and only 1 exposure date is collected, then the collected exposure date will map to both the start date (--STDTC) and end date (--ENDTC) in the tabulation exposure dataset(s).

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