| 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 |
| Interventions | EX | 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 into the database or populated during tabulation dataset creation. |
| Interventions | EX | 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. |
| Interventions | EX | 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 | 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 system-generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain. |
| Interventions | EX | N/A | N/A | 4 | EPOCH | Epoch | Name of the trial epoch with which this element of the arm is associated. | What is the trial epoch? | [Epoch](Period/Phase/Applicant-defined phrase) | Char | R/C | [protocol specific] | EPOCH | Maps directly to the tabulation variable listed in the Tabulation Target column. | (EPOCH) | N/A | If 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. |
| Interventions | EX | N/A | N/A | 5 | EXYN | Any Study Product Taken | An indication of whether the subject used study product. | Were any [study product/dose] taken? | Any Study Products | Char | O | Indicate if the subject used any study products. If Yes, include the appropriate details where indicated. | N/A | Does not map to a 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. 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. |
| Interventions | EX | N/A | N/A | 6 | EXCAT | Category of Product | A grouping of topic-variable values based on user-defined characteristics. | What is the category of the [study product/dose] ? | [Study Product Category]; NULL | Char | O | Record the study product category, if not pre-printed on the CRF. | EXCAT | 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 header. |
| Interventions | EX | N/A | N/A | 7 | EXSCAT | Subcategory of Product | A sub-division of the EXCAT values based on user-defined characteristics. | What is the subcategory of the [study product/dose] ? | [Study Product Subcategory]; NULL | Char | O | Record the study product subcategory, if not pre-printed on the CRF. | EXSCAT | 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. EXSCAT can only be used if there is an EXCAT and it must be a subcategorization of EXCAT. |
| Interventions | EX | N/A | N/A | 8 | EXTRT | Name of Product | Name of the study product given for the observation. | What was the study product name? | [Study Product Name] | Char | R/C | Record the name of study product. | EXTRT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | EXTRT 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. |
| Interventions | EX | N/A | N/A | 9 | EXREFID | Exposure Reference ID | An internal or external identifier. | What is the [study product/dose] label identifier? | Product Label Identifier | Char | R/C | Record product label identifier. | EXREFID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This packaging identifier may be collected in different ways. |
| Interventions | EX | N/A | N/A | 10 | EXLOT | Lot Number | Lot number of the EXTRT product. | What was the lot number of the [study product/dose] used? | Lot Number | Char | R/C | Record the lot number that appears on the container holding the study product. | EXLOT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | The 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. |
| Interventions | EX | N/A | N/A | 12 | EXDOSFRM | Exposure Dose Form | The dosage form in which the EXTRT is physically presented. | What was the dose form of the [study product/dose]? | Dose Form | Char | R/C | Record the dose form or enter the appropriate code from the code list. | EXDOSFRM | Maps 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. |
| Interventions | EX | N/A | N/A | 13 | EXSTDAT | Exposure Start Date | The 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) Date | Char | HR | Record the start date of the study product administration using this format (DD-MON-YYYY). | EXSTDTC | 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 EXSTDTC in ISO 8601 format. | N/A | N/A | Date 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. |
| Interventions | EX | N/A | N/A | 14 | EXSTTIM | Exposure Start Time | The 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) Time | Char | R/C | Record the start time (as complete as possible) when administration of study product started. | EXSTDTC | 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 EXSTDTC in ISO 8601 format. | N/A | N/A | Recommend collecting the time a product was started only when a protocol or data collection scenario requires it. |
| Interventions | EX | N/A | N/A | 15 | EXENDAT | Exposure End Date | The 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) Date | Char | R/C | Record the end date or last date of administration of study product using this format (DD-MON-YYYY). | EXENDTC | 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 EXENDTC in ISO 8601 format. | N/A | N/A | If 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. |
| Interventions | EX | N/A | N/A | 16 | EXENTIM | Exposure End Time | The 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) Time | Char | R/C | Record the time, (as complete as possible) when study product administration stopped. | EXENDTC | 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 EXENDTC in ISO 8601 format. | N/A | N/A | Recommend 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. |
| Interventions | EX | N/A | N/A | 17 | EXDSTXT | Exposure Dose Description | Dose (per administration). | What was the dose [per administration] (of [study product/dose]) ? | Dose | Char | R/C | Record 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; EXDOSE | This 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/A | N/A | Dose 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). |
| Interventions | EX | N/A | N/A | 18 | EXDOSU | Exposure Dose Unit | The unit for intended dose (per administration) for EXDOSE, EXDOSTOT, or EXDOSTXT. | What was the unit for the dose? | Unit | Char | R/C | Record the unit of dose or amount taken per period recorded (e.g., ng, mg, mg/kg). | EXDOSU | Maps directly to the tabulation variable listed in the Tabulation Target column. | (UNIT) | N/A | 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). 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. |
| Interventions | EX | N/A | N/A | 19 | EXDOSFRQ | Exposure Dosing Frequency per Interval | The number of doses given/administered/taken during a specific interval. | What was the frequency of [study product/dose] dosing? | Frequency | Char | R/C | Record the frequency the study product was administered for a defined period of time. | EXDOSFRQ | Maps directly to the tabulation variable listed in the Tabulation Target column. | (FREQ) | N/A | 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. |
| Interventions | EX | N/A | N/A | 20 | EXROUTE | Exposure Route of Administration | The route of administration of the study product. | What was the route of administration (of the [study product/dose] )? | Route | Char | R/C | Record the route of administration (e.g., ORAL) or enter the appropriate code from the code list. | EXROUTE | Maps 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. |
| Interventions | EX | N/A | N/A | 22 | EXDOSADJ | Dose Adjusted | An indication of whether the dose was adjusted. | Was the dose adjusted? | (Dose) Adjusted | Char | O | Select either Yes or No to indicate whether there was a change in dosing. | N/A | When 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/A | Typically, 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. |
| Interventions | EX | N/A | N/A | 23 | EXADJ | Reason for Dose Adjustment | Description of or explanation for why a dose of the study product was adjusted. | What was the reason the dose was adjusted (from planned)? | Reason Adjusted | Char | O | If there was a change in dosing, record the reason for change. | EXADJ | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Captures 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. |
| Interventions | EX | N/A | N/A | 24 | EXITRPYN | EX Exposure Interrupted | An indication of whether the exposure was interrupted. | Was the [(study) product/dose] interrupted? | [(Study) Product / Dose] Interrupted | Char | O | Record if there was an interruption in the study product use or dosing. | N/A | Does not map to a tabulation variable. | (NY) | N/A | The 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". |
| Interventions | EX | N/A | N/A | 25 | EXCINTD | Exposure Interruption Duration | The collected duration of the product interruption. | If the dose was interrupted, how long was the interruption? | (Interruption) Duration | Char | O | Record the duration of product use interruption. | SUPPEX.QVAL | This 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/A | N/A | In some situations, the duration of the interruption may be calculated from the administration start and end times recorded elsewhere in the CRF. |
| Interventions | EX | N/A | N/A | 26 | EXCINTDU | Exposure Interruption Duration Units | The unit for the collected duration of product interruption. | If the dose was interrupted, what were the units for the interruption duration? | (Interruption Duration) Unit | Char | O | Record the unit (e.g., MINUTES, HOURS, DAYS) for the duration of product use interruption. | SUPPEX.QVAL | This 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)| 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-348 |
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| The unit should be collected and converted into ISO 8601 period format. |
| Interventions | EX | N/A | N/A | 27 | EXLOC | Exposure Location of Dose Administration | A description of the anatomical location of administration. | What was the anatomical location of the ([study product/dose] ) administration? | Anatomical Location | Char | O | Record the body location where the study product was administered (e.g., SHOULDER, HIP, ARM). | EXLOC | 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 where the study product was administered. LAT, DIR, PORTOT are used to further describe the anatomical location. |
| Interventions | EX | N/A | N/A | 28 | EXVAMT | Exposure Vehicle Amount | The amount of the prepared product (product + vehicle) administered or given. | What was the total amount (product + vehicle)(of [study product/dose] ) administered? | Total Amount | Num | O | Record the total amount (product +vehicle) that was administered/given to the subject. | EXVAMT | Maps 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/A | N/A | Administration 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. |
| Interventions | EX | N/A | N/A | 29 | EXVAMTU | Exposure Vehicle Amount Units | The unit of measure for the prepared product (product + vehicle). | What was the unit for the amount (of [study product/dose] ) administered? | Unit | Char | O | Record the unit of total amount (product +vehicle) administered/given to the subject (e.g., mL). | EXVAMTU | Maps 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. |
| Interventions | EX | N/A | N/A | 32 | EXTPT | Exposure Planned Time Point Name | A 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] | Char | R/C | Record the planned time point of study product administration if not pre-printed on the CRF. | EXTPT | Maps 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/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 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. |
| Interventions | EX | N/A | N/A | 34 | EXLAT | Exposure Laterality | Qualifier 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? | Side | Char | O | Record the side of the body location where the study product was administered (e.g., Left, Right). | EXLAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | (LAT) | N/A | Further 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. |
| Interventions | EX | N/A | N/A | 35 | EXDIR | Exposure 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 ([study product/dose]) administration? | Directionality | Char | O | Record the directionality of the body location where the study product was administered (e.g., Anterior, Lower, Proximal, Upper). | EXDIR | 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. |