| 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 | EC | 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. |
| Interventions | EC | 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 | EC | 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 | EC | 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 | EC | N/A | N/A | 5 | ECYN | Any Study product Taken | An indication of whether the subject used the 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 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. |
| Interventions | EC | N/A | N/A | 6 | ECCAT | 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. | ECCAT | 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. |
| Interventions | EC | N/A | N/A | 7 | ECSCAT | Subcategory of Product | A sub-division of the ECCAT 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. | ECSCAT | 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. ECSCAT can only be used if there is an ECCAT and it must be a subcategorization of ECCAT. |
| Interventions | EC | N/A | N/A | 8 | ECTRT | Product | Name of the study product. | What was the [study /investigational product] name? | [Study Product/Investigational Product Name] | Char | R/C | Record the name of study product. | ECTRT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | ECTRT is the name of the product. |
| Interventions | EC | N/A | N/A | 9 | ECPRESP | Exposure as Collected Pre-Specified | An indication that a specific intervention or a group of interventions is pre-specified on a CRF. | N/A | N/A | Char | O | N/A | ECPRESP | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | For 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. |
| Interventions | EC | N/A | N/A | 10 | ECOCCUR | Exposure as Collected Occurrence | An 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] | Char | O | Indicate if the subject used study product. If Yes, include the appropriate details where indicated. | ECOCCUR | Maps directly to the tabulation variable listed in the Tabulation Target column. Not applicable when ECMOOD is "Scheduled". | (NY) | N/A | ECOCCUR 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. |
| Interventions | EC | N/A | N/A | 11 | ECREASOC | Exposure Reason for Occur Value | An 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) Taken | Char | O | Indicate why the study product was or was not used. | SUPPEC.QVAL | This 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/A | N/A | The 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". |
| Interventions | EC | N/A | N/A | 12 | ECMOOD | Exposure as Collected Mood | Mode 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/Performed | Char | O | Indicate if this record has happened or is intended to happen. | ECMOOD | Maps 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. |
| Interventions | EC | N/A | N/A | 13 | ECREFID | Exposure as Collected Reference ID | An internal or external identifier (e.g., kit number, bottle label, vial identifier). | What is the [study product/dose] label identifier? | [Study Product] Label Identifier | Char | O | Record product label identifier. | ECREFID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This 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. |
| Interventions | EC | N/A | N/A | 14 | ECLOT | Lot Number | Lot number of the ECTRT 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. | ECLOT | 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 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. |
| Interventions | EC | N/A | N/A | 15 | ECDOSFRM | Exposure as Collected Dose Form | The dosage form in which the ECTRT is physically presented. | What was the dose form of the [studyproduct /dose]? | Dose Form | Char | R/C | Record the dose form (e.g., SOLUTION, TABLET, LOTION) or enter the appropriate code from the code list. | ECDOSFRM | 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 for the same study product. |
| Interventions | EC | N/A | N/A | 16 | ECSTDAT | Exposure as Collected Start Date | The 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) Date | Char | HR | Record the start date of the study product administration using this format (DD-MON-YYYY). | ECSTDTC | 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 ECSTDTC in ISO 8601 format. | N/A | N/A | Date 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. |
| Interventions | EC | N/A | N/A | 17 | ECSTTIM | Exposure as Collected Start Time | The 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) Time | Char | R/C | Record the start time (as complete as possible) when administration of study product started. | ECSTDTC | 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 ECSTDTC in ISO 8601 format. | N/A | N/A | Recommend 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. |
| Interventions | EC | N/A | N/A | 18 | ECENDAT | Exposure as Collected End Date | The 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) Date | Char | R/C | Record the end date of the study product use using this format (DD-MON-YYYY). | ECENDTC | 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 ECENDTC in ISO 8601 format. | N/A | N/A | Date 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. |
| Interventions | EC | N/A | N/A | 19 | ECENTIM | Exposure as Collected 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 use stopped (e.g., for infusions this is the time when the infusion ended). | ECENDTC | 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 ECENDTC in ISO 8601 format. | N/A | N/A | Recommend 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. |
| Interventions | EC | N/A | N/A | 20 | ECDSTXT | Exposure as Collected Dose Description | The dose of study product taken (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 to/taken by the subject in the period recorded; from the start date/time to the end date/time inclusive. | ECDOSTXT; ECDOSE | This 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/A | N/A | Dose 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. |
| Interventions | EC | N/A | N/A | 21 | ECDOSU | Exposure as Collected Dose Units | The unit for intended dose (per administration) for ECDOSE, ECDOSTOT, or ECDOSTXT. | What were the units for the dose? | Units | Char | R/C | Record the unit of dose or amount taken per period recorded (e.g., ng, mg, mg/kg). | ECDOSU | Maps 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. |
| Interventions | EC | N/A | N/A | 22 | ECDOSFRQ | EC Dosing Frequency per Interval | The number of doses 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 used for a defined period of time (e.g., BID, QID, TID). | ECDOSFRQ | Maps 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. |
| Interventions | EC | N/A | N/A | 23 | ECROUTE | EC Route of Administration | The route of administration of the study product | What was the route of use (of the [study product/dose])? | Route | Char | R/C | Record the route of administration (e.g., IV, ORAL, TRANSDERMAL) or enter the appropriate code from the code list. | ECROUTE | 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 | EC | N/A | N/A | 24 | ECDOSADJ | 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 ECADJ is collected, does not map to a tabulation variable. When ECADJ is not collected, applicant may represent this variable in SUPPEC. | (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 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. |
| Interventions | EC | N/A | N/A | 25 | ECADJ | 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? | Reason Adjusted | Char | O | If there was a change in dosing, record the reason for change. | ECADJ | 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, 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. |
| Interventions | EC | N/A | N/A | 26 | ECITRPYN | EC 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 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". |
| Interventions | EC | N/A | N/A | 27 | | EC Interruption Duration | The collected duration of the study product use interruption. | What was the duration of the interruption in product use? | (Interruption) Duration | Char | O | Record the duration of the interruption in project use. | SUPPEC.QVAL | This 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/A | N/A | This 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. |
| Interventions | EC | N/A | N/A | 28 | | EC Interruption Duration Units | The unit for the collected duration of the interruption in product use. | What was the interruption duration unit? | (Interruption Duration) Unit | Char | O | Record the unit (e.g., MINUTES, HOURS, DAYS) for the duration of interruption in product use. | SUPPEC.QVAL | This 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) | (EXCINTDU) | The unit should be collected as a qualifier to the number for duration. |
| Interventions | EC | N/A | N/A | 29 | ECLOC | EC 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). | ECLOC | 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 | EC | N/A | N/A | 30 | ECLAT | Exposure as Collected 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). | ECLAT | 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 | EC | N/A | N/A | 31 | ECDIR | Exposure as Collected 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). | ECDIR | 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. |
| Interventions | EC | N/A | N/A | 32 | | EC Vehicle Amount | The amount of the prepared product (product + vehicle) used. | What was the total amount (Product + Vehicle) (of [study product/dose]) used? | Total Amount (Product + Vehicle) | Num | O | Record the total amount (product +vehicle) that was administered/given to the subject. | ECVAMT | 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 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. |
| Interventions | EC | N/A | N/A | 33 | ECVAMTU | EC Vehicle Amount Units | The unit of measurement for the prepared product (product + vehicle). | What was the unit for the amount (of [study product/dose] used)? | Unit | Char | O | Record the unit of total amount (product +vehicle) used by the subject (e.g., mL). | ECVAMTU | Maps directly to the tabulation variable listed in the Tabulation Target column. | (UNIT) | N/A | Unit of the used amount |
| Interventions | EC | N/A | N/A | 34 | ECTPT | EC 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 [product study /dose] use? | [Planned Time Point Name] | Char | R/C | Record the planned time point of study product use if not pre-printed on the CRF. | ECTPT | Maps 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/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 as the column heading. |