| 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 |
| Events | DV | 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. |
| Events | DV | 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. |
| Events | DV | 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 collection domains. However, this collection variable is populated only in the tabulation DM domain. |
| Events | DV | N/A | N/A | 4 | DVCAT | Category for Protocol Deviation | A grouping of topic-variable values based on user-defined characteristics. | What is the category of the protocol deviation? | [Protocol Deviation Category]; NULL | Char | O | Record the deviation category, if not pre-printed on the CRF. | DVCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as "Category" can be included as the column header. |
| Events | DV | N/A | N/A | 5 | DVSCAT | Subcategory for Protocol Deviation | A sub-division of the DVCAT values based on user-defined characteristics. | What is the subcategory of the protocol deviation? | [Protocol Deviation Subcategory]; NULL | Char | O | Record the deviation event subcategory, if not pre-printed on the CRF. | DVSCAT | 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. DVSCAT can only be used if there is an DVCAT, and it must be a subcategorization of DVCAT. |
| Events | DV | N/A | N/A | 6 | DVYN | Any Protocol Deviation | An indication of whether there were any protocol deviations. | Were there any protocol deviations? | Any Deviations | Char | O | Enter Yes if a protocol deviation occurred and No if none occurred. Ensure that any adverse event which triggers a protocol deviation (e.g., concomitant medication use, newly discovered medical history) is noted in the respective CRF. | 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. |
| Events | DV | N/A | N/A | 7 | DVDECOD | Protocol Deviation Coded Term | The applicant-defined standardized text for the name of the protocol deviation. | What was the (standardized) protocol deviation (term/(code)? | (Standardized) Protocol Deviation (Term) | Char | R/C | Record protocol deviations identified and/or select the appropriate code from the list of protocol deviation terms. | DVDECOD | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | DVTERM and DVDECOD may have the same value. If the CRF is collecting protocol deviations using a codelist of responses, then DVDECOD should be used to store the codelist response. Appicants must use either DVDECOD or DVTERM on the CRF and, in some cases, both may be used. For example, if the CRF collects "Specify, Other" or similar additional free-text descriptions of codelist items, then DVTERM should be used to store the detailed descriptive text. |
| Events | DV | N/A | N/A | 8 | DVTERM | Protocol Deviation Term | The reported or pre-specified name of the protocol deviation. | What was the protocol deviation term? | (Specify) Protocol Deviation | Char | R/C | Record the appropriate code from the list of protocol deviation terms. | DVTERM | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | DVTERM and DVDECOD may have the same value. If the CRF is collecting protocol deviations using a free-text field, then DVTERM should be used to store the free-text response. Applicants may use either DVDECOD or DVTERM on the CRF, but a value in DVTERM is required in the tabulation datasets. |
| Events | DV | N/A | N/A | 9 | DVSTDAT | Deviation Start Date | The start date of deviation, represented in an unambiguous date format (e.g., DD-MON-YYYY). | What was the protocol deviation start date? | Start Date | Char | O | Record the start date that the protocol deviation using this format (DD-MON-YYYY). This should be the start or occurrence of the protocol deviation, not the date it was discovered or reported. | DVSTDTC | 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 DVSTDTC in ISO 8601 format. | N/A | N/A | This may be derived if not collected on a CRF. |
| Events | DV | N/A | N/A | 10 | DVSTTIM | Deviation Start Time | The start time of the deviation, represented in an unambiguous time format (e.g., hh:mm:ss). | What was the protocol deviation start time? | Start Time | Char | O | If appropriate, record the start time (as complete as possible) of the protocol deviation in an unambiguous time format (e.g., hh:mm:ss). This should be the start or occurrence of the protocol deviation, not the time it was discovered or reported. | DVSTDTC | 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 DVSTDTC in ISO 8601 format. | N/A | N/A | N/A |
| Events | DV | N/A | N/A | 11 | DVENDAT | Deviation End Date | The end date of the deviation, represented in an unambiguous date format (e.g., DD-MON-YYYY). | What was the protocol deviation end date? | End Date | Char | O | Record the end date of the protocol deviation using this format (DD-MON-YYYY). This should be the date the protocol deviation stopped, not the date it was discovered or reported. | DVENDTC | 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 DVENDTC in ISO 8601 format. | N/A | N/A | N/A |
| Events | DV | N/A | N/A | 12 | DVENTIM | Deviation End Time | The end time of the deviation, represented in an unambiguous time format (e.g., hh:mm:ss). | What was the protocol deviation end time? | End Time | Char | O | If appropriate, record the end time (as complete as possible) of the protocol deviation in an unambiguous time format (e.g., hh:mm:ss). This should be the time the protocol deviation stopped, not the time it was discovered or reported. | DVENDTC | 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 DVENDTC in ISO 8601 format. | N/A | N/A | N/A |
| Events | DV | N/A | N/A | 13 | DVSPID | DV Applicant-Defined Identifier | An applicant-defined identifier. This is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined identifier field. | [Applicant-defined question] | [Applicant defined] | Char | O | If collected on the CRF, the applicant may insert instructions to ensure each record has a unique identifier. | DVSPID | Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain. | N/A | N/A | Because SPID is an applicant-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the applicant's data collection system. |