| 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 |
| Findings | IE | 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. |
| Findings | IE | 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. |
| Findings | IE | 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. |
| Findings | IE | N/A | N/A | 4 | VISIT | Visit Name | The name of an encounter that encompasses planned and unplanned trial study interventions, procedures, and assessments that may be performed on a subject. | What is the visit name? | [Visit] | Char | R/C | N/A | VISIT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain. |
| Findings | IE | N/A | N/A | 5 | VISDAT | Visit Date | Date the encounter occurred (or started). | What [is/was] the date of the visit? | (Visit) Date | Char | R/C | Record the [date/start date] of the visit using theis format (DD-MON-YYYY). | N/A | This field is not a tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable IEDTC in ISO 8601 format. | N/A | N/A | The date the inclusion and exclusion assessments were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit or the collection date can be included on the Inclusion/Exclusion CRF using the date (IEDAT) field. |
| Findings | IE | N/A | N/A | 6 | IEYN | Any Incl/Excl Criteria Findings | Indication whether the subject met all the eligibility requirements for this study at the time the subject was enrolled. | Were all eligibility criteria met? | Met Criteria | Char | HR | Record Yes if all eligibility criteria were met at the time the subject was enrolled. Record No if subject did not meet all criteria at the time the subject was enrolled. | N/A | Does not map to an tabulation variable. | (NY) | N/A | The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification if all other fields on the CRF were deliberately left blank. |
| Findings | IE | N/A | N/A | 7 | IEDAT | Inclusion/Exclusion Collection Date | The date of collection of the inclusion/exclusion criteria represented in an unambiguous date format (e.g., DD-MON-YYYY). | What was the date the eligibility criteria assessment was performed? | Date | Char | O | Record complete date when the eligibility assessment was performed using this format (DD-MON-YYYY). | IEDTC | This does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable IEDTC in ISO 8601 format. | N/A | N/A | A complete date is expected. The date of collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required. |
| Findings | IE | N/A | N/A | 8 | IECAT | Inclusion/Exclusion Category | A grouping category to denote whether the protocol entry criterion being assessed is inclusion criteria or exclusion criteria. | What was the category of the criterion? | Criterion Type | Char | R/C | Check the appropriate box to indicate whether the criterion exception was related to the subject's inclusion or exclusion. | IECAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | (IECAT) | N/A | These categories have been defined in controlled terminology that must be used. Only records for criteria that are not met appear in the IE tabulation domain. IECAT must be populated. This criterion category may be collected on the CRF in a tick/checkbox format or it may be included as part of the criterion identification and mapped when the tabulation datasets are created. |
| Findings | IE | N/A | N/A | 9 | IESCAT | Inclusion/Exclusion Subcategory | A sub-division of the IECAT values based on user-defined characteristics. | What was the subcategory of the criterion? | [Criterion Subtype]; NULL | Char | O | If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended. | IESCAT | 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 "Subcategory" can be included as the column heading. This can be used to distinguish criteria for a sub-study or to categorize the criterion as a major or minor exception. |
| Findings | IE | N/A | N/A | 10 | IETESTCD | Inclusion/Exclusion Criterion Short Name | The unique identifier associated with the criterion that was the exception. | What was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met? | Exception Criterion Identifier | Char | HR | If the subject was not eligible, record the identifying code for each criterion that was an exception. | IETESTCD | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This field is required to appear on the CRF, but may be null if there are no exceptions to the inclusion/exclusion criteria. The CRF should allow multiple exceptions to be recorded. Applicants may provide a list of inclusion/exclusion criteria and the unique identifying codes to the site. The list provided should be versioned/updated when the protocol changes and the criteria are changed. Applicants should use applicant-developed controlled terminology for IETESTCD. |
| Findings | IE | N/A | N/A | 11 | IETEST | Inclusion/Exclusion Criterion | Descriptive name of the inclusion or exclusion criterion that was the exception. | What was the description of the inclusion criterion the subject did not meet or the exclusion criterion the subject met? | Exception Criterion Description | Char | O | Record the description of the criterion, if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended. | IETEST | Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable IETESTCD may be determined from the value collected in IETEST. The tabulation variables IETESTCD and IETEST are required in the tabulation datasets. | N/A | N/A | Applicants could automatically populated the text in EDC systems when the criterion identifier is populated by the investigator. This can be verified by the PI to ensure the right exception identifier was selected. |
| Findings | IE | N/A | N/A | 12 | IEORRES | I/E Criterion Original Result | An indication of which inclusion criterion was not met or exclusion criterion was met. | What is the result? | (Result) | Char | HR | If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended. | IEORRES | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | | This is only a data collection field when a complete list of inclusion and exclusion criteria are included on the CRF with Yes/No response options. If the applicant collects only the criteria that are not fulfilled, then, when an inclusion criterion is not met, IEORRES is mapped to "N" and when an exclusion criterion is met, IEORRES is mapped to "Y". |