E2B Elements Reference
This page lists static and system-generated (looked up) E2B elements that are sent to the safety system in the Safety Case, alongside the mapped E2B elements.
| E2B ID | E2B Element | Data Type | Source | Lookup Field | Static Value | Explanation |
|---|---|---|---|---|---|---|
| N.1.1 | Type of Messages in Batch | Number (2) | Static | 1 | This is always set to “1” for ICH ICSR. |
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| N.1.2 | Batch Number | Number (100) | Looked Up | safety_case__v.cdms_safety_case_unique_id__v | This value is a concatenation of the Site for the Subject (ISO two letter code), the unique identifier for your EDC system (unique to all Studies in that vault), the vault’s ID, the object record’s ID, a dash (“-“), and the numeric value for the Nth message of the case (for example, “US-VAULTCDMS-110377V6800000000L003-1”). The EDC system identifier has “TEST” appended to it when in non-production environments. For the message number, “0” is the first send, “1” is the first follow up, and so on. |
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| N.1.3 | Batch Sender Identifier | Text (60) | Looked Up | transmission_profile__v.batch_sender_identifier__v | This is the Batch Sender Identifier specified in the study’s Transmission Profile. This matches up with the sender profile configured in the safety system. |
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| N.1.4 | Batch Receiver Identifier | Text (60) | Looked Up | safety_definition__v.batch_receiver_identifier__v | This is the Batch Receiver Identifier specified in the study’s Transmission Profile. This matches up with the receiver profile configured in the safety system. |
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| N.1.5 | Date of Batch Transmission | Datetime | Looked Up | safety_message__v.date_of_transmission__v | The full date and time (in UTC) of when Vault creates the Safety Message and its XML file. |
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| N.2.r.1 | Message Identifier | Text (100) | Looked Up | safety_case__v.cdms_safety_case_unique_id__v-safety_message__v.message_id__v | This is the same as “N.1.2”. |
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| N.2.r.2 | Message Sender Identifier | Text (60) | Looked Up | transmission_profile__v.batch_sender_identifier__v | This is the same as “N.1.2”. |
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| N.2.r.3 | Message Receiver Identifier | Text (60) | Looked Up | safety_definition__v.batch_receiver_identifier__v | This is the same as “N.1.2”. |
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| N.2.r.4 | Date of Message Creation | Datetime | Looked Up | safety_message__v.created_date__v | This is the same as “N.1.5”. |
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| C.1.1 | Sender's (case) Safety Report Unique Identifier | Text (100) | Looked Up | safety_case__v.cdms_safety_case_unique_id__v | This value is a concatenation of the Site for the Subject (ISO two letter code), the unique identifier for your EDC system (unique to all Studies in that vault), the vault’s ID, and the object record’s ID (for example, “US-VAULTCDMS-110377V6800000000L003”). The EDC system identifier has “TEST” appended to it when in non-production environments. |
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| C.1.2 | Date of Creation | Datetime | Looked Up | safety_message__v.created_date__v | Vault creates the Safety Message right before transmitting it. This field captures the date of creation to the second. It acts as a message identifier. |
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| C.1.3 | Type of Report | Number (1) | Static | 2 | This is set to “2” for “Report from Study”. |
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| C.1.4 | Date Report Was First Received from Source | Datetime | Looked Up | safety_case__v.date_report_first_received_from_source__v | This field captures the date and time when all required fields (Items) are captured for an SAE. |
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| C.1.5 | Date of Most Recent Information for This Report | Datetime | Looked Up | safety_message__v.date_most_recent_info_in_report__v | Stores the Last Submitted Date for all Form instances contained in the E2B XML |
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| C.1.7 | Does This Case Fulfill the Local Criteria for an Expedited Report? | Boolean | Static | true | ||
| C.1.8.1 | Worldwide Unique Case Identification Number | Text (100) | Looked Up | safety_case__v.cdms_safety_case_unique_id__v | This is the same as “C.1.1”. |
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| C.1.8.2 | First Sender of This Case | Number (1) | Static | 2 | This is always set to “2” for “Other”. |
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| C.1.11.1 | Report Nullification / Amendment | Number (1) | Condition based | If the Message Type is “Amendment”, Vault sets this field to “2”. If the Message Type is “Nullification”, Vault sets this field to “1”. |
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| C.2.r.1.2 | Reporter's Given Name | Text (60) | Looked Up | safety_case__v.first_reporter_first_name__v | If the field is null, this isn’t included. |
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| C.2.r.1.4 | Reporter's Family Name | Text (60) | Looked Up | safety_case__v.first_reporter_last_name__v | If the field is null, this isn’t included. |
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| C.2.r.3 | Reporter's Country Code | Text (2) | Looked Up | safety_case__v.first_reporter_country__v | ||
| C.2.r.5 | Primary Source for Regulatory Purposes | Number (1) | Static | 1 | ||
| C.3.2 | Sender's Organization | Text (100) | Looked Up | study__v.organization___v | This is the Name of the study’s Organization (in EDC, the sender). |
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| C.5.3 | Sponsor Study Number | Text (50) | Looked Up | study__v.name__v | This is the study’s name/label. |
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| C.5.4 | Study Type Where Reaction(s) / Event(s) Were Observed | Number (1) | Static | 1 | This is always set to “1”, for “Clinical Trials”. |
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| E.i.9 | Identification of the Country Where the Reaction/Event Occurred | Text (2) | Looked Up | site__v.study_country__v | 2 character country code for the site’s Study Country |
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| D.7.1.r.1a | MedDRA Version for Medical History | Text (4) | Looked Up | mc_request__vr.dictionary_release__v.display_name__v | “MedDRA” is removed from the string. This field is only sent once it is Coded or Autocoded, because there’s no place for the Medical History Term in the E2B, only the coded values. |
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| D.7.1.r.1b | Medical History (disease / surgical / procedure / etc.) (MedDRA Code) | Number (8) | Looked Up | mc_request__v.col5_id__v | ||
| D.1 | Patient (name or initials) | Text (60) | Looked Up | study_country__v-site__v -subject__v |