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.

Transmission ID

E2B ID E2B Element Data Type Value Source Lookup Field Static Value
N.1.1 Type of Messages in Batch Number (2) Static 1
N.1.2 Batch Number Number (100) Looked Up safety_case__v.cdms_safety_case_unique_id__v
N.1.3 Batch Sender Identifier Text (60) Looked Up transmission_profile__v.batch_sender_identifier__v
N.1.4 Batch Receiver Identifier Text (60) Looked Up safety_definition__v.batch_receiver_identifier__v
N.1.5 Date of Batch Transmission Datetime Looked Up safety_message__v.date_of_transmission__v
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
N.2.r.2 Message Sender Identifier Text (60) Looked Up transmission_profile__v.batch_sender_identifier__v
N.2.r.3 Message Receiver Identifier Text (60) Looked Up safety_definition__v.batch_receiver_identifier__v
N.2.r.4 Date of Message Creation Datetime Looked Up safety_message__v.created_date__v

Safety Case ID

E2B ID E2B Element Data Type Value Source Lookup Field Static Value
C.1.1 Sender's (case) Safety Report Unique Identifier Text (100) Looked Up safety_case__v.cdms_safety_case_unique_id__v
C.1.2 Date of Creation Datetime Looked Up safety_message__v.created_date__v
C.1.3 Type of Report Number (1) Static 2
C.1.4 Date Report Was First Received from Source Datetime Looked Up safety_case__v.date_report_first_received_from_source__v
C.1.5 Date of Most Recent Information for This Report Datetime Looked Up safety_message__v.date_most_recent_info_in_report__v
C.1.7 Does This Case Fulfil 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
C.1.8.2 First Sender of This Case Number (1) Static 2
C.1.11.1 Report Nullification / Amendment Number (1) Condition based
C.2.r.1.2 Reporter's Given Name Text (60) Looked Up safety_case__v.first_reporter_first_name__v
C.2.r.1.4 Reporter's Family Name Text (60) Looked Up safety_case__v.first_reporter_last_name__v
C.2.r.3 Reporter's Country Code Text (2) Looked Up safety_case__v.first_reporter_country__v
C.2.r.4 Qualification Number (1) Static 3
C.2.r.5 Primary Source for Regulatory Purposes Number (1) Static 1
C.3.1 Sender Type Number (1) Static 1
C.3.2 Sender's Organisation Text (100) Looked Up Sponsor / Organization
C.5.3 Sponsor Study Number Text (50) Looked Up study__v.name__v
C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed Number (1) Static 1

Serious Adverse Event

E2B ID E2B Element Data Type Value Source Lookup Field Static Value
E.i.9 Identification of the Country Where the Reaction/Event Occurred Text (2) Looked Up site__v.study_country__v

Adverse Event

E2B ID E2B Element Data Type Value Source Lookup Field Static Value
E.i.2.1a MedDRA Version for Reaction / Event Text (4) Looked Up mc_request__v.dictionary_release__vr.display_name__v ("MedDRA" removed from the string)
E.i.2.1b Reaction/Event (MedDRA Code) Number (8) Looked Up mc_request__v.col5_id__v

Medical History

E2B ID E2B Element Data Type Value Source Lookup Field Static Value
D.7.1.r.1a MedDRA Version for Medical History Text (4) Looked Up mc_request__vr.dictionary_release__v.display_name__v ("MedDRA" removed from the string)
D.7.1.r.1b Medical History (disease / surgical / procedure / etc.) (MedDRA Code) Number (8) Looked Up mc_request__v.col5_id__v

Patient Characteristics

E2B ID E2B Element Data Type Value Source Lookup Field Static Value
D.1 Patient (name or initials) Text (60) Looked Up study_country__v-site__v -subject__v

Suspected Drug

E2B ID E2B Element Data Type Value Source Lookup Field Static Value
G.k.1 Characterization of Drug Role Number (1) Static 1
G.k.22 Medicinal Product Name as Reported by the Primary Source Text (250) Looked Up study__v.name__v