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 |
|