E2B Generation: NMPA E2B(R3) Mapping

When you export a Case to an E2B file, either for an outbound Transmission or directly from the Case page, Vault Safety maps all case data and documents to the appropriate E2B data elements. This article describes how Vault maps information to generate NMPA E2B(R3) files.

See E2B Generation Data Mapping for details about all other E2B formats supported by Vault Safety.

Note: Vault Safety automatically validates E2B files. Case and Submission Validation provides more information. In addition, Vault Safety enables you to configure custom Validation Criteria for Case data through the user-friendly Vault Expression Engine. For more information, see Configure Custom Validation Criteria.

NMPA E2B(R3) Mapping

The following tables define how each E2B data element is mapped for an NMPA E2B(R3) file. Use the section below to review only regional NMPA mappings that are different from the ICH mappings.

N.1 ICH ICSR Transmission Identification (batch wrapper)

E2B Data Element Name	Populated Value
N.1.1 Types of Message in batch	This value is always `1` for ICH ICSR.
N.1.2 Batch Number	The value in the E2B Message ID field on the Transmission (Submission or Distribution) record.
N.1.3 Batch Sender Identifier	The value in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.1.4 Batch Receiver Identifier	The value in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.1.5 Date of Batch Transmission	The value in the Transmission Date field on the Transmission (Submission or Distribution) record. Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.

N.2.r ICH ICSR Message Header (message wrapper)

E2B Data Element Name	Populated Value
N.2.r.1 Message Identifier	The value in the UID field on the Case.
N.2.r.2 Message Sender Identifier	The value in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.2.r.3 Message Receiver Identifier	The value in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.2.r.4 Date of Message Creation	If the Case is Approved or Closed, the date in the Approval Date field. Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.

C.1 Identification of the Case Safety Report

E2B Data Element Name	Populated Value
C.1.1 Sender's (case) Safety Report Unique Identifier	The value in the UID field on the Case Number object.
C.1.2 Date of Creation	The date in the Approval Date field if the Case is Approved or Closed. If Approval Date is unavailable, the date of report generation or Transmission with a system warning. Otherwise, the date and time when the report was generated or Transmitted, calculated with full precision down to the second.
C.1.3 Type of Report	The appropriate value is populated, based on the option selected in the Report Type field on the Case: `1`: Spontaneous `2`: Study `3`: Other `4`: Unknown
C.1.4 Date Report Was First Received from Source	For initial and follow-up Cases, the date in the Receipt Date field on the Case.
C.1.5 Date of Most Recent Information for This Report	The date in the New Info Date field on the Case.
C.1.7 Does This Case Fulfil the Local Criteria for an Expedited Report?	If the Local Expedited Criteria (`case_expedited__v`) field on the Transmission (Submission or Distribution) record has a value, Vault uses this value. If this field is not specified on the Transmission, Vault looks at the Expedited field on the Case. If the value is Yes, this element is populated with `1` (expedited). Otherwise, this element is populated with `2` (non-expedited). If both fields are blank, nullFlavor (`NI`) is exported.
C.1.CN.1 Report Source 报告来源	Vault populates an E2B code from the NMPA Report Source controlled vocabulary corresponding to the value in the NMPA Report Source field on the primary Reporter-type Localized Case Contact: `1`: Regulatory agency `2`: Personal `3`: Medical institution `4`: Operating business `5`: Documentation `6`: Research `7`: Item `8`: Other
C.1.CN.2 Report Classification 报告分类	Vault populates an E2B code from the NMPA Report Classification controlled vocabulary corresponding to the value in the Localized Case details using the following priority order: The NMPA Report Classification field in the Details section The Classification and Study Type values The available codes are: `11`: Domestic Report, Clinical Study `12`: Domestic Reporting Post Marketing `21`: Overseas report Clinical Study `22`: Overseas Reporting Post Marketing
C.1.CN.3 Report Holder / Manufacturer Authorization Holder Information 持有人标识	For non-clinical trial study Cases and postmarket Cases, Vault exports a value using the following priority order: If the primary suspect Case Product has a Case Product Registration in China, Vault exports the value in the Official Name field of the Localized Organization record for China. If the primary suspect Case Product has any Product Registrations in China, Vault exports the value in the Official Name field of any Localized Organization record with this information populated. If the primary suspect Case Product does not have any Product Registrations in China, Vault checks other suspect Case Products for any Product Registrations in China and exports the value in the Official Name field of any Localized Organization record with this information populated. For multiple matches in any of the above scenarios, Vault exports the Official Name of the most recently created Localized Organization.

C.1.6 Additional Available Documents Held by Sender

E2B Data Element Name	Populated Value
C.1.6.1 Are Additional Documents Available?	Populated as True if there are documents attached to the Case with the document type of Case > Source > Attachment.
C.1.6.1.r.1 Documents Held by Sender	The text in the Attachment Description and Attachment Description Continued fields on any documents attached to the Case with the document type of Case > Source > Attachment. Text is populated to a limit of 2,000 characters. This field is mapped even when the document is a placeholder or blank.
C.1.6.1.r.2 Included Documents	If any documents are attached to the Case with the document type of Case > Source > Attachment and the Retransmit field set to Yes, they are encoded. If the Retransmit field is set to No or is blank, documents are not encoded. Depending on your Admin’s configuration, Vault may exclude attachment contents on Transmissions for Cases or Localized Cases with previous Transmissions that included the attachment to the same reporting destination.

E2B Data Element Name

Populated Value

C.1.6.1 Are Additional Documents Available?

Populated as True if there are documents attached to the Case with the document type of Case > Source > Attachment.

C.1.6.1.r.1 Documents Held by Sender

The text in the Attachment Description and Attachment Description Continued fields on any documents attached to the Case with the document type of Case > Source > Attachment. Text is populated to a limit of 2,000 characters. This field is mapped even when the document is a placeholder or blank.

C.1.6.1.r.2 Included Documents

If any documents are attached to the Case with the document type of Case > Source > Attachment and the Retransmit field set to Yes, they are encoded. If the Retransmit field is set to No or is blank, documents are not encoded.

Depending on your Admin’s configuration, Vault may exclude attachment contents on Transmissions for Cases or Localized Cases with previous Transmissions that included the attachment to the same reporting destination.

C.1.8 Worldwide Unique Case Identification

E2B Data Element Name	Populated Value
C.1.8.1 Worldwide Unique Case Identification Number	The value in the Worldwide UID field on the Case Number object.
C.1.8.2 First Sender of This Case	The value in the First Sender field on the original inbound Transmission. The Transmission Date is used to find the original Transmission.
C.1.9.1 Other Case Identifiers in Previous Transmissions	Populated as True if there are any Case Identifier objects associated with the Case. If there are no Case Identifier objects associated with the Case, `NI` is exported.
C.1.9.1.r.1 Source(s) of the Case Identifier	Repeated for the value in the Source field on each Case Identifier object. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank.
C.1.9.1.r.2 Case Identifier(s)	The value in the Case Identifier field on the Case Identifier object. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank.
C.1.10.r Identification Number of the Report Which Is Linked to This Report	The value in the Related Case Identifier field on the Case Relationship object. This value is exported when the Retransmit field on the record is set to Yes.
C.1.11.1 Report Nullification/Amendment	The appropriate value is populated, based on the option selected in the Reason field on the Transmission: `1`: Nullification `2`: Amendment
C.1.11.2 Reason for Nullification/Amendment	The text in the Reason Text field on the Transmission, to a limit of 2,000 characters.

C.2.r Primary Source(s) of Information

E2B Data Element Name	Populated Value
C.2.r.1.1 Reporter's Title	The value in the Title field on a Reporter-type Case Contact.
C.2.r.1.2 Reporter's Given Name	The value in the First Name field on a Reporter-type Case Contact.
C.2.r.1.3 Reporter's Middle Name	The value in the Middle Name field on a Reporter-type Case Contact.
C.2.r.1.4 Reporter's Family Name	The value in the Last Name field on a Reporter-type Case Contact.
C.2.r.2.1 Reporter's Organisation	The value in the Organization field on a Reporter-type Case Contact. Any text that exceeds the 60-character limit for this data element is truncated.
C.2.r.2.2 Reporter's Department	The value in the Department field on a Reporter-type Case Contact.
C.2.r.2.3 Reporter's Street	The value in the Street Name field on a Reporter-type Case Contact.
C.2.r.2.4 Reporter's City	The value in the City field on a Reporter-type Case Contact.
C.2.r.2.5 Reporter's State or Province	Populates the State/Province field on the Case Contact object for the primary reporter.
C.2.r.2.6 Reporter's Postcode	The value in the Zip/Postal Code field on a Reporter-type Case Contact.
C.2.r.2.7 Reporter's Telephone	The value in the Telephone field on a Reporter-type Case Contact.
C.2.r.3 Reporter's Country Code	The ISO code in the Country field on a Reporter-type Case Contact.
C.2.r.4 Qualification	The value in the Qualification field on a Reporter-type Case Contact. If Patient or Parent is selected in this field, then the E2B code of `5` is mapped.
C.2.r.5 Primary Source for Regulatory Purposes	Populated with `1` (true) if the Primary Source field is set to Yes on the associated Reporter-type Case Contact.
C.2.r.CN.1 E.Mail Address 电子邮箱	The email address of the primary Reporter-type Case Contact.

C.3 Information on Sender of Case Safety Report

E2B Data Element Name	Populated Value
C.3.1 Sender Type	The value in the Sender Type field in the Organization record associated with the Sender User on the Transmission (Submission or Distribution) record. If the Sender User is not specified on the Transmission, by default Vault maps the Sender Type from the Organization on the Case.
C.3.2 Sender Organization	The value in the Organization field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record. If the Sender User is not specified on the Transmission, by default Vault maps the Organization on the Case. Any text that exceeds the 100-character limit for this data element is truncated.
C.3.3.1 Sender's Department	The value in the Department field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.2 Sender's Title	The value in the Title field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.3 Sender's Given Name	The value in the First Name field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.4 Sender's Middle Name	The value in the Middle Name field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.5 Sender's Family Name	The value in the Last Name field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.1 Sender's Street Address	The value in the Street field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.2 Sender's City	The value in the City field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.3 Sender's State or Province	The value in the State / Province field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.4 Sender's Postcode	The value in the Zip/Postal Code field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.5 Sender's Country Code	The 2-letter ISO code associated with the country selected in the Country field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.6 Sender's Telephone	The value in the Telephone field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.7 Sender's Fax	The value in the Fax field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.8 Sender's E-mail Address	The value in the Email field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.

C.4.r Literature Reference(s)

E2B Data Element Name	Populated Value
C.4.r.1 Literature Reference(s)	The value in the Reference document field for any Case documents classified with the Case > Source > Literature document type, to a limit of 500 characters. When Vault generates a report for a Case linked to a Literature Article in your SafetyDocs Vault and if the document’s Retransmit field value is Yes, Vault maps the Vancouver Citation value on the Literature Article record to this data element. For Localized Case Documents, Vault overrides the Vancouver Citation with the Reference field value, if populated. Multiple literature source documents are encoded in separate C.4.r.1 blocks.
C.4.r.2 Included Documents	Case documents of the following classifications with the Retransmit field value of Yes are encoded in Transmissions: Case > Source > Literature Literature > Literature Article > Full-Text Literature > Literature Article > Summary Depending on your Admin’s configuration, Vault may exclude the contents of literature articles on Transmissions for Cases or Localized Cases with previous Transmissions that included the literature article to the same reporting destination.

E2B Data Element Name

Populated Value

C.4.r.1 Literature Reference(s)

The value in the Reference document field for any Case documents classified with the Case > Source > Literature document type, to a limit of 500 characters.

When Vault generates a report for a Case linked to a Literature Article in your SafetyDocs Vault and if the document’s Retransmit field value is Yes, Vault maps the Vancouver Citation value on the Literature Article record to this data element. For Localized Case Documents, Vault overrides the Vancouver Citation with the Reference field value, if populated.

Multiple literature source documents are encoded in separate C.4.r.1 blocks.

C.4.r.2 Included Documents

Case documents of the following classifications with the Retransmit field value of Yes are encoded in Transmissions:

Case > Source > Literature
Literature > Literature Article > Full-Text
Literature > Literature Article > Summary

Depending on your Admin’s configuration, Vault may exclude the contents of literature articles on Transmissions for Cases or Localized Cases with previous Transmissions that included the literature article to the same reporting destination.

C.5 Study Identification

E2B Data Element Name	Populated Value
C.5.1.r.1 Study Registration Number	The value in the Registration Number field on the Case Study Registration object.
C.5.1.r.2 Study Registration Country	The 2-letter ISO code associated with the country selected in the Country field on the Case Study Registration object. For EMA E2B exports, country codes within the jurisdiction of EMA are replaced with EU in the resulting E2B file.
C.5.2 Study Name	The values in the Study Name and Study Name (Continued) fields on the associated Case, to a limit of 2,000 characters.
C.5.3 Sponsor Study Number	The value in the Study Number field on the associated Study.
C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed	The value in the Study Type field on the Case.

D Patient Characteristics

E2B Data Element Name	Populated Value
D.1 Patient (name or initials)	The value in the Patient Initials / ID field on the Case.

D.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number

E2B Data Element Name	Populated Value
D.1.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number (GP Medical Record Number)	The value in the MRN - GP field on the Case.
D.1.1.2 Patient Medical Record Number(s) and Source(s) of the Record Number (Specialist Record Number)	The value in the MRN - Specialist field on the Case.
D.1.1.3 Patient Medical Record Number(s) and Source(s) of the Record Number (Hospital Record Number)	The value in the MRN - Hospital field on the Case.
D.1.1.4 Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation Number)	The value in the MRN - Investigation field on the Case.

D.2 Age Information

E2B Data Element Name	Populated Value
D.2.1 Date of Birth	The date in the Date of Birth field on the Case. For this data element to be transmitted, the full date is required with year, month, and day.
D.2.2a Age at Time of Onset of Reaction / Event (number)	The value in the Age field on the Case. In accordance with ICH guidelines, this element is not transmitted if the Patient Date of Birth (D.2.1) is transmitted.
D.2.2b Age at Time of Onset of Reaction / Event (unit)	The value in the Age (unit) field on the Case. In accordance with ICH guidelines, this element is not transmitted if the Patient Date of Birth (D.2.1) is transmitted.
D.2.2.1a Gestation Period When Reaction / Event Was Observed in the Foetus (number)	The value in the Gestation field on the Case.
D.2.2.1b Gestation Period When Reaction/Event Was Observed in the Foetus (unit)	The unit in the Gestation (unit) field on the Case.
D.2.3 Patient Age Group (as per reporter)	The value in the Age Group field on the Case. In accordance with ICH guidelines, this element is transmitted only when both the Patient Date of Birth (D.2.1) and Age at Onset (D.2.2) are not transmitted.
D.3 Body Weight (kg)	The value in the Weight field on the Case, normalized to the accepted unit.
D.4 Height (cm)	The value in the Height field on the Case, normalized to the accepted unit.
D.5 Sex	The value in the Sex field on the Case.
D.6 Last Menstrual Period Date	The date in the Last Menstrual field on the Case.

D.7 Relevant Medical History and Concurrent Conditions

E2B Data Element Name	Populated Value
D.7.1.r.1a MedDRA Version for Medical History	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code)	The MedDRA LLT coded on the Case Medical History object.
D.7.1.r.2 Start Date	The date in the Start Date field on the Case Medical History object.
D.7.1.r.3 Continuing	The appropriate value is populated, based on the Continuing field on the Case Medical History object.
D.7.1.r.4 End Date	The date in the End Date field on the Case Medical History object.
D.7.1.r.5 Comments	The text in the Comments field on the Case Medical History object, to a limit of 2,000 characters.
D.7.1.r.6 Family History	The value in the Family History field on the Case Medical History object.
D.7.2 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event)	The text in the Medical History Text field on the Case, to a limit of 10,000 characters.
D.7.3 Concomitant Therapies	Set to True when the Concomitant Therapies field is set to Yes on the Case.

D.8.r Relevant Past Drug History

E2B Data Element Name	Populated Value
D.8.r.1 Name of Drug as Reported	The value in the Drug (Reported) field on the Case Drug History record.
D.8.r.2a MPID Version Date/Number	The value in the MPID Version field on the Case Drug History record.
D.8.r.2b Medicinal Product Identifier (MPID)	The value in the MPID field on the Case Drug History record.
D.8.r.3a PhPID Version Date/Number	The value in the PhPID Version field on the Case Drug History record.
D.8.r.3b Pharmaceutical Product Identifier (PhPID)	The value in the PhPID field on the Case Drug History record.
D.8.r.4 Start Date	The date in the Start Date field on the Case Drug History record. If the value is a partial date, for example including only the year or year and month, Vault does not populate this data element.
D.8.r.5 End Date	The date in the End Date field on the Case Drug History record. If the value is a partial date, for example including only the year or year and month, Vault does not populate this data element.
D.8.r.6a MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.8.r.6b Indication (MedDRA code)	The MedDRA LLT coded for the indication on the Case Drug History record.
D.8.r.7a MedDRA Version for Reaction	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.8.r.7b Reaction (MedDRA code)	The value in the Reaction MedDRA field on the Case Drug History record.

D.9 In case of Death

E2B Data Element Name	Populated Value
D.9.1 Date of Death	The date in the Date of Death field on the Case. If the value is a partial date, including only the year or year and month, Vault exports the nullFlavor `ASKU`.
D.9.2.r.1a MedDRA Version for Reported Cause(s) of Death	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.9.2.r.1b Reported Cause(s) of Death (MedDRA code)	The MedDRA LLT coded on the Reported Case Cause of Death object.
D.9.2.r.2 Reported Cause(s) of Death (free text)	The value in the Cause of Death (Reported) field on the Localized Case Cause of Death record. If blank, Vault exports `死因不明`.
D.9.3 Was Autopsy Done?	If the Cause of Death (Reported) field on the Localized Case Cause of Death record is blank, Vault exports the nullFlavor `UNK`. Otherwise, Vault exports the value in the Autopsy or Autopsy (reason omitted) field on the Case.
D.9.4.r.1a MedDRA Version for Autopsy-determined Cause(s) of Death	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.9.4.r.1b Autopsy-determined Cause(s) of Death (MedDRA code)	The MedDRA LLT coded on the Autopsy-Determined Case Cause of Death object.
D.9.4.r.2 Autopsy-determined Cause(s) of Death (free text)	The information in the Name (Reported) field on the Autopsy-Determined Case Cause of Death object.

D.10 For a Parent-child / Foetus Report, Information Concerning the Parent

E2B Data Element Name	Populated Value
D.10.1 Parent Identification	The value in the Patient ID field on the associated Parent Information Case.
D.10.2.1 Date of Birth of Parent	The date in the Date of Birth field on the associated Parent Information Case. For this data element to be transmitted, the full date is required with year, month, and day.
D.10.2.2a Age of Parent (number)	The value in the Age field on the associated Parent Information Case.
D.10.2.2b Age of Parent (unit)	The unit in the Age (unit) field on the associated Parent Information Case.
D.10.3 Last Menstrual Period Date of Parent	The date in the Last Menstrual field on the associated Parent Information Case.
D.10.4 Body Weight (kg) of Parent	The value in the Weight field on the associated Parent Information Case.
D.10.5 Height (cm) of Parent	The value in the Height (normalized) field on the associated Parent Information Case.
D.10.6 Sex of Parent	The value in the Sex field on the associated Parent Information Case.
D.10.7.1.r.1a MedDRA Version for Medical History	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information Case.
D.10.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code)	The MedDRA LLT coded on the Case Medical History object on the associated Parent Information Case.
D.10.7.1.r.2 Start Date	The date in the Start Date field on the Case Medical History object on the associated Parent Information Case.
D.10.7.1.r.3 Continuing	The value in the Continuing field on the Case Medical History object on the associated Parent Information Case.
D.10.7.1.r.4 End Date	The date in the End Date field on the Case Medical History object on the associated Parent Information Case.
D.10.7.1.r.5 Comments	The text in the Comments field on the Case Medical History object on the associated Parent Information Case, to a limit of 2,000 characters.
D.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent	The text in the Medical History Text field on the associated Parent Information Case, to a limit of 10,000 characters.

D.10.8.r Relevant Past Drug History of Parent

E2B Data Element Name	Populated Value
D.10.8.r.1 Name of Drug as Reported	The text in the Name Reported field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.2a MPID Version Date/Number	The value in the MPID Version field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.2b Medicinal Product Identifier (MPID)	The value in the MPID field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.3a PhPID Version Date/Number	The value in the PhPID Version field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.3b Pharmaceutical Product Identifier (PhPID)	The value in the PhPID field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.4 Start Date	The date in the Start Date field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.5 End Date	The date in the End Date field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.6a MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information Case.
D.10.8.r.6b Indication (MedDRA code)	The indication MedDRA LLT coded on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.7a MedDRA Version for Reaction	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information Case.
D.10.8.r.7b Reactions (MedDRA code)	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information Case.

D.CN Regional Patient Data

E2B Data Element Name	Populated Value
D.CN.1 Patient Nationality 民族	The NMPA Patient Nationality value from the Patient-type Localized Case Contact.
D.CN.2 Race 种族	An E2B Code from the NMPA Race controlled vocabulary value based on the NMPA Patient Race field of a Localized Case Contact record using the following Contact Type priority order: Patient Reporter for which the Qualification is Patient The available E2B Codes are: `1:` East Asian (yellow) `2:` Caucasian (white) `3:` Negro (black) `4:` Australian (brown)
D.CN.3 Medical institution Name and Pharmaceutical Company Name 医疗机构/经营企业名称	Vault exports up to 120 characters from the Facility Name field of a Localized Case Contact record using the following Contact Type priority order: Patient Reporter for which the Qualification is Patient
D.CN.4 Nationality 国籍（地区）	The two-letter ISO code for the Contact Country value using the following priority order: The Patient-type Localized Case Contact record The Reporter-type Localized Case Contact record for which the Qualification is Patient The Patient-type Case Contact record
D.CN.5 Contact 联系电话	Vault populates a field value or nullFlavor from the primary Reporter-type Case Contact record using the following priority order: Telephone Telephone Reason Omitted
D.CN.6 Description of Gestation 妊娠相关描述	The Additional Pregnancy Related Information value from the Narrative section of the Localized Case.

E.I Reaction/Event as Reported by the Primary Source

E2B Data Element Name	Populated Value
E.i.1.1a Reaction / Event as Reported by the Primary Source in Native Language	The text in the Event (Reported) field on the Case Adverse Event.
E.i.1.1b Reaction / Event as Reported by the Primary Source Language	The text in the Event (Reported) - Language field on the Case Adverse Event.
E.i.1.2 Reaction / Event as Reported by the Primary Source for Translation	The text in the Event (Reported) - English (`event_reported_english__v`) field on the Case Adverse Event.
E.i.2.1a MedDRA Version for Reaction / Event	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
E.i.2.1b Reaction / Event (MedDRA code)	The value in the Event (MedDRA) field on the Case Adverse Event.
E.i.3.1 Term Highlighted by the Reporter	The value in the Highlighted Term field on the Case Adverse Event.

E.i.3.2 Seriousness Criteria at Event Level

E2B Data Element Name Populated Value

E.i.3.2a Results in Death Set to True when Results in death is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2b Life Threatening Set to True when Life threatening is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2c Caused / Prolonged Hospitalisation Set to True when Caused / prolonged hospitalisation is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2d Disabling / Incapacitating Set to True when Disabling / incapacitating is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2e Congenital Anomaly / Birth Defect Set to True when Congenital anomaly / birth defect is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2f Other Medically Important Condition Set to True when Other medically important condition or Required Intervention to Prevent Permanent Impairment/Damage (Devices) is selected in the Seriousness field on the Case Adverse Event.

E.i.4 Date of Start of Reaction / Event The date in the Onset field on the Case Adverse Event record. If the value is a partial date, including only the year or year and month, Vault does not populate this data element.

E.i.5 Date of End of Reaction / Event The date in the Cessation field on the Case Adverse Event record. If the value is a partial date, including only the year or year and month, Vault does not populate this data element.

E.i.6a Duration of Reaction / Event (number) The value in the Duration field on the Case Adverse Event.

E.i.6b Duration of Reaction / Event (unit) The unit in the Duration (unit) field on the Case Adverse Event.

E.i.7 Outcome of Reaction / Event at the Time of Last Observation

The value in the Outcome field on the Case Adverse Event.

You must select a Vault E2B code value for this section.

See the following table for the E2B code values and their corresponding E2B(R3) Code values.

Vault E2B Code	E2B(R3) Code
`1` - Recovered/Resolved	`1` - Recovered/Resolved
`2` - Recovering/Resolving	`2` - Recovering/Resolving
`3` - Not Recovered/Not Resolved/Ongoing	`3` - Not Recovered/Not Resolved.Ongoing
`4` - Recovered/Resolved with Sequelae	`4` - Recovered/Resolved with Sequelae
`5` - Fatal	`5` - Fatal
`0` - Unknown	`0` - Unknown

E.i.8 Medical Confirmation by Healthcare Professional Populated based on the value in the HCP Confirmed field on the Case Adverse Event. This field is only transmitted when the Qualification field on the primary (Rank 1) Reporter-type Case Contact does not designate a health professional. That is, the Qualification Controlled Vocabulary does not correspond to E2B codes 1, 2, or 3.

E.i.9 Identification of the Country Where the Reaction / Event Occurred The value in the Event Country field on the Case Adverse Event.

F.r Results of Tests and Procedures Relevant to the Investigation of the Patient

E2B Data Element Name	Populated Value
F.r.1 Test Date	The date or the Reason Omitted value in the Test Date field on the Case Test Result.
F.r.2.1 Test Name (free text)	The value in the Test Name (Reported) field on the Case Test Result.
F.r.2.2a MedDRA Version for Test Name	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
F.r.2.2b Test Name (MedDRA code)	The MedDRA LLT coded on the Case Test Result.
F.r.3.1 Test Result (code)	The value in the Result (code) field on the Case Test Result.
F.r.3.3 Test Result (unit)	The unit in the Result (Unit) field on the Case Test Result. In accordance with ICH guidelines, this element is not populated if the Test Result (code) (F.r.3.1) is provided.
F.r.4 Normal Low Value	The unit and value in the Normal Low Value field on the Case Test Result. If the result does not have a unit, Vault will map any text entered instead.
F.r.5 Normal High Value	The unit and value in the Normal High Value field on the Case Test Result. If the result does not have a unit, Vault will map any text entered instead.
F.r.6 Comments (free text)	The value in the Comments field on the Case Test Result.
F.r.7 More Information Available	The value in the More Information Available field on the Case Test Result.

G.k Drug(s) Information

E2B Data Element Name Populated Value

G.k.1 Characterisation of Drug Role The value in the Drug Role field on the Case Product record.

G.k.2.4 Identification of the Country Where the Drug Was Obtained The value in the Country Obtained field on the Case Product record.

G.k.2.5 Investigational Product Blinded The value in the Blinded field on the Case Product record.

G.k.5a Cumulative Dose to First Reaction (number) The value in the Cumulative Dose field on the Case Product record.

G.k.5b Cumulative Dose to First Reaction (unit) The unit in the Cumulative Dose (unit) field on the Case Product record.

G.k.6a Gestation Period at Time of Exposure (number) The value in the Gestation Exposure field on the Case Product record.

G.k.6b Gestation Period at Time of Exposure (unit) The unit in the Gestation Exposure (unit) field on the Case Product record.

G.k.8 Action(s) Taken with Drug

The value in the Action Taken field on the Case Product record.

You must select a Vault E2B code value for this section.

See the following table for the E2B code values and their corresponding E2B(R3) Code values.

Vault E2B Code	E2B(R3) Code
`1` - Drug Withdrawn	`1` - Drug Withdrawn
`2` - Dose Reduced	`2` - Dose Reduced
`3` - Dose Increased	`3` - Dose Increased
`4` - Dose Not Changed	`4` - Dose Not Changed
`0` - Unknown	`0` - Unknown
`9` - Not Applicable	`9` - Not Applicable

G.k.10.r Additional Information on Drug (coded) The value in the Additional Information field on the Case Product record.

G.k.11 Additional Information on Drug (free text) The value in the Additional Information (text) field on the Case Product record.

G.k.2 Drug Identification

E2B Data Element Name	Populated Value
G.k.2.1.1a MPID Version Date / Number	The value in the MPID Version field on the Case Product record.
G.k.2.1.1b Medicinal Product Identifier (MPID)	The value in the MPID field on the Case Product record.
G.k.2.1.2a PhPID Version Date/Number	The value in the PhPID Version field on the Case Product record.
G.k.2.1.2b Pharmaceutical Product Identifier (PhPID)	The value in the PhPID field on the Case Product record.
G.k.2.2 Medicinal Product Name as Reported by the Primary Source	The value in the Product (Reported) field on the Localized Case Product record.

G.k.2.3.r Substance / Specified Substance Identifier and Strength

E2B Data Element Name	Populated Value
G.k.2.3.r.1 Substance / Specified Substance Name	The value in the Name (Reported) field on the Case Product Substance.
G.k.2.3.r.2a Substance / Specified Substance TermID Version Date/Number	The value in the TermID Version field on the Case Product Substance.
G.k.2.3.r.2b Substance / Specified Substance TermID	The value in the TermID field on the Case Product Substance.
G.k.2.3.r.3a Strength (number)	The value in the Strength (Number) field on the Case Product Substance.
G.k.2.3.r.3b Strength (unit)	The unit in the Strength (Unit) field on the Case Product Substance.

G.k.3 Holder and Authorisation / Application Number of Drug

E2B Data Element Name	Populated Value
G.k.3.1 Authorisation / Application Number	If the Registration Country is within the jurisdiction of the agency or is blank, this is populated with the information entered in the Registration Number field on the Case Product record. If the Registration Country is not in the jurisdiction of the agency, this data element is blank.
G.k.3.2 Country of Authorisation / Application	If the Registration Country is within the jurisdiction of the agency, this is populated with the 2-letter country code for the country selected in the Registration Country field on the Case Product record. If the Registration Country is not in the jurisdiction of the agency or is blank, this data element is blank.
G.k.3.3 Name of Holder / Applicant	If the Registration Country is within the jurisdiction of the agency or is blank, this is populated with the information entered in the Registration Holder/Applicant field on the Case Product record. If the Registration Country is not in the jurisdiction of the agency, this data element is blank.

E2B Data Element Name

Populated Value

G.k.3.1 Authorisation / Application Number

If the Registration Country is within the jurisdiction of the agency or is blank, this is populated with the information entered in the Registration Number field on the Case Product record.

If the Registration Country is not in the jurisdiction of the agency, this data element is blank.

G.k.3.2 Country of Authorisation / Application

If the Registration Country is within the jurisdiction of the agency, this is populated with the 2-letter country code for the country selected in the Registration Country field on the Case Product record.

If the Registration Country is not in the jurisdiction of the agency or is blank, this data element is blank.

G.k.3.3 Name of Holder / Applicant

If the Registration Country is within the jurisdiction of the agency or is blank, this is populated with the information entered in the Registration Holder/Applicant field on the Case Product record.

If the Registration Country is not in the jurisdiction of the agency, this data element is blank.

G.k.4.r Dosage and Relevant Information

E2B Data Element Name	Populated Value
G.k.4.r.1a Dose (number)	The value in the Dose (number) field on the Case Product Dosage.
G.k.4.r.1b Dose (unit)	The unit in the Dose (unit) field on the Case Product Dosage.
G.k.4.r.2 Number of Units in the Interval	The value in the Frequency (number) field on the Case Product Dosage.
G.k.4.r.3 Definition of the Time Interval Unit	The unit in the Frequency (unit) field on the Case Product Dosage.
G.k.4.r.4 Date and Time of Start of Drug	The date in the First Admin Date field on the Case Product Dosage. If the value is a partial date, including only the year or year and month, Vault does not populate this data element.
G.k.4.r.5 Date and Time of Last Administration	The value in the Last Admin Date field on the Case Product Dosage. If the value is a partial date, including only the year or year and month, Vault does not populate this data element.
G.k.4.r.6a Duration of Drug Administration (number)	The value in the Duration (number) field on the Case Product Dosage.
G.k.4.r.6b Duration of Drug Administration (unit)	The unit in the Duration (unit) field on the Case Product Dosage.
G.k.4.r.7 Batch / Lot Number	The value in the Batch/Lot Number field on the Case Product Dosage. This element is not transmitted when nullFlavours are selected.
G.k.4.r.8 Dosage Text	The value in the Dosage Text field on the Case Product Dosage. When a custom value is entered in the Dose (Unit) field, the Dose and Dose (Unit) values are mapped to this element, preceded by the label "DOSAGE:".
G.k.4.r.9.1 Pharmaceutical Dose Form (free text)	The value in the Dose Form Text field on the Case Product Dosage.
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number	If the Dose Form TermID Version field value maps to a current EDQM Term, the EDQM Version field is exported. If the field value does not map to a current EDQM Term, Vault does not populate this data element.
G.k.4.r.9.2b Pharmaceutical Dose Form TermID	If the Dose Form TermID field value maps to a current EDQM Term, the EDQM Code field is exported. If the field value does not map to a current EDQM Term, Vault does not populate this data element.
G.k.4.r.10.1 Route of Administration	The value in the Patient RoA field on the Case Product Dosage. This field is included only if structured data is not provided in G.k.4.r.10.2a/b.
G.k.4.r.10.2a Route of Administration TermID Version Date / Number	If the Patient RoA TermID Version field value maps to a current EDQM Term, the EDQM Version field is exported. If the field value does not map to a current EDQM Term, Vault does not populate this data element.
G.k.4.r.10.2b Route of Administration TermID	If the Patient RoA TermID field value maps to a current EDQM Term, the EDQM Code field is exported. If the field value does not map to a current EDQM Term, Vault does not populate this data element.
G.k.4.r.11.1 Parent Route of Administration (free text)	The value in the Parent RoA field on the Case Product Dosage.
G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number	If the Parent RoA TermID Version field value maps to a current EDQM Term, the EDQM Version field is exported. If the field value does not map to a current EDQM Term, Vault does not populate this data element.
G.k.4.r.11.2b Parent Route of Administration TermID	If the Parent RoA TermID field value maps to a current EDQM Term, the EDQM Code field is exported. If the field value does not map to a current EDQM Term, Vault does not populate this data element.
G.k.4.r.CN.1 Dose information Expiration Date/ Expires Date 失效日期/有效期至	The Expiration Date value from the Case Product Dosage record.

G.k.7.r Indication for Use in Case

E2B Data Element Name	Populated Value
G.k.7.r.1 Indication as Reported by the Primary Source	The text from the Name (Reported) field on the Case Product Indication.
G.k.7.r.2a MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
G.k.7.r.2b Indication (MedDRA code)	The MedDRA LLT coded on the Case Product Indication.

G.k.9.i Drug-reaction(s) / Event(s) Matrix

E2B Data Element Name	Populated Value
G.k.9.i.1 Reaction(s) / Event(s) Assessed	The specific reaction or event being assessed, referenced in the Case Adverse Event field on the Case Assessment. This is not a user-entered element.
G.k.9.i.3.1a Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number)	The value in the First Dose Latency (number) field on the Case Assessment.
G.k.9.i.3.1b Time Interval between Beginning of Drug Administration and Start of Reaction / Event (unit)	The unit in the First Dose Latency (unit) field on the Case Assessment.
G.k.9.i.3.2a Time Interval between Last Dose of Drug and Start of Reaction / Event (number)	The value in the Last Dose Latency (number) field on the Case Assessment.
G.k.9.i.3.2b Time Interval between Last Dose of Drug and Start of Reaction / Event (unit)	The unit in the Last Dose Latency (unit) field on the Case Assessment.
G.k.9.i.4 Did Reaction Recur on Re-administration?	The appropriate value is populated, based on the value in the Reaction Recurrence field on the Case Assessment: `1`: yes - yes (rechallenge was done, reaction reccurred) `2`: yes - no (rechallenge was done, reaction did not recur) `3`: yes - unk (rechallenge was done, outcome unknown) `4`: no - n/a (no rechallenge was done, recurrence is not applicable)

G.k.9.i.2.r Assessment of Relatedness of Drug to Reaction(s) / Event(s)

E2B Data Element Name Populated Value

G.k.9.i.2.r.1 Source of Assessment

Vault maps this value from one of the following fields on the Case Assessment Result, ordered by priority:

Vault first attempts to map the E2B code corresponding to the Source Type Controlled Vocabulary.
If Vault cannot map the E2B code, Vault maps the free text value from the Source (text) field.

G.k.9.i.2.r.2 Method of Assessment

Vault maps a text value from one of the following fields on the Case Assessment Result, ordered by priority:

Vault first attempts to map the picklist value corresponding to the Method of Assessment Controlled Vocabulary.
If no Method of Assessment Controlled Vocabulary value was selected, Vault maps the free text value from the Method (text) field.

G.k.9.i.2.r.3 Result of Assessment

Vault maps a text value from one of the following fields on the Case Assessment Result, ordered by priority:

If enabled, the value is mapped from the Assessment Result (Override) field.

Note: An Admin must add the Assessment Result (Override) field to the layout and Veeva Support must enable this usage in your Vault.

Vault otherwise attempts to map the E2B code corresponding to the Assessment Result Controlled Vocabulary.
If Vault cannot map the E2B code, Vault maps the free text value from the Result (text) field.

G.k.9.i.2.r.CN.1 Initial Report/Marketing Licensee Evaluation Source 初始报告人/上市许可持有人评估来源

Vault populates the E2B Code from the Localized Case Assessment Source controlled vocabulary corresponding to the value in the Localized Assessment Source field on the Localized Case Assessment Result record:

1: NMPA Primary Reporter
2: NMPA Listed Licensees

G.k.9.i.2.r.CN.2 Assessment Results 评估结果

Vault populates the E2B Code from the Localized Case Assessment Result controlled vocabulary corresponding to the value in the Localized Assessment Result field on the Localized Case Assessment Result record:

1: Certain or Positive
2: Likely or Probable
3: Possible
4: Unlikely or Probably Unrelated
5: Unassessable/unclassifiable or Not Available
6: To Be Evaluated

If the Localized Assessment Result field on the Localized Case Assessment Result record is blank or does not match a value above, Vault populates the E2B Code from the Case Assessment Result controlled vocabulary corresponding to the value in the Assessment Result field on the Case Assessment Result record:

1: Related
2: Probably Related or Reasonable Possibility
3: Possibly Related
4: Unlikely Related or Not Related
5: Not Applicable

Vault does not populate this data element if the value in the Special Adverse Event field in the Details section of the Localized Case is Non-reportable Event.

G.k.9.i.CN.1 Unexpected (Labeled?) 是否非预期

For non-clinical trial study Cases and postmarket Cases, Vault exports a code based on the Expected value from the Case Assessment Expectedness record generated for a core Datasheet or a Datasheet for China. Available values are:

1: Expected
2: Unexpected

G.k.9.i.CN.2 Is stopped or reduced, does the reaction disappear or decrease? 停药或减量后，反应是否消失或减轻

Vault exports a code based on a combination of the E2B Codes corresponding to the Action Taken value on the Case Product and the Outcome value on the Case Adverse Event:

Action Taken E2B Code	Outcome E2B Code	Code Exported
`1` or `2`	`1`, `2` or `4`	`1`
	`3` or `5`	`2`
	`0`	`3`
`3`, `4` or `9`	Any	`4`
`0`	Any	`3`

G.k.CN Regional Drug Data

E2B Data Element Name	Populated Value
G.k.CN.1 Generic Name 药品通用名	For Localized Case Product records with Chinese in the Localization field, Vault exports a field value using the following priority order: Generic Name Product Name If the applicable Localized Case Product has any other Localization, Vault populates the Product Name from the Case Product record.
G.k.CN.2 Related Medical Device 相关器械	The Related Device Information value from the Localized Case Product record.
G.k.CN.3 Is this MAH Product? 是否为本持有人产品	For non-clinical trial study Cases and postmarket Cases, Vault exports a value as follows: For domestic Cases, if the primary Case Adverse Event record has China in the Event Country field, Vault exports `是` (true). For Cases without a Classification: If the Case Product record is an External Product, Vault exports `否` (false). If the Organization value on the Case Product record matches the Organization on the Transmission, Vault exports `是` (true). If the Organization value on the Case Product record does not match the Organization on the Transmission, Vault exports `否` (false).
G.k.CN.4 Approval Number/ Acceptance Number 批准文号/受理号	For non-clinical trial study Cases and postmarket Cases, the Registration Number from the Case Product Registration in China. If multiple registrations exist, Vault exports the value from the registration with Default Registration selected or the most recently created registration. For clinical trial study Cases, the value in the CTA Approval Numbers field of the Study Product record.

H Narrative Case Summary and Further Information

E2B Data Element Name	Populated Value
H.1 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information	The text from the Narrative on the Localized Case.
H.2 Reporter's Comments	The text from the Reporter's Comments field on the Case, to a limit of 20,000 characters.
H.4 Sender's Comments	The value in the Company Comments field on the Case, to a limit of 20,000 characters. For Domestic Cases with Localization Scope set to Company Comments or blank, the Localized Company Comments are populated to this element.

H.3.r Sender's Diagnosis

E2B Data Element Name	Populated Value
H.3.r.1a MedDRA Version for Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
H.3.r.1b Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event (MedDRA code)	The MedDRA LLT coded on the Case Diagnosis.

H.5.r Case Summary and Reporter's Comments in Native Language

E2B Data Element Name Populated Value

H.5.r.1a Case Summary and Reporter's Comments Text

E2B Data Element Name	Populated Value
H.5.r.1a Case Summary and Reporter's Comments Text	If there is a Case document classified with the Case > Summary > Narrative, the contents of that document is populated in this element, to a limit of 100,000 characters. For Domestic Cases with Localization Scope set to "Narrative" or blank, the Localized Narrative document is populated to this element. This information is separate from the data captured by H.2 Reporter's Comments.
H.5.r.1b Case Summary and Reporter's Comments Language	The 3-letter ISO code from the Language (ISO) document field for the Case document classified with the Case > Summary >Narrative. For Domestic Cases with Localization Scope set to "Narrative" or blank, the language selected on the Localized Narrative document (Document field (`language_iso__v`) is populated to this element. This information is separate from the data captured by H.2 Reporter's Comments.

If there is a Case document classified with the Case > Summary > Narrative, the contents of that document is populated in this element, to a limit of 100,000 characters.

For Domestic Cases with Localization Scope set to "Narrative" or blank, the Localized Narrative document is populated to this element.

This information is separate from the data captured by H.2 Reporter's Comments.

H.5.r.1b Case Summary and Reporter's Comments Language

The 3-letter ISO code from the Language (ISO) document field for the Case document classified with the Case > Summary >Narrative.

For Domestic Cases with Localization Scope set to "Narrative" or blank, the language selected on the Localized Narrative document (Document field (language_iso__v) is populated to this element.

This information is separate from the data captured by H.2 Reporter's Comments.

NMPA E2B(R3) Mapping - NMPA Regional Mappings

C.1 Identification of the Case Safety Report

E2B Data Element Name Populated Value

C.1.CN.1 Report Source 报告来源

E2B Data Element Name	Populated Value
C.1.CN.1 Report Source 报告来源	Vault populates an E2B code from the NMPA Report Source controlled vocabulary corresponding to the value in the NMPA Report Source field on the primary Reporter-type Localized Case Contact: `1`: Regulatory agency `2`: Personal `3`: Medical institution `4`: Operating business `5`: Documentation `6`: Research `7`: Item `8`: Other
C.1.CN.2 Report Classification 报告分类	Vault populates an E2B code from the NMPA Report Classification controlled vocabulary corresponding to the value in the Localized Case details using the following priority order: The NMPA Report Classification field in the Details section The Classification and Study Type values The available codes are: `11`: Domestic Report, Clinical Study `12`: Domestic Reporting Post Marketing `21`: Overseas report Clinical Study `22`: Overseas Reporting Post Marketing
C.1.CN.3 Report Holder / Manufacturer Authorization Holder Information 持有人标识	For non-clinical trial study Cases and postmarket Cases, Vault exports a value using the following priority order: If the primary suspect Case Product has a Case Product Registration in China, Vault exports the value in the Official Name field of the Localized Organization record for China. If the primary suspect Case Product has any Product Registrations in China, Vault exports the value in the Official Name field of any Localized Organization record with this information populated. If the primary suspect Case Product does not have any Product Registrations in China, Vault checks other suspect Case Products for any Product Registrations in China and exports the value in the Official Name field of any Localized Organization record with this information populated. For multiple matches in any of the above scenarios, Vault exports the Official Name of the most recently created Localized Organization.

Vault populates an E2B code from the NMPA Report Source controlled vocabulary corresponding to the value in the NMPA Report Source field on the primary Reporter-type Localized Case Contact:

1: Regulatory agency
2: Personal
3: Medical institution
4: Operating business
5: Documentation
6: Research
7: Item
8: Other

C.1.CN.2 Report Classification 报告分类

Vault populates an E2B code from the NMPA Report Classification controlled vocabulary corresponding to the value in the Localized Case details using the following priority order:

The NMPA Report Classification field in the Details section
The Classification and Study Type values

The available codes are:

11: Domestic Report, Clinical Study
12: Domestic Reporting Post Marketing
21: Overseas report Clinical Study
22: Overseas Reporting Post Marketing

C.1.CN.3 Report Holder / Manufacturer Authorization Holder Information 持有人标识

For non-clinical trial study Cases and postmarket Cases, Vault exports a value using the following priority order:

If the primary suspect Case Product has a Case Product Registration in China, Vault exports the value in the Official Name field of the Localized Organization record for China.
If the primary suspect Case Product has any Product Registrations in China, Vault exports the value in the Official Name field of any Localized Organization record with this information populated.
If the primary suspect Case Product does not have any Product Registrations in China, Vault checks other suspect Case Products for any Product Registrations in China and exports the value in the Official Name field of any Localized Organization record with this information populated.

For multiple matches in any of the above scenarios, Vault exports the Official Name of the most recently created Localized Organization.

C.2.r Primary Source(s) of Information

E2B Data Element Name	Populated Value
C.2.r.CN.1 E.Mail Address 电子邮箱	The email address of the primary Reporter-type Case Contact.

D.8.r Relevant Past Drug History

E2B Data Element Name	Populated Value
D.8.r.4 Start Date	The date in the Start Date field on the Case Drug History record. If the value is a partial date, for example including only the year or year and month, Vault does not populate this data element.
D.8.r.5 End Date	The date in the End Date field on the Case Drug History record. If the value is a partial date, for example including only the year or year and month, Vault does not populate this data element.

D.9 In case of Death

E2B Data Element Name	Populated Value
D.9.1 Date of Death	The date in the Date of Death field on the Case. If the value is a partial date, including only the year or year and month, Vault exports the nullFlavor `ASKU`.
D.9.2.r.2 Reported Cause(s) of Death (free text)	The value in the Cause of Death (Reported) field on the Localized Case Cause of Death record. If blank, Vault exports `死因不明`.
D.9.3 Was Autopsy Done?	If the Cause of Death (Reported) field on the Localized Case Cause of Death record is blank, Vault exports the nullFlavor `UNK`. Otherwise, Vault exports the value in the Autopsy or Autopsy (reason omitted) field on the Case.

D.CN Regional Patient Data

E2B Data Element Name	Populated Value
D.CN.1 Patient Nationality 民族	The NMPA Patient Nationality value from the Patient-type Localized Case Contact.
D.CN.2 Race 种族	An E2B Code from the NMPA Race controlled vocabulary value based on the NMPA Patient Race field of a Localized Case Contact record using the following Contact Type priority order: Patient Reporter for which the Qualification is Patient The available E2B Codes are: `1:` East Asian (yellow) `2:` Caucasian (white) `3:` Negro (black) `4:` Australian (brown)
D.CN.3 Medical institution Name and Pharmaceutical Company Name 医疗机构/经营企业名称	Vault exports up to 120 characters from the Facility Name field of a Localized Case Contact record using the following Contact Type priority order: Patient Reporter for which the Qualification is Patient
D.CN.4 Nationality 国籍（地区）	The two-letter ISO code for the Contact Country value using the following priority order: The Patient-type Localized Case Contact record The Reporter-type Localized Case Contact record for which the Qualification is Patient The Patient-type Case Contact record
D.CN.5 Contact 联系电话	Vault populates a field value or nullFlavor from the primary Reporter-type Case Contact record using the following priority order: Telephone Telephone Reason Omitted
D.CN.6 Description of Gestation 妊娠相关描述	The Additional Pregnancy Related Information value from the Narrative section of the Localized Case.

E.i.3.2 Seriousness Criteria at Event Level

E2B Data Element Name	Populated Value
E.i.4 Date of Start of Reaction / Event	The date in the Onset field on the Case Adverse Event record. If the value is a partial date, including only the year or year and month, Vault does not populate this data element.
E.i.5 Date of End of Reaction / Event	The date in the Cessation field on the Case Adverse Event record. If the value is a partial date, including only the year or year and month, Vault does not populate this data element.

G.k.2 Drug Identification

E2B Data Element Name	Populated Value
G.k.2.2 Medicinal Product Name as Reported by the Primary Source	The value in the Product (Reported) field on the Localized Case Product record.

G.k.4.r Dosage and Relevant Information

E2B Data Element Name	Populated Value
G.k.4.r.4 Date and Time of Start of Drug	The date in the First Admin Date field on the Case Product Dosage. If the value is a partial date, including only the year or year and month, Vault does not populate this data element.
G.k.4.r.5 Date and Time of Last Administration	The value in the Last Admin Date field on the Case Product Dosage. If the value is a partial date, including only the year or year and month, Vault does not populate this data element.
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number	If the Dose Form TermID Version field value maps to a current EDQM Term, the EDQM Version field is exported. If the field value does not map to a current EDQM Term, Vault does not populate this data element.
G.k.4.r.9.2b Pharmaceutical Dose Form TermID	If the Dose Form TermID field value maps to a current EDQM Term, the EDQM Code field is exported. If the field value does not map to a current EDQM Term, Vault does not populate this data element.
G.k.4.r.10.2a Route of Administration TermID Version Date / Number	If the Patient RoA TermID Version field value maps to a current EDQM Term, the EDQM Version field is exported. If the field value does not map to a current EDQM Term, Vault does not populate this data element.
G.k.4.r.10.2b Route of Administration TermID	If the Patient RoA TermID field value maps to a current EDQM Term, the EDQM Code field is exported. If the field value does not map to a current EDQM Term, Vault does not populate this data element.
G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number	If the Parent RoA TermID Version field value maps to a current EDQM Term, the EDQM Version field is exported. If the field value does not map to a current EDQM Term, Vault does not populate this data element.
G.k.4.r.11.2b Parent Route of Administration TermID	If the Parent RoA TermID field value maps to a current EDQM Term, the EDQM Code field is exported. If the field value does not map to a current EDQM Term, Vault does not populate this data element.
G.k.4.r.CN.1 Dose information Expiration Date/ Expires Date 失效日期/有效期至	The Expiration Date value from the Case Product Dosage record.

G.k.9.i.2.r Assessment of Relatedness of Drug to Reaction(s) / Event(s)

E2B Data Element Name Populated Value

G.k.9.i.2.r.CN.1 Initial Report/Marketing Licensee Evaluation Source 初始报告人/上市许可持有人评估来源

1: NMPA Primary Reporter
2: NMPA Listed Licensees

G.k.9.i.2.r.CN.2 Assessment Results 评估结果

1: Certain or Positive
2: Likely or Probable
3: Possible
4: Unlikely or Probably Unrelated
5: Unassessable/unclassifiable or Not Available
6: To Be Evaluated

1: Related
2: Probably Related or Reasonable Possibility
3: Possibly Related
4: Unlikely Related or Not Related
5: Not Applicable

Vault does not populate this data element if the value in the Special Adverse Event field in the Details section of the Localized Case is Non-reportable Event.

G.k.9.i.CN.1 Unexpected (Labeled?) 是否非预期

1: Expected
2: Unexpected

G.k.9.i.CN.2 Is stopped or reduced, does the reaction disappear or decrease? 停药或减量后，反应是否消失或减轻

Vault exports a code based on a combination of the E2B Codes corresponding to the Action Taken value on the Case Product and the Outcome value on the Case Adverse Event:

Action Taken E2B Code	Outcome E2B Code	Code Exported
`1` or `2`	`1`, `2` or `4`	`1`
	`3` or `5`	`2`
	`0`	`3`
`3`, `4` or `9`	Any	`4`
`0`	Any	`3`

G.k.CN Regional Drug Data

E2B Data Element Name	Populated Value
G.k.CN.1 Generic Name 药品通用名	For Localized Case Product records with Chinese in the Localization field, Vault exports a field value using the following priority order: Generic Name Product Name If the applicable Localized Case Product has any other Localization, Vault populates the Product Name from the Case Product record.
G.k.CN.2 Related Medical Device 相关器械	The Related Device Information value from the Localized Case Product record.
G.k.CN.3 Is this MAH Product? 是否为本持有人产品	For non-clinical trial study Cases and postmarket Cases, Vault exports a value as follows: For domestic Cases, if the primary Case Adverse Event record has China in the Event Country field, Vault exports `是` (true). For Cases without a Classification: If the Case Product record is an External Product, Vault exports `否` (false). If the Organization value on the Case Product record matches the Organization on the Transmission, Vault exports `是` (true). If the Organization value on the Case Product record does not match the Organization on the Transmission, Vault exports `否` (false).
G.k.CN.4 Approval Number/ Acceptance Number 批准文号/受理号	For non-clinical trial study Cases and postmarket Cases, the Registration Number from the Case Product Registration in China. If multiple registrations exist, Vault exports the value from the registration with Default Registration selected or the most recently created registration. For clinical trial study Cases, the value in the CTA Approval Numbers field of the Study Product record.

H Narrative Case Summary and Further Information

E2B Data Element Name	Populated Value
H.1 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information	The text from the Narrative on the Localized Case.