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 ICSR Transmission. |
| N.1.3 Batch Sender Identifier | The value in the Origin ID field on the Transmission Profile associated with the ICSR Transmission. |
| N.1.4 Batch Receiver Identifier | The value in the Destination ID field on the Transmission Profile associated with the ICSR Transmission. |
| N.1.5 Date of Batch Transmission | The value in the Transmission Date field on the ICSR Transmission. 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 ICSR Transmission. |
| N.2.r.3 Message Receiver Identifier | The value in the Destination ID field on the Transmission Profile associated with the ICSR Transmission. |
| N.2.r.4 Date of Message Creation | If the Case is Approved, Closed, or Superseded, the date in the Approval Date field.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
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. |
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 ( |
| 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 ( |
| 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:
|
| 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
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 ICSR Transmission. If the Sender (User) is not specified on the Transmission, 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 ICSR Transmission. If the Sender (User) is not specified on the Transmission, 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 ICSR Transmission. |
| C.3.3.2 Sender's Title | The value in the Title field in the User record associated with the Sender (User) on the ICSR Transmission. |
| 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 ICSR Transmission. |
| 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 ICSR Transmission. |
| 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 ICSR Transmission. |
| 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 ICSR Transmission. |
| C.3.4.2 Sender's City | The value in the City field in the User record associated with the Sender (User) on the ICSR Transmission. |
| 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 ICSR Transmission. |
| 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 ICSR Transmission. |
| 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 ICSR Transmission. |
| C.3.4.6 Sender's Telephone | The value in the Telephone field in the User record associated with the Sender (User) on the ICSR Transmission. |
| C.3.4.7 Sender's Fax | The value in the Fax field in the User record associated with the Sender (User) on the ICSR Transmission. |
| 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 ICSR Transmission. |
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 a value from the Literature Article using the following priority:
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:
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 Registration Number on the Case Study Registration. |
| C.5.1.r.2 Study Registration Country | The 2-letter ISO code associated with the Country on the Case Study Registration. |
| C.5.2 Study Name | Vault exports a value using the following priority:
|
| C.5.3 Sponsor Study Number | The Study Number 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 of Birth on the Case. For Vault to transmit this value, the full date is required with year, month, and day. |
| D.2.2a Age at Time of Onset of Reaction / Event (number) | The Age on the Case. To comply with NMPA specifications, Vault exports whole numbers only. In accordance with ICH guidelines, Vault does not transmit this element if the Patient Date of Birth (D.2.1) data element includes a value. |
| D.2.2b Age at Time of Onset of Reaction / Event (unit) | The Age (unit) 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 entered 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
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 | When the NMPA Center on the related Transmission Profile is CDR and the Transmission Reason is Initial, Vault exports the Onset date of the Case Adverse Event if the date is later than the New Info Date of the Case. Otherwise, Vault does not export a value. When the NMPA Center on the related Transmission Profile is CDR and the Transmission Reason is not Initial:
When the NMPA Center on the related Transmission Profile is not CDR, Vault exports the Onset date of the Case Adverse Event. If the value is a partial date, including only the year or year and month, Vault does not populate this data element. |
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| E.i.5 Date of End of Reaction / Event | When the NMPA Center on the related Transmission Profile is CDR, Vault exports the Cessation date of the Case Adverse Event if the date is later than the First Admin Date of the Case Product Dosage of any Case Product. Otherwise, Vault does not export a value. When the NMPA Center on the related Transmission Profile is not CDR, Vault exports the Cessation date of the Case Adverse Event. If the value is a partial date, including only the year or year and month, Vault does not populate this data element. |
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| 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.
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| 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.
|
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| 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) | If the Result (Unit) on the Case Test Result matches an Agency Unit of Measurement for the NMPA, Vault exports the corresponding Code. When there is no match, Vault exports the value to data element F.r.3.4. |
| F.r.3.4 Result Unstructured Data (free text) | If the Result (Unit) on the Case Test Result does not match an Agency Unit of Measurement for the NMPA, Vault exports the Result (Text) on the Case Test Result. In accordance with ICH guidelines, Vault:
Note When a Test Result (Number) exists but the Test Result (Unit) is blank, if there is a value in the Result (Unit) Text field, Vault populates the number and unit text in this data element.
|
| 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. | ||||||||||||||
| 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) | If the Cumulative Dose (Unit) on the Case Product matches an Agency Unit of Measurement for the NMPA, Vault exports the corresponding Code. When there is no match, Vault exports {DF}.
|
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| 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.
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| 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 entered 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 | Vault exports a value on the Localized Case Product using the following priority:
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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. Vault exports this value only if there is no MPID Version on the Case Product. |
| G.k.2.3.r.2b Substance / Specified Substance TermID | The value in the TermID field on the Case Product Substance. Vault exports this value only if there is no MPID on the Case Product. |
| 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) | If the Strength (Unit) on the Case Product Substance matches an Agency Unit of Measurement for the NMPA, Vault exports the corresponding Code. When there is no match, Vault exports {DF}.
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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. |
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) | If the Dose (Unit) on the Case Product Dosage matches an Agency Unit of Measurement for the NMPA, Vault exports the corresponding Code. When there is no match, Vault exports {DF}.
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| 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 | Vault exports a value as follows:
For partial dates with only the month and year, Vault populates the first day of the month. For partial dates with only the year, Vault populates the first day of the year. |
| G.k.4.r.5 Date and Time of Last Administration | The Last Admin Date on the Case Product Dosage. For partial dates with only the month and year, Vault populates the first day of the month. For partial dates with only the year, Vault populates the first day of the year. |
| G.k.4.r.6a Duration of Drug Administration (number) | The Duration (number) on the Case Product Dosage. Vault does not export zero. |
| 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 nullFlavors are selected. |
| G.k.4.r.8 Dosage Text | The Dosage Text on the Case Product Dosage. When the Dose (Unit) is a custom value, Vault maps the Dose and Dose (Unit) values to this element preceded by the label DOSAGE:.
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| G.k.4.r.9.1 Pharmaceutical Dose Form (free text) | The Name of the Localized Dose Form with a Localization of Chinese that corresponds to the Dose Form Text on the Case Product Dosage. When multiple matches exist, Vault exports the value from the earliest-created record. Vault includes this field only if structured data is not provided in G.k.4.r.9.2a/b. |
| G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number | If the Dose Form TermID Version on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Version from an EDQM record using the following priority order:
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| G.k.4.r.9.2b Pharmaceutical Dose Form TermID | If the Dose Form TermID on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Code from an EDQM record using the following priority order:
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| G.k.4.r.10.1 Route of Administration | The Name of the Localized Route of Administration with a Localization of Chinese that corresponds to the Patient RoA on the Case Product Dosage. When multiple matches exist, Vault exports the value from the earliest-created record. Vault includes this field 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 on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Version from an EDQM record using the following priority order:
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| G.k.4.r.10.2b Route of Administration TermID | If the Patient RoA TermID on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Code from an EDQM record using the following priority order:
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| G.k.4.r.11.1 Parent Route of Administration (free text) | The Parent RoA 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 on the Case Product Dosage maps to an EDQM term, Vault maps an EDQM Version from an EDQM record using the following priority order:
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| G.k.4.r.11.2b Parent Route of Administration TermID | If the Parent RoA TermID on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Code from an EDQM record using the following priority order:
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| 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:
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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 a value based on a Case Assessment Result field, using the following priority:
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| G.k.9.i.2.r.2 Method of Assessment | Vault maps a value based on a Case Assessment Result field, using the following priority:
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| G.k.9.i.2.r.3 Result of Assessment | Vault maps a value based on a Case Assessment Result field, using the following priority:
Note: Your Admin must add the Assessment Result (Override) field to the Case Assessment Result layout and Veeva Support must enable this usage in your Vault.
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| 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 | When the NMPA Center on the related Transmission Profile is CDR, 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:
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| 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:
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. |
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| G.k.9.i.CN.1 Unexpected (Labeled?) 是否非预期 | When the NMPA Center on the related Transmission Profile is CDR, Vault exports a code based on the Expected value on the Case Assessment Expectedness record generated for a core Datasheet or a Datasheet for China. Available values are:
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| 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 Case Assessment field using the following priority:
Regardless of the source field, Vault exports a code as follows:
If both the Dechallenge Override and Dechallenge fields are blank, 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:
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G.k.CN Regional Drug Data
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 on the Narrative on the Localized Case. If the Localized Case Product includes Additional CTA Approval Numbers, Vault maps those and appends 批准文号.
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| 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 | 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 ( 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
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 if the Classification of the Localized Case is Domestic and the Country of the Case Contact is China. |
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.
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| 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.
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| 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.
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D.CN Regional Patient Data
E.i.3.2 Seriousness Criteria at Event Level
| E2B Data Element Name | Populated Value |
|---|---|
| E.i.4 Date of Start of Reaction / Event | When the NMPA Center on the related Transmission Profile is CDR and the Transmission Reason is Initial, Vault exports the Onset date of the Case Adverse Event if the date is later than the New Info Date of the Case. Otherwise, Vault does not export a value. When the NMPA Center on the related Transmission Profile is CDR and the Transmission Reason is not Initial:
When the NMPA Center on the related Transmission Profile is not CDR, Vault exports the Onset date of the Case Adverse Event. 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 | When the NMPA Center on the related Transmission Profile is CDR, Vault exports the Cessation date of the Case Adverse Event if the date is later than the First Admin Date of the Case Product Dosage of any Case Product. Otherwise, Vault does not export a value. When the NMPA Center on the related Transmission Profile is not CDR, Vault exports the Cessation date of the Case Adverse Event. 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 | Vault exports a value on the Localized Case Product using the following priority:
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G.k.4.r Dosage and Relevant Information
| E2B Data Element Name | Populated Value |
|---|---|
| G.k.4.r.1b Dose (unit) | If the Dose (Unit) on the Case Product Dosage matches an Agency Unit of Measurement for the NMPA, Vault exports the corresponding Code. When there is no match, Vault exports {DF}.
|
| G.k.4.r.4 Date and Time of Start of Drug | Vault exports a value as follows:
For partial dates with only the month and year, Vault populates the first day of the month. For partial dates with only the year, Vault populates the first day of the year. |
| G.k.4.r.5 Date and Time of Last Administration | The Last Admin Date on the Case Product Dosage. For partial dates with only the month and year, Vault populates the first day of the month. For partial dates with only the year, Vault populates the first day of the year. |
| G.k.4.r.6a Duration of Drug Administration (number) | The Duration (number) on the Case Product Dosage. Vault does not export zero. |
| G.k.4.r.8 Dosage Text | The Dosage Text on the Case Product Dosage. When the Dose (Unit) is a custom value, Vault maps the Dose and Dose (Unit) values to this element preceded by the label DOSAGE:.
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| G.k.4.r.9.1 Pharmaceutical Dose Form (free text) | The Name of the Localized Dose Form with a Localization of Chinese that corresponds to the Dose Form Text on the Case Product Dosage. When multiple matches exist, Vault exports the value from the earliest-created record. Vault includes this field only if structured data is not provided in G.k.4.r.9.2a/b. |
| G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number | If the Dose Form TermID Version on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Version from an EDQM record using the following priority order:
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| G.k.4.r.9.2b Pharmaceutical Dose Form TermID | If the Dose Form TermID on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Code from an EDQM record using the following priority order:
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| G.k.4.r.10.1 Route of Administration | The Name of the Localized Route of Administration with a Localization of Chinese that corresponds to the Patient RoA on the Case Product Dosage. When multiple matches exist, Vault exports the value from the earliest-created record. Vault includes this field 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 on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Version from an EDQM record using the following priority order:
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| G.k.4.r.10.2b Route of Administration TermID | If the Patient RoA TermID on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Code from an EDQM record using the following priority order:
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| G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number | If the Parent RoA TermID Version on the Case Product Dosage maps to an EDQM term, Vault maps an EDQM Version from an EDQM record using the following priority order:
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| G.k.4.r.11.2b Parent Route of Administration TermID | If the Parent RoA TermID on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Code from an EDQM record using the following priority order:
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| 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 | When the NMPA Center on the related Transmission Profile is CDR, 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:
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| 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:
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. |
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| G.k.9.i.CN.1 Unexpected (Labeled?) 是否非预期 | When the NMPA Center on the related Transmission Profile is CDR, Vault exports a code based on the Expected value on the Case Assessment Expectedness record generated for a core Datasheet or a Datasheet for China. Available values are:
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| 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 Case Assessment field using the following priority:
Regardless of the source field, Vault exports a code as follows:
If both the Dechallenge Override and Dechallenge fields are blank, 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:
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G.k.CN Regional Drug Data
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 on the Narrative on the Localized Case. If the Localized Case Product includes Additional CTA Approval Numbers, Vault maps those and appends 批准文号.
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