Note: Vault automatically validates E2B files. In addition, Vault enables you to configure custom Validation Criteria for Case data through the user-friendly Vault Expression Engine.
| 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. |
| 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| N.2.r.4 Date of Message Creation | If the Case is Approved, Closed, or Superseded, the date in the Approval Date field.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. |
| E2B Data Element Name | Populated Value |
|---|---|
| C.1.1 Sender's (case) Safety Report Unique Identifier | The UID on the Case Version. |
| C.1.2 Date of Creation | If the Case is Approved, Closed, or Superseded, the date in the Approval Date field. 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 | Vault populates a code based on the Report Type of the Case:
|
| C.1.4 Date Report Was First Received from Source | For initial and follow-up Cases, the Receipt Date on the Case. When the Receipt Date includes a time and time zone, Vault truncates the value to YYYYMMDD.
|
| C.1.5 Date of Most Recent Information for This Report | The New Info Date on the Case. When the New Info Date includes a time and time zone, Vault truncates the value to YYYYMMDD.
|
| 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 ICSR Transmission 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, Vault populates this element with 1 (expedited). Otherwise, Vault populates this element with 2 (non-expedited). If both fields are blank, nullFlavor ( |
| 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.1.8.1 Worldwide Unique Case Identification Number | The Worldwide UID on the Case Version. |
| 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. |
| 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.3.1.KR.1 Health Professional Type | Vault maps the value in the MFDS Health Professional Type field on the Localized Organization related to the Organization for the Sender (User) on the Transmission Profile as follows:
If the relevant Organization includes multiple Localized Organizations, Vault maps a value based on the most recently created record with a value in the MFDS Health Professional Type field. |
| 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. |
| 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. |
| E2B Data Element Name | Populated Value |
|---|---|
| C.5.1.r.1 Study Registration Number | The Registration Number on the Case Study Registration. For domestic Cases, Vault exports this value only for studies registered in Korea. |
| C.5.1.r.2 Study Registration Country | The 2-letter ISO code associated with the Country on the Case Study Registration. For domestic Cases, Vault exports this value only for studies registered in Korea. |
| 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 Localized Study Number on the associated Localized Study. If none exists, Vault exports the Study Number on the associated Study. |
| C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed | The Study Type on the Case. |
| C.5.4.KR.1 Other Studies Type | Based on the MFDS Other Study Type in the Study section of the Localized Case, Vault populates an E2B code corresponding to the MFDS Other Study Type controlled vocabulary. If the MFDS Other Study Type field is blank and the Study Type is Other Study, Vault exports E2B code Vaults configured for the ICH E2D(R1) study types have additional population logic for this data element. |
| E2B Data Element Name | Populated Value |
|---|---|
| D.1 Patient (name or initials) | The value in the Patient Initials / ID field on the Case. |
| 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. |
| 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. If Date of Birth, Age at Vaccination, Age, Age Group, and Gestation are blank, Vault exports the nullFlavor MSK.
|
| D.2.2a Age at Time of Onset of Reaction / Event (number) | The Age on the Case. In accordance with ICH guidelines, Vault does not transmit this data element if the D.2.1 Date of Birth 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, Vault does not transmit this data element if the D.2.1 Date of Birth data element includes a value. |
| 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. |
| 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 record. |
| D.7.1.r.2 Start Date | The date in the Start Date field on the Case Medical History record. |
| D.7.1.r.3 Continuing | The appropriate value is populated, based on the Continuing field on the Case Medical History record. |
| D.7.1.r.4 End Date | The date in the End Date field on the Case Medical History record. |
| D.7.1.r.5 Comments | The text in the Comments field on the Case Medical History record, 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 record. |
| 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. |
| 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.1.KR.1a Medicinal Product Version | The value in the MPID Version field of the Case Drug History record. |
| D.8.r.1.KR.1b Medicinal Product ID | For domestic Localized Cases, Vault exports the value in the Local MPID field on the Localized Case Drug History record. If the field is blank, Vault exports the value in the MPID field on the related Case Drug History record. For foreign Localized Cases, Vault exports the value in the MPID field on the related Case Drug History record. |
| D.8.r.2a MPID Version Date/Number | The MPID Version on the Case Drug History record. When the value corresponds to a date, Vault converts it to YYYYMMDD format.
|
| 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 PhPID Version on the Case Drug History record. When the value corresponds to a date, Vault converts it to YYYYMMDD format.
|
| 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. |
| D.8.r.5 End Date | The date in the End Date field on the Case Drug History record. |
| 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. |
| E2B Data Element Name | Populated Value |
|---|---|
| D.9.1 Date of Death | The date in the Date of Death field on the Case. |
| 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 text in the Name (Reported) field on the Case Cause of Death record. |
| D.9.3 Was Autopsy Done? | The value in the Autopsy 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. |
| E2B Data Element Name | Populated Value |
|---|---|
| D.10.1 Parent Identification | The Patient ID on the associated Parent Information. |
| D.10.2.1 Date of Birth of Parent | The Date of Birth on the associated Parent Information. For Vault to transmit this value, the full date is required with year, month, and day. |
| D.10.2.2a Age of Parent (number) | The Age on the associated Parent Information. In accordance with ICH guidelines, Vault does not transmit this data element if the D.10.2.1 Date of Birth of Parent data element includes a value. |
| D.10.2.2b Age of Parent (unit) | The Age (unit) on the associated Parent Information. In accordance with ICH guidelines, Vault does not transmit this data element if the D.10.2.1 Date of Birth of Parent data element includes a value. |
| D.10.3 Last Menstrual Period Date of Parent | The date in the Last Menstrual field on the associated Parent Information. |
| D.10.4 Body Weight (kg) of Parent | The value in the Weight field on the associated Parent Information. |
| D.10.5 Height (cm) of Parent | The value in the Height (normalized) field on the associated Parent Information. |
| D.10.6 Sex of Parent | The value in the Sex field on the associated Parent Information. |
| 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. |
| D.10.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code) | The MedDRA LLT coded on the Case Medical History record on the associated Parent Information. |
| D.10.7.1.r.2 Start Date | The date in the Start Date field on the Case Medical History record on the associated Parent Information. |
| D.10.7.1.r.3 Continuing | The value in the Continuing field on the Case Medical History record on the associated Parent Information. |
| D.10.7.1.r.4 End Date | The date in the End Date field on the Case Medical History record on the associated Parent Information. |
| D.10.7.1.r.5 Comments | The text in the Comments field on the Case Medical History record on the associated Parent Information, 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, to a limit of 10,000 characters. |
| 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 record on the associated Parent Information. |
| D.10.8.r.1.KR.1a Medicinal Product Version | For Parent Information records, Vault exports the value in the WHODrug Version field of the Case Drug History record. |
| D.10.8.r.1.KR.1b Medicinal Product ID | For domestic Localized Parent Information, Vault exports the value in the Local MPID field on the Localized Case Drug History record. If the field is blank, Vault exports the value in the MPID field on the related Case Drug History record. For foreign Localized Parent Information, Vault exports the value in the MPID field on the related Case Drug History record. |
| D.10.8.r.2a MPID Version Date/Number | The MPID Version on the Case Drug History record on the associated Parent Information. When the value corresponds to a date, Vault converts it to YYYYMMDD format.
|
| D.10.8.r.2b Medicinal Product Identifier (MPID) | The value in the MPID field on the Case Drug History record on the associated Parent Information. |
| D.10.8.r.3a PhPID Version Date/Number | The PhPID Version on the Case Drug History record on the associated Parent Information. When the value corresponds to a date, Vault converts it to YYYYMMDD format.
|
| D.10.8.r.3b Pharmaceutical Product Identifier (PhPID) | The value in the PhPID field on the Case Drug History record on the associated Parent Information. |
| D.10.8.r.4 Start Date | The date in the Start Date field on the Case Drug History record on the associated Parent Information. |
| D.10.8.r.5 End Date | The date in the End Date field on the Case Drug History record on the associated Parent Information. |
| 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. |
| D.10.8.r.6b Indication (MedDRA code) | The indication MedDRA LLT coded on the Case Drug History record on the associated Parent Information. |
| 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. |
| 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. |
| E2B Data Element Name | Populated Value |
|---|---|
| E.i.1.1a Reaction / Event as Reported by the Primary Source in Native Language | Depending on your Vault's Deferred Domestic Processing: Localized Event Reported in Native Language setting, Vault exports the Event (Reported) field from either the global Case Adverse Event or the Localized Case Adverse Event. |
| E.i.1.1b Reaction / Event as Reported by the Primary Source Language | Depending on your Vault's Deferred Domestic Processing: Localized Event Reported in Native Language setting, Vault exports the Event (Reported) - Language field from either the global Case Adverse Event or the Localized 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 Event (LLT) 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. |
| 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. | ||||||||||||||
| E.i.5 Date of End of Reaction / Event | The date in the Resolved field on the Case Adverse Event. | ||||||||||||||
| 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.
|
||||||||||||||
| 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. |
| 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.3.2 Test Result (value / qualifier) | The values in the Test Result (Qualifier) and (Number) fields 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. Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, this element is not populated. Instead, the Test Result (Number) and Result (Unit) Text fields are mapped to F.r.3.4. |
| 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.3.4 Result Unstructured Data (free text) | The value in the Result (Text) field on the Case Test Result. In accordance with ICH guidelines, Vault adheres to the following rules when mapping this field:
Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, the number and unit text are populated in this 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. |
| E2B Data Element Name | Populated Value | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| G.k.1 Characterisation of Drug Role | The Drug Role 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) | 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.
|
||||||||||||||
| 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. |
| E2B Data Element Name | Populated Value |
|---|---|
| G.k.2.1.1a MPID Version Date / Number | The MPID Version on the Case Product. When the value corresponds to a date, Vault converts it to YYYYMMDD format.
|
| 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.KR.1a Medicinal Product Version | For foreign Cases, Vault exports the MPID Version on the Case Product. For domestic Cases, Vault exports the G.k.2.1.KR.1a tag, but leaves it blank. |
| G.k.2.1.KR.1b Medicinal Product ID | For foreign Cases, Vault exports the value in the MPID field of the Case Product record. For domestic Cases Vault exports the value in the Local MPID field on the Localized Case Product record. If the field is blank, Vault exports the value in the MPID field on the Case Product record. |
| G.k.2.1.2a PhPID Version Date/Number | The PhPID Version on the Case Product. When the value corresponds to a date, Vault converts it to YYYYMMDD format.
|
| 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 Case Product record. |
| E2B Data Element Name | Populated Value |
|---|---|
| G.k.2.3.r.1 Substance / Specified Substance Name | The Name (Reported) on the Case Product Substance. |
| G.k.2.3.r.1.KR.1a Substance ID Version | For foreign Cases with a value exported to the G.k.2.3.r.1.KR.1b data element, Vault exports the MPID Version in the Registration section of the related Case Product. For domestic Cases with a value exported to the G.k.2.3.r.1.KR.1b data element, Vault exports the G.k.2.3.r.1.KR.1a tag, but leaves it blank. |
| G.k.2.3.r.1.KR.1b Substance ID | For foreign Cases, Vault exports the CAS Number of the Substance related to the Case Product. For domestic Cases, Vault exports a value using the following priority order:
|
| G.k.2.3.r.2a Substance / Specified Substance TermID Version Date/Number | The TermID Version 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 TermID 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 Strength (Number) on the Case Product Substance. |
| G.k.2.3.r.3b Strength (unit) | The Strength (Unit) field on the Case Product Substance. |
| 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.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 First Admin Date field on the Case Product Dosage. |
| G.k.4.r.5 Date and Time of Last Administration | The Last Admin Date field on the Case Product Dosage. |
| G.k.4.r.6a Duration of Drug Administration (number) | The Duration (number) on the Case Product Dosage. Vault truncates values to whole numbers. |
| 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:.
|
| G.k.4.r.9.1 Pharmaceutical Dose Form (free text) | The Dose Form Text on the Case Product Dosage. |
| G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number | The Dose Form TermID Version on the Case Product Dosage. |
| G.k.4.r.9.2b Pharmaceutical Dose Form TermID | The Dose Form TermID on the Case Product Dosage. |
| G.k.4.r.10.1 Route of Administration | The Patient RoA 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 | The Patient RoA TermID Version on the Case Product Dosage. |
| G.k.4.r.10.2b Route of Administration TermID | The Patient RoA TermID on the Case Product Dosage. |
| 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 | The Parent RoA TermID Version on the Case Product Dosage. |
| G.k.4.r.11.2b Parent Route of Administration TermID | The Parent RoA TermID on the Case Product Dosage. |
| 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. |
Vault does not export this section for device constituent assessments.
| 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 First Dose Latency (number) on the Case Assessment. Vault truncates values to whole numbers. |
| 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 Last Dose Latency (number) on the Case Assessment. Vault truncates values to whole numbers. |
| 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:
|
Vault does not export this section for device constituent assessments.
| 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:
|
| G.k.9.i.2.r.2.KR.1 KR Method of Assessment | If the Method of Assessment on the Case Assessment Result is either KRCT or WHO-UMC, Vault exports the E2B code corresponding to the Case Assessment Method controlled vocabulary value, as follows:
For foreign Cases, Vault does not export a value. |
| G.k.9.i.2.r.3.KR.1 WHO-UMC Result of Assessment | For domestic Cases that are not associated with a clinical trial Study:
|
| G.k.9.i.2.r.3.KR.2 KRCT Result of Assessment | For domestic study Cases, Vault maps an E2B code based on the Assessment Result field value on the Case Assessment Result record as follows:
|
| 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 Case, to a limit of 100,000 characters. |
| H.2 Reporter's Comments | The Reporter's Comments 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. |
| 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. |
| E2B Data Element Name | Populated Value |
|---|---|
| H.5.r.1a Case Summary and Reporter's Comments Text | If there is a Case document classified as Case > Summary > Narrative, Vault populates the contents of that document in this element, to a limit of 100,000 characters. For Localized Cases with Localization Scope set to Narrative or blank, Vault populates the localized narrative document 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 as Case > Summary > Narrative. For Localized Cases with Localization Scope set to Narrative or blank, Vault populates the language selected on the localized narrative document field ( This information is separate from the data captured by H.2 Reporter's Comments. |
| E2B Data Element Name | Populated Value |
|---|---|
| C.2.r.4.KR.1 Other Health Professional Type | Whenever a Case Contact has the Qualification field set to Other health professional, Vault maps the value in the MFDS Other Health Professional Type field as follows:
|
| E2B Data Element Name | Populated Value |
|---|---|
| C.3.1.KR.1 Health Professional Type | Vault maps the value in the MFDS Health Professional Type field on the Localized Organization related to the Organization for the Sender (User) on the Transmission Profile as follows:
If the relevant Organization includes multiple Localized Organizations, Vault maps a value based on the most recently created record with a value in the MFDS Health Professional Type field. |
| E2B Data Element Name | Populated Value |
|---|---|
| C.5.1.r.1 Study Registration Number | The Registration Number on the Case Study Registration. For domestic Cases, Vault exports this value only for studies registered in Korea. |
| C.5.1.r.2 Study Registration Country | The 2-letter ISO code associated with the Country on the Case Study Registration. For domestic Cases, Vault exports this value only for studies registered in Korea. |
| C.5.3 Sponsor Study Number | The Localized Study Number on the associated Localized Study. If none exists, Vault exports the Study Number on the associated Study. |
| C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed | The Study Type on the Case. |
| C.5.4.KR.1 Other Studies Type | Based on the MFDS Other Study Type in the Study section of the Localized Case, Vault populates an E2B code corresponding to the MFDS Other Study Type controlled vocabulary. If the MFDS Other Study Type field is blank and the Study Type is Other Study, Vault exports E2B code Vaults configured for the ICH E2D(R1) study types have additional population logic for this data element. |
| E2B Data Element Name | Populated Value |
|---|---|
| D.8.r.1.KR.1a Medicinal Product Version | The value in the MPID Version field of the Case Drug History record. |
| D.8.r.1.KR.1b Medicinal Product ID | For domestic Localized Cases, Vault exports the value in the Local MPID field on the Localized Case Drug History record. If the field is blank, Vault exports the value in the MPID field on the related Case Drug History record. For foreign Localized Cases, Vault exports the value in the MPID field on the related Case Drug History record. |
| E2B Data Element Name | Populated Value |
|---|---|
| D.10.8.r.1.KR.1a Medicinal Product Version | For Parent Information records, Vault exports the value in the WHODrug Version field of the Case Drug History record. |
| D.10.8.r.1.KR.1b Medicinal Product ID | For domestic Localized Parent Information, Vault exports the value in the Local MPID field on the Localized Case Drug History record. If the field is blank, Vault exports the value in the MPID field on the related Case Drug History record. For foreign Localized Parent Information, Vault exports the value in the MPID field on the related Case Drug History record. |
| E2B Data Element Name | Populated Value |
|---|---|
| G.k.2.1.KR.1a Medicinal Product Version | For foreign Cases, Vault exports the MPID Version on the Case Product. For domestic Cases, Vault exports the G.k.2.1.KR.1a tag, but leaves it blank. |
| G.k.2.1.KR.1b Medicinal Product ID | For foreign Cases, Vault exports the value in the MPID field of the Case Product record. For domestic Cases Vault exports the value in the Local MPID field on the Localized Case Product record. If the field is blank, Vault exports the value in the MPID field on the Case Product record. |
| E2B Data Element Name | Populated Value |
|---|---|
| G.k.2.3.r.1.KR.1a Substance ID Version | For foreign Cases with a value exported to the G.k.2.3.r.1.KR.1b data element, Vault exports the MPID Version in the Registration section of the related Case Product. For domestic Cases with a value exported to the G.k.2.3.r.1.KR.1b data element, Vault exports the G.k.2.3.r.1.KR.1a tag, but leaves it blank. |
| G.k.2.3.r.1.KR.1b Substance ID | For foreign Cases, Vault exports the CAS Number of the Substance related to the Case Product. For domestic Cases, Vault exports a value using the following priority order:
|
| G.k.2.3.r.2a Substance / Specified Substance TermID Version Date/Number | The TermID Version on the Case Product Substance. Vault exports this value only if there is no MPID Version on the Case Product. |
| E2B Data Element Name | Populated Value |
|---|---|
| G.k.4.r.6a Duration of Drug Administration (number) | The Duration (number) on the Case Product Dosage. Vault truncates values to whole numbers. |
| 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:.
|
| E2B Data Element Name | Populated Value |
|---|---|
| G.k.9.i.3.1a Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number) | The First Dose Latency (number) on the Case Assessment. Vault truncates values to whole numbers. |
| G.k.9.i.3.2a Time Interval between Last Dose of Drug and Start of Reaction / Event (number) | The Last Dose Latency (number) on the Case Assessment. Vault truncates values to whole numbers. |
| E2B Data Element Name | Populated Value |
|---|---|
| G.k.9.i.2.r.2.KR.1 KR Method of Assessment | If the Method of Assessment on the Case Assessment Result is either KRCT or WHO-UMC, Vault exports the E2B code corresponding to the Case Assessment Method controlled vocabulary value, as follows:
For foreign Cases, Vault does not export a value. |
| G.k.9.i.2.r.3.KR.1 WHO-UMC Result of Assessment | For domestic Cases that are not associated with a clinical trial Study:
|
| G.k.9.i.2.r.3.KR.2 KRCT Result of Assessment | For domestic study Cases, Vault maps an E2B code based on the Assessment Result field value on the Case Assessment Result record as follows:
|