Learn how Vault Safety imports E2B(R3) and (R2) files.
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
About E2B Case Import
Vault Safety can import E2B files using one of the following methods:
- Manually uploading the document and using the Create Inbox Item From Document action.
Import an Inbox Item provides more information. - Receiving an E2B file from an inbound AS2 Gateway Transmission
- Receiving an E2B file from the Receive E2B API
See Receive an E2B Transmission to learn more about the process of receiving E2B files from an AS2 Gateway or API Transmission.
When you import a Case from an E2B file, Vault maps all data and documents to the appropriate object records, fields, and documents.
When you import an Inbox Item from an E2B file, because only certain fields are displayed on Inbox Item layouts, many fields and child records do not appear until you promote to a Case.
Note: To successfully import attachments from an E2B file, the Case > Source > Attachment and Case > Source > Literature document types must exist in your Vault. Per default configuration, these document types must be assigned the Case Source Lifecycle and system-managed auto-naming must be enabled. If attachments fail to import, contact your Admin to verify these settings.
For information on PMDA E2B(R3) XML import data mapping of Japan-specific objects and fields, see PMDA E2B(R3) Case Import.
E2B Data Element Field Mapping
Read the following information to learn how Vault Safety maps information to create a Case and during an E2B(R3) or E2B(R2) import.
Note: For E2B ACK Generation mapping, see Receive an E2B Transmission: ACK Generation Mapping.
E2B(R2)
M.1 ICH ICSR Transmission Identification (batch wrapper)
| E2B Data Element Name | Populated Value |
|---|---|
| M.1.4 Batch Number | Populates the E2B Message ID field on the Inbound Transmission. |
| M.1.5 Batch Sender Identifier | Populates the Origin ID field on the Inbound Transmission. |
| M.1.7b Date of Batch Transmission | Populates the date in the Transmission Date field on the Inbound Transmission. |
ICH ICSR Message Header (message wrapper)
| E2B Data Element Name | Populated Value |
|---|---|
| Message Identifier | Populates the UID field on the Case Identifier object. |
| Message Sender Identifier | Populates the Origin ID field on the Inbound Transmission. |
| Message Receiver Identifier | Populates the Destination ID field on the Inbound Transmission. |
| Date of Message Creation | Populates the Message Creation Date on the Inbound Transmission. |
A: Administrative and Identification Numbers
A.1 Identification of the Case Safety Report
A.2 Primary Source(s) of Information
| E2B Data Element Name | Populated Value |
|---|---|
| A.2.1.1a Reporter's Title | Populates the Title field on the Case Contact record. |
| A.2.1.1b Reporter's Given Name | Populates the First Name field on the Case Contact record. |
| A.2.1.1c Reporter's Middle Name | Populates the Middle Name field on the Case Contact record. |
| A.2.1.1d Reporter's Family Name | Populates the Last Name field on the Case Contact record. |
| A.2.1.2a Reporter's Organisation | Populates the Organization field on the Case Contact record. |
| A.2.1.2b Reporter's Department | Populates the Department field on the Case Contact record. |
| A.2.1.2c Reporter's Street | Populates the Street field on the Case Contact record. |
| A.2.1.2d Reporter's City | Populates the City field on the Case Contact record. |
| A.2.1.2e Reporter's State or Province | Populates the State/Province field on the Case Contact record. |
| A.2.1.2f Reporter's Postcode | Populates the Postal Code/Zip Code field on the Case Contact record. |
| A.2.1.3 Reporter's Country Code | Populates the appropriate Country on the Case Contact object, based on the ISO code.
If the ISO Code for the Reporter's Country Code is not found, Vault attempts to match the country code in the E2B file to an alias in the Country Code Alias field of the Country object. If found, the alias is populated. When multiple countries in Vault Safety match the country code on the file, Vault maps to the first code in alphabetical order. |
| A.2.1.4 Qualification | Populates the Qualification field on the Case Contact record. |
A.3 Information on Sender of Case Safety Report
| E2B Data Element Name | Populated Value |
|---|---|
| A.3.1.1 Sender Type | Populates the Sender Type field on the Sender Case Contact on the Inbound Transmission. |
| A.3.1.2 Sender's Organisation | Populates the Organisation field on the Sender Case Contact on the Inbound Transmission. |
| A.3.1.3a Sender's Department | Populates the Department field on the Sender Case Contact on the Inbound Transmission. |
| A.3.1.3b Sender's Title | Populates the Title field on the Sender Case Contact on the Inbound Transmission. |
| A.3.1.3c Sender's Given Name | Populates the First Name field on the Sender Case Contact on the Inbound Transmission. |
| A.3.1.3d Sender's Middle Name | Populates the Middle Name field on the Sender Case Contact on the Inbound Transmission. |
| A.3.1.3e Sender's Family Name | Populates the Last Name field on the Sender Case Contact on the Inbound Transmission. |
| A.3.1.4a Sender's Street Address | Populates the Street field on the Sender Case Contact on the Inbound Transmission. |
| A.3.1.4b Sender's City | Populates the City field on the Sender Case Contact on the Inbound Transmission. |
| A.3.1.4c Sender's State or Province | Populates the State / Province field on the Sender Case Contact on the Inbound Transmission. |
| A.3.1.4d Sender's Postcode | Populates the Postal Code / Zip Code field on the Sender Case Contact on the Inbound Transmission. |
| A.3.1.4e Sender's Country Code | Populates the Country field on the Sender Case Contact on the Inbound Transmission.
If the ISO Code for the Sender's Country Code is not found, Vault attempts to match the country code in the E2B file to an alias in the Country Code Alias field of the Country object. If found, the alias is populated. When multiple countries in Vault Safety match the country code on the file, Vault maps to the first code in alphabetical order. |
| A.3.1.4f Sender's Telephone | Populates the Telephone field on the Sender Case Contact on the Inbound Transmission. |
| A.3.1.4i Sender's Fax | Populates the Fax field on the Sender Case Contact on the Inbound Transmission. |
| A.3.1.4 Sender's E-mail Address | Populates the Email field on the Sender Case Contact on the Inbound Transmission. |
| A.2.2 Literature Reference(s) | Vault creates a placeholder document with the Case > Source > Literature document type and imports this value to the Reference document field. |
| A.2.3.1 Study Name | Populates the Study Name field on the Case. |
| A.2.3.2 Sponsor Study Number | Populates the Study Number field on the Case. |
| A.2.3.3 Study Type Where Reaction(s) / Event(s) Were Observed | Populates the Product Usage Reason field on the Case. |
B: Information on the Case
B.1 Patient Characteristics
| E2B Data Element Name | Populated Value |
|---|---|
| B.1.1 Patient initials | Populates the Patient Initials / ID field on the Case. |
| B.1.1.1a GP medical record number | Populates the MRN - GP field on the Case. |
| B.1.1.1b Specialist record number | Populates the MRN - Specialist field on the Case. |
| B.1.1.1c Hospital record number | Populates the MRN - Hospital field on the Case. |
| B.1.1.1d Investigation number | Populates the MRN - Investigation field on the Case. |
| B.1.2.1 Date of birth | Populates the Date of Birth field on the Case. |
| B.1.2.2a Age at time of onset of reaction/event (number) | Populates the Age field on the Case. |
| B.1.2.2b Age at time of onset of reaction/event (unit) | Populates the Age (unit) field on the Case. |
| B.1.2.2.1a Gestation Period When Reaction / Event Was Observed in the Foetus (value) | Populates the Gestation field on the Case. |
| B.1.2.2.1b Gestation Period When Reaction / Event Was Observed in the Foetus (unit) | Populates the unit in the Gestation (unit) field on the Case. |
| B.1.2.3 Patient age group | The option populated in the Age Group field on the Case. |
| B.1.3 Body Weight (kg) | Populates the Weight field on the Case. |
| B.1.4 Height (cm) | Populates the Height (normalized) field on the Case. |
| B.1.5 Sex | Populates the Sex field on the Case. |
| B.1.6 Last menstrual period date | Populates the Last Menstrual field on the Case. |
| B.1.7.1a.1 MedDRA Version for Medical History | Populates the active MedDRA dictionary in the MedDRA Version field on the Case. |
| B.1.7.1a.2 Medical History (disease / surgical procedure / etc.) (MedDRA code) | Codes the MedDRA LLT on the Case Medical History object. |
| B.1.7.1c Start Date | Populates the Start Date field on the Case Medical History object. |
| B.1.7.1d Continuing | Populates the Continuing field on the Case Medical History object. |
| B.1.7.1f End Date | Populates the End Date field on the Case Medical History object. |
| B.1.7.1g Comments | Populates the Comments field on the Case Medical History object. |
| B.1.7.2 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event) | Populates the Medical History Text field on the Case. If this field is blank on the E2B file, Vault does not create the Medical Event record on the Inbox Item. |
| B.1.8a Name of Drug as Reported | Populates the Name Reported field on the Case Drug History Object. |
| B.1.8c Start date | Populates the Start Date field on the Case Drug History Object. |
| B.1.8e End Date | Populates the End Date field on the Case Drug History Object. |
| B.1.8f.1 MedDRA Version for Reaction | Populates the active MedDRA dictionary in the MedDRA Version field on the Case. |
| B.1.8f.2 Indication (MedDRA code) | Codes the MedDRA LLT for the indication on the Case Drug History Object. |
| B.1.8g.1 MedDRA Version for Reaction | Populates the active MedDRA dictionary on the Case, taken from the MedDRA Version field. |
| B.1.8g.2 Reaction (MedDRA code) | Populates the Reaction MedDRA field on the Case Drug History Object. |
| B.1.9.1 Date of Death | Populates the Date of Death field on the Case. |
| B.1.9.2a MedDRA Version for Reported Cause(s) of Death | Populates the active MedDRA dictionary on the Case, taken from the MedDRA Version field. |
| B.1.9.2b Reported Cause(s) of Death (MedDRA code) | Codes the MedDRA LLT on the Reported Case Cause of Death object. |
| B.1.9.3 Was Autopsy Done? | Populates the Autopsy field on the Case. |
| B.1.9.4a MedDRA Version for Autopsy-determined Cause(s) of Death | Populates the active MedDRA dictionary on the Case, taken from the MedDRA Version field. |
| B.1.9.4b Autopsy-determined Cause(s) of Death | Codes the MedDRA LLT on the Autopsy-Determined Case Cause of Death object. If Vault cannot find a match for the MedDRA term, the value is mapped as free text to the Cause (Reported) (name_reported__v) field. |
| B.1.10.1 Parent Identification | Populates the Patient ID field on the associated Parent-type Case. |
| B.1.10.2.1 Date of Birth of Parent | Populates the Date of Birth field on the associated Parental-type Case. |
| B.1.10.2.2a Age of Parent (number) | Populates the Age field on the associated Parental-type Case. |
| B.1.10.2.2b Age of Parent (unit) | Populates the Age (unit) field on the associated Parental-type Case. |
| B.1.10.3 Last Menstrual Period Date of Parent | Populates the Last Menstrual field on the associated Parental-type Case. |
| B.1.10.4 Body Weight (kg) of Parent | Populates the Weight field on the associated Parental-type Case. |
| B.1.10.5 Height (cm) of Parent | Populates the Height (normalized) field on the associated Parental-type Case. |
| B.1.10.6 Sex of Parent | Populates the Sex field on the Parent Information Case. |
| B.1.10.7.1a.1 MedDRA Version for Medical History | Populates the active MedDRA dictionary in the MedDRA Version field on the associated Parental-type Case. |
| B.1.10.7.1a.2 Medical History (disease / surgical procedure/ etc.) (MedDRA code) | Codes the MedDRA LLT on the Case Medical History object on the associated Parental-type Case. |
| B.1.10.7.1c Start Date (value) | Populates the Start Date field on the Case Medical History object on the associated Parental-type Case. |
| B.1.10.7.1d Continuing | Populates the Continuing field on the Case Medical History object on the associated Parental-type Case. |
| B.1.10.7.1f End Date | Populates the End Date field on the Case Medical History object on the associated Parental-type Case. |
| B.1.10.7.1g Comments | Populates the Comments field on the Case Medical History object on the associated Parental-type Case, to a limit of 2,000 characters. |
| B.1.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent | Populates the Medical History Text field on the associated Parental-type Case, to a limit of 10,000 characters. |
| B.1.10.8a Name of Drug as Reported | Populates the Name Reported field on the Case Drug History object on the associated Parental-type Case. |
| B.1.10.8c Start date | Populates the Start Date field on the Case Drug History object on the associated Parental-type Case. |
| B.1.10.8e End Date | Populates the End Date field on the Case Drug History object on the associated Parental-type Case. |
| B.1.10.8f.1 MedDRA Version for Indication | Populates the active MedDRA dictionary in the MedDRA Version field on the associated Parental-type Case. |
| B.1.10.8f.2 Indication (MedDRA code) | Codes the indication MedDRA LLT on the Case Drug History object on the associated Parental-type Case. |
| B.1.10.8g.1 MedDRA Version for Reaction | Populates the active MedDRA dictionary in the MedDRA Version field on the associated Parental-type Case. |
| B.1.10.8g.2 Reactions (MedDRA code) | Populates the active MedDRA dictionary in the MedDRA Version field on the associated Parental-type Case. |
B.2 Reaction(s)/Event(s)
| E2B Data Element Name | Populated Value |
|---|---|
| B.2.i.0 Reaction / Event as Reported by the Primary Source in Native Language | Populates the Event (Reported) field on the Case Adverse Event. |
| B.2.i.1a MedDRA Version for Reaction / Event (LLT) | Populates the active MedDRA dictionary on the Case, taken from the MedDRA Version field. |
| B.2.i.1b Reaction / Event (MedDRA code) | Populates the Event (MedDRA) field on the Case Adverse Event. |
| B.2.i.3 Term highlighted by the reporter | Populates the Highlighted Term field on the Case Adverse Event. |
| B.2.i.4b Date of start of reaction/event (value) | Populates the Onset field on the Case Adverse Event. |
| B.2.i.5b Date of end of reaction/event (value) | Populates the Resolved field on the Case Adverse Event. |
| B.2.i.6a Duration of reaction/event (value) | Populates the Duration field on the Case Adverse Event. |
| B.2.i.6b Duration of reaction/event (unit) | Populates the Duration (unit) field on the Case Adverse Event. |
| B.2.i.7.1a Time interval between beginning of suspect drug administration and start of reaction/event | Populates the First Dose Latency (number) field on the Case Assessment. |
| B.2.i.7.1b Time interval unit between suspect drug administration and start of reaction/event | Populates the unit in the First Dose Latency (unit) field on the Case Assessment. |
| B.2.i.7.2a Time interval between last dose and start of reaction/event | Populates the Last Dose Latency (number) field on the Case Assessment. |
| B.2.i.7.2b Time interval unit between last dose and start of reaction/event | Populates the unit in the Last Dose Latency (unit) field on the Case Assessment. |
| B.2.i.8 Outcome of reaction/event at the time of last observation | Populates the Outcome field on the Case Adverse Event. |
B.3 Results of Tests and Procedures Relevant to the Investigation of the Patient
| E2B Data Element Name | Populated Value |
|---|---|
| B.3.1 Test Date | Populates Date field on the Case Test Result. |
| B.3.1c Test Name (free text) | Populates the Name (Reported) field on the Case Test Result. |
| B.3.1d Result | Populates the Result (qualifier) field on the Case Test Result. |
| B.3.1e Test Result (unit) | Populates the unit in the Result (unit) field on the Case Test Result. If the unit of measurement does not map to a value in Vault, the custom unit is populated in the Result (Unit) Text field. |
| B.3.1.1 Normal Low Value | Populates the unit and value in the Normal Low Value field on the Case Test Result. |
| B.3.1.2 Normal High Value | Populates the unit and value in the Normal High Value field on the Case Test Result. |
| B.3.1.3 More Information Available | Populates the More Information Available field on the Case Test Result. |
| B.3.2 Results of tests and procedures relevant to the investigation of the patient | Populates the Comment field on the Case Test Result. |
B.4 Drug(s) Information
B.4 Repeated Product Merging
During an E2B(R2) import, Vault Safety compares repeated B.4 sections and ensures information for the same product is consolidated to a single Case Product. Repeated B.4 sections are consolidated and imported to a single Case Product when each of the following data elements match:
- B.4.k.2.1 Proprietary medicinal product name
- All B.4.k.2.2 Active substance names
- B.4.k.2.3 Identification of the country where the drug was obtained
Product Dosage Merging
Vault compares all product dosages under B.4.k to ensure only a single Case Product Dosage is imported when there information for the same product dosage repeated in multiple B.4 product sections. Product dosages are merged when each of the following data elements match:
- B.4.k.3 Batch/lot number
- All B.4.k.5 Structured Dosage Information (B.4.k.5.1 to B.4.k.5.7)
- B.4.k.6 Dosage text
- B.4.k.7 Pharmaceutical form (Dosage form)
- B.4.k.8 Route of administration
- B.4.k.9 Parent route of administration (in case of a parent child/fetus report)
- B.4.k.12 Date of start of drug
- B.4.k.14 Date of last administration
- B.4.k.15 Duration of drug administration
Product Dosage Merging
Vault consolidates repeated product indications (B.4.k.11b) to a single Case Product Indication record during import.
If B.4.k.11b matches between two elements but B.4.k.11a (MedDRA Version for Indication) is different, only one Indication record is imported and the latest B.4.k.11a MedDRA Version is used.
| E2B Data Element Name | Populated Value |
|---|---|
| B.4.k.1 Characterisation of Drug Role | Populates the Drug Role field on the Case Product object. |
| B.4.k.2.1 Medicinal Product Name as Reported by the Primary Source | Populates the Product (Reported) field on the Case Product object. Note: If this field is blank on the E2B file, the Product (Reported) field on the Case Product object is populated with the first substance, based on alphabetical order, in the B.4.k.2.2 Substance / Specified Substance Name data element. |
| B.4.k.2.2 Substance / Specified Substance Name | Populates the Name (Reported) field on the Case Product Substance object. |
| B.4.k.2.3 Identification of the Country Where the Drug Was Obtained | Populates the Country Obtained field on the Case Product object.
If the ISO Code for the Country Where the Drug Was Obtained is not found, Vault attempts to match the country code in the E2B file to an alias in the Country Code Alias field of the Country object. If found, the alias is populated. When multiple countries in Vault Safety match the country code on the file, Vault maps to the first code in alphabetical order. |
| B.4.k.4.1 Authorisation / Application Number | Populates the Registration Number field on the Case Product object. |
| B.4.k.4.2 Country of Authorisation / Application | Populates the Registration Country field on the Case Product object.
If the ISO Code for the Country of Authorisation / Application is not found, Vault attempts to match the country code in the E2B file to an alias in the Country Code Alias field of the Country object. If found, the alias is populated. When multiple countries in Vault Safety match the country code on the file, Vault maps to the first code in alphabetical order. |
| B.4.k.4.3 Name of Holder / Applicant | Populates the Registration Holder/Applicant field on the Case Product object. |
| B.4.k.5.1 Dose (number) | Populates the Dose (number) field on the Case Product Dosage. |
| B.4.k.5.2 Dose (unit) | Populates the unit in the Dose (unit) field on the Case Product Dosage. |
| B.4.k.5.4 Number of Units in the Interval | Populates the Frequency (number) field on the Case Product Dosage. |
| B.4.k.5.5 Definition of the Time Interval Unit | Populates the unit in the Frequency (unit) field on the Case Product Dosage. |
| B.4.k.12 Date and Time of Start of Drug | Populates the First Administration field on the Case Product Dosage. |
| B.4.k.14 Date and Time of Last Administration | Populates the Last Administration field on the Case Product Dosage. |
| B.4.k.15a Duration of Drug Administration (number) | Populates the Duration (number) field on the Case Product Dosage. |
| B.4.k.15b Duration of Drug Administration (unit) | Populates the unit in the Duration (unit) field on the Case Product Dosage. |
| B.4.k.3 Batch / Lot Number | Populates the Batch/Lot Number field on the Case Product Dosage. |
| B.4.k.6 Dosage Text | Populates the Dose Text field on the Case Product Dosage. |
| B.4.k.7 Pharmaceutical Dose Form (free text) | Populates the Dose Form Text field on the Case Product Dosage. |
| B.4.k.8 Route of Administration (free text) | Populates the Patient RoA Text field on the Case Product Dosage. |
| B.4.k.9 Parent Route of Administration (free text) | Populates the Parent RoA Text field on the Case Product Dosage. |
| B.4.k.5.6 Cumulative Dose to First Reaction (number) | Populates the Cumulative Dose field on the Case Product object. |
| B.4.k.5.7 Cumulative Dose to First Reaction (unit) | Populates the unit in the Cumulative Dose (unit) field on the Case Product object. |
| B.4.k.10a Gestation Period at Time of Exposure (number) | Populates the Gestation Exposure field on the Case Product object. |
| B.4.k.10b Gestation Period at Time of Exposure (unit) | Populates the unit in the Gestation Exposure (unit) field on the Case Product object. |
| B.4.k.11a MedDRA Version for Indication | Populates the active MedDRA dictionary on the Case, taken from the MedDRA Version field. |
| B.4.k.11b Indication (MedDRA code) | Codes the MedDRA LLT on the Case Product Indication. |
| B.4.k.16 Action(s) Taken with Drug | Populates the Action Taken field on the Case Product object. |
| B.4.k.18.1a MedDRA version for reaction(s)/event(s) assessed | Populates the active MedDRA dictionary on the Case, taken from the MedDRA Version field. |
| B.4.k.18.1b Reaction(s) / Event(s) Assessed | Populates the specific reaction or event being assessed, in the Case Adverse Event field on the Case Assessment. |
| B.4.k.18.2 Source of Assessment | Vault maps this value to one of the following fields on the Case Assessment Result, ordered by priority:
|
| B.4.k.18.3 Method of Assessment | Vault maps this value to one of the following fields on the Case Assessment Result, ordered by priority:
|
| B.4.k.18.4 Result of Assessment | Vault maps the value to one of the following fields on the Case Assessment Result, ordered by priority:
|
| B.4.k.13.1a Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number) | Populates the First Dose Latency (number) field on the Case Assessment. |
| B.4.k.13.1b Time Interval between Beginning of Drug Administration and Start of Reaction / Event (unit) | Populates the unit in the First Dose Latency (unit) field on the Case Assessment. |
| B.4.k.13.2a Time Interval between Last Dose of Drug and Start of Reaction / Event (number) | Populates the Last Dose Latency (number) field on the Case Assessment. |
| B.4.k.13.2b Time Interval between Last Dose of Drug and Start of Reaction / Event (unit) | Populates the unit in the Last Dose Latency (unit) field on the Case Assessment. |
| B.4.k.17.1 Did Reaction Recur on Re-administration? B.4.k.17.2 If yes to item B.4.k.17.1, which reactions or events recurred |
B.4.k.17.1 populates the Reaction Recurrence field defined in B.4.k.17.2 on the Case Assessment. Otherwise, if B.4.k.17.2 is blank, B.4.k.17.1 populates all Case Assessment records. |
| B.4.k.19 Additional Information on Drug (free text) | Populates the Additional Information (text) field on the Case Product object. |
B.5 Narrative Case Summary and Further Information
| E2B Data Element Name | Populated Value |
|---|---|
| B.5.1 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information | Populates the Narrative on the Case. |
| B.5.2 Reporter's Comments | Populates the Reporter's Comments field on the Case. |
| B.5.3a MedDRA Version for Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event | Populates the active MedDRA dictionary on the Case, taken from the MedDRA Version field. |
| B.5.3b Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event (MedDRA code) | Codes the MedDRA LLT on the Case Diagnosis. |
| B.5.4 Sender's Comments | Populates the Company Comments field on the Case. |
E2B(R3)
N.1 ICH ICSR Transmission Identification (batch wrapper)
| E2B Data Element Name | Populated Value |
|---|---|
| N.1.2 Batch Number | Populates the E2B Message ID field on the Inbound Transmission. |
| N.1.5 Date of Batch Transmission | Populates the date in the Transmission Date field on the Inbound Transmission. |
N.2.r ICH ICSR Message Header (message wrapper)
| E2B Data Element Name | Populated Value |
|---|---|
| N.2.r.1 Message Identifier | Populates the UID field on the Case Identifier object. |
| N.2.r.2 Message Sender Identifier | Populates the Origin ID field on the Inbound Transmission. |
| N.2.r.3 Message Receiver Identifier | Populates the Destination ID field on the Inbound Transmission. |
| N.2.r.4 Date of Message Creation | Populates the Message Creation Date on the Inbound Transmission. |
C.1 Identification of the Case Safety Report
| E2B Data Element Name | Populated Value |
|---|---|
| C.1.1 Sender's (case) Safety Report Unique Identifier | Populates the UID field on the Case Identifier object. |
| C.1.3 Type of Report | Populates the Report Type field on the Case. |
| C.1.4 Date Report Was First Received from Source | Populates the Receipt Date field on the Inbound Transmission. If the Inbound Transmission specifies an Origin Organization where the PV Agreement field is set to Agent, this date also populates the Case Receipt Date. Otherwise, Vault maps N.1.5 to the Case Receipt Date. |
| C.1.5 Date of Most Recent Information for This Report | If the Inbound Transmission specifies an Origin Organization where the PV Agreement field is set to Agent, this date populates the Case New Info Date. Otherwise, Vault maps N.1.5 to the Case New Info Date. |
C.1.6 Additional Available Documents Held by Sender
| E2B Data Element Name | Populated Value |
|---|---|
| C.1.6.1 Are Additional Documents Available? | Attachments included in the transmission under C.1.6 are imported and classified using the Case > Source > Attachment document type. |
| C.1.6.1.r.1 Documents Held by Sender | Populates the Attachment Description and Attachment Description Continued fields on documents imported with the Case > Source > Attachment document type. |
| C.1.6.1.r.2 Included Documents | Attachments included in the transmission under C.1.6 are imported and classified using the Case > Source > Attachment document type. |
| C.1.7 Does This Case Fulfil the Local Criteria for an Expedited Report? | Populates the Expedited Flag field on the Case. |
C.1.8 Worldwide Unique Case Identification
C.2.r Primary Source(s) of Information
| E2B Data Element Name | Populated Value |
|---|---|
| C.2.r.1.1 Reporter's Title | Populates the Title field on the Case Contact object. |
| C.2.r.1.2 Reporter's Given Name | Populates the First Name field on the Case Contact object. |
| C.2.r.1.3 Reporter's Middle Name | Populates the Middle Name field on the Case Contact object. |
| C.2.r.1.4 Reporter's Family Name | Populates the Last Name field on the Case Contact object. |
| C.2.r.2.1 Reporter's Organisation | Populates the Organization field on the Case Contact object. |
| C.2.r.2.2 Reporter's Department | Populates the Department field on the Case Contact object. |
| C.2.r.2.3 Reporter's Street | Populates the Street field on the Case Contact object. |
| C.2.r.2.4 Reporter's City | Populates the City field on the Case Contact object. |
| C.2.r.2.5 Reporter's State or Province | Populates the State/Province field on the Case Contact object.
During import, Vault checks if the EMA state code is mapped to a Country State/Province or Localized Country/State Province record for the Reporter's Country. If a record exists, it is mapped to the Primary Reporter details on the Inbox Item. If no record is found, the State/Province field is populated with text from the file. Note: If the imported Country has domestic state code mappings in Vault, but the value imported to the State/Province field does not match a mapped value, an INVALID tag appears next to the field. The State or Province from the E2B file is imported as text to the Global-language State/Province field. To update the State/Province to a valid value, in the State/Province field, select a value from the picklist. |
| C.2.r.2.6 Reporter's Postcode | Populates the Postal Code/Zip Code field on the Case Contact object. |
| C.2.r.2.7 Reporter's Telephone | Populates the Telephone field on the Case Contact object. |
| C.2.r.3 Reporter's Country Code | Populates the appropriate Country on the Case Contact object, based on the ISO code.
If no ISO code is found, Vault attempts to match the country code in the E2B file to an alias in the Country Code Alias field of the Country object. If found, the alias is populated. When multiple countries in Vault Safety match the country code on the file, Vault maps to the first code in alphabetical order. |
| C.2.r.4 Qualification | Populates the Qualification field on the Case Contact object. |
| C.2.r.5 Primary Source for Regulatory Purposes | Populates the Primary Source field on the Case Contact object. |
C.3 Information on Sender of Case Safety Report
| E2B Data Element Name | Populated Value |
|---|---|
| C.3.1 Sender Type | Populates the Sender Type field on the Sender Case Contact on the Inbound Transmission. |
| C.3.2 Sender's Organisation | Populates the Organisation field on the Sender Case Contact on the Inbound Transmission. |
| C.3.3.1 Sender's Department | Populates the Department field on the Sender Case Contact on the Inbound Transmission. |
| C.3.3.2 Sender's Title | Populates the Title field on the Sender Case Contact on the Inbound Transmission. |
| C.3.3.3 Sender's Given Name | Populates the First Name field on the Sender Case Contact on the Inbound Transmission. |
| C.3.3.4 Sender's Middle Name | Populates the Middle Name field on the Sender Case Contact on the Inbound Transmission. |
| C.3.3.5 Sender's Family Name | Populates the Last Name field on the Sender Case Contact on the Inbound Transmission. |
| C.3.4.1 Sender's Street Address | Populates the Street field on the Sender Case Contact on the Inbound Transmission. |
| C.3.4.2 Sender's City | Populates the City field on the Sender Case Contact on the Inbound Transmission. |
| C.3.4.3 Sender's State or Province | Populates the State / Province field on the Sender Case Contact on the Inbound Transmission. |
| C.3.4.4 Sender's Postcode | Populates the Postal Code / Zip Code field on the Sender Case Contact on the Inbound Transmission. |
| C.3.4.5 Sender's Country Code | Populates the Country field on the Sender Case Contact on the Inbound Transmission.
If the ISO Code for the Sender's Country Code is not found, Vault attempts to match the country code in the E2B file to an alias in the Country Code Alias field of the Country object. If found, the alias is populated. When multiple countries in Vault Safety match the country code on the file, Vault maps to the first code in alphabetical order. |
| C.3.4.6 Sender's Telephone | Populates the Telephone field on the Sender Case Contact on the Inbound Transmission. |
| C.3.4.7 Sender's Fax | Populates the Fax field on the Sender Case Contact on the Inbound Transmission. |
| C.3.4.8 Sender's E-mail Address | Populates the Email field on the Sender Case Contact on the Inbound Transmission. |
C.4.r Literature Reference(s)
| E2B Data Element Name | Populated Value |
|---|---|
| C.4.r.1 Literature Reference(s) | Vault creates a document with the Case > Source > Literature document type and imports this value to the Reference document field. |
| C.4.r.2 Included Documents | Included documents are imported with the Case > Source > Literature document type. |
C.5 Study Identification
| E2B Data Element Name | Populated Value |
|---|---|
| C.5.1.r.1 Study Registration Number | Populates the Registration Number field on the Case Study Registration object. |
| C.5.1.r.2 Study Registration Country | Populates the Country field on the Case Study Registration object.
If the ISO Code for the Study Registration Country is not found, Vault attempts to match the country code in the E2B file to an alias in the Country Code Alias field of the Country object. If found, the alias is populated. When multiple countries in Vault Safety match the country code on the file, Vault maps to the first code in alphabetical order. |
| C.5.2 Study Name | Populates the Study Name field on the Case. |
| C.5.3 Sponsor Study Number | Populates the Study Number field on the Case. |
| C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed | Populates the Product Usage Reason field on the Case. |
D Patient Characteristics
| E2B Data Element Name | Populated Value |
|---|---|
| D.1 Patient (name or initials) | Populates 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) | Populates 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) | Populates 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) | Populates 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) | Populates the MRN - Investigation field on the Case. |
D.2 Age Information
| E2B Data Element Name | Populated Value |
|---|---|
| D.2.1 Date of Birth | Populates the date in the Date of Birth field on the Case. |
| D.2.2a Age at Time of Onset of Reaction / Event (number) | Populates the Age field on the Case. |
| D.2.2b Age at Time of Onset of Reaction / Event (unit) | Populates the Age (unit) field on the Case. |
| D.2.2.1a Gestation Period When Reaction / Event Was Observed in the Foetus (number) | Populates the Gestation field on the Case. |
| D.2.2.1b Gestation Period When Reaction/Event Was Observed in the Foetus (unit) | Populates the appropriate unit in the Gestation (unit) field on the Case. |
| D.2.3 Patient Age Group (as per reporter) | Populates the Age Group field on the Case. |
| D.3 Body Weight (kg) | Populates the Weight (normalized) field on the Case. |
| D.4 Height (cm) | Populates the Height (normalized) field on the Case. |
| D.5 Sex | Populates the Sex field on the Case. |
| D.6 Last Menstrual Period Date | Populates 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 | Populates the MedDRA Version field on the Case. |
| D.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code) | Populates the Name (MedDRA) field on the Case Medical History object. |
| D.7.1.r.2 Start Date | Populates the date in the Start Date field on the Case Medical History object. |
| D.7.1.r.3 Continuing | Populates the Continuing field on the Case Medical History object. |
| D.7.1.r.4 End Date | Populates the date in the End Date field on the Case Medical History object. |
| D.7.1.r.5 Comments | Populates the Comments field on the Case Medical History object. |
| D.7.1.r.6 Family History | Populates 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) | Populates the date in the Medical History Text field on the Case. If this field is blank on the E2B file, Vault does not create the Medical Event record on the Inbox Item. |
| D.7.3 Concomitant Therapies | Populates the date in the Concomitant Therapies field 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 | Populates the Name Reported field on the Case Drug History Object. |
| D.8.r.2a MPID Version Date/Number | Populates the MPID Version field on the Case Drug History Object. |
| D.8.r.2b Medicinal Product Identifier (MPID) | Populates the MPID field on the Case Drug History Object. |
| D.8.r.3a PhPID Version Date/Number | Populates the PhPID Version field on the Case Drug History Object. |
| D.8.r.3b Pharmaceutical Product Identifier (PhPID) | Populates the PhPID field on the Case Drug History Object. |
| D.8.r.4 Start Date | Populates the date in the Start Date field on the Case Drug History Object. |
| D.8.r.5 End Date | Populates the End Date field on the Case Drug History Object. |
| D.8.r.6a MedDRA Version for Indication | Populates the MedDRA Version field on the Case. |
| D.8.r.6b Indication (MedDRA code) | Populates the Indication MedDRA field on the Case Drug History Object. |
| D.8.r.7a MedDRA Version for Reaction | Populates the MedDRA Version field on the Case. |
| D.8.r.7b Reaction (MedDRA code) | Populates the Reaction MedDRA field on the Case Drug History Object. |
D.8.r.1 Name of Drug as Reported
| E2B Data Element Name | Populated Value |
|---|---|
| D.8.r.1.EU.1 Name part - Invented name | Populates the Invented Name Part field on the Case Drug History object. This is an EMA E2B(R3) field. |
| D.8.r.1.EU.2 Name part - Scientific name | Populates the Scientific Name Part field on the Case Drug History object. This is an EMA E2B(R3) field. |
| D.8.r.1.EU.3 Name part - Trademark name | Populates the Trademark Name Part field on the Case Drug History object. This is an EMA E2B(R3) field. |
| D.8.r.1.EU.4 Name part - Strength name | Populates the Strength Name Part field on the Case Drug History object. This is an EMA E2B(R3) field. |
| D.8.r.1.EU.5 Name part - Form name | Populates the Form Name Part field on the Case Drug History object. This is an EMA E2B(R3) field. |
| D.8.r.1.EU.6 Name part - Container name | Populates the Container Name Part field on the Case Drug History object. This is an EMA E2B(R3) field. |
| D.8.r.1.EU.7 Name part - Device name | Populates the Device Name Part field on the Case Drug History object. This is an EMA E2B(R3) field. |
| D.8.r.1.EU.8 Name part - Intended use name | Populates the Intended Use Name Part field on the Case Drug History object. This is an EMA E2B(R3) field. |
D.8.r.EU Substance / Specified Substance Identifier and Strength
| E2B Data Element Name | Populated Value |
|---|---|
| D.8.r.EU.r.1 Substance / Specified Substance Name | Populates the Name (Reported) field on the Case Drug History Substance object. This is an EMA E2B(R3) field. |
| D.8.r.EU.r.2a Substance/Specified Substance TermID Version Date/Number | Populates the TermID Version field on the Case Drug History Substance object. This is an EMA E2B(R3) field. |
| D.8.r.EU.r.2b Substance/Specified Substance TermID | Populates the TermID field on the Case Drug History Substance object. This is an EMA E2B(R3) field. |
| D.8.r.EU.r.3a Strength (number) | Populates the Strength (Number) field on the Case Drug History Substance object. This is an EMA E2B(R3) field. |
| D.8.r.EU.r.3b Strength (unit) | Populates the Strength (Unit) field on the Case Drug History Substance object. This is an EMA E2B(R3) field. |
D.9 In case of Death
| E2B Data Element Name | Populated Value |
|---|---|
| D.9.1 Date of Death | Populates the date in the Date of Death field on the Case. |
| D.9.2.r.1a MedDRA Version for Reported Cause(s) of Death | Populates the MedDRA Version field on the Case. |
| D.9.2.r.1b Reported Cause(s) of Death (MedDRA code) | Populates the Name (MedDRA) field on the Case Cause of Death object. |
| D.9.2.r.2 Reported Cause(s) of Death (free text) | Populates the Name (Reported) field on the Case Cause of Death object. |
| D.9.3 Was Autopsy Done? | Populates the Autopsy field on the Case. |
| D.9.4.r.1a MedDRA Version for Autopsy-determined Cause(s) of Death | Populates the MedDRA Version field on the Case. |
| D.9.4.r.1b Autopsy-determined Cause(s) of Death (MedDRA code) | Populates the Name (MedDRA) field on the Case Cause of Death object. |
| D.9.4.r.2 Autopsy-determined Cause(s) of Death (free text) | Populates the Name (Reported) field on the 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 | Populates the Patient ID field on the Case.* |
| D.10.2.1 Date of Birth of Parent | Populates the date in the Date of Birth field on the Case.* |
| D.10.2.2a Age of Parent (number) | Populates the Age field on the Case.* |
| D.10.2.2b Age of Parent (unit) | The unit entered in the Age (unit) field on the Case.* |
| D.10.3 Last Menstrual Period Date of Parent | Populates the date in the Last Menstrual field on the Case.* |
| D.10.4 Body Weight (kg) of Parent | Populates the Weight (normalized) field on the Case.* |
| D.10.5 Height (cm) of Parent | Populates the Height (normalized) field on the Case.* |
| D.10.6 Sex of Parent | Populates the Sex field on the Parent Information Case. |
| D.10.7.1.r.1a MedDRA Version for Medical History | Populates the MedDRA Version field on the Case.* |
| D.10.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code) | Populates the Name (MedDRA) field on the Case Medical History object.* |
| D.10.7.1.r.2 Start Date | Populates the date in the Start Date field on the Case Medical History object.* |
| D.10.7.1.r.3 Continuing | Populates the Continuing field on the Case Medical History object.* |
| D.10.7.1.r.4 End Date | Populates the date in the End Date field on the Case Medical History object.* |
| D.10.7.1.r.5 Comments | Populates the Comments field on the Case Medical History object.* |
| D.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent | Populates the Medical History Text field on the Case.* |
| An asterisk (*) denotes that this value is imported to a Parental-type Case. | |
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 | Populates the Name Reported field on the Case Drug History object.* |
| D.10.8.r.2a MPID Version Date/Number | Populates the MPID Version field on the Case Drug History object.* |
| D.10.8.r.2b Medicinal Product Identifier (MPID) | Populates the MPID field on the Case Drug History object.* |
| D.10.8.r.3a PhPID Version Date/Number | Populates the PhPID Version field on the Case Drug History object.* |
| D.10.8.r.3b Pharmaceutical Product Identifier (PhPID) | Populates the PhPID field on the Case Drug History object.* |
| D.10.8.r.4 Start Date | Populates the date in the Start Date field on the Case Drug History object.* |
| D.10.8.r.5 End Date | Populates the date in the End Date field on the Case Drug History object.* |
| D.10.8.r.6a MedDRA Version for Indication | Populates the MedDRA Version field on the Case. |
| D.10.8.r.6b Indication (MedDRA code) | Populates the Indication MedDRA field on the Case Drug History object.* |
| D.10.8.r.7a MedDRA Version for Reaction | Populates the MedDRA Version field on the Case. |
| D.10.8.r.7b Reactions (MedDRA code) | Populates the MedDRA Version field on the Case.* |
| An asterisk (*) denotes that this value is imported to a Parental-type Case. | |
D.10.8.r.1 Relevant Past Drug History of Parent
| E2B Data Element Name | Populated Value |
|---|---|
| D.10.8.r.1.EU.1 Name part - Invented name | Populates the Invented Name Part field on the Case Drug History object on the associated Parental-Type Case. This is an EMA E2B(R3) field. |
| D.10.8.r.1.EU.2 Name part - Scientific name | Populates the Scientific Name Part field on the Case Drug History object on the associated Parental-Type Case. This is an EMA E2B(R3) field. |
| D.10.8.r.1.EU.3 Name part - Trademark name | Populates the Trademark Name Part field on the Case Drug History object on the associated Parental-Type Case. This is an EMA E2B(R3) field. |
| D.10.8.r.1.EU.4 Name part - Strength name | Populates the Strength Name Part field on the Case Drug History object on the associated Parental-Type Case. This is an EMA E2B(R3) field. |
| D.10.8.r.1.EU.5 Name part - Form name | Populates the Form Name Part field on the Case Drug History object on the associated Parental-Type Case. This is an EMA E2B(R3) field. |
| D.10.8.r.1.EU.6 Name part - Container name | Populates the Container Name Part field on the Case Drug History object on the associated Parental-Type Case. This is an EMA E2B(R3) field. |
| D.10.8.r.1.EU.7 Name part - Device name | Populates the Device Name Part field on the Case Drug History object on the associated Parental-Type Case. This is an EMA E2B(R3) field. |
| D.10.8.r.1.EU.8 Name part - Intended use name | Populates the Intended Use Name Part field on the Case Drug History object on the associated Parental-Type Case. This is an EMA E2B(R3) field. |
D.10.8.r.EU Substance / Specified Substance Identifier and Strength
| E2B Data Element Name | Populated Value |
|---|---|
| D.10.r.EU.r.1 Substance / Specified Substance Name | Populates the Name (Reported) field on the Case Drug History Substance object on the associated Parental-Type Case. This is an EMA E2B(R3) field. |
| D.10.8.r.EU.r.2a Substance/Specified Substance TermID Version Date/Number | Populates the TermID Version field on the Case Drug History Substance object on the associated Parental-Type Case. This is an EMA E2B(R3) field. |
| D.10.8.r.EU.r.2b Substance/Specified Substance TermID | Populates the TermID field on the Case Drug History Substance object on the associated Parental-Type Case. This is an EMA E2B(R3) field. |
| D.10.8.r.EU.r.3a Strength (number) | Populates the Strength (Number) field on the Case Drug History Substance objecton the associated Parental-Type Case. This is an EMA E2B(R3) field. |
| D.10.8.r.EU.r.3b Strength (unit) | Populates the Strength (Unit) field on the Case Drug History Substance object on the associated Parental-Type Case. This is an EMA E2B(R3) field. |
E.I Reaction(s) / Event(s)
| E2B Data Element Name | Populated Value |
|---|---|
| E.i.1.1a Reaction / Event as Reported by the Primary Source in Native Language | Populates the Event (Reported) field on the Case Adverse Event. |
| E.i.1.1b Reaction / Event as Reported by the Primary Source Language | Populates the Event (Reported) - Language field on the Case Adverse Event. |
| E.i.1.2 Reaction / Event as Reported by the Primary Source for Translation | Populates the Event (Reported) - English field on the Case Adverse Event. |
| E.i.2.1a MedDRA Version for Reaction / Event | Populates the MedDRA Version field on the Case. |
| E.i.2.1b Reaction / Event (MedDRA code) | Populates the Event (MedDRA) field on the Case Adverse Event. |
| E.i.3.1 Term Highlighted by the Reporter | Populates 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 | Populates the Seriousness field on the Case Adverse Event. |
| E.i.3.2b Life Threatening | Populates the Seriousness field on the Case Adverse Event. |
| E.i.3.2c Caused / Prolonged Hospitalisation | Populates the Seriousness field on the Case Adverse Event. |
| E.i.3.2d Disabling / Incapacitating | Populates the Seriousness field on the Case Adverse Event. |
| E.i.3.2e Congenital Anomaly / Birth Defect | Populates the Seriousness field on the Case Adverse Event. |
| E.i.3.2f Other Medically Important Condition | Populates the Seriousness field on the Case Adverse Event. |
| E.i.4 Date of Start of Reaction / Event | Populates the date in the Onset field on the Case Adverse Event. |
| E.i.5 Date of End of Reaction / Event | Populates the date in the Resolved field on the Case Adverse Event. |
| E.i.6a Duration of Reaction / Event (number) | Populates the Duration field on the Case Adverse Event. |
| E.i.6b Duration of Reaction / Event (unit) | The unit entered in the Duration (unit) field on the Case Adverse Event. |
| E.i.7 Outcome of Reaction / Event at the Time of Last Observation | Populates the Outcome field on the Case Adverse Event. |
| E.i.8 Medical Confirmation by Healthcare Professional | When True, sets the HCP Confirmed field to Yes on the Case Adverse Event. |
| E.i.9 Identification of the Country Where the Reaction / Event Occurred | Populates the Event Country field on the Case Adverse Event.
If the ISO Code for the Country Where the Reaction / Event Occurred is not found, Vault attempts to match the country code in the E2B file to an alias in the Country Code Alias field of the Country object. If found, the alias is populated. When multiple countries in Vault Safety match the country code on the file, Vault maps to the first code in alphabetical order. |
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 | Populates the date in the Date field on the Case Test Result. |
| F.r.2.1 Test Name (free text) | Populates the Name (Reported) field on the Case Test Result. |
| F.r.2.2a MedDRA Version for Test Name | Populates the MedDRA Version field on the Case. |
| F.r.2.2b Test Name (MedDRA code) | Populates the Name (MedDRA) field on the Case Test Result. |
| F.r.3.1 Test Result (code) | Populates the Result (code) field on the Case Test Result. |
| F.r.3.2 Test Result (value / qualifier) | Populates the Result (qualifier) field on the Case Test Result. |
| F.r.3.3 Test Result (unit) | Populates the appropriate unit in the Result (unit) field on the Case Test Result. If the unit of measurement does not map to a value in Vault, the custom unit is populated in the Result (Unit) Text field. |
| F.r.3.4 Result Unstructured Data (free text) | Populates the Result (Text) field on the Case Test Result. |
| F.r.4 Normal Low Value | Populates the unit and value in the Normal Low Value field on the Case Test Result. |
| F.r.5 Normal High Value | Populates the unit and value in the Normal High Value field on the Case Test Result. |
| F.r.6 Comments (free text) | Populates the Comments field on the Case Test Result. |
| F.r.7 More Information Available | Populates 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 | Populates the Drug Role field on the Case Product object. |
| G.k.2.4 Identification of the Country Where the Drug Was Obtained | Populates the Country Obtained field on the Case Product object.
If the ISO Code for the Country Where the Drug Was Obtained is not found, Vault attempts to match the country code in the E2B file to an alias in the Country Code Alias field of the Country object. If found, the alias is populated. When multiple countries in Vault Safety match the country code on the file, Vault maps to the first code in alphabetical order. |
| G.k.2.5 Investigational Product Blinded | Populates the Blinded field on the Case Product object. |
| G.k.5a Cumulative Dose to First Reaction (number) | Populates the Cumulative Dose field on the Case Product object. |
| G.k.5b Cumulative Dose to First Reaction (unit) | Populates the appropriate unit in the Cumulative Dose (unit) field on the Case Product object. |
| G.k.6a Gestation Period at Time of Exposure (number) | Populates the Gestation Exposure field on the Case Product object. |
| G.k.6b Gestation Period at Time of Exposure (unit) | Populates the appropriate unit in the Gestation Exposure (unit) field on the Case Product object. |
| G.k.8 Action(s) Taken with Drug | Populates the Action Taken field on the Case Product object. |
| G.k.10.r Additional Information on Drug (coded) | Populates the Additional Information field on the Case Product object. |
| G.k.11 Additional Information on Drug (free text) | Populates the Additional Information (text) field on the Case Product object. |
G.k.2 Drug Identification
| E2B Data Element Name | Populated Value |
|---|---|
| G.k.2.1.1a MPID Version Date / Number | Populates the MPID Version field on the Case Product object. |
| G.k.2.1.1b Medicinal Product Identifier (MPID) | Populates the MPID field on the Case Product object. This data element is used to match Case Products to the Product Library. |
| G.k.2.1.2a PhPID Version Date/Number | Populates the PhPID Version field on the Case Product object. |
| G.k.2.1.2b Pharmaceutical Product Identifier (PhPID) | Populates the PhPID field on the Case Product object. This data element is used to match Case Products to the Product Library. |
| G.k.2.2 Medicinal Product Name as Reported by the Primary Source | Populates the Product (Reported) field on the Case Product object. This data element is used to match Case Products to the Product Library. |
| G.k.2.2.EU.9.r.1 Device Component Name | Populates the Product (Reported) field on the Case Product record for a device constituent in a Combination Product. |
| G.k.2.2.EU.9.r.4 Device Batch Lot Number | Populates the Lot Number field on the Case Product record for a device constituent in a Combination Product. |
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 | Populates the Name (Reported) field on the Case Product Substance object. |
| G.k.2.3.r.2a Substance / Specified Substance TermID Version Date/Number | Populates the TermID Version field on the Case Product Substance object. |
| G.k.2.3.r.2b Substance / Specified Substance TermID | Populates the TermID field on the Case Product Substance object. |
| G.k.2.3.r.3a Strength (number) | Populates the Strength (Number) field on the Case Product Substance object. |
| G.k.2.3.r.3b Strength (unit) | Populates the appropriate unit in the Strength (Unit) field on the Case Product Substance object. |
G.k.3 Holder and Authorisation / Application Number of Drug
| E2B Data Element Name | Populated Value |
|---|---|
| G.k.3.1 Authorisation / Application Number | Populates the Registration Number field on the Case Product object. This data element is used to match Case Products to the Product Library. |
| G.k.3.2 Country of Authorisation / Application | Populates the Registration Country field on the Case Product object.
If the ISO Code for the Country of Authorisation / Application is not found, Vault attempts to match the country code in the E2B file to an alias in the Country Code Alias field of the Country object. If found, the alias is populated. When multiple countries in Vault Safety match the country code on the file, Vault maps to the first code in alphabetical order. |
| G.k.3.3 Name of Holder / Applicant | Populates the Registration Holder/Applicant field on the Case Product object. |
G.k.4.r Dosage and Relevant Information
Note: Vault attempts to map dose forms and routes of administration to EDQM Terms. If multiple matches are found, Vault populates the EDQM Term marked as “Primary for Import”. Manage EDQM Mapping for Dose Form and Routes of Administration Terms provides more information.
| E2B Data Element Name | Populated Value |
|---|---|
| G.k.4.r.1a Dose (number) | Populates the Dose (number) field on the Case Product Dosage. |
| G.k.4.r.1b Dose (unit) | Populates the appropriate unit in the Dose (unit) field on the Case Product Dosage. |
| G.k.4.r.2 Number of Units in the Interval | Populates the Frequency (number) field on the Case Product Dosage. |
| G.k.4.r.3 Definition of the Time Interval Unit | Populates the appropriate unit in the Frequency (unit) field on the Case Product Dosage. |
| G.k.4.r.4 Date and Time of Start of Drug | Populates the First Administration field on the Case Product Dosage. |
| G.k.4.r.5 Date and Time of Last Administration | Populates the Last Administration field on the Case Product Dosage. |
| G.k.4.r.6a Duration of Drug Administration (number) | Populates the Duration (number) field on the Case Product Dosage. |
| G.k.4.r.6b Duration of Drug Administration (unit) | Populates the appropriate unit in the Duration (unit) field on the Case Product Dosage. |
| G.k.4.r.7 Batch / Lot Number | Populates the Batch/Lot Number field on the Case Product Dosage. |
| G.k.4.r.8 Dosage Text | Populates the Dose Text field on the Case Product Dosage. |
| G.k.4.r.9.1 Pharmaceutical Dose Form (free text) | Populates the Dose Form Text field on the Case Product Dosage. |
| G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number | Populates the Dose Form TermID Version field on the Case Product Dosage. |
| G.k.4.r.9.2b Pharmaceutical Dose Form TermID | Populates the Dose Form TermID field on the Case Product Dosage. |
| G.k.4.r.10.1 Route of Administration (free text) | Populates the Patient RoA Text field on the Case Product Dosage. |
| G.k.4.r.10.2a Route of Administration TermID Version Date / Number | Populates the Patient RoA TermID Version field on the Case Product Dosage. |
| G.k.4.r.10.2b Route of Administration TermID | Populates the Patient RoA TermID field on the Case Product Dosage. |
| G.k.4.r.11.1 Parent Route of Administration (free text) | Populates the Parent RoA Text field on the Case Product Dosage. |
| G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number | Populates the Parent RoA TermID Version field on the Case Product Dosage. |
| G.k.4.r.11.2b Parent Route of Administration TermID | Populates the Parent RoA TermID field on the Case Product Dosage. |
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 | Populates the Name Reported field on the Case Product Indication. |
| G.k.7.r.2a MedDRA Version for Indication | Populates the MedDRA Version field on the Case. |
| G.k.7.r.2b Indication (MedDRA code) | Populates the Name (MedDRA) field 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 | Populates the specific reaction or event being assessed, in the Case Adverse Event field on the Case Assessment. |
| G.k.9.i.3.1a Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number) | Populates 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) | Populates the appropriate 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) | Populates 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) | Populates the appropriate unit in the Last Dose Latency (unit) field on the Case Assessment. |
| G.k.9.i.4 Did Reaction Recur on Re-administration? | Populates the Reaction Recurrence field on the Case Assessment. |
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 imports the value to one of the following fields on the Case Assessment Result, ordered by priority:
|
| G.k.9.i.2.r.2 Method of Assessment | Vault imports the value to one of the following fields on the Case Assessment Result, ordered by priority:
|
| G.k.9.i.2.r.3 Result of Assessment | Vault imports the value to one of the following fields on the Case Assessment Result, ordered by priority:
|
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 | Populates the Narrative on the Case. The contents of this element are also imported into a case document classified as Case > Summary > Narrative. |
| H.2 Reporter's Comments | Populates the Reporter's Comments field on the Case. |
| H.4 Sender's Comments | Populates the Company Comments field on the Case and the Sender Comments field on the Transmission. |
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 | Populates the MedDRA Version field on the Case. |
| H.3.r.1b Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event (MedDRA code) | Populates the Name (MedDRA) field 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 | The contents of this element are imported into a case document classified as Case > Summary > Narrative. |
| H.5.r.1b Case Summary and Reporter's Comments Language | Maps the 3-letter ISO code to the appropriate option in the Language (ISO) document field for the Case document classified with the Case > Summary > Narrative. |