E2B Case Import Data Mapping

Learn how Vault Safety imports E2B (R3) and (R2) files.

Sections in This Article

About E2B Case Import

Vault Safety can import E2B files using one of the following methods:

When you import a Case from an E2B file, Vault Safety maps all case data and documents to the appropriate object records, fields, and documents.

When you import an Inbox Item or AER from an E2B file, because only certain fields are displayed on Inbox Items and AER page 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 administrator to verify these settings.

E2B Import Study and Product Matching

Vault Safety attempts to match E2B-imported Cases with the relevant Studies and Products set up in the Business Admin library.

The system only looks at Studies and Products under the Organization set on the E2B document.

The following flowchart summarizes how the system performs Study and Product matching during E2B import:

Study and Product Matching Flowchart
Study and Product Matching Flow
  • Study Matching

    Note For AERs, the E2B Report Type (C.1.3 / A.1.4) must be Study to import study information and attempt study matching. This restriction does not apply to Inbox Item E2B import.

    The system matches Study and Study Registrations using one of the following two scenarios:

    • Scenario 1: (E2B R3 only) If the E2B file contains at least one valid Study Registration, the study is matched using the registration number and country on Study Registrations.

      A Study Registration is valid when it contains both C.5.1.r.1 (Registration Number) and C.5.1.r.2 (Registration Country), with a valid country code.

    • Scenario 2: (E2B R2 and R3) If there is no valid study registration in the E2B file, the study is matched using the Study Number. This is the only Study matching scenario available for E2B R2 imports.

    The following table describes the matching logic and result for scenarios 1 and 2:

    Scenario Matching Result
    E2B R3 E2B R2 Vault Object Vault Field
    1 C.5.1.r.1 N/A Study > Study Registration registration_number__v If both the Registration Number and Country match a Study Registration:
    • Study link added to the Case > Study (study__v) field.
    • Study Registration link added to the Case > Study Registration (study_registration__v) field.
    C.5.1.r.2 N/A Study > Study Registration country__v
    2 C.5.3 A.2.3.2 Study name_v
    • Study link added to the Case > Study (study__v) field.
    • Study Registration not matched.

    For E2B R3 imports, if multiple Studies contain a matching Study Registration, the system uses C.5.3 (Study Number) to find the correct Study. If C.5.3 does not match any Study, no match is found and the E2B notification logs a warning.

    Note There is no match if any E2B C.5.1.r.1 (Registration Number) or C.5.1.r.2 (Registration Country) conflict with the Registration Numbers and Countries listed on the Vault Safety Study record. In other words, the Vault Safety Study must contain all registrations contained in an E2B R3 file.

  • Study Product Matching

    The following prerequisites must be met to match Study Products:

    • The E2B study must have been matched to a Vault Safety Study.
    • The E2B product must not be blinded (G.k.2.5).
      If blinded, the product is imported as an External Product.
    • The E2B drug role (G.k.1/B.4.k.1) must be Suspect, Interacting, Drug not administered, or unspecified (null).
      If unspecified, the Drug Role is mapped to Suspect on import.

    When the above prerequisites are met, the system attempts to match the Study Product using the MPID, PHPID, Substance TermID, or Name:

    Scenario Matching Result
    E2B R3 E2B R2 Vault Object Vault Field
    1 G.k.2.1.1b N/A Study Product > Product Registration mpid__v If any scenario (1–5) matches:
    • Product link added to the Case Product > Study Product (study_product__v) field.
    • Case Product > Product Type (object_type__v) is set to Study Product.
    2 G.k.2.1.2b N/A Study Product > Product Registration phpid__v
    3 G.k.2.3.r.2b N/A Study Product > (all) Study Product Substances
    term_id__v
    4 G.k.3.1 B.4.k.4.1 Study Product > Product Registration registration_number__v
    5 G.k.2.2 N/A Study Product name__v

    If none of the above scenarios match, the system attempts non-Study Product matching. If there is no match to a non-Study Product, the system attempts to match the reported Product using the Product Aliases and Substance Aliases library. You can add new aliases to a Product or Substance. If the system can’t find a match using aliases, t the Case Product is imported with the Case Product > Product Type (object_type__v) set to External Product.

    Primary Product: The first imported Case Product with Drug Role=Suspect that's matched to a Study Product is made the primary Case Product. If there are no Case Products with Drug Role=Suspect, the first imported Study Product is made primary.

  • Product Matching (Non-Study)

    The system attempts to match the Case Product to the Product library using the following logic:

    Scenario Matching Result
    E2B R3 E2B R2 Vault Object Vault Field
    1 G.k.2.1.1b N/A Product > Product Registration mpid__v If a scenario 1–3 matches:
    • Product link added to the Case Product > Product (product__v) field.
    • Product Registration link added to the Case Product > Product Registration (product_registration__v) field.
    • Case Product > Product Type (object_type__v) is set to the type on the matching product.
    2 G.k.2.1.2b N/A Product > Product Registration phpid__v
    3 G.k.3.1 B.4.k.4.1 Product > Product Registration registration_number_v
    4 G.k.2.2 B.4.k.2.1 Product name__v If only scenario 4 matches:
    • Product link added to the Case Product > Product (product__v) field.
    • Case Product > Product Type (object_type__v) is set to the type on the matching product.

    If none of the above scenarios match, the system attempts to match the reported Product using the Product Aliases and Substance Aliases library. You can add new aliases to a Product or Substance.

    If the E2B product is blinded:

    • No Product or Product Registration matched.
    • Case Product > Product Type > (object_type__v) is set to External Product.

    Primary Product: The first imported Case Product with Drug Role=Suspect that's matched to a Product is made the primary Case Product. If there are no Case Products with Drug Role=Suspect, the first imported Case Product is made primary.

  • Product and Substance Alias Matching

    You must have added Product and Substance aliases to the library in order to use them to match the reported Product.

    The system attempts to match the reported Case Product to an alias from the Product Aliases list. If there is a match, the reported Case Product is linked to a Case Product in the library.

    If the system can not find a match using the Product Aliases list, the system attempts to match the reported Product Substance to an alias from the Substance Aliases list. If there is a match, the reported Product substance is linked to the associated Product of the substance alias.

    Note that there must be an absolute match for the system to match the reported Case Product to a product in the library. The following diagram illustrates an example of an absolute match and a non-absolute match:

    absolute-non-absolute-alias-match
    Absolute and Non-Absolute Alias Match
    • 1If there are multiple reported substances that match one product in the Library, the system still links the reported Case Product to the respective product in the library, in this scenario, Cholecap.
    • 2If the reported substances match to different products in the Library, the system does not find a product match. In this scenario, the reported Case Product does not match to either DrugX or Cholecap. Similarly, if one reported substance matches multiple products in the Library, the system can not find an associated product match for the reported substance.

    If the system can not find any matches for the reported Product, the system imports it with the Case Product > Product Type (object_type__v) set to External Product.

E2B Imported MedDRA

If your vault has an active MedDRA dictionary, the system auto-codes MedDRA terms when the E2B file contains reported medical terms with no MedDRA code.

Case MedDRA Version

When you create an Imported Case from an E2B file, the Case MedDRA Version is set by using the MedDRA Version in the E2B file. If there is no MedDRA Version, or multiple MedDRA Versions in the source E2B file, the Case MedDRA Version is set to “-”. This also occurs when the E2B MedDRA Version is older than the oldest supported version in MedDRA central.

When you promote a Case from an Inbox Item or AER, the Case MedDRA Version is set by the vault’s active MedDRA Version.

Import Non-Current MedDRA Terms

The centralized MedDRA dictionary supports auto-coding of non-current terms during E2B import. This capability exists for all MedDRA-supported languages except Japanese.

The Recode-Tag tag is displayed when the E2B MedDRA Version is not in sync with the Case MedDRA Version or if the coded term is non-current.

Recode-Term-from-E2B-Import
Recode Tag Displayed Next to MedDRA Term from E2B Import

When you import an E2B file that contains current terms from an older MedDRA Version (for example, 18.0) than the oldest MedDRA Version supported in MedDRA central, the system will attempt to code the term if it exists. The Imported Case will display a Recode-Tag tag next to the coded term.

Note Coding of non-current terms is not supported when the E2B file contains a term that only exists in a newer version than the latest supported MedDRA Version in MedDRA central.

E2B Data Element Field Mapping

Toggle between the following tabs to learn how Vault Safety maps information to create a Case and during an E2B (R3) or E2B (R2) import.

Tip For E2B ACK Generation mapping, see Receive an E2B Transmission: ACK Generation Mapping.

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

E2B Data Element Name Populated Value
A.1.0.1 Sender's (case) Safety Report Unique Identifier Populates the UID field on the Case Number object. If the <safetyreportversion> tag is included, this tag populates the Safety Report Version field on the Inbound Transmission.
A.1.1 Reporter's Country Code Populates the appropriate Country on the Case Contact object, based on the ISO code.
A.1.2 Identification of the Country Where the Reaction / Event Occurred Populates the Event Country field on the primary Case Adverse Event.
A.1.3 Date of Transmission

Populates the Transmission Date field on the Inbound Transmission.

If the Inbound Transmission specifies an Origin Organization where the PV Agreement field is not set to Agent, this date also populates the Case Receipt Date and the Case New Info Date. Otherwise, the system maps A.1.6 to the Case Receipt Date and A.1.7 to the Case New Info Date.

A.1.4 Type of Report Populates the Report Type field on the Case.
A.1.5.1 Serious Populates the Seriousness field on the Case Adverse Event.
A.1.5.2 Seriousness Criteria Populates the Seriousness field on the Case Adverse Event.
A.1.6 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, the system maps A.1.3 to the Case Receipt Date.

A.1.7 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, the system maps A.1.3 to the Case New Info Date.
A.1.8.1 Are Additional Documents Available Attachments included in the transmission under C.1.6 are imported and classified using the Case > Source > Attachment document type.
A.1.8.2 Documents Held by Sender Populates the Attachment Description and Attachment Description Continued fields on documents imported with the Case > Source > Attachment document type.
A.1.9 Does this case fulfill the local criteria for an expedited report Populates the Expedited Flag field on the Case.
A.1.10.1 Regulatory authority's case report number Populates the Worldwide UID field on the Case Number object.
A.1.10.2 Other sender's case report number Populates the First Sender field on the original inbound Transmission.

The Transmission Date is used to find the original Transmission.

A.1.11 Other Case Identifiers in Previous Transmissions Case identifiers are imported using the Case Identifier object.
A.1.11.1 Source(s) of the Case Identifier Populates the Source field on the Case Identifier object.
A.1.11.2 Case Identifier(s) Populates the Name field on the Case Identifier object.
A.1.12 Identification Number of the Report Which Is Linked to This Report Populates the Related Case Identifier field on the Case Relationship object.
A.1.13 Report Nullification / Amendment Populates the Reason field on the Inbound Transmission.
A.1.13.1 Reason for Nullification / Amendment Populates the Reason Text field on the Inbound Transmission.
A.1.14 Medical Confirmation by Healthcare Professional When True, sets the HCP Confirmed field to Yes on the Case Adverse Event.

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.
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.
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) The system 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 The option populated in the Gender 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.
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 the system 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 Gender field on the 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.
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

The system 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

The system 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.
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.
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.
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 The system maps this value to one of the following fields on the Case Assessment Result, ordered by priority:
  1. Source Type
  2. Source (text)
B.4.k.18.3 Method of Assessment The system maps this value to one of the following fields on the Case Assessment Result, ordered by priority:
  1. Method of Assessment
  2. Method (text)
B.4.k.18.4 Result of Assessment The system maps the value to one of the following fields on the Case Assessment Result, ordered by priority:
  1. Assessment Result
  2. Result (text)
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 Text field 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 Sender Comments field on the Case.

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.1.2 Date of Creation

Populates the Transmission Date field on the Inbound Transmission.

If the Inbound Transmission specifies an Origin Organization where the PV Agreement field is not set to Agent, this date also populates the Case Receipt Date and the Case New Info Date. Otherwise, the system maps C.1.4 to the Case Receipt Date and C.1.5 to the Case New Info Date.

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, the system maps C.1.2 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, the system maps C.1.2 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

E2B Data Element Name Populated Value
C.1.8.1 Worldwide Unique Case Identification Number Populates the Worldwide UID field on the Case Number object.
C.1.8.2 First Sender of This Case Populates the First Sender field on the original inbound Transmission.
C.1.9.1 Other Case Identifiers in Previous Transmissions Case identifiers are imported using the Case Identifier object.
C.1.9.1.r.1 Source(s) of the Case Identifier Populates the Source field on the Case Identifier object.
C.1.9.1.r.2 Case Identifier(s) Populates the Name field on the Case Identifier object.
C.1.10.r Identification Number of the Report Which Is Linked to This Report Populates the Related Case Identifier field on the Case Relationship object.
C.1.11.1 Report Nullification/Amendment Populates the Reason field on the Inbound Transmission.
C.1.11.2 Reason for Nullification/Amendment Populates the Reason Text field on the Inbound Transmission.

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.
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.
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'Country Code Populates the Country field on the Sender Case Contact on the Inbound Transmission.
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) The system 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.
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 Gender 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.
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 Gender field on the 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.

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.
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.
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.
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 If EDQM mapping for dose forms and routes of administration is enabled, the system attempts to map dose forms and routes of administration to EDQM Terms. If multiple matches are found, the system populates the EDQM Term marked as “Primary for Import”. Enable 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 The system imports the value to one of the following fields on the Case Assessment Result, ordered by priority:
  1. Source Type
  2. Source (text)
G.k.9.i.2.r.2 Method of Assessment The system imports the value to one of the following fields on the Case Assessment Result, ordered by priority:
  1. Method of Assessment
  2. Method (text)
G.k.9.i.2.r.3 Result of Assessment The system imports the value to one of the following fields on the Case Assessment Result, ordered by priority:
  1. Assessment Result
  2. Result (text)

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 Text field 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 Sender Comments field on the Transmission and Case.

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.

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