E2B Generation: FDA E2B(R2) Mapping

M.1.1 Types of Message in Batch

Vault populates 1 for ICH ICSR.

M.1.2 Message Format Version

Vault populates 2.1 for an ICSR, or 1.0 for an acknowledgment.

M.1.3 Message Format Release

Vault populates 1.

M.1.4 Batch Number

The E2B Message ID on the Transmission.

M.1.5 Batch Sender Identifier

The Origin ID on the Transmission Profile associated with the Transmission.

M.1.6 Batch Receiver Identifier

The Destination ID on the Transmission Profile associated with the Transmission.

M.1.7b Date of Batch Transmission

The date and time of report generation or transmission, calculated with full precision down to the second.

N.2.r.4 Date of Message Creation

If the Case is Approved or Closed, the Approval Date. Otherwise, the date and time of report generation or transmission, calculated with full precision down to the second.

A.1.0.1 Sender’s (case) Safety Report Unique Identifier

The UID on the Case Version. If the Transmission includes a Safety Report Version, Vault also populates the <safetyreportversion> tag and value in this data element.

A.1.1 Reporter’s Country Code

The ISO code in the Country field on the Reporter-type Case Contact.

A.1.2 Identification of the Country Where the Reaction / Event Occurred

The Event Country on the primary Case Adverse Event.

A.1.3b Date of Transmission

If the Case is Approved, Closed, or Superseded, the Approval Date. Otherwise, the date and time of report generation or transmission, calculated with full precision down to the second.

A.1.4 Type of Report

Based on the Report Type on the Case, Vault populates:

• 1: Spontaneous
• 2: Study
• 3: Other
• 4: Unknown

A.1.5.1 Serious

Vault populates 1 (Yes) if there is at least one Case Adverse Event with seriousness criteria.

A.1.5.2 Seriousness Criteria

Populated with seriousness tags corresponding to the criteria in the Seriousness field across all Case Adverse Events. A seriousness criteria tag is set to 1 (Yes) if there is at least one Case Adverse Event with that seriousness criteria.

A.1.6 Date Report Was First Received from Source

• For initial Cases, the Receipt Date on the Case.
• For follow-up Cases, the Initial Receipt Date on the Case.

A.1.7 Date of Most Recent Information for This Report

The New Info Date on the Case.

A.1.8.1 Are Additional Documents Available

Vault populates 1 (true) if there are documents of the Case > Source > Attachment type attached to the Case.

A.1.8.2 Documents Held by Sender

The Attachment Description and Attachment Description Continued values on any documents of the Case > Source > Attachment type attached to the Case, to a limit of 2,000 characters.

A.1.9 Does this case fulfill the local criteria for an expedited report

• For non-combination product reports, Vault populates a value based on the Local Expedited Criteria value on the Transmission. If blank, Vault references the Expedited value on the Case.

  For Yes, Vault populates 1 (expedited). Otherwise, Vault populates 2 (non-expedited).

• For combination product reports, Vault populates a value as follows:

  • 4 (5-day): When the Device Report Type of the Case Product contains Public Health Risk
  • 5 (malfunction-only): When the only Device Report Type value is Malfunction
  • If neither condition is met, Vault uses the same logic as non-combination product reports to populate 1 or 2.

A.1.10.1 Regulatory authority’s case report number

The Worldwide UID on the Case Version.

A.1.10.2 Other sender’s case report number

The First Sender on the original Inbound Transmission. Vault uses the transmission date to find the original Transmission.

A.1.11 Other Case Identifiers in Previous Transmissions

Vault populates 1 (true) if there are any Case Identifiers associated with the Case.

A.1.11.1 Source(s) of the Case Identifier

The Source on the Case Identifier record. Vault transmits this element only when the Type value of the Case Identifier is Re-Transmittable or blank.

A.1.11.2 Case Identifier(s)

The Case Identifier on the Case Identifier record. Vault transmits this element only when the Type value of the Case Identifier is Re-Transmittable or blank.

A.1.12 Identification Number of the Report Which Is Linked to This Report

The Related Case Identifier value on the Case Relationship record. Vault transmits this element only when the Retransmit value is Yes.

A.1.13 Report Nullification / Amendment

Set to 1 (true) when the Reason on the Transmission is Nullification.

A.1.13.1 Reason for Nullification / Amendment

The Reason Text on the Transmission, to a limit of 2,000 characters.

A.1.14 Medical Confirmation by Healthcare Professional

The HCP Confirmed value on the Case Adverse Event. Vault transmits this element only when the Qualification on the primary (Rank 1) Reporter-type Case Contact does not correspond to E2B code 1, 2, or 3 based on the Qualification controlled vocabulary.

A.2.1.1a Reporter’s Title

The Title on the Reporter-type Case Contact.

A.2.1.1b Reporter’s Given Name

The First Name on the Reporter-type Case Contact.

A.2.1.1c Reporter’s Middle Name

The Middle Name on the Reporter-type Case Contact.

A.2.1.1d Reporter’s Family Name

The Last Name on the Reporter-type Case Contact.

A.2.1.2a Reporter’s Organisation

The Organization on the Reporter-type Case Contact, to a limit of 60 characters.

A.2.1.2b Reporter’s Department

The Department on the Reporter-type Case Contact.

A.2.1.2c Reporter’s Street

The Street on the Reporter-type Case Contact.

A.2.1.2d Reporter’s City

The City on the Reporter-type Case Contact.

A.2.1.2e Reporter’s State or Province

The State/Province on the Reporter-type Case Contact.

A.2.1.2f Reporter’s Postcode

The Postal Code/Zip Code on the Reporter-type Case Contact.

A.2.1.3 Reporter’s Country Code

The ISO code in the Country field on the Reporter-type Case Contact.

A.2.1.4 Qualification

The Qualification on the Reporter-type Case Contact.

A.3.1.1 Sender Type

The Sender Type on the Organization record associated with the Sender (User) on the Transmission. If the Sender (User) is blank, Vault maps the Sender Type from the Organization on the Case.

A.3.1.2 Sender’s Organisation

The Organization on the User record associated with the Sender (User) on the Transmission. If the Sender (User) is blank, Vault maps the Organization on the Case.

A.3.1.3a Sender’s Department

The Department on the User record associated with the Sender (User) on the Transmission.

A.3.1.3b Sender’s Title

The Title on the User record associated with the Sender (User) on the Transmission.

A.3.1.3c Sender’s Given Name

The First Name on the User record associated with the Sender (User) on the Transmission.

A.3.1.3d Sender’s Middle Name

The Middle Name on the User record associated with the Sender (User) on the Transmission.

A.3.1.3e Sender’s Family Name

The Last Name on the User record associated with the Sender (User) on the Transmission.

A.3.1.4a Sender’s Street Address

The Street on the User record associated with the Sender (User) on the Transmission.

A.3.1.4b Sender’s City

The City on the User record associated with the Sender (User) on the Transmission.

A.3.1.4c Sender’s State or Province

The State / Province on the User record associated with the Sender (User) on the Transmission.

A.3.1.4d Sender’s Postcode

The Postal Code / Zip Code on the User record associated with the Sender (User) on the Transmission.

A.3.1.4e Sender’s Country Code

The 2-letter ISO code associated with the Country on the User record associated with the Sender (User) on the Transmission.

A.3.1.4f Sender’s Telephone

The Telephone value on the User record associated with the Sender (User) on the Transmission.

A.3.1.4i Sender’s Fax

The Fax value on the User record associated with the Sender (User) on the Transmission.

A.3.1.4 Sender’s E-mail Address

The Email value on the User record associated with the Sender (User) on the Transmission.

A.2.2 Literature Reference(s)

The Reference value for any Case documents with the Retransmit field set to Yes and classified as:

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

Vault exports up to 500 characters.

When Vault generates a report for a Case linked to a Literature Article in your SafetyDocs Vault and if the document’s Retransmit field value is Yes, Vault maps a value from the Literature Article using the following priority:

1. Vancouver Citation (English)
2. Vancouver Citation

For Localized Case Documents, Vault overrides the Vancouver Citation with the Reference field value, if populated.

Citations and reference text for literature source documents are encoded in a single A.2.2 block.

A.2.3.1 Study Name

The Study Name and Study Name (Continued) values on the associated Study, to a limit of 2,000 characters.

A.2.3.2 Sponsor Study Number

The Study Number on the associated Study.

A.2.3.3 Study Type Where Reaction(s) / Event(s) Were Observed

Based on the Study Type on the Case, Vault populates an E2B code corresponding to the Study Type controlled vocabulary.

A.3.2.1 Receiver Type

The Receiver Type of the Receiver Person on the Transmission Profile. If Receiver Person is blank, Vault maps the Sender Type from the Destination organization on the Transmission Profile.

Per E2B(R2) guidelines, only the following values are mapped:

• 1: Pharmaceutical company
• 2: Regulatory authority
• 4: Regional pharmacovigilance center
• 5: WHO collaborating center for international drug monitoring

A.3.2.2a Receiver’s Organisation

The Organization of the Receiver Person on the Transmission Profile.

A.3.2.2b Receiver’s Department

The Department on the Person record associated with the Receiver Person on the Transmission Profile.

A.3.2.2c Receiver’s Title

The Title on the Person record associated with the Receiver Person on the Transmission Profile.

A.3.2.2d Receiver’s Given Name

The First Name on the Person record associated with the Receiver Person on the Transmission Profile.

A.3.2.2e Receiver’s Middle Name

The Middle Name on the Person record associated with the Receiver Person on the Transmission Profile.

A.3.2.2f Receiver’s Family Name

The Last Name on the Person record associated with the Receiver Person on the Transmission Profile.

A.3.2.3a Receiver’s Street Address

The Street on the Person record associated with the Receiver Person on the Transmission Profile.

A.3.2.3b Receiver’s City

The City on the Person record associated with the Receiver Person on the Transmission Profile.

A.3.2.3c Receiver’s State or Province

The State / Province on the Person record associated with the Receiver Person on the Transmission Profile.

A.3.2.3d Receiver’s Postcode

The Postal Code / Zip Code on the Person record associated with the Receiver Person on the Transmission Profile.

A.3.2.3e Receiver’s Country Code

The 2-letter ISO code associated with the Country on the Person record associated with the Receiver Person on the Transmission Profile.

A.3.2.3f Receiver’s Telephone

The Telephone value on the Person record associated with the Receiver Person on the Transmission Profile.

A.3.2.3g Receiver’s Telephone Extension

The Telephone Extension on the Person record associated with the Receiver Person on the Transmission Profile.

A.3.2.3h Receiver’s Telephone Country

The Telephone Country on the Person record associated with the Receiver Person on the Transmission Profile.

A.3.2.3i Receiver’s Fax

The Fax value on the Person record associated with the Receiver Person on the Transmission Profile.

A.3.2.3j Receiver’s Fax Extension

The Fax Extension on the Person record associated with the Receiver Person on the Transmission Profile.

A.3.2.3k Receiver’s Fax Country

The Fax Country on the Person record associated with the Receiver Person on the Transmission Profile.

A.3.2.3l Receiver’s E-mail Address

The Email value on the Person record associated with the Receiver Person on the Transmission Profile.

B.1.1 Patient initials

The Patient Initials / ID on the Case.

B.1.1.1a GP medical record number

The MRN - GP on the Case.

B.1.1.1b Specialist record number

The MRN - Specialist on the Case.

B.1.1.1c Hospital record number

The MRN - Hospital on the Case.

B.1.1.1d Investigation number

The MRN - Investigation on the Case.

B.1.2.1 Date of birth

The Date of Birth on the Case. For Vault to transmit this data element, the full date is required with year, month, and day.

B.1.2.2a Age at time of onset of reaction/event (number)

The Age on the Case.

B.1.2.2b Age at time of onset of reaction/event (unit)

The Age (unit) on the Case.

B.1.2.2.1a Gestation Period When Reaction / Event Was Observed in the Foetus (value)

The Gestation value on the Case.

B.1.2.2.1b Gestation Period When Reaction / Event Was Observed in the Foetus (unit)

The Gestation (unit) on the Case.

B.1.2.3 Patient age group

The Age Group on the Case. In accordance with ICH guidelines, Vault transmits this element only when both the Patient Date of Birth (B.1.2.1) and Age at Onset (B.1.2.2) are not transmitted.

B.1.3 Body Weight (kg)

The Weight on the Case, normalized to the accepted unit.

B.1.4 Height (cm)

The Height on the Case, normalized to the accepted unit.

B.1.5 Sex

The Sex on the Case.

B.1.6 Last menstrual period date

The Last Menstrual Period on the Case.

B.1.7.1a.1 MedDRA Version for Medical History

The active MedDRA dictionary on the Case, taken from the MedDRA Version field.

B.1.7.1a.2 Medical History (disease / surgical procedure / etc.) (MedDRA code)

The MedDRA LLT on the Case Medical History.

B.1.7.1c Start Date

The Start Date on the Case Medical History.

B.1.7.1d Continuing

The Continuing value on the Case Medical History.

B.1.7.1f End Date

The End Date on the Case Medical History.

B.1.7.1g Comments

The Comments on the Case Medical History, to a limit of 100 characters.

B.1.7.2 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event)

The Medical History Text on the Case, to a limit of 10,000 characters.

B.1.8a Name of Drug as Reported

The Name Reported on the Case Drug History.

B.1.8c Start date

The Start Date on the Case Drug History.

B.1.8e End Date

The End Date on the Case Drug History.

B.1.8f.1 MedDRA Version for Reaction

The active MedDRA dictionary on the Case, taken from the MedDRA Version field.

B.1.8f.2 Indication (MedDRA code)

The MedDRA LLT coded for the indication on the Case Drug History.

B.1.8g.1 MedDRA Version for Reaction

The active MedDRA dictionary on the Case, taken from the MedDRA Version field.

B.1.8g.2 Reaction (MedDRA code)

The Reaction MedDRA value on the Case Drug History.

B.1.9.1 Date of Death

The Date of Death on the Case.

B.1.9.2a MedDRA Version for Reported Cause(s) of Death

The active MedDRA dictionary on the Case, taken from the MedDRA Version field.

B.1.9.2b Reported Cause(s) of Death (MedDRA code)

From the Reported Case Cause of Death record, Vault exports a value using the following priority:

1. If a Cause of Death (LLT) (name_meddra__v) value exists, Vault exports the MedDRA code.
2. If a coded term is unavailable, Vault exports the Cause of Death (Reported) (name_reported__v) value.

B.1.9.3 Was Autopsy Done?

The Autopsy value on the Case.

B.1.9.4a MedDRA Version for Autopsy-determined Cause(s) of Death

The active MedDRA dictionary on the Case, taken from the MedDRA Version field.

B.1.9.4b Autopsy-determined Cause(s) of Death (MedDRA code)

From the Autopsy-Determined Case Cause of Death record, Vault exports a value using the following priority:

1. If a Cause of Death (LLT) (name_meddra__v) value exists, Vault exports the MedDRA code.
2. If a coded term is unavailable, Vault exports the Cause of Death (Reported) (name_reported__v) value.

B.1.10.1 Parent Identification

The Patient ID on the associated Parent Information record.

B.1.10.2.1 Date of Birth of Parent

The Date of Birth on the associated Parent Information record. For Vault to transmit this data element, the full date is required with year, month, and day.

B.1.10.2.2a Age of Parent (number)

The Age on the associated Parent Information record. Vault does not export ages above 100.

B.1.10.2.2b Age of Parent (unit)

The Age (unit) on the associated Parent Information record.

B.1.10.3 Last Menstrual Period Date of Parent

The Last Menstrual Period on the associated Parent Information record.

B.1.10.4 Body Weight (kg) of Parent

The Weight on the associated Parent Information record.

B.1.10.5 Height (cm) of Parent

The Height (normalized) on the associated Parent Information record.

B.1.10.6 Sex of Parent

The Sex on the associated Parent Information record.

B.1.10.7.1a.1 MedDRA Version for Medical History

The active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information record.

B.1.10.7.1a.2 Medical History (disease / surgical procedure/ etc.) (MedDRA code)

The MedDRA LLT coded on the Case Medical History on the associated Parent Information record.

B.1.10.7.1c Start Date (value)

The Start Date on the Case Medical History on the associated Parent Information record.

B.1.10.7.1d Continuing

The Continuing value on the Case Medical History on the associated Parent Information record.

B.1.10.7.1f End Date

The End Date on the Case Medical History on the associated Parent Information record.

B.1.10.7.1g Comments

The Comments on the Case Medical History on the associated Parent Information record, to a limit of 2,000 characters.

B.1.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent

The Medical History Text on the associated Parent Information record, to a limit of 10,000 characters.

B.1.10.8a Name of Drug as Reported

The Name Reported value on the Case Drug History on the associated Parent Information record.

B.1.10.8c Start date

The Start Date on the Case Drug History on the associated Parent Information record.

B.1.10.8e End Date

The End Date on the Case Drug History on the associated Parent Information record.

B.1.10.8f.1 MedDRA Version for Indication

The active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information record.

B.1.10.8f.2 Indication (MedDRA code)

The indication MedDRA LLT coded on the Case Drug History on the associated Parent Information record.

B.1.10.8g.1 MedDRA Version for Reaction

The active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information record.

B.1.10.8g.2 Reactions (MedDRA code)

The active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information record.

B.2.i.0 Reaction / Event as Reported by the Primary Source in Native Language

Depending on your Vault’s Deferred Domestic Processing: Localized Event Reported in Native Language setting, Vault exports the Event (Reported) from either the global Case Adverse Event or the Localized Case Adverse Event.

B.2.i.1a MedDRA Version for Reaction / Event (LLT)

The active MedDRA dictionary on the Case, taken from the MedDRA Version field.

B.2.i.1b Reaction / Event (MedDRA code)

The Event (MedDRA) on the Case Adverse Event.

B.2.i.3 Term highlighted by the reporter

The Highlighted Term on the Case Adverse Event.

Seriousness criteria at event level

Vault populates a value based on the Seriousness on the Case Adverse Event.

B.2.i.4b Date of start of reaction/event (value)

The Onset value on the Case Adverse Event.

B.2.i.5b Date of end of reaction/event (value)

The Resolved value on the Case Adverse Event.

B.2.i.6a Duration of reaction/event (value)

The Duration on the Case Adverse Event.

B.2.i.6b Duration of reaction/event (unit)

The Duration (unit) on the Case Adverse Event.

B.2.i.7.1a Time interval between beginning of suspect drug administration and start of reaction/event

The First Dose Latency (number) on the Case Assessment.

Vault does not export this element for device constituent assessments.

B.2.i.7.1b Time interval unit between suspect drug administration and start of reaction/event

The First Dose Latency (unit) on the Case Assessment.

Vault does not export this element for device constituent assessments.

B.2.i.7.2a Time interval between last dose and start of reaction/event

The Last Dose Latency (number) on the Case Assessment.

Vault does not export this element for device constituent assessments.

B.2.i.7.2b Time interval unit between last dose and start of reaction/event

The Last Dose Latency (unit) on the Case Assessment.

Vault does not export this element for device constituent assessments.

B.2.i.8 Outcome of reaction/event at the time of last observation

The Outcome on the Case Adverse Event.

You must select a Vault E2B Code value for this section. See the following mapping table:

B.3.1 Test Date

The Test Date on the Case Test Result.

B.3.1c Test Name

Vault exports a Case Test Result value, using the following priority order:

1. If the Name MedDRA (LLT) (name_meddra__v) field is coded, Vault exports the MedDRA code.
2. If a coded term is unavailable, Vault exports the value in the Test Name (Reported) (name_reported__v) field.

B.3.1d Result

The Test Result (Qualifier) and Test Result (Number) on the Case Test Result.

B.3.1e Test Result (unit)

The Result (Unit) on the Case Test Result.

B.3.1.1 Normal Low Value

The Normal Low Value unit and value on the Case Test Result. If the result does not have a unit, Vault will map any text instead.

B.3.1.2 Normal High Value

The Normal High Value unit and value on the Case Test Result. If the result does not have a unit, Vault will map any text instead.

B.3.1.3 More Information Available

The More Information Available value on the Case Test Result.

If Vault truncates any values mapped to the B.3.2 Results of tests and procedures relevant to the investigation of the patient data element due to character limitations, Vault populates 1 (Yes).

B.3.2 Results of tests and procedures relevant to the investigation of the patient

Vault populates the following Case Test Result values:

• Test Name (Code) (If blank, the Test Name (Reported) value.)
• Test Date
• Result (Code)
• Result (Text)
• Comments

Vault populates these values to a limit of 2,000 characters.

B.4.k.1 Characterisation of Drug Role

Vault populates an E2B code based on the Drug Role on the Case Product:

For Combination Products, this value is based on the non-device Product Constituent. When the Combination Product includes a Company Product, Vault determines the non-device Product Constituent based on Product Registrations, if possible. If Vault cannot determine which Product Constituent is not a device, both Product Constituents are exported to <drug> blocks and the Drug Rule of each constituent is populated.

B.4.k.2.1 Medicinal Product Name as Reported by the Primary Source

The Product (Reported) on the Case Product.

B.4.k.2.2 Substance / Specified Substance Name

The Name (Reported) on the Case Product Substance.

B.4.k.2.3 Identification of the Country Where the Drug Was Obtained

The Country Obtained on the Case Product.

Investigational Product Blinded

The Blinded value on the Case Product.

B.4.k.4.1 Authorisation / Application Number

If the registration country is within the jurisdiction of the agency or is blank, Vault populates the Registration Number on the Case Product. Otherwise, this data element is blank.

B.4.k.4.2 Country of Authorisation / Application

If the registration country is within the jurisdiction of the agency, Vault populates the Registration Country on the Case Product. Otherwise, this data element is blank.

B.4.k.4.3 Name of Holder / Applicant

If the registration country is within the jurisdiction of the agency or is blank, Vault populates the Registration Holder/Applicant on the Case Product. Otherwise, this data element is blank.

B.4.k.5.1 Dose (number)

The Dose (number) on the Case Product Dosage. Vault maps text that exceeds the character limit to B.4.k.6.

B.4.k.5.2 Dose (unit)

The Dose (unit) on the Case Product Dosage. Vault maps text that exceeds the character limit to B.4.k.6.

B.4.k.5.3 Number of separate dosages

The number of individual Case Product Dosage records associated with the Case.

B.4.k.5.4 Number of Units in the Interval

The Frequency on the Case Product Dosage. When the Frequency value is a non-standard frequency measurement (cyclical, as necessary, or total), Vault leaves this element blank and populates the non-standard unit in B.4.k.6.

B.4.k.5.5 Definition of the Time Interval Unit

Vault maps an E2B(R2) code based on the Frequency unit on the Case Product Dosage. When the Frequency value is a non-standard frequency measurement (cyclical, as necessary, or total), Vault leaves this element blank and populates the non-standard unit in B.4.k.6.

B.4.k.12 Date and Time of Start of Drug

The First Administration value on the Case Product Dosage.

B.4.k.14 Date and Time of Last Administration

The Last Administration value on the Case Product Dosage.

B.4.k.15a Duration of Drug Administration (number)

The Duration (number) on the Case Product Dosage.

B.4.k.15b Duration of Drug Administration (unit)

The Duration (unit) on the Case Product Dosage.

B.4.k.3 Batch / Lot Number

The Batch/Lot Number on the Case Product Dosage.

B.4.k.6 Dosage Text

The Dosage Text on the Case Product Dosage. For custom Dose (Unit)s, Vault maps the Dose and Dose (Unit) values to this element, preceded by the label DOSAGE:.

If the B.4.k.5.1 Dose (number) and B.4.k.5.2 Dose (unit) values exceed data element character limits, Vault maps additional text to this data element, preceded by the label DOSAGE:.

For FDA and ICH E2B R2 only, when the Frequency value is a non-standard frequency measurement (cyclical, as necessary, or total), Vault also maps the frequency value and unit to this element.

B.4.k.7 Pharmaceutical Dose Form

The Dose Form Text on the Case Product Dosage. If the value exceeds 50 characters, Vault maps the text to the B.4.k.19 data element.

B.4.k.8 Route of Administration

The E2B code corresponding to the Route of Administration in the Patient RoA field on the Case Product Dosage. If the Case Product Dosage does not include a Patient RoA TermID and Patient RoA TermID Version, Vault maps the Patient RoA value as text to the B.4.k.19 data element.

B.4.k.9 Parent Route of Administration

The E2B code corresponding to the Route of Administration in the Parent RoA field on the Case Product Dosage. If the Case Product Dosage does not include a Parent RoA TermID and Parent RoA TermID Version, Vault maps the Parent RoA value as text to the B.4.k.19 data element.

B.4.k.5.6 Cumulative Dose to First Reaction (number)

The Cumulative Dose on the Case Product.

If the value exceeds character limits, Vault maps additional text to B.4.k.19 Additional Information on Drug (free text).

B.4.k.5.7 Cumulative Dose to First Reaction (unit)

The Cumulative Dose (unit) on the Case Product.

If the value exceeds character limits, Vault maps additional text to B.4.k.19 Additional Information on Drug (free text).

B.4.k.10a Gestation Period at Time of Exposure (number)

The Gestation Exposure value on the Case Product.

B.4.k.10b Gestation Period at Time of Exposure (unit)

The Gestation Exposure (unit) on the Case Product.

B.4.k.11a MedDRA Version for Indication

The active MedDRA dictionary on the Case, taken from the MedDRA Version field.

B.4.k.16 Action(s) Taken with Drug

The Action Taken on the Case Product.

You must select a Vault E2B Code value for this section. See the following mapping table:

B.4.k.18.1a MedDRA version for reaction(s)/event(s) assessed

The active MedDRA dictionary on the Case, taken from the MedDRA Version field.

Vault does not export this element for device constituent assessments.

B.4.k.18.1b Reaction(s) / Event(s) Assessed

The reaction or event being assessed, referenced in the Case Adverse Event field on the Case Assessment. This is not a user-entered element. Vault does not export this element for device constituent assessments.

B.4.k.18.2 Source of Assessment

A Case Assessment Result field value, using the following priority:

1. Source Type
2. Source (text)

Vault does not export this element for device constituent assessments.

B.4.k.18.3 Method of Assessment

A Case Assessment Result field value, using the following priority:

1. Method of Assessment
2. Method (text)

Vault does not export this element for device constituent assessments.

B.4.k.18.4 Result of Assessment

A Case Assessment Result field value, using the following priority:

1. Assessment Result (Override)

1. Assessment Result
2. Result (text)

Vault does not export this element for device constituent assessments.

B.4.k.13.1a Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number)

The First Dose Latency (number) on the Case Assessment. When required, Vault truncates values to the five-character limit for this data element.

Vault does not export this element for device constituent assessments.

B.4.k.13.1b Time Interval between Beginning of Drug Administration and Start of Reaction / Event (unit)

The First Dose Latency (unit) on the Case Assessment. When required, Vault truncates values to the five-character limit for this data element.

Vault does not export this element for device constituent assessments.

B.4.k.13.2a Time Interval between Last Dose of Drug and Start of Reaction / Event (number)

The Last Dose Latency (number) on the Case Assessment.

Vault does not export this element for device constituent assessments.

B.4.k.13.2b Time Interval between Last Dose of Drug and Start of Reaction / Event (unit)

The Last Dose Latency (unit) on the Case Assessment.

Vault does not export this element for device constituent assessments.

B.4.k.17.1 Did Reaction Recur on Re-administration?

Based on the Reaction Recurrence on the Case Assessment, Vault populates:

• 1: yes - yes (rechallenge was done, reaction recurred)
• 2: yes - no (rechallenge was done, reaction did not recur)
• 3: no - n/a (no rechallenge was done, recurrence is not applicable) or yes - unk (rechallenge was done, outcome unknown)

Vault does not export this element for device constituent assessments.

B.4.k.19 Additional Information on Drug (free text)

Vault populates data from the following sources:

• The Additional Information (text) on the Case Product.
• The following Case Product Dosage fields when Vault cannot export values to the B.4.k.7, B.4.k.8, or B.4.k.9 data elements:
  • Dose Form
  • Dose Form Text
  • Dose Form TermID
  • Patient RoA
  • Patient RoA TermID Version
  • Parent RoA
  • Parent RoA TermID Version
  • Dosage Text
• The Expiration Date on the Case Product. The exported format is Expiration Date: YYYY-MM-DD. For partial dates, the format is YYYY-MM or YYYY.
• If the Blinded value is Yes on the Case Product, Vault appends INVESTIGATIONAL to this element.
• If the Drug Role value is Drug not administered on the Case Product, Vault appends DRUG NOT ADMINISTERED to this element.
• If values exceed the B.4.k.5.6 and B.4.k.5.7 data element character limits, Vault maps additional text to this data element, preceded by the label CUMULATIVE DOSAGE:.

B.5.1 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information

The Narrative on the Case, to a limit of 20,000 characters.

For domestic Cases with Localization Scope set to Narrative or blank, Vault populates the Localized Narrative document this element. For any other setup, Vault exports only the primary narrative. Vault does not export any additional translated narratives and/or language tags.

B.5.2 Reporter’s Comments

The Reporter’s Comments on the Case, to a limit of 20,000 characters.

B.5.3a MedDRA Version for Sender’s Diagnosis / Syndrome and / or Reclassification of Reaction / Event

The MedDRA Version on the Case.

B.5.3b Sender’s Diagnosis / Syndrome and / or Reclassification of Reaction / Event (MedDRA code)

The MedDRA LLT coded on the Case Diagnosis.

B.5.4 Sender’s Comments

The Company Comments on the Case, to a limit of 2,000 characters. When Company Comments exceed the character limit, Vault truncates the value.

For domestic Cases with Localization Scope set to Company Comments or blank, Vault maps the Localized Company Comments to this element.

A.1.FDA.15 Combination Product Report Flag

If the Case Product contains a Combination Product value, Vault populates 1 (Yes).

A.2.1.3.FDA.4 Reporter’s Email Address

The Email Address on the Reporter-type Case Contact.

B.4.k.2.4.FDA.1a Expiration Date Format

Based on the Expiration Date on the device-type Case Product, Vault specifies the code for the appropriate format.

B.4.k.2.4.FDA.1b Expiration Date

The Expiration Date on the device-type Case Product.

B.4.k.2.FDA.5 Product available for evaluation

The Device Available value on the device-type Case Product.

B.4.k.2.6.FDA.1a Product return date format

Based on the Returned Date on the device-type Case Product, Vault specifies the appropriate format.

B.4.k.2.6.FDA.1b Product return date

The Returned Date on the device-type Case Product.

B.4.k.20.FDA.1 Brand Name

The Trade Name on the Product associated with the device-type Case Product, to a limit of 80 characters. If blank on the Product, Vault populates the Trade Name on the Product Registration, if available.

B.4.k.20.FDA.2 Common Device Name

The Generic Name on the Product associated with the device-type Case Product.

B.4.k.20.FDA.3 Product Code

The Product Code on the Product Registration associated with the device-type Product Constituent.

B.4.k.20.FDA.4a Device Manufacturer Name

If there is an organization linked to the Manufacturer on the corresponding Product, Vault maps the Name on that Organization. Otherwise, Vault maps the Name on the organization linked to the Organization field on the Product record.

B.4.k.20.FDA.4b Manufacturer Address

If there is an organization linked to the Manufacturer on the corresponding Product, Vault maps the Street on that Organization. Otherwise, Vault maps the Street on the organization linked to the Organization field on the Product record.

B.4.k.20.FDA.4c Manufacturer City

If there is an organization linked to the Manufacturer on the corresponding Product, Vault maps the City on that Organization. Otherwise, Vault maps the City on the organization linked to the Organization field on the Product record.

B.4.k.20.FDA.4d Manufacturer State

If there is an organization linked to the Manufacturer on the corresponding Product, Vault maps the State on that Organization. Otherwise, Vault maps the State on the organization linked to the Organization field on the Product record.

B.4.k.20.FDA.4e Manufacturer Country

If there is an organization linked to the Manufacturer on the corresponding Product, Vault maps the Country on that Organization. Otherwise, Vault maps the Country on the organization linked to the Organization field on the Product record.

B.4.k.20.FDA.5 Model Number

The Model Number on the device-type Case Product.

B.4.k.20.FDA.6 Catalog Number

The Catalog Number on the device-type Case Product.

B.4.k.20.FDA.7 Serial Number

The Serial Number on the device-type Case Product.

B.4.k.20.FDA.8 Unique Identifier UDI#

The Unique Identifier on the device-type Case Product.

B.4.k.20.FDA.9a Implant Date Format

Based on the Date Implanted on the device-type Case Product, Vault specifies the appropriate format.

B.4.k.20.FDA.9b Implanted Date

The Date Implanted on the device-type Case Product.

B.4.k.20.FDA.10a Explanted Date Format

Based on the Date Explanted on the device-type Case Product, Vault specifies the appropriate format.

B.4.k.20.FDA.10b Explanted Date

The Date Explanted on the device-type Case Product.

B.4.k.20.FDA.11a Approximate age of device/product

The Device Age - Number on the device-type Case Product.

B.4.k.20.FDA.11b Approximate age unit of device/product

The Device Age - Unit on the device-type Case Product.

B.4.k.20.FDA.12 Single Use Device

The Single Use value on the device-type Case Product.

B.4.k.20.FDA.13a Device Manufacture Date Format

Based on the Manufacture Date on the device-type Case Product, Vault specifies the appropriate format.

B.4.k.20.FDA.13b Device Manufacture Date

The Manufacture Date on the device-type Case Product.

B.4.k.20.FDA.14.1a Recall

For each device constituent of a Combination Product, Vault populates 1 (Yes) when the Remedial Action value is Recall on the Case Product or, if blank, the Case.

B.4.k.20.FDA.14.1b Repair

For each device constituent of a Combination Product, Vault populates 1 (Yes) when the Remedial Action value is Repair on the Case Product or, if blank, the Case.

B.4.k.20.FDA.14.1c Replace

For each device constituent of a Combination Product, Vault populates 1 (Yes) when the Remedial Action value is Replace on the Case Product or, if blank, the Case.

B.4.k.20.FDA.14.1d Relabeling

For each device constituent of a Combination Product, Vault populates 1 (Yes) when the Remedial Action value is Relabeling on the Case Product or, if blank, the Case.

B.4.k.20.FDA.14.1e Notification

For each device constituent of a Combination Product, Vault populates 1 (Yes) when the Remedial Action value is Notification on the Case Product or, if blank, the Case.

B.4.k.20.FDA.14.1f Inspection

For each device constituent of a Combination Product, Vault populates 1 (Yes) when the Remedial Action value is Inspection on the Case Product or, if blank, the Case.

B.4.k.20.FDA.14.1g Patient monitoring

For each device constituent of a Combination Product, Vault populates 1 (Yes) when the Remedial Action value is Patient monitoring on the Case Product or, if blank, the Case.

B.4.k.20.FDA.14.1h Modification/Adjustment

For each device constituent of a Combination Product, Vault populates 1 (Yes) when the Remedial Action value is Modification/Adjustment on the Case Product or, if blank, the Case.

B.4.k.20.FDA.14.1i Other

For each device constituent of a Combination Product, when the Remedial Action on the Case Product is Other, Vault populates the associated Remedial Action Other text.

If Remedial Action is blank on the Case Product and the Remedial Action on the Case is Other, Vault populates the associated Remedial Action - Other text.

B.4.k.20.FDA.15 Device Usage

The Device Usage Type on the device-type Case Product.

B.4.k.20.FDA.16 Device Lot Number

The Lot Number on the Product associated with the device-type Case Product.

B.4.k.20.FDA.17 Malfunction

For each device constituent of a Combination Product, Vault populates 1 (Yes) when the Malfunction value is Yes on the Case Product or, if blank, the Case.

B.4.k.20.FDA.18.1a Correction

When the Device Follow-Up Type on the Case is Correction, Vault populates 1 (Yes).

B.4.k.20.FDA.18.1b Additional Information

When the Device Follow-Up Type on the Case is Additional Information, Vault populates 1 (Yes).

B.4.k.20.FDA.18.1c Response to FDA request

When the Device Follow-Up Type on the Case is Response to FDA Request, Vault populates 1 (Yes).

B.4.k.20.FDA.18.1d Device Evaluation

When the Device Follow-Up Type on the Case is Device Evaluation, Vault populates 1 (Yes).

B.4.k.20.FDA.19.1a Evaluation Type

For each device constituent of a Combination Product, Vault populates the following harmonized FDA/IMDRF codes when found on the Case Product Device Code record:

• Medical Device Problem
• Type of Investigation
• Investigation Finding
• Investigation Conclusion

B.4.k.20.FDA.19.1b Evaluation Value

The level 1, 2, or 3 harmonized FDA/IMDRF codes on the device-type Case Product.

B.4.k.20.FDA.20 Operator of the Device

The Operator of Device on the Product associated with the device-type Case Product.