Generate Masked Safety Reports

Vault can selectively mask sensitive information on Individual Case Safety Reports (ICSRs). When you generate a Submission or Distribution, you can choose to protect confidential or blinded data, such as all of a patient’s identifiable and health information, only identifiable information, or unblinded study data. In addition, your Admin can configure masking settings on Partner Distribution Lists. This enables generating masked distributions for partner organizations, while continuing to generate unblinded ICSRs for agency submissions.

Vault generates masked reports for the following types of Transmissions:

  • Distributions: When configured by your Admin, Vault generates masked Distributions. Otherwise, you can edit the masking fields on Distributions. Vault generates masked Distributions when the following conditions are met:
  • Submissions: Based on your Admin’s configuration, Vault generates Submissions with masking for all Cases or only foreign Cases. You can also edit the masking fields on Submissions.

The following Submission and Distribution fields control safety report masking:

Prerequisites

To use the features on this page, your Admin must configure:

In addition to the masking field settings for Submissions and Distributions, your Admin can enable your Vault to:

Patient Content Protection

When generating Transmissions, use the Patient Content Protection field to configure masking for personally identifiable information (PII). The options are:

  • Mask PII: Masks the fields in the table below.
  • Mask PII (EU Guidance): Masks the same fields as the Mask PII option, with some exceptions.
  • Mask E2B (Includes PII): Masks the same fields as the Mask PII option, with some additions.

You can configure masking exceptions for Patient Content Protection (PCP) using the Exceptions to Patient Content Protection field.

Mask Personally Identifiable Information (PII)

Vault masks the following fields when you select Mask PII while configuring a Partner Distribution Rule:

Object Field FDA 3500A/FDA eMDR/CIOMS I/EU MIR Mask Indicator E2B(R3) Mask Indicator E2B(R2) Mask Indicator
Case Contact Title (title_value__v) ***** MSK PRIVACY
Case Contact First Name (firstname_value__v) ***** MSK PRIVACY
Case Contact Middle Name (middlename_value__v) ***** MSK PRIVACY
Case Contact Last Name (lastname_value__v) ***** MSK PRIVACY
Case Contact Organization (organization_value__v) ***** MSK PRIVACY
Case Contact Department (department_value__v) ***** MSK PRIVACY
Case Contact Street (street_value__v) ***** MSK PRIVACY
Case Contact City (city_value__v) N/A N/A PRIVACY1
Case Contact State / Province (state_province_value__v) N/A N/A PRIVACY1
Case Contact Postal Code (postalcode_value__v) ***** MSK PRIVACY
Case Contact Telephone (telephone_value__v) ***** MSK Left Blank2
Case Contact Fax (fax__v) ***** MSK Left Blank2
Case Contact Email Address (email_address__v) ***** MSK Left Blank2
Case Version Reporter First Name (reporter_first_name__v) ***** MSK PRIVACY
Case Version Reporter Last Name (reporter_last_name__v) ***** MSK PRIVACY
Case Version Patient ID (patient_id_value__v) ***** MSK PRIVACY
Case Version Sex (gender_value__v) Left blank MSK3 Left Blank2
Case Version Race (race__v) Left blank4 N/A N/A
Case Version Ethnicity (ethnicity__v) Left blank4 N/A N/A
Case Version MRN - GP (mrn_gp_value__v) ***** MSK Left Blank2
Case Version MRN - Specialist (mrn_specialist_value__v) ***** MSK Left Blank2
Case Version MRN - Hospital (mrn_hospital_value__v) ***** MSK Left Blank2
Case Version MRN - Investigation (mrn_investigation_value__v) ***** MSK Left Blank2
Case Version Date of Birth (dob_idate__v) **-***-**** MSK Left Blank2
Case Version Date of Birth (normalized) (dob_normalized__v) **-***-**** MSK Left Blank2
Case Version Last Menstrual (last_menstrual_idate__v) **-***-**** MSK3 Left Blank2
Case Version Last Menstrual (normalized) (last_menstrual_normalized__v) **-***-**** MSK Left Blank2
Case Version Medical History Text (medical_history_text__v) ***** MSK3 Left Blank2
Case Version Date of Death (dod_idate__v) **-***-**** MSK3 Left Blank2
Case Version Date of Death (normalized) (dod_normalized__v) **-***-**** MSK Left Blank2
Case Product Date Implanted (date_implanted__v) **-***-**** MSK Left Blank2
Case Product Date Explanted (date_explanted__v) **-***-**** MSK Left Blank2
1. Masked on ICH E2B(R2) and FDA E2B(R2) reports only.
2. This is either not a valid element or nullFlavor for E2B(R2). If this is a valid element, the element will not be transmitted in place of being masked.
3. When exporting an EMA E2B(R3) with a transmission destination of EMA or Swissmedic, this field is not masked. If the field contains a manually entered MSK value, then the field is omitted from the transmission.
4. These regional data elements appear only on FDA MedWatch 3500A and FDA eMDR reports.

Mask PII (EU Guidance)

When the Patient Content Protection on a Submission is Mask PII (EU Guidance), Vault masks the same fields as for the Mask PII setting with the following exceptions:

  • Vault does not mask the following Case Version fields:
    • Patient ID
    • Sex
    • MRN - Investigation
    • Date of Birth
    • Date of Birth (normalized)
    • Last Menstrual
    • Last Menstrual (normalized)
    • Medical History Text
    • Date of Death
    • Date of Death (normalized)
  • For the Sender (User) on the Submission, Vault exports the following fields as blank:
    • Title
    • First Name
    • Middle Name
    • Last Name
    • Street
    • City
    • State / Province
    • Zip / Postal Code
    • Country Code
    • Telephone
    • Fax

Exceptions to Patient Content Protection

When using PCP, you can select PII fields to leave unmasked. You can configure masking exceptions for the following fields using the Exceptions to Patient Content Protection drop-down:

Exception Unmasked Field Object
Blank Fields - -
Parent Sex Sex (gender_value__v)1 Case Version (Parent)
Patient Sex Sex (gender_value__v)1 Case Version
Reporter Country Country (country_value__v) Case Contact (Reporter)
Null Flavors All fields configured with Reasons Omitted options. -
1. When exporting an EMA E2B(R3) with a transmission destination of EMA or Swissmedic, this field is not masked. If the field contains a manually entered MSK value, then the field is omitted from the transmission.

E2B Mask (Includes Personally Identifiable Information)

Vault masks all of the PII fields listed above, as well as the fields in the following table when you select E2B Mask while configuring a Partner Distribution Rule.

Object Field FDA 3500A/FDA eMDR/CIOMS I/EU MIR Mask Indicator E2B(R3) Mask Indicator E2B(R2) Mask Indicator
Case Contact Title (title_value__v) ***** MSK PRIVACY
Case Contact First Name (firstname_value__v) ***** MSK PRIVACY
Case Contact Middle Name (middlename_value__v) ***** MSK PRIVACY
Case Contact Last Name (lastname_value__v) ***** MSK PRIVACY
Case Contact Organization (organization_value__v) ***** MSK PRIVACY
Case Contact Department (department_value__v) ***** MSK PRIVACY
Case Contact Street (street_value__v) ***** MSK PRIVACY
Case Contact Street - Line 2 (street_line_2_value__v) ***** MSK Left Blank1
Case Contact Postal Code (postalcode_value__v) ***** MSK PRIVACY
Case Contact County (county_value__v) ***** MSK Left Blank1
Case Contact Country (country_value__v) *****
Form checkbox is blank (G.3)		 MSK Left Blank1
Case Contact Telephone (telephone_value__v) ***** MSK Left Blank1
Case Contact Fax (fax__v) ***** MSK Left Blank1
Case Contact Email Address (email_address__v) ***** MSK Left Blank1
Case Contact City (city_value__v) ***** MSK PRIVACY
Case Contact State / Province (state_province_value__v) ***** MSK PRIVACY
Case Version Reporter First Name (reporter_first_name__v) ***** MSK PRIVACY
Case Version Reporter Last Name (reporter_last_name__v) ***** MSK PRIVACY
Case Version Patient ID (patient_id_value__v) ***** MSK PRIVACY
Case Version Sex (gender_value__v) Left blank MSK Left Blank1
Case Version MRN - GP (mrn_gp_value__v) ***** MSK Left Blank1
Case Version MRN - Specialist (mrn_specialist_value__v) ***** MSK Left Blank1
Case Version MRN - Hospital (mrn_hospital_value__v) ***** MSK Left Blank1
Case Version MRN - Investigation (mrn_investigation_value__v) ***** MSK Left Blank1
Case Version Date of Birth (dob_idate__v) **-***-**** MSK Left Blank1
Case Version Date of Birth (normalized) (dob_normalized__v) **-***-**** MSK Left Blank1
Case Version Last Menstrual (last_menstrual_idate__v) **-***-**** MSK Left Blank1
Case Version Last Menstrual (normalized) (last_menstrual_normalized__v) **-***-**** MSK Left Blank1
Case Version Medical History Text (medical_history_text__v) ***** MSK Left Blank1
Case Version Date of Death (dod_idate__v) **-***-**** MSK Left Blank1
Case Version Date of Death (normalized) (dod_normalized__v) **-***-**** MSK Left Blank1
Case Version Event Onset (event_onset_idate__v) **-***-**** MSK Left Blank1
Case Version Event Onset (normalized) (event_onset_normalized__v) **-***-**** MSK Left Blank1
Case Version Race (race__v) ***** MSK Left Blank1
Case Version Ethnicity (ethnicity__v) ***** MSK Left Blank1
Case Version Pregnant at Vaccination (pregnant_at_vaccination__v) ***** MSK Left Blank1
Case Product Date Implanted (date_implanted__v) **-***-**** MSK Left Blank1
Case Product Date Explanted (date_explanted__v) **-***-**** MSK Left Blank1
Case Version Product Generic Name (generic_name__v) ***** MSK Left Blank1
Case Version MPID Version (mpid_version__v) ***** MSK Left Blank1
Case Adverse Event Onset (onset_idate__v) **-***-**** MSK Left Blank1
Case Adverse Event Onset (normalized) (onset_normalized__v) **-***-**** MSK Left Blank1
Case Adverse Event Cessation (resolved_idate__v) **-***-**** MSK Left Blank1
Case Adverse Event Cessation (normalized) (resolved_normalized__v) **-***-**** MSK Left Blank1
Case Adverse Event Duration
Duration (unit)
(duration_number__v)
(duration_unit__v)		 ***** MSK Left Blank1
Case Drug History Start Date (startdate_idate__v) **-***-**** MSK Left Blank1
Case Drug History Start Date Normalized (startdate_normalized__v) **-***-**** MSK Left Blank1
Case Drug History End Date (enddate_idate__v) **-***-**** MSK Left Blank1
Case Drug History End Date Normalized (end_date_normalized__v) **-***-**** MSK Left Blank1
Case Medical History Start Date (startdate_idate__v) **-***-**** MSK Left Blank1
Case Drug History Start Date Normalized (startdate_normalized__v) **-***-**** MSK Left Blank1
Case Drug History Continuing (continuing_value__v) ***** MSK Left Blank1
Case Drug History End Date (enddate_idate__v) **-***-**** MSK Left Blank1
Case Drug History End Date Normalized (enddate_normalized__v) **-***-**** MSK Left Blank1
Case Product Dosage First Administration (firstadmin_idate__v) **-***-**** MSK Left Blank1
Case Product Dosage First Administration (normalized) (firstadmin_normalized__v) **-***-**** MSK Left Blank1
Case Product Dosage Last Administration (lastadmin_idate__v) **-***-**** MSK Left Blank1
Case Product Dosage Last Administration (normalized) (lastadmin_normalized__v) **-***-**** MSK Left Blank1
Case Product Dosage Duration (number)
Duration (unit)
(duration_number__v)
(duration_unit__v)		 **-***-**** MSK Left Blank1
1. This is either not a valid element or nullFlavor for E2B(R2). If this is a valid element, the element will not be transmitted in place of being masked.

Study Content Protection

Use the Study Content Protection field to configure masking for unblinded information on Study Cases.

Mask Unblinded Content

Vault masks the fields in the table when you select Mask Unblinded Content while configuring a Partner Distribution Rule. Consider the following when masking unblinded content:

  • When you select Mask Unblinded Content on a Spontaneous Case with Study Content Protection, the Case’s Product information will remain unblinded on CIOMS I, FDA 3500A, and EU MIR forms.
  • By default, Product Dosage information is unmasked. However, your Admin can enable Mask Dosage in Blinded Distributions to apply with the Mask Unblinded Content option.
Object Field FDA 3500A/FDA eMDR/CIOMS I/EU MIR Mask Indicator E2B(R2) and (R3) Mask Indicator
Case Product Dosage Batch/Lot Number (batchlot_number__v) Left Blank Left Blank
Case Product Product (Coded) (product_name_v) Blinded name or ***** if no blinded name Blinded name or MSK if no blinded name
Case Product Product (Reported) (product_reported__v) Blinded name or ***** if no blinded name Blinded name or MSK if no blinded name
Case Product MPID (mpid__v) ***** Left Blank
Case Product MPID Version (mpid_version__v) ***** Left Blank
Case Product PhPID (phpid__v) ***** Left Blank
Case Product PhPID Version (phpid_version__v) ***** Left Blank
Case Product Registration Number (registration_number__v) Left Blank Left Blank
Case Product Registration Country (registration_country__v) ***** Left Blank
Case Product Registration Holder/Applicant (registration_mah__v) ***** Left Blank
Case Product Organization (Organization__v) ***** Left Blank
Case Product Expiration Date (expiration_date__v) ***** Left Blank
Case Product Name (name__v) ***** Left Blank
Product Manufacturer (manufacturer__v) ***** Left Blank
Case Product Model Number (model_number__v) ***** Left Blank
Case Product Catalog Number (catalog_number__v) ***** Left Blank
Case Product Serial Number (serial_number__v) ***** Left Blank
Case Product Lot Number (lot_number__v) ***** Left Blank
Case Product Unique Identifier (unique_Identifier__v) ***** Left Blank
Case Product Reprocessed/Reused (reprocessed__v) ***** Left Blank
Case Product Reprocessor (reprocessor__v) ***** Left Blank
Case Product Additional Information (additional_information_coded__v) ***** Left Blank
Case Product Other Additional Information (additional_information_text__v) ***** Left Blank
Case Product Blinded (blinded__v) ***** Left Blank
Product Generic Name (generic_name__v) ***** Left Blank
Case Product Substance Name (Reported) (name_reported__v) ***** Left Blank
Case Product Substance TermID Version (termid_version__v) ***** Left Blank
Case Product Substance TermID (termid__v) ***** Left Blank
Case Product Substance Strength (Number) (strength_number__v) ***** Left Blank
Case Product Substance Strength (Unit) (strength_unit__v) ***** Left Blank

Dosage Masking for Study Products

Vault does not mask product dosage in masked Distributions. However, Vault supports masking Study Product dosage on E2B, CIOMS I, FDA MedWatch 3500A, and FDA eMDR reports. If configured by your Admin, Study Product dosage masking applies to:

  • Masked Distributions where Study Content Protection is Mask Unblinded Content
  • Blinded report previews (manually generated from blinded study Cases)

Masked Dosage Fields

If dosage masking is enabled, Vault masks the following dosage information:

  • Dose
  • Patient Route of Administration
    • Including Parent Route of Administration, when present, on CIOMS I forms
  • Dose Frequency

Dosage Masking by Format

The following table outlines how dosage masking impacts different report types:

Report Type Dosage Masking
CIOMS I Vault populates ***** in Box 15 and 16.
FDA MedWatch 3500A Vault populates ***** in Box C3.
FDA eMDR Vault populates ***** in data element C.3.
E2B(R3) Vault omits section G.k.4.r.
E2B(R2) Vault omits the following data elements:
  • B.4.k.3
  • B.4.k.5
  • B.k.4.6
  • B.k.4.7
  • B.4.k.8
  • B.4.k.9
  • B.4.k.12
  • B.4.k.14
  • B.4.k.15

Reporter Masking for Postmarket Non-Literature Cases

If configured by your Admin, Vault masks reporter information in all outbound Submissions and Distribution for postmarket non-literature Cases. The following conditions must be met to mask reporter fields for a Case:

  • The Case Report Type must correspond to a postmarket, non-literature report type:
    • Postmarket: The Case must meet one of the following conditions to be considered “postmarket”:
      1. Non-Study Report Type: The Case Report Type specifies a non-study report type. That is, the Report Type corresponds to a Controlled Vocabulary of “Spontaneous” (E2B Code of 1), “Other” (E2B Code of 3), or “Not Available” (E2B Code of 4).
      2. Postmarket Study Case: The Case Report Type corresponds to a Study Controlled Vocabulary (E2B Code of 2) and the Case Study Type corresponds to a Controlled Vocabulary of “Individual Patient Use” (E2B Code of 2) or “Other Study” (E2B Code of 3).
    • Non-Literature: The Case Report Type field specifies a non-literature report type. That is, the option selected corresponds to a Report Type Controlled Vocabulary with the Literature field set to “No” or unspecified.

Masked Reporter Fields

Vault masks the following information for Reporter-type Case Contacts when generating any report format:

Object Field
Reporter-type Case Contact Title (title_value__v)
Reporter-type Case Contact First Name (firstname_value__v)
Reporter-type Case Contact Middle Name (middlename_value__v)
Reporter-type Case Contact Last Name (lastname_value__v)
Reporter-type Case Contact Organization (organization_value__v)
Reporter-type Case Contact Department (department_value__v)
Reporter-type Case Contact Street (street_value__v)
Reporter-type Case Contact Postal Code (postalcode_value__v)
Reporter-type Case Contact Telephone (telephone_value__v)
Reporter-type Case Contact Fax (fax__v)
Reporter-type Case Contact Email Address (email_address__v)

Reporter Masking by Format

The following table outlines how reporter masking impacts different report types:

Report Type Reporter Masking
  • CIOMS I
  • FDA MedWatch 3500A
  • FDA eMDR
  • EU MIR
 Vault exports only the Reporter Qualification and Reporter Country fields. If these fields are blank, Vault transmits no reporter information.
E2B(R3)

Vault masks specified reporter fields with MSK. Vault does not transmit empty fields.

In accordance with FDA guidance, for FDA VAERS E2B(R3) and FDA E2B(R3) reports, when the reporter's country is the United States, data elements in the C.2.r Primary Source(s) of Information section are unmasked even when the Mask Reporter For PM Non-Literature Case setting is enabled.
E2B(R2) Specified reporter fields are masked with PRIVACY. Vault does not transmit empty fields.