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:
- The Study belongs to a Partner Distribution type of Reporting Family with a Distribution Rule that references a Safety Rule Set with a Study Content Protection value of Yes.
- The Study Content Protection value of the Distribution is Yes.
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:

Patient Content Protection
Exceptions to Patient Content Protection
Study Content Protection

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:

Mask dosage for Study Products
Mask the reporter for postmarket non-literature Cases
Unmask open-label Products within blinded Studies on blinded CIOMS I and FDA 3500A forms

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:

Note: When the Date of Birth field is masked, Age and Age Group information is transmitted during E2B transmission.

Object	Field	FDA 3500A/FDA eMDR/CIOMS I/EU MIR Mask Indicator	E2B(R3) Mask Indicator	E2B(R2) Mask Indicator
Case Contact (`case_contact__v`)	Title (`title_value__v`)	`*****`	`MSK`	`PRIVACY`
	First Name (`firstname_value__v`)	`*****`	`MSK`	`PRIVACY`
	Middle Name (`middlename_value__v`)	`*****`	`MSK`	`PRIVACY`
	Last Name (`lastname_value__v`)	`*****`	`MSK`	`PRIVACY`
	Organization (`organization_value__v`)	`*****`	`MSK`	`PRIVACY`
	Department (`department_value__v`)	`*****`	`MSK`	`PRIVACY`
	Street (`street_value__v`)	`*****`	`MSK`	`PRIVACY`
	City (`city_value__v`)	N/A	N/A	`PRIVACY`¹
	State / Province (`state_province_value__v`)	N/A	N/A	`PRIVACY`¹
	Postal Code (`postalcode_value__v`)	`*****`	`MSK`	`PRIVACY`
	Telephone (`telephone_value__v`)	`*****`	`MSK`	Left blank²
	Fax (`fax__v`)	`*****`	`MSK`	Left blank²
	Email Address (`email_address__v`)	`*****`	`MSK`	Left blank²
Case (`case_version__v`)	Reporter First Name (`reporter_first_name__v`)	`*****`	`MSK`	`PRIVACY`
	Reporter Last Name (`reporter_last_name__v`)	`*****`	`MSK`	`PRIVACY`
	Patient Initials (`patient_id_value__v`)	`*****`	`MSK`	`PRIVACY`
	Sex (`gender_value__v`)	Left blank	`MSK`³	Left blank²
	Race (`race__v`)	Left blank⁴	N/A	N/A
	Ethnicity (`ethnicity__v`)	Left blank⁴	N/A	N/A
	MRN - GP (`mrn_gp_value__v`)	`*****`	`MSK`	Left blank²
	MRN - Specialist (`mrn_specialist_value__v`)	`*****`	`MSK`	Left blank²
	MRN - Hospital (`mrn_hospital_value__v`)	`*****`	`MSK`	Left blank²
	MRN - Investigation (`mrn_investigation_value__v`)	`*****`	`MSK`	Left blank²
	Date of Birth (`dob_idate__v`)	`--***`	`MSK`	Left blank²
	Date of Birth (normalized) (`dob_normalized__v`)	`--***`	`MSK`	Left blank²
	Last Menstrual (`last_menstrual_idate__v`)	`--***`	`MSK`³	Left blank²
	Last Menstrual (normalized) (`last_menstrual_normalized__v`)	`--***`	`MSK`	Left blank²
	Medical History Text (`medical_history_text__v`)	`*****`	`MSK`³	Left blank²
	Date of Death (`dod_idate__v`)	`--***`	`MSK`³	Left blank²
	Date of Death (normalized) (`dod_normalized__v`)	`--***`	`MSK`	Left blank²
Case Product (`case_product__v`)	Date Implanted (`date_implanted__v`)	`--***`	`MSK`	Left blank²
Case Product (`case_product__v`)	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 (`case_version__v`) (Parent)
Patient Sex	Sex (`gender_value__v`)¹	Case (`case_version__v`)
Reporter Country	Country (`country_value__v`)	Case Contact (`case_contact__v`) (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.

Note: For FDA VAERS E2B(R3) exports, as MSK is not a valid nullFlavor for these E2B data elements, Vault does not mask:

FDA.D.13 - Pregnant at Time of Vaccination
FDA.C.2.r.2.3 - Reporter’s Street Address - LINE 2

Object	Field	FDA 3500A/FDA eMDR/CIOMS I/EU MIR Mask Indicator	E2B(R3) Mask Indicator	E2B(R2) Mask Indicator
Case Contact (`case_contact__v`)	County (`county_value__v`)	`*****`	`MSK`	Left blank¹
	Country (`country_value__v`)	`****` Form checkbox is blank (G.3)*	`MSK`	Left blank¹
	City (`city_value__v`)	`*****`	`MSK`	`PRIVACY`
	State / Province (`state_province_value__v`)	`*****`	`MSK`	`PRIVACY`
Case (`case_version__v`)	Event Onset (`event_onset_idate__v`)	`--***`	`MSK`	Left blank¹
	Event Onset (normalized) (`event_onset_normalized__v`)	`--***`	`MSK`	Left blank¹
	Race (`race__v`)	`*****`	`MSK`	Left blank¹
	Ethnicity (`ethnicity__v`)	`*****`	`MSK`	Left blank¹
	Pregnant at Vaccination (`pregnant_at_vaccination__v`)	`*****`	`MSK`	Left blank¹
	Product Generic Name (`generic_name__v`)	`*****`	`MSK`	Left blank¹
	MPID Version (`mpid_version__v`)	`*****`	`MSK`	Left blank¹
Case Adverse Event (`case_adverse_event__v`)	Onset (`onset_idate__v`)	`--***`	`MSK`	Left blank¹
	Onset (normalized) (`onset_normalized__v`)	`--***`	`MSK`	Left blank¹
	Cessation (`resolved_idate__v`)	`--***`	`MSK`	Left blank¹
	Cessation (normalized) (`resolved_normalized__v`)	`--***`	`MSK`	Left blank¹
	Duration Duration (unit) (`duration_number__v) (duration_unit__v`)	`*****`	`MSK`	Left blank¹
Case Drug History (`case_drug_history__v`)	Start Date (`startdate_idate__v`)	`--***`	`MSK`	Left blank¹
	Start Date Normalized (`startdate_normalized__v`)	`--***`	`MSK`	Left blank¹
	End Date (`enddate_idate__v`)	`--***`	`MSK`	Left blank¹
	End Date Normalized (`end_date_normalized__v`)	`--***`	`MSK`	Left blank¹
Case Medical History (`case_medical_history__v`)	Start Date (`startdate_idate__v`)	`--***`	`MSK`	Left blank¹
	Start Date Normalized (`startdate_normalized__v`)	`--***`	`MSK`	Left blank¹
	Continuing (`continuing_value__v`)	`*****`	`MSK`	Left blank¹
	End Date (`enddate_idate__v`)	`--***`	`MSK`	Left blank¹
	End Date Normalized (`enddate_normalized__v`)	`--***`	`MSK`	Left blank¹
Case Product Dosage (`case_product_dosage__v`)	First Administration (`firstadmin_idate__v`)	`--***`	`MSK`	Left blank¹
	First Administration (normalized) (`firstadmin_normalized__v`)	`--***`	`MSK`	Left blank¹
	Last Administration (`lastadmin_idate__v`)	`--***`	`MSK`	Left blank¹
	Last Administration (normalized) (`lastadmin_normalized__v`)	`--***`	`MSK`	Left blank¹
	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.

Note: Study Content Protection is not supported when generating PMDA E2B(R3) reports for the PMDA.

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 (`case_product__v`)	Product (Coded) (`product_name_v`)	Blinded name or `*****` if no blinded name	Blinded name or `MSK` if no blinded name
	Product (Reported) (`product_reported__v`)	Blinded name or `*****` if no blinded name	Blinded name or `MSK` if no blinded name
	MPID (`mpid__v`)	`*****`	Left blank
	MPID Version (`mpid_version__v`)	`*****`	Left blank
	PhPID (`phpid__v`)	`*****`	Left blank
	PhPID Version (`phpid_version__v`)	`*****`	Left blank
	Registration Number (`registration_number__v`)	Left blank	Left blank
	Registration Country (`registration_country__v`)	`*****`	Left blank
	Registration Holder/Applicant (`registration_mah__v`)	`*****`	Left blank
	Organization (`Organization__v`)	`*****`	Left blank
	Expiration Date (`expiration_date__v`)	`*****`	Left blank
	Name (`name__v`)	`*****`	Left blank
	Model Number (`model_number__v`)	`*****`	Left blank
	Catalog Number (`catalog_number__v`)	`*****`	Left blank
	Serial Number (`serial_number__v`)	`*****`	Left blank
	Lot Number (`lot_number__v`)	`*****`	Left blank
	Unique Identifier (`unique_Identifier__v`)	`*****`	Left blank
	Reprocessed/Reused (`reprocessed__v`)	`*****`	Left blank
	Reprocessor (`reprocessor__v`)	`*****`	Left blank
	Additional Information (`additional_information_coded__v`)	`*****`	Left blank
	Other Additional Information (`additional_information_text__v`)	`*****`	Left blank
	Blinded (`blinded__v`)	`*****`	Left blank
Case Product Dosage (`case_product_dosage__v`)	Batch/Lot Number (`batchlot_number__v`)	Left blank	Left blank
Case Product Substance (`case_product_substance__v`)	Name (Reported) (`name_reported__v`)	`*****`	Left blank
	TermID Version (`termid_version__v`)	`*****`	Left blank
	TermID (`termid__v`)	`*****`	Left blank
	Strength (Number) (`strength_number__v`)	`*****`	Left blank
	Strength (Unit) (`strength_unit__v`)	`*****`	Left blank
Product (`product__v`)	Manufacturer (`manufacturer__v`)	`*****`	Left blank
Product (`product__v`)	Generic Name (`generic_name__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

Note: Dose Frequency is not displayed if the Frequency field is blank when generating a report.

Dosage Masking by Format

Vault masks dosage by report type as follows:

CIOMS I: Populates ***** in Box 15 and 16
FDA MedWatch 3500A: Populates ***** in Box C3
FDA eMDR: Populates ***** in data element C.3
E2B(R3): Omits section G.k.4.r
E2B(R2): 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:

Title (title_value__v)
First Name (firstname_value__v)
Middle Name (middlename_value__v)
Last Name (lastname_value__v)
Organization (organization_value__v)
Department (department_value__v)
Street (street_value__v)
Postal Code (postalcode_value__v)
Telephone (telephone_value__v)
Fax (fax__v)
Email Address (email_address__v)

If the Patient Content Protection field specifies E2B Mask on a Transmission, Vault also masks the reporter’s Country (country_value__v).

Reporter Masking by Format

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

Report Type Reporter Masking

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.

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.