Generate Masked Safety Reports

You can configure Submissions and Distributions to mask sensitive information selectively on Individual Case Safety Reports (ICSRs).

Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.

About Masked Safety Reports

When you configure a Submission or Distribution, you can choose to protect confidential or blinded data in the generated ICSR, such as all of a patient’s identifiable and health information, only identifiable information, or unblinded study data.

By setting content confidentiality preferences for Partner Distributions, you can generate masked distributions for partner organizations while continuing to generate unblinded ICSRs for agency submissions.

There are masking settings specific to Partner Distribution families. Each setting masks or hides certain information on generated regulatory reports or E2B Transmissions.

The following fields control safety report masking:

Patient Content Protection (patient_content_protection__v)
Exceptions to Patient Content Protection (exceptions_to_patient_content_protection__v)
Study Content Protection (study_content_protection__v)

See the following table for an overview of how to generate masked safety reports for Transmissions:

Transmission Type	Set Up
Distribution	To automatically generate Distributions with masking applied, your Admin can configure masking options in a Partner Distribution List. Otherwise, you can manually edit the masking fields on a Distribution.
Submission	To automatically generate Submissions with masking applied, your Admin can configure the Mask PII parameter on a Safety Rule Set to apply to all Cases or only foreign Cases. Otherwise, you can manually edit the masking fields on a Submission.

In addition to the masking field settings for Submissions and Distributions, your Admin can optionally enable the system to mask dosage to study products and mask the reporter for postmarket non-literature Cases.

Your Admin may also configure unmasked export of open-label Products within blinded Studies on blinded CIOMS I and FDA 3500A forms.

Prerequisite

Ensure that your Vault has the Masked Content Distributions feature enabled.

Patient Content Protection

Use the Patient Content Protection field to configure masking for personally identifiable information (PII).

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

Mask Personal Identifiable Information (PII)

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

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

Object	Field	FDA 3500A/CIOMS I 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	Gender (`gender_value__v`)	Left blank	MSK³	Left Blank²
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 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, this field is not masked. If the field contains a manually entered MSK value, then the field is omitted from the transmission.

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 dropdown menu:

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

If you do not see the Exceptions to Patient Content Protection field, your Admin may need to Enable Configurable Field Masking.

Select any number of fields from the dropdown menu to leave unmasked.

E2B Mask (Includes Personal Identifiable Information)

Vault Safety 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, the following fields are not masked, as MSK is not a valid nullFlavor setting for these E2B data elements:

FDA.D.13 - Pregnant at Vaccination
FDA.D.1f - Street Line 2 (Patient)
FDA.C.2.r.2.3 - Street Line 2 (Reporter)

Object	Field	FDA 3500A/CIOMS I 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	Gender (`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.

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

Mask Unblinded Content

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

Note: 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 and 3500A forms.

Note: 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/CIOMS I 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

By default, Product Dosage information is unmasked in generated reports for masked Distributions.

However, Vault Safety supports the option to mask Study Product dosage on E2B, CIOMS I, and FDA 3500A reports.

Enable Dosage Masking for Study Products

Your Admin can enable Mask Dosage in Blinded Distributions in your Vault.

If enabled, Study Product dosage masking applies to reports generated in the following conditions:

Masked Distributions where Study Content Protection is set to “Mask Unblinded Content”
Blinded report previews (manually generated from a blinded Study Case)

Masked Dosage Fields

If dosage masking is enabled, the following dosage information is masked:

Dose
Patient Route of Administration
Dose Frequency

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

Dosage Masking by Format

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

Report Type	Dosage Masking
CIOMS I	Box 15 and 16 are populated with *****
FDA 3500A	Box C.3 is populated with *****
E2B(R3)	Dosage section G.k.4.r is omitted
E2B(R2)	Dosage sections are omitted: 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

Vault Safety provides a system-level setting to support masking reporter information in all outbound Submissions and Distribution for postmarket non-literature Cases. This setting is controlled from the Submission and Distribution Settings page in the Admin area.

The following conditions must be met to mask reporter fields for a Case:

The Mask Reporter for PM Non-Literature Case system setting must be enabled in your Vault.
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.

Enable Reporter Masking System Setting

Go to Admin > Settings > Submission and Distribution Settings. Your Permission Set must have permission to View the Submission and Distribution Settings page to access this page.
Enable the Mask Reporter for PM Non-Literature Case field.

Note: Once enabled, reporter masking applies to all postmarket non-literature Cases, regardless of the masking settings on the Transmission.

Masked Reporter Fields

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

Note: If the Patient Content Protection field specifies ‘E2B Mask’ on a Transmission, the system masks the Reporter Country in addition to the fields below in the generated report.

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	Only the Reporter Qualification and Reporter Country fields are exported, if populated. If these fields are blank, no reporter information is transmitted.
FDA 3500A	Only the Reporter Qualification and Reporter Country fields are exported, if populated. If these fields are blank, no reporter information is transmitted.
E2B(R3)	Specified reporter fields are masked with MSK. Empty fields are not transmitted. 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. Empty fields are not transmitted.