Generate Masked Safety Reports

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

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

There are different masking settings that you can choose from when setting up a Partner Distribution family. Each setting masks or hides certain information on generated regulatory reports or E2B transmissions.

The following masking 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, an 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, an admin can configure 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, you can optionally enable the system to mask dosage to study products and mask the reporter for postmarket non-literature Cases.

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 Personal Identifiable Information (PII).

You can configure masking exceptions for Patient Content Protection 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 Postal Code (postalcode_value__v) ***** MSK PRIVACY
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 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_menstural_idate__v) **-***-**** MSK Left Blank1
Case Version Last Menstrual (normalized) (last_menstrural_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 Product Date Implanted (date_implanted__v) **-***-**** MSK Left Blank1
Case Product Date Explanted (date_explanted__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.

Exceptions to Patient Content Protection

When using PCP, you can select personal identifiable information 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) Case Version (Parent)
Patient Sex Gender (gender_value__v) Case Version
Reporter Country Country (country_value__v) Case Contact (Reporter)

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

The Exceptions to Patient Content Protection Field
Exceptions to Patient Content Protection Field

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

The Exceptions to Patient Content Protection Field Selected Values
Exceptions to Patient Content Protection Field with Selected Fields

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_menstural_idate__v) **-***-**** MSK Left Blank1
Case Version Last Menstrual (normalized) (last_menstrural_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 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.

Tip By default, product dosage information is unmasked. However, Veeva support can enable Dosage Masking 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

Contact Veeva Support to request enabling dosage information masking 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)

Note If dosage masking is enabled, Study Product dosage masking applies regardless of the Case report type. In other words, if a Study Product is added to a Spontaneous or other non-Study report type Case, the dosage will still be masked.

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

  1. In the Admin area, go to Settings > Submission and Distribution Settings.
    Your permission set must have permission to View the Submission and Distribution Settings page to access this page.
  2. 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.
E2B(R2) Specified reporter fields are masked with PRIVACY. Empty fields are not transmitted.

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