EMA(R3) masking rule updates
Summary
EMA(R3) masking rules as per GVP Module VI Addendum II publication (Enhancement 38245158)
Description
EMA published guidelines on good pharmacovigilance practices (GVP) Module VI Addendum II – Masking of personal data in individual case safety reports submitted to EudraVigilance. Argus is enhanced to support updated regulatory guidance.
The checkbox, Apply EMA Masking Rules, is added in the Console > Reporting Destination > Reports tab. When EMA R3 profile (standard or custom) is selected in Message Profile, the checkbox is enabled for selection. If this is set, then mapping changes are applied to the EMA E2B R3 report as per the masking rules defined in GVP Module VI Addendum II publication for elements that require changes in Argus.
Note:
Other elements are not impacted as they already satisfy the defined rules.- E2B(R3) data elements to be masked
- REPORTERTITLE[C.2.r.1.1]
- REPORTERGIVENAME[C.2.r.1.2]
- REPORTERMIDDLENAME[C.2.r.1.3]
- REPORTERFAMILYNAME[C.2.r.1.4]
- REPORTERORGANIZATION[C.2.r.2.1]
- REPORTERDEPARTMENT[C.2.r.2.2]
- REPORTERSTREET[C.2.r.2.3]
- REPORTERPOSTCODE[C.2.r.2.6]
- REPORTERPHONE[C.2.r.2.7]
- PATIENTGPMEDICALRECORDNUMB[D.1.1.1]
- PATIENTSPECIALISTRECORDNUMB[D.1.1.2]
- PATIENTHOSPITALRECORDNUMB[D.1.1.3]
- PARENTIDENTIFICATION[D.10.1]
- E2B(R3) data elements to be left blank
- SENDERTITLE[C.3.3.2]
- SENDERGIVENAME[C.3.3.3]
- SENDERMIDDLENAME[C.3.3.4]
- SENDERFAMILYNAME[C.3.3.5]
- SENDERSTREETADDRESS[C.3.4.1]
- SENDERCITY[C.3.4.2]
- SENDERSTATE[C.3.4.3]
- SENDERPOSTCODE[C.3.4.4]
- SENDERCOUNTRYCODE[C.3.4.5]
- SENDERTELR3[C.3.4.6]
- SENDERFAXR3[C.3.4.7]
- E2B(R3) data elements send the data without masking
- REPORTERCITY[C.2.r.2.4]
- REPORTERSTATE[C.2.r.2.5]
- PATIENTINITIAL[D.1]
- PATIENTBIRTHDATER3[D.2.1]
- PARENTBIRTHDATER3[D.10.2.1]
- PATIENTINVESTIGATIONNUMB[D.1.1.4]
For more details, refer to ArgusInterchange2026.1.01_E2B (R3) Export Mappings.xlsx - EMA E2B(R3) export mapping document.
Parent topic: Regulatory enhancements