EMA regulation and business rule updates

Summary

Description

EU ICSR IG rev 2 business rule updates

E2B(R3) profile has been enhanced for post marketing and clinical ICSRs as per the business rules published by EU ICSR IG Business Rules and EV Human Business Rules.

The business rules for date and time states that No date/time value should exceed the current CET time plus 12 hours. Failure of the validation of the date format generates an error. Conformance rules in Oracle Argus, validates the dates based on UK GMT, and hence to comply with the business rules, all date-time validations in the EMA(R3) profile have been modified from UK GMT to CET.
As per the latest EU Clinical Trial Regulation, released on 31-Jan-2022, the Study Registration Number[C.5.1.r.1] must have a valid EudraCT number or unique EU trial number [Format: YYYY-5NNNNNXX- VV] when the data element Study Registration Country (ICH E2B(R3) C.5.1.r.2) contains the value EU.

Oracle Argus Safety enables you to add the EU trial number in the study configuration.

Export mappings are updated to enable transmitting EU Trial number in the STUDYREGNUMB[C.5.1.r.1] element, and conformance rules are provided to validate data present in the STUDYREGNUMB[C.5.1.r.1] element for the correct format.

DRUGDOSAGETEXT[G.k.4.r.8] for vaccines mapping change as per the EMA guidelines (Enhancement 34451821)

In Oracle Argus, DRUGDOSAGETEXT[G.k.4.r.8] was populated with the concatenation of dose and dose units separated by a space for vaccine products. As per the regulatory requirement from EMA, details of the dose that resulted in the adverse reaction are required in the DRUGDOSAGETEXT[G.k.4.r.8] element.

Export mappings for DRUGDOSAGETEXT[G.k.4.r.8] in EMA E2B(R3) profile has been updated to send free text present in dose description instead of dose and dose units information. Drug and drug-device combination products work on the similar logic.

DRUGSTARTPERIOD[G.k.9.i.3.1a] to not populate for event without onset latency information (Bug 34766412)

In Oracle Argus, the DRUGSTARTPERIOD[G.k.9.i.3.1a] and DRUGSTARTPERIODUNIT[G.k.9.i.3.1ab] elements were mapped to onset from the first dose and onset from the last dose respectively in the product event details. In the absence of data in these fields, the data was being populated from the corresponding fields present at the product level. Deriving the data from product level is not compliant with the EMA regulations.

Hence, the DRUGSTARTPERIOD [G.k.9.i.3.1a] and DRUGSTARTPERIODUNIT[G.k.9.i.3.1ab] elements have been directly mapped to the fields in product event details.

Negative ACK received from EMA due to negative value in E2B(R3) field TESTRESULT[F.r.3.2] (Bug 33752952)

EMA does not accept negative values in the TESTRESULT[F.r.3.2] element, but there may be test results that have negative values. The export mapping logic for the TESTRESULT[F.r.3.2] element has been modified to populate negative values in the TESTRESULTTEXT[F.r.3.4] element with the label: Test Result.

Code system version for OID (Enhancement 28955562)

The HL7 view of E2B(R3) EMA, MFDS, and NMPA reports displayed codeSystemVersion=1.0 for codeSystem=2.16.840.1.113883.3.989.2.1.1.23 associated with:

REPORTTYPE[C.1.3]
DUPLICATER3[C.1.9]
NULLIFICATIONREASON[C.1.11.2]

The codesystemversion has been changed to 2.0 as per the regulation.

DRUGSTRUCTUREDOSAGENUMB[G.k.4.r.1a] tag to transmit individual dosage (Enhancement 33563052)

The DRUGSTRUCTUREDOSAGENUMB [G.k.4.r.1a] element in EMA E2B(R3) populated the product of dosage regimen dose and frequency. As per the EMA guidelines, each individual dosage must be transmitted independent of the frequency.

The export mappings has been modified to transmit only the dosage data.

Allow tradename to be selected for non-interventional study products (Enhancement 20270050): As per the EMA regulation, for non-interventional studies, the MEDICINALPRODUCT[G.K.2.2/ B.4.k.2.1] element must have trade name of the product. The E2B(R3) and E2B(R2) export mappings for the EMA profile have been revised to transmit trade name in the MEDICINALPRODUCT[G.K.2.2/ B.4.k.2.1] element, derived based on the license for which the report is scheduled. If there are multiple study products in the case, then the trade name for other products are derived based on the license that matches the agency country for which the report is scheduled.
Error when viewing ICSR in the decoded view with date formats CCYYMMDDhhmm+/-ZZzz (Enhancement 33982604): The decoded view displayed 500 Internal Server, if the dates present in ICSR were in the CCYYMMDDhhmm[+/-ZZzz] and CCYYMMDDhhmm[+/-ZZ] format. Oracle Argus has been enhanced to support these date formats during E2B(R3) import along with the existing formats.

For more information, refer to the following eTRM documents:

ArgusInterchange841_E2B(R2) Export Mappings.xlsx
ArgusInterchange841_E2B(R3) Export Mappings.xlsx
ArgusInterchange841_E2B(R3) Import Mappings.xlsx
Argus_Safety8.4.1_CaseForm_Console_Updates_Summary.xlsx