E2B form is the international standard format for sending and receiving the individual case safety reports (ICSRs) electronically as a structured data using XML or SGML.
In agXchange ESM, you can view the adverse event information in the E2B format using the E2BForm view. In the E2B form view, you also can print the report in the PDF format.
In ESM, you can view and print the ICSRs in the E2B format on the following listing pages:
Import Section page
Export Section page
Cases awaiting Acknowledgments page
Archived Cases: Import Section or Export Section page
Reports: Transaction page
Note: E2B Form view is applicable for the Medical Device Reports (MDRs) displayed on the eMDR (R2) tab.
Korean Cases
The Korean tags are exported into R3 xml file only when any of the following conditions are satisfied.
Distribution
Contact Country = "Korea, Republic of" OR
Distribution Contact Authority = "MFDS" OR
Recipient Company Unit Country = "Korea, Republic of" OR
Recipient Company Unit Authority = "MFDS"
These tags are validated by specific rules mentioned by Korean authority (MFDS)
Note: Similarly, import of Korean R3 tags to the corresponding ARISg fields is also supported..
Sender ID for Korean R3 case
Once the case is successfully distributed and distributed case is processed by ESMServer, the case is available at the export section. For a Korean R3 export case, the generated XML file displays “MFDS” as a Prefix for Sender ID tags such as N.1.3 and N.2.r.2, irrespective of type of submission (CT/CU/KR/FR).
Depending on the type of submission (CT/CU/KR/FR) value is populated for the Receiver id tags such as N.1.4 and N.2.r.3.
Examples:
MFDS-FR
MFDS-CT
MFDS-CU
MFDS-KR
where MFDS is the value of interchange id of Receiver Unit.
You can export the Clinical Trail (CT) , Compassionate Use (CU), post-marketing t(KR) and post-marketing (FR) Korean cases individually. Exporting the combination of these cases displays an error.
WHODD C Version is populated in R3 XML only for Korean post-marketing (FR) case.
The export and import of Korean R3 tags released by MFDS are as follows:
1. C.2. r.4. KR.1: Other HealthCare Professional
2. C.3.1. KR.1: Health Care professional detailed classification
3. C.5.4. KR.1 Other Examination details
4. G.k.9. i.2. r.3. KR.1 WHO-UMC Evaluation result
5, G.k.9. i.2. r.3. KR.2 KRCT evaluation result
6. G.k.9. i.2. r.2. KR.1 Assessment Method.
7. D.8. r.1. KR.1a/1b – Drug Code and Drug Code Version (Domestic cases)
8. D.10.8. r.1. KR.1a/1b- Drug Code and Drug Code Version (Domestic cases)
9. G.k.2.1. KR.1a/1b - Drug Code and Drug Code Version (Domestic cases)
10. G.k.2.3. r.1. KR.1a/1b – Substance ID and Substance ID version (Domestic cases)