Supported Scenarios for FAERS E2B(R3)

This table summarizes the FDA-supported reporting scenarios for submitting Individual Case Safety Reports (ICSRs) to FAERS by using the E2B(R3) standard.

Scenario	Batch Receiver Identifier (N.1.4)	Message Receiver Identifier (N.2.r.3)	Type of Report (C.1.3)	Study Type Where Reaction(s) / Event(s) Were Observed (C.5.4)	IND Number where AE Occurred (FDA C.5.5a)	Additional Details
Pre-market report on an IND or IND-Exempt BA/BE study	ZZFDA_PREMKT	CDER_IND or CBER_IND or CDER_IND_EXEMPT_BA_BE	2 (Report from study)	1 (Clinical trials)	<IND Number> or <Pre-ANDA Number>	List cross-referenced INDs in FDA.C.5.6.r
CDER report from Clinical Case : Solicited reports or reports from Organized Data Collection System	ZZFDA	CDER	2 (Report from study)	2 (Individual patient use) or 3 (Other studies)	Use nullFlavor NA if not available	N/A
Pre-market report with cross-referenced INDs	ZZFDA_PREMKT	CDER_IND or CBER_IND	2 (Report from study)	1 (Clinical trials)	<IND Number>	List cross-referenced INDs in FDA.C.5.6.r
Spontaneous IND : Pre-market IND not approved and not marketed in US but is marketed outside of the US, where AE occurred.	ZZFDA_PREMKT	CDER_IND or CBER_IND	1 (Spontaneous)	N/A	<IND Number>	N/A
For a post-market study report, submit two reports: IND and NDA/BLA.	Report 1: ZZFDA_PREMKT Report 2: ZZFDA	Report 1: CDER_IND or CBER_IND Report 2: CDER	Both: 2 (Report from study)	Both: 1 (Clinical trials)	<IND Number> (for Report 1)	N/A
Post-market safety report	ZZFDA	CDER	1 (Spontaneous)	N/A	(empty)	N/A
Pre-market IND not approved/not marketed inside/outside US, AE outside US.	ZZFDA_PREMKT	CDER_IND or CBER_IND	2 (Report from study)	1 (Clinical trials)	<IND Number>	N/A
Pre-market INDs not approved/not marketed inside/outside US, AE outside US.	ZZFDA_PREMKT	CDER_IND or CBER_IND	2 (Report from study)	1 (Clinical trials)	<Parent IND Number>	N/A
Pre-market AGGREGATE report	ZZFDA_PREMKT	CDER_IND or CBER_IND	2 (Report from study)	1 (Clinical trials)	<IND Number> (parent IND)	Patient = AGGREGATE; Linked Report IDs required

For more information, see the FAERS E2B(R3) IND Aggregate Report Generation Guidelines article on MOS (ID:KB868496) and the ArgusInterchange2025.4.01_E2B (R3) Export Mappings document.

FAERS IND reporting - CROSSREPORTEDIND[C.5.6.r]

This table summarizes the different system‑supported methods for populating the Cross Reported IND (C.5.6.r) field in FAERS IND submissions.

Scenario	Description
Automatic mapping from related licenses: transmit each unique license number as a separate repeating cross-referenced IND element. Duplicate and withdrawn licenses are not transmitted.	License numbers (excluding the value populated in C.5.5a for the case) that belong to the same case study product and associated with other studies as a Clinical Reference Number with Reference Type = CDER_IND / CBER_IND, where: Type = INV Country = USA License number with the following logic: For example: Product 1 Contains License1 and License2, Type=INV and Country= USA, Study 1 includes Product 1; License 1 Study 2 includes Product 1; License 2 When FAERS IND report is generated for Study 1, License 1 as INDNUMB[C.5.5.a], License 2 is transmitted as CROSSREPORTEDIND[C.5.6.r].
Direct mapping from Study Configuration: these configured references are transmitted as cross-referenced INDs.	From Study Configuration > Clinical References, where Reference Type = Cross Reported IND and Country = United States.
Direct mapping from Case Form > Additional Information: any INDs provided here are transmitted as cross-referenced IND numbers (unique values only).	From Case Form > Additional Information > Reference > Cross Reported IND
No cross-reported INDs: the element is populated with nullFlavor = NA (Not Applicable).	Applies when none of the above sources provide any cross-reported IND numbers.