Minimum Requirement for Electronic Report Generation

The minimum requirements (mandatory) for generating an ICSR report are as follows:

1. One identifiable patient - any one of several data elements is considered sufficient to define an identifiable patient (such as initials, age, sex)
2. One identifiable reporter - any one of several data elements is considered sufficient to define an identifiable reporter (such as initials, address, qualifications)
3. One adverse event/reaction (or outcome), and
4. One suspect or interacting drug

Reporting Destination can be configured with a message profile for E2B(R2), E2B(R3), eMDR or eVAERS report form.

E2B (R2) report contains the following information:

A: Administrative and Identification Information

A.1 - Identification of the case safety report

A.2 - Primary source(s) of information

A.3 - Information on sender and receiver of case safety report

B: Information on the Case:

B.1 - Patient characteristics

B.2 - Reaction(s)/event(s)

B.3 - Results of tests and procedures relevant to the investigation of the patient

B.4 - Drug(s) information

B.5 - Narrative case summary and further information

E2B (R3) and eVAERS reports are built using HL7 version 3 (V3) messaging standards with the following sections:

Section A:

C.1 - Identification of the Case Safety Report

C.2 - Primary Source(s) of Information

C.3 - Information on Sender of Case Safety Report

C.4 - Literature Reference(s)

C.5 - Study Identification

Section B

D - Patient Characteristics

E - Reaction(s)/Event(s)

F - Results of Tests and Procedures Relevant to the Investigation of the Patient

G - Drug(s) Information, and

H - Narrative Case Summary and Further Information

eMDR reports are built using HL7 version 3 (V3) messaging standards with the following sections:

A - Patient Information

B - Adverse Event or Product Problem

C - Suspect Product Information

D - Suspect medical device

E - Initial Reporter

F - For Use by User Facility/Importer (Devices Only)

G - All manufacturers

H - Device manufacturers only

The following are the key features of reports in HL7 format:

1. Structure and Cardinality - Messages are built using Health Level 7 Version 3 (HL7 V3) messaging standard.
2. International Standard Code Sets - International Standard Code Sets are used in HL7 messages: ISO 5218, ISO 639-2, NCI and UCUM.
3. Null flavors - ICH ICSR uses the codes from the HL7 Messaging Standard to categorize exceptions. Null flavor such as NI, NA, UNK enables transmission of an empty element and provides an explanation for the reason for the lack of data using codes. Confidential information such as Patient or Reporter's name and address can be masked by the sender due to security, privacy or other reasons by using MSK Null flavor.
4. Attachments can be presented in-line within the ICSR message itself. In-line data is transmitted as part of the encapsulated data value in the ICSR message.