Description
This document is a guide for implementing the standard adopted by the ICH1 for electronic transmission of Individual Case Safety Reports (ICSRs) according to the ICH E2B(R3) message standard. This Implementation Guide (IG) was jointly developed by the ICH E2B(R3) and M2 Expert Working Groups (EWGs). The E2B(R3) EWG provided business requirements and the M2 EWG provided technical content for this IG. These two EWGs were reconstituted as the ICH E2B(R3) EWG in November 2010.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
10Scope of the electronic transmission guidance
Medicine deliberately and fraudulently mislabelled with respect to identity and/or source
Base Model RMIM designed for pharmaceutical reports
Products for which batch/lot information is particularly important
Products for which batch/lot information is particularly important
Dose unit for these should be provided as arbitrary unit {DF}
In case of investigational drugs, provide as much information as known.
concomitant medications are only those health products taken by the patient at the time the reaction is observed
Suspect medications are those health products taken by the patient and suspected by the reporter to have contributed to the adverse reaction.
Subject of safety reports including overdose or medication error; Substance presented as having properties for treating or preventing disease in human beings
Stakeholders
10Group that jointly developed the guidance
Organisation that holds a valid marketing authorisation for a medicinal product
Data element G.k.3.3 defined in POCP_MT030200UV.
The organisation that received the ICH ICSR message
The organisation that submitted the ICH ICSR message
The organisation that is receiving the ICH ICSR and generating the acknowledgement.
The organisation that is submitting the ICH ICSR.
Sender providing causality assessment via algorithms or Bayesian analysis
Holders of approved applications or master files
the one reported or implied by the primary reporter
Regulatory Context
Regulatory Activities
6Case fulfillment of local criteria for expedited reporting; Does This Case Fulfil the Local Criteria for an Expedited Report?; C.1.7 indicates whether the case fulfils the local expedited requirements.; Regulatory submission type for serious adverse events
An unsolicited communication describing an adverse drug reaction
MCCI_IN200101UV01 interaction for grouping messages.
Administering survey instruments in a clinical trial at screening and/or exit visits; obtaining patient feedback regarding various topics throughout a trial
Harmonisation of scientific and technical aspects by ICH
Transmission of ICSRs according to the ICH E2B(R3) message standard
Document Types
10Paper-based safety information exchange format
Message sent in response to an ICSR submission
ACK.M/A - ICH ICSR Batch Acknowledgement Header structure and data elements.
Transaction sent after receipt of an ICSR to confirm processing.
Scientific papers attached to ICSRs using specific data elements like C.4.r.2.
Example of a clinical document that can be attached to an ICSR.
Example of a clinical document that can be attached to an ICSR.
Data element C.4.r.2 containing the actual content of referenced literature.
Section C.4.r for literature articles describing individual cases.
Documents received from the primary source (e.g. clinical records, hospital records) should be listed individually.
Attributes
10Includes death, life threatening, and hospitalization; Criteria such as death, life threatening, or hospitalization
International standard date/time notation format.
Data element G.k.2.4 defined in POCP_MT030100UV.
Commit Reject - fatal error prevents loading
Commit Accept - ICSR message successfully loaded
ACK.B.r.5 data element
ACK.M.4: captures the date on which the batch file was transmitted.
ACK.A.4: code to inform the submitter whether to take action or re-send.
Property indicating the algorithm used for data compression (e.g., deflate).
Property identifying the type of encapsulated data (e.g., application/PDF).
Technical Details
Substances
4Core components of pharmaceutical products identified via ISO 11238
Medicinal product names or active ingredient names should be provided.; If MPID/PhPID unavailable, each active ingredient should be specified individually
Previous exposure history in business rules
Drug taken by parent that may have caused adverse events in the child/foetus.
Testing Methods
6Technical method for HL7 V3 message representation
Example of method of assessment
Method of causality assessment based on overall impression; Example of method of assessment
Method of causality assessment
Used to investigate non-drug causes like infectious hepatitis
Data block F.r relevant to the investigation of the patient
Processes
4Standardization of transmission between partners
Section D.8.r concerning drugs administered and stopped before adverse event onset.
Data element D.7.3 indicating therapies like radiotherapy or dietary supplements.
Facilitated by the ICH ICSR to enhance analysis
Clinical Concepts
10Topic of the ICH guideline elements
Any untoward medical occurrence that results in death, is life-threatening, or requires hospitalization
Evaluation of the relationship between a product and an adverse event.
Reporter's or sender's assessment of the medical condition.
Example of a reaction with short time interval
Onset of reaction/event in relation to drug administration
suspected by the reporter to have contributed to the adverse reaction described in Section E
Suspected condition requiring investigation
Criteria for assessing the severity of a reaction or event
Relevant Medical History and Concurrent Conditions of Parent
Identified Hazards
Hazards
1Primary driver for expedited exchange of safety information
Standards & References
External Standards
7Standard used to identify Media Type for encapsulated data.
Used for time interval units
Citation style developed by the International Committee of Medical Journal Editors.
Country code is the 2-letter ISO 3166 part 1 code corresponding to the country of the primary source.; Two character country code list; Used for country identification in G.k.2.4 and G.k.3.2
The Unified Code for Units of Measure for units of strength and dose; terminologies include UCUM for units of measurement; Codes for units of measurement like Year, Month, Week, Day; UCUM codes for Year: {Decade}; Unified Code for Units of Measure used for duration units; Unified Code for Units of Measure for test results; Strength units use constrained UCUM codes; Used for dose units and time interval units; Unified Code for Units of Measure used for dose and gestation units
Used for coding indications, reactions, and causes of death; Coding for indications and sender's diagnosis; Medical Dictionary for Regulatory Activities used for coding medical sections; Medical Dictionary for Regulatory Activities used to classify adverse event information; terminologies include MedDRA for medical history, indication, and reaction; Used for coding medical history, indications, reactions, and causes of death.; Standard terminology used for coding medical history, indications, an
Acknowledgement Message in HL7; HL7 uses a single format to represent dates and times; Both the Sender's (case) Safety Report Unique Identifier and the Worldwide Unique Case Identification Number data elements are mapped to the repeatable XML attribute in the HL7 ICSR model.; HL7 ICSR model used for mapping data elements; HL7 defines the data type of G.k.2.4 as string; Messaging standard used for the transmission infrastructure of acknowledgements.; Organization that developed the schemas; Stand
Specifications
10Message specification for electronic transmission
A technical specification addressing a business requirement
Schema for individual ICSR messages including nullifications
Schema defining root element for Batch messages
Schema defining basic and generic HL7 data types
Core schema defining properties for all elements
ACK.A.5 provides a description of errors detected in the ICH ICSR batch XML.; eXtensible Markup Language used for message structure
Used to describe missing or non-transmitted information in XML
Data Type: Boolean
OIDs provided in this IG should be used in XML messages for the ICH ICSR.; it might be necessary to mask some of the elements used to identify the reporter in the transmitted message.; Format for transmitting ICSR data elements; Format for electronic transmission of ICSR data; The format into which ICSR data and attachments are embedded.
ICH References (6)
Implementation Guide for Electronic Transmission of Individual Case Safety Reports; Electronic Transmission of Individual Case Safety Reports Implementation Guide; Implementation Guide for electronic transmission of Individual Case Safety Reports; fully structured format using the relevant E2B(R3) data elements; Details of ICH E2B(R3) Data Elements and message specifications.; Implementation guide for electronic transmission of ICSRs; Implementation Guide for electronic transmission of ICSRs; Im
Source of the definition for Spontaneous Reporting
Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
Provides definitions for seriousness criteria; ICH E2A recommends blinded therapy should not be reported
Provides guidance on identifiable patients and reporters; Provides definitions for seriousness criteria
Renamed from E2B(M) in 2005; Previous version of the ICSR standard used for regulatory compliance; nullFlavor is only allowed when sender is retransmitting a case that was first received ICH E2B (R2) format.; Guideline referenced for definitions of Reporter and Sender
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- DSCSA Implementation: Product Tracing Requirements — Compliance Policy
- E6(R3) Good Clinical Practice: Annex 2
- Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry: Guidance for Industry
- Best Practices for Communication Between IND Sponsors and FDA During Drug Development
- Botanical Drug Development: Guidance for Industry
- Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
- Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
- ANDA Submissions -- Refuse-to-Receive Standards Rev.2