Guidance for Industry
 
E2BM  Data Elements for
 
Transmission Of Individual Case

 Safety Reports
 
U.S. Department of Health and Human Services
 
Food and Drug Administration
 
Center for Drug Evaluation and Research (CDER)
 
Center for Biologics Evaluation and Research (CBER) 
April  2002 
ICH
 
Revision 1 
 Guidance for Industry 

E2BM  Data Elements for
 
Transmission Of Individual Case

 Safety Reports
 
Additional copies are available from:
 
Office of Drug Information (HFD-240)
 
Center for Drug Evaluation and Research (CDER),
 
5600 Fishers Lane,
 
Rockville, MD 20857 (Tel) 301-827-4573
 
http://www.fda.gov/cder/guidance/index.htm
 
or
 
Office of Communication, Training, and Manufacturers Assistance (HFM-40),
 
Center for Biologics Evaluation and Research (CBER)
 
1401 Rockville Pike,
 
Rockville, MD 20852-1448,
 
http://www.fda.gov/cber/guidelines.htm;
 
(Fax) 888-CBERFAX or 301-827-3844 

(Voice Information) 800-835-4709 or 301-827-1800
 
U.S. Department of Health and Human Services
 
Food and Drug Administration
 
Center for Drug Evaluation and Research (CDER)
 
Center for Biologics Evaluation and Research (CBER) 
April   2002 
ICH
 
Revision 1 
 Table of Contents 
I.  INTRODUCTION ................................................................................................................. 1
 
1.1  Scope of This Guidance.........................................................................................................1
 
1.2.  Background...........................................................................................................................2
 
1.3  Notes on Format of this Document........................................................................................2
 
1.4  Definition of Data Elements ..................................................................................................2
 
1.5  Minimum Information..........................................................................................................3
 
II.  GUIDANCE: CONTENT OF THE DATA ELEMENTS ................................................... 3
 
A. Administrative and Identification Information.........................................................................4
 
A.1 Identification of the case safety report....................................................................................4
 
A.2 Primary sources of information .............................................................................................8
 
A.3 Information on sender and receiver of case safety report.........................................................9
 
B.  Information on the Case .....................................................................................................10
 
B.1 Patient characteristics........................................................................................................10
 
B.2 Reactions or events.............................................................................................................14
 
B.3 Results of tests and procedures relevant to the investigation of the patient..............................16
 
B.4 Drug information................................................................................................................17
 
B.5 Narrative case summary and further information..................................................................22
 
GLOSSARY................................................................................................................................. 24
 
ATTACHMENT 1 ....................................................................................................................... 25
 
ATTACHMENT 2:...................................................................................................................... 27
 
ATTACHMENT 3 ....................................................................................................................... 28
 
1
  Guidance for Industry1 
E2BM Data Elements For Transmission Of
 
Individual Case Safety Reports
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. 

It does not create or confer any rights for or on any person and does not operate to bind FDA or the 

public.  An alternative approach may be used if such approach satisfies the requirements of the applicable 

statutes and regulations. 

This guidance is intended to assist applicants who plan to submit individual case safety reports 
(ICSRs) to FDA. This guidance revises E2B step 4 document signed off by the International 
Conference on Harmonisation (ICH) in July 1997 and issued by the FDA in January 1998. It provides 
additional information and clarification as well as some modifications of the E2B step 4 document 
signed off on July 17, 1997.  The revision incorporates adjustments based on the successful pilot 
projects being conducted in the three ICH regions. It is recommended that the reader review this 
document as well as the M2 ICSR message specification document version 2.3. A new attachment 3 
provides examples of the use of ICSR identifiers. 
I.  INTRODUCTION 
1.1  Scope of This Guidance 
The objectives of the working group are to standardize the data elements for transmission of 
individual case safety reports by identifying, and where necessary or advisable, by defining the data 
elements for the transmission of all types of individual case safety reports, regardless of source and 
destination. This includes case safety reports for both pre and postapproval periods and covers both 
adverse drug reaction and adverse event reports. It is not intended that this format be used for cases in 
the integrated safety summary of a marketing license application dossier. For adverse reactions 
1  This guidance was developed within the Expert Working Group (Efficacy) of the International Conference 
on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been 
subject to consultation by the regulatory parties, in accordance with the ICH process. This document was endorsed by 
the ICH Steering Committee at Step 4 of the ICH process, in July 1997. This revision was signed off by ICH on 
November 9, 2000, and a final version was issued by ICH on February 5, 2001. 
1
  encountered in clinical trials, this format should be used only for those subject to expedited reporting. 
This guidance does not encompass the definition of database structures, the design of a paper report 
form, quality control or quality assurance aspects, or technical security issues. 
1.2.	  Background 
Because of national and international agreements, rules, and regulations, individual case safety reports 
of adverse drug reactions and adverse events need to be transmitted (e.g., 21 CFR 314.80): 
 	  From identified reporting sources to regulatory authorities and pharmaceutical companies; 
 	  Between regulatory authorities; 
 	  Between pharmaceutical companies and regulatory authorities; 
 	  Within authorities or pharmaceutical companies; 
 	  From clinical investigators, via the sponsor, to ethics committees; 
 	  From authorities to the World Health Organization (WHO) Collaborating Center for 
International Drug Monitoring. 
The transmission of such individual case safety reports currently relies on paper-based formats (e.g., 
yellow cards, Council for the International Organizations of Medical Sciences (CIOMS) forms, 
MedWatch) or electronic media (e.g. within pharmaceutical companies, or with WHO), usually by on
line access, tape, or file transfer. 
Considering the large number of potential participants in a world-wide exchange of information, there 
is a need for an electronic format capable of accommodating direct database to database transmission 
using message transfers. 
Successful electronic transmission of information relies on the definition of common data elements, 
provided in this document, and standard transmission procedures to be specified by the ICH 
Electronic Standards for the Transfer of Regulatory Information (ESTRI)  Expert Working Group 
(M2). 
This document has taken into account the documents provided by ICH sponsors, the ENS-CARE 
Single Case Format, EuroSCaPE format, and the CIOMS IA proposal, and comments received 
following the circulation of these papers. 
1.3	  Notes on Format of this Document 
Section II and its subsections designated A and B contain notes that are directed toward clarifying the 
nature of the data that should be provided. In addition, there are notes to assist in defining the format 
that should be used to transmit the data.  These notes are designated as User Guidance. 
If a data element has a limited set of choices, these choices are presented in bold Italic type.  The 
standard allows for this information to be transmitted in encoded format. 
1.4	  Definition of Data Elements 
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  The format for individual case safety reports includes provisions for transmitting all the relevant data 
elements useful to assess an individual adverse drug reaction or adverse event report. The data 
elements are sufficiently comprehensive to cover complex reports from most sources, different data 
sets, and transmission situations or requirements; therefore, not every data element will be available 
for every transmission. In many, if not most instances, a substantial number of the data elements will 
not be known and therefore not included in the transmission. Where it was deemed important, 
provisions for unknown or not applicable were included (e.g., outcome, route of administration). 
However, since the transmission is intended to be electronic, it was thought to be unnecessary to 
include provisions to assign values of unknown for all data elements. Different ways of including the 
same data have been provided to cope with differing information contents (e.g., age information can 
be sent as date of birth and date of reaction or event, age at the time of reaction or event, or patient age 
group according to the available information; see section B.1.2 and the respective user guidance). In 
this example, age should be provided by using the most precise available data element rather than by 
including multiple elements of redundant data. 
Structured data are strongly recommended in electronic transmission, and provisions have been made 
for including information in this way. However, structuring the data also implies the use of 
controlled vocabularies, which are not yet available for some data elements. Electronic transmission 
of individual case safety reports should be implemented with the Medical Dictionary for Regulatory 
Activities (MedDRA) where applicable.  When MedDRA terms are used, the version number should 
be provided. MedDRA terms should be provided as either text or code, according to the regional 
preferences, until January 2003 when codes will be used in all regions. In certain instances, there are 
provisions for the transmission of some free text items, including a full text case summary narrative. 
The transmission of other unstructured data, such as full clinical records or images is outside the 
scope of this guidance. 
1.5  Minimum Information 
The minimum information for the transmission of a report should include at least one identifiable 
patient (section B.1), one identifiable reporter (section A.2), one reaction or event (section B.2), and 
one suspect drug (section B.4). Because it is often difficult to obtain all the information, any one of 
several data elements is considered sufficient to define an identifiable patient (e.g., initials, age, sex) 
or an identifiable reporter (e.g., initials, address, qualification). It is also recognized that the patient 
and the reporter can be the same individual and still fulfill the minimum reporting criteria. 
In addition, to properly process the report, the following administrative information should be 
provided: the senders (case) safety report unique identifier (A.1.0.1), the date of receipt of the most 
recent information (A.1.7), the worldwide unique case identification number (A.1.10) and the sender 
identifier (A.3.1.2). 
II.  GUIDANCE: CONTENT OF THE DATA ELEMENTS 
The message content contains header information followed by E2B Data Elements. See the M2 ICSR 
Message Specification for information about the header. 
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  The data elements are divided into sections pertaining to: 
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) or 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 
A. Administrative and Identification Information 
A.1 Identification of the case safety report 
A.1.0.1 Senders (case) safety report unique identifier 
User Guidance: This identifier should remain constant in subsequent transmissions of the case by the 
same sender. Retransmitters should replace this value with their own unique identifier. The value 
should be a concatenation of country code-company or regulator name-report number. The country 
code is the country of the primary source of the report (A.1.1). The company or regulator name is an 
internationally unique abbreviation or code for the senders organization. The report number is the 
organizations international case number. Each component is separated from the other by a hyphen. 
For example a report transmitted by a company to a regulatory authority concerning a case from 
France would populate A.1.0.1 with FR-companyname-12345 where 12345 is a companys unique 
case report number. 
A.1.1 Identification of the country of the primary source 
User Guidance: Generally, this item would be the only country provided. Provisions have been made 
to include other countries for unusual cases concerning foreign travel and sources of manufactured 
material (A.1.2 and B.4.k.2.3). See the companion document for appropriate country codes. 
A.1.2  Identification of the country where the reaction or event occurred 
User Guidance: For example, this should be the country where the reaction was detected while the 
patient was traveling, but the report was made by a health professional on the patients return. 
A.1.3  Date of this transmission 
User Guidance: A full precision date should be used (i.e., day, month, year) 
A.1.4  Type of report 
4
     Spontaneous report 
   Report from study 
   Other 
   Not available to sender (unknown) 
User Guidance:   A separate category for the designation of a literature source is covered in item A.2.2 
and is not duplicated in this section, which is intended to capture the type of report. If the case in the 
literature arises from spontaneous observations, type of report should be Spontaneous report. If the 
case arises from a study, type of report should be Report from study. If it is unclear from the 
literature report whether or not the cases cited are spontaneous observations or arise from a study, 
then this item should be Other. 
Differentiation between types of studies (e.g. clinical trials or others should be given in section 
A.2.3.3). 
The Not available to sender option allows for the transmission of information by a secondary sender 
(e.g., regulatory authority) where the initial sender did not specify the type of report; it differs from 
Other, which indicates the sender knows the type of report but cannot fit it into the categories 
provided. 
A.1.5  Seriousness 
A.1.5.1  Serious 
Yes or no 
A.1.5.2. Seriousness criteria (more than one can be chosen) 
   Results in death 
   Is life-threatening 
   Requires inpatient hospitalization or prolongation of existing hospitalization 
   Results in persistent or significant disability or incapacity  (as per reporter's opinion) 
   Is a congenital anomaly or birth defect 
   Other medically important condition 
User Guidance: The terms life-threatening and other medically important condition are defined in 
the ICH E2A guidance. All the criteria apply to the case as a whole and should not be confused with 
the outcomes of individual reactions or events that are provided in section B.2.i.8. In addition, 
section B.2.i.3 can be used to identify the seriousness of each reaction or event in accordance with the 
user guidance of the item. 
A.1.6 Date report was first received from source 
User Guidance: For senders dealing with initial information, this should always be the date the 
5
  information was received from the primary source. When retransmitting information received from 
another regulatory agency or another company or any other secondary source, A.1.6 is the date the 
retransmitter first received the information. A full precision date should be used (i.e., day, month, 
year). 
A.1.7 Date of receipt of the most recent information for this report 
User Guidance: Because reports are sent at different times to multiple receivers, the initial (and 
follow up) status is dependent upon the receiver. For this reason, an item to capture follow-up status 
is not included. However, the date of receipt of the most recent information taken together with the 
sender identifier (A.3.1.2) and senders (case) report unique identifier (A.1.0.1) provide a 
mechanism for each receiver to identify whether the report being transmitted is an initial or follow-up 
report. For this reason, these items are considered critical for each transmission. A full precision 
date should be used (i.e., day, month, year). 
A.1.8 Additional available documents held by sender 
A.1.8.1  Are additional documents available? 
Yes or no 
A.1.8.2 List of documents held by sender 
User Guidance:   The documents received from the primary source (e.g., clinical records, hospital 
records, autopsy reports) should be listed. These documents may not be obtainable in many instances. 
A.1.9 Does this case fulfill the local criteria for an expedited report? 
Yes or no 
User Guidance: The definition of expedited is dependent upon the local regulatory requirements. 
This item should be used by the sender to indicate if the case fulfills the local expedited requirements. 
When the countries of origin and destination of the transmission differ, the receiver should be aware 
that the information might not be applicable to their regulatory requirements. 
A.1.10 Worldwide unique case identification number. 
User Guidance:   Only A.1.10.1 or A.1.10.2 should be used.  No case should ever have more than one 
of these items completed. The contents of whichever item is used should remain unchanged for any 
transmissions subsequent to the original transmission. When a regulator is the initial sender, A.1.10.1 
should be used. When an entity other than a regulator is the initial sender, A.1.10.2 should be used. 
When a sender has not previously received a valid E2B/M2 report electronically, the identifiers 
(content and format) in A.1.0.1 and A.1.10.1 or A.1.10.2 should be identical. Retransmitters should 
use their own senders (case) safety report unique identifier (A.1.0.1), but not change A.1.10.1 or 
A.1.10.2. See examples in attachment 3. 
6
  A.1.10.1 Regulatory authoritys case report number 
A.1.10.2 Other senders case report number 
A.1.11 Other case identifiers in previous transmissions 
Yes 
User Guidance: This item should be completed only if the answer is yes. 
A.1.11.1 Source of the case identifier (e.g., name of the company, name of regulatory agency) 
User Guidance:   This repeatable item should be used in conjunction with A.1.11.2 to provide all other 
case identifiers electronically transmitted, perhaps by multiple other senders. If the case has been 
received from another sender, all other case identifiers included in A.1.11.1 and A.1.11.2 should be 
present. In addition, the identifier of the previous sender (A.1.0.1) should be included here by the 
retransmitter. See examples in attachment 3. 
A.1.11.2 Case identifiers 
A.1.12 Identification number of the report that is linked to this report (repeat as necessary) 
User Guidance:   This section should be used to identify reports or cases that warrant being evaluated 
together. This includes, but is not limited to, a mother-child pair where both had reactions or events, 
siblings with common exposure, several reports involving the same patient (e.g., a report sent via 
paper without a valid E2B/M2 electronic report identifier), several similar reports from the same 
reporter (cluster).  This item can also be used when a sender decides to create two or more ICSRs to 
provide individualized information on two or more suspect drugs in a single case (see B.2.i.7 and 
B.4.k.13). See examples in attachment 3. 
A.1.13 Report nullification 
Yes 
User Guidance: This item should be used to indicate that a previously transmitted report should be 
considered completely void (nullified), for example when the whole case was found to be erroneous. 
It is essential to use the same case report number previously submitted. 
A.1.13.1 Reason for nullification 
A.1.14 Was the case medically confirmed, if not initially from a health professional? 

Yes or no 

User Guidance: This section should be completed if the primary source of information was a lawyer, 

consumer, or other nonhealth professional. It is important because of regional differences in 

7
  regulations concerning lay reports. 
A.2 Primary sources of information 
The primary source of the information is the person who reports the facts. This person should be 
distinguished from senders (secondary sources) who are transmitting the information, (e.g., industry to 
regulatory authority). 
Any or all of the three subsections (A.2.1, A.2.2., A.2.3) can be used. In the case of a published study 
or published individual case, the reporter would be the investigator or first author, and details on 
publication and trial type should also be provided. 
A.2.1 Primary sources (repeat as necessary) 
A.2.1.1 Reporter identifier (name or initials) 
User Guidance: The identification of the reporter may be prohibited by certain national 
confidentiality laws or directives. The information should be provided when it is in conformance 
with the regional confidentiality requirements, and this guidance applies to all the subsections of 
A.2.1.  Notwithstanding the above, at least one subsection should be completed to ensure there is an 
identifiable reporter. If only the name of the reporter is known and providing this name is prohibited 
because of confidentiality requirements, initials can be used. 
A.2.1.2 Reporters address
 
User Guidance:   See the companion document for format specifications. 

A.2.1.3 Country 

User Guidance:   See the companion document for format specifications. 

A.2.1.4 Qualification 
   Physician 
   Pharmacist 
   Other health professional 
   Lawyer 
   Consumer or other nonhealth professional 
User Guidance:   In some regions, consumer and lawyer reports should be transmitted only when there 
is medical confirmation. 
A.2.2 Literature references 
User Guidance:   References are provided in the Vancouver Convention (known as "Vancouver style") 
as developed by the International Committee of Medical Journal Editors. The standard format as well 
8
  as those for special situations can be found in the following reference, which is in the Vancouver 
style. International Committee of Medical Journal Editors. Uniform requirements for manuscripts 
submitted to biomedical journals. N Engl J Med 1997; 336:309-15. 
A.2.3 Study identification 
A.2.3.1 Study name 
A.2.3.2 Sponsor study number 
User Guidance:   This section would be completed only if the sender is the study sponsor or has been 
informed of the study number by the sponsor. 
A.2.3.3 Study type in which the reactions or events were observed 
   Clinical trials 
   Individual patient use; (e.g., compassionate use or named patient basis) 
   Other studies (e.g., pharmacoepidemiology, pharmacoeconomics, intensive monitoring, PMS) 
A.3 Information on sender and receiver of case safety report 
A.3.1 Sender 
A.3.1.1 Type 
   Pharmaceutical company 
   Regulatory authority 
   Health professional 
   Regional pharmacovigilance center 
   WHO collaborating center for international drug monitoring 
   Other (e.g., distributor, study sponsor, or contract research organization) 
User Guidance:   In this context, a pharmaceutical company includes biotechnology companies and 
other manufacturers required to submit individual case safety reports. 
A.3.1.2 Sender identifier 
User Guidance:   Identifies the sender, (e.g., company name or regulatory authority name).  This item 
should always be completed. 
A.3.1.3 Person responsible for sending the report 
User Guidance:   Name of person in the company or agency who is responsible for the authorization of 
report dissemination. This would usually be the same person who signs the cover memo for paper 
submissions. The inclusion of the name of this person in the transmission may be subject to national 
9
  or international regulations. 
A.3.1.4 Senders address, fax, telephone, and E-mail address 

A.3.2 Receiver
 
User Guidance:   See the user guidance concerning the sender (A.3.1). 

A.3.2.1 Type 
   Pharmaceutical company 
   Regulatory authority 
   Regional pharmacovigilance center 
   WHO collaborating center for international drug monitoring 
   Other (e.g., a company affiliate or a partner) 
A.3.2.2 Receiver identifier  (see glossary) 
A.3.2.3 Receivers address, fax, telephone, and E-mail address 
B.  Information on the Case 
B.1 Patient characteristics 
User Guidance:   In cases where a fetus or suckling infant sustains an adverse reaction or event, 
information on both the parent and the child or fetus should be provided. Reports of these cases are 
referred to as parent-child or parent-fetus report. Several general principles should be used for filing 
these reports. If there has been no reaction or event affecting the child or fetus, the parent-child or 
parent-fetus report does not apply. For those cases describing fetal demise or early spontaneous 
abortion, only a parent report is applicable. If both the parent and the child or fetus sustain adverse 
events, two reports should be provided but they should be linked by using sections A.1.12 in each of 
the reports. When only the child or fetus has an adverse reaction or event (other than early 
spontaneous abortion or fetal demise) the information provided in this section applies to the child or 
fetus, and characteristics concerning the parent who was the source of exposure to the drug should be 
provided in section B.1.10. 
B.1.1 Patient (name or initials) 
User Guidance:   The identification of the patient may be prohibited by certain national confidentiality 
laws or directives. The information should be provided when it is in conformance with the 
confidentiality requirements. This also applies to medical record numbers (B.1.1.1). 
B.1.1.1 Patient medical record numbers and the sources of the record number (if allowable) 
User Guidance:   Record numbers can include the health professional record number, hospital record 
number, or patient or subject identification number in a study. The source of the number should be 
10
  specified to ensure the possibility of retrieval when possible and desirable. 
B.1.2 Age information 
User Guidance:   Only one of the elements describing age should be used. The choice should be based 
upon the most precise information available. 
B.1.2.1 Date of birth 
User Guidance:   A full precision date should be used (i.e., day, month, year). If the full date of birth is 
unknown, an approximate age can be used in section B.1.2.2. 
B.1.2.2 Age at time of onset of reaction or event 
User Guidance:   If several reactions or events are in the report, the age at the time of the first reaction 
or event should be used. For fetal reactions or events the next item B.1.2.2.1 Gestation period when 
reaction or event was observed in the fetus should be used. When providing the age in decades, 
please note that, for example, the 7th decade refers to a person in their 60s. See the companion 
document for format specifications. 
B.1.2.2.1 Gestation period when reaction or event was observed in the fetus 
User Guidance:   The gestation period at the time of exposure is captured in section B.4.k.10. 
See the companion document for format specifications. 
B.1.2.3 Patient age group (as per reporter) 
   Neonate 
   Infant 
   Child 
   Adolescent 
   Adult 
   Elderly 
User Guidance: The terms are not defined in this document and are intended to be used as they were 
reported by the primary source. This section should be completed only when the age is not provided 
more specifically in sections B.1.2.1 or B.1.2.2. 
B.1.3 Weight (kg) 

User Guidance:  The weight at the time of the event or reaction. 

B.1.4 Height (cm) 
B.1.5 Sex 
11
  User guidance:   See the companion document for format specifications. 
B.1.6 Last menstrual period date 
User guidance:   Imprecise dates can be included, (i.e., month and year, or year only).   See the 
companion document for format specifications. 
B.1.7 Relevant medical history and concurrent conditions (not including reaction or event) 
B.1.7.1 Structured information on relevant medical history  including onset and resolution date as well 
as relevant comments (repeat as necessary). 
Disease / surgical procedure / etc.  Start date  Continuing  End date  Comments 
Y/N/U 
User Guidance:    Medical judgment should be exercised in completing this section. Information 
pertinent to understanding the case is desired, such as diseases, conditions such as pregnancy, surgical 
procedures, and psychological trauma. Each of the items in the table can be repeated as appropriate. 
If precise dates are unknown and a text description aids in understanding the medical history, or if 
concise additional information is helpful in showing the relevance of the past medical history, this 
information can be included in the comments column. 
If applicable, MedDRA terms should be used in the main descriptive column for disease or surgical 
procedures.  Imprecise dates can be used for both start and end dates.  See the companion document 
for format specifications for the continuing column. 
B.1.7.2 Text for relevant medical history and concurrent conditions  (not including reaction or event) 
User Guidance:   If structured information is unavailable in the senders database, this item should be 
used. Otherwise, it is preferable to send structured data in segment B.1.7.1. 
B.1.8 Relevant past drug history (repeat the line as necessary) 
Name of drug  Start date  End date  Indication  Reactions 
as reported 
User Guidance: This segment concerns drugs previously taken, but not those taken concomitantly or 
drugs that may have potentially been involved in the current reaction or event. Information concerning 
concomitant and other suspect drugs should be included in section B4. The information provided here 
can also include previous experience with similar drugs. Medical judgment should be exercised in 
completing this section. When completing the item concerning the name of the drug, it is important to 
use the words provided by the primary source. Trade name, generic name, or class of drug can be 
used. The term none  should be used when appropriate (e.g., when there is no previous exposure to 
the drug or vaccine, or no previous reaction following exposure).  If applicable, MedDRA terms 
12
  should be used in the indication and reaction columns.   Imprecise dates can be used for both start and 
end dates. 
B.1.9. In case of death 
B.1.9.1 Date of death 
User Guidance:  An imprecise date can be used.  See the companion document for format 
specifications. 
B.1.9.2  Reported cause of death  (repeat as necessary) 

User Guidance:   MedDRA term should be used if applicable
 
B.1.9.3 Was autopsy done? 
Yes/No/Unknown 
B.1.9.4 Autopsy-determined cause of death (repeat as necessary) 
User Guidance:   MedDRA term should be used if applicable 
B.1.10 For a parent-child report or parent-fetus report, information concerning the parent 
User Guidance:   This section should be used in the case of a parent-child or parent-fetus report where 
the parent had no reaction or event. See user guidance for section B.1. Guidance regarding 
confidentiality is provided in B.1.1 and should be considered before providing the parent 
identification. For the subsections B.1.10.4 through B.1.10.8, the guidances provided for B.1.3 
through B.1.5 and B.1.7 through B.1.8 should be reviewed. 
B.1.10.1 Parent identification 
B.1.10.2 Parent age information 
User Guidance: The date of birth should be used if the precise birthday is known; otherwise the age 
should be used. 
B.1.10.2.1 Date of birth of parent 
User Guidance:   A full precision date should be used.  See the companion document for format 
specifications. 
B.1.10.2.2 Age of parent 
B.1.10.3 Last menstrual period date 
13
  User Guidance:   A full precision date should be used.  See the companion document for format 
specifications. If a precise date is unavailable, the gestation period at time of exposure in B.4.k.10 
should be completed. 
B.1.10.4 Weight (kg) of parent 
B.1.10.5 Height (cm) of parent 
B.1.10.6 Sex of parent 
B.1.10.7 Relevant medical history and concurrent conditions of parent (not including reaction or 
event) 
B.1.10.7.1 Structured information (parent) 
Disease / surgical procedure / etc.  Start date  Continuing  End date  Comments 
Y/N/U 
B.1.10.7.2 Text for relevant medical history and concurrent conditions of parent (not including 
reaction or event) 
B.1.10.8 Relevant past drug history of parent 
Name of drug  Start date  End date  Indication  Reactions (if any and known) 
As reported 
B.2 Reactions or events 
User Guidance:   The designation of i in this section indicates that each item is repeatable and that it 
carries an appropriate correspondence to the same i in all subsections. A separate block (i) should be 
used for each reaction or event term. For example, if two reactions are observed, the first reaction 
would be described in items B.2.1.0 through B.2.1.8, and the other reaction would be described in 
items B.2.2.0 through B.2.2.8. The reaction or event specified in the first iteration should be the one 
used in assessing the intervals in B.4.k.13. 
B.2.i.0 Reaction or event as reported by the primary source 
User Guidance:   The original reporter's words and/or short phrases used to describe the reaction or 
event. (The original reporter's words and/or short phrases used to describe reaction or event can also 
be included in the narrative B.5.1). 
B.2.i.1 Reaction or event in MedDRA terminology (Lowest Level Term) 
User Guidance:   Only the MedDRA Lowest Level Term (LLT) most closely corresponding to the 
14
  reaction or event as reported by the primary source should be provided. In the exceptional 
circumstance when a MedDRA term cannot be found the sender should use good clinical judgment to 
complete this item with the best MedDRA approximation (see MedDRA TERM 
SELECTION:POINTS TO CONSIDER). MedDRA terms should be provided, as either text or code, 
according to the regional preferences until January 2003 when codes should be used in all regions. 
For international transmissions, English is the generally accepted language. 
B.2.i.2 Reaction or event in MedDRA terminology (Preferred Term) 
User Guidance:   The term can be a sign, symptom, or diagnosis. This also applies to the other items of 
structured data such as indication or diseases in past medical history.  MedDRA terms are to be 
provided, either as text or code, according to the regional preferences until January 2003 when codes 
should be used in all regions. For international transmissions, English is the generally accepted 
language. 
B.2.i.3 Term highlighted by the reporter 
1= Yes, highlighted by the reporter, NOT serious 
2= No, not highlighted by the reporter, NOT serious 
3= Yes, highlighted by the reporter, SERIOUS 
4= No, not highlighted by the reporter, SERIOUS 
User Guidance:   A highlighted term is a reaction or event that the primary source indicated was a 
major concern or reason for reporting the case. If the information is not explicitly provided by the 
initial reporter, the term should not be considered a highlighted term. The seriousness of the reaction 
or event should be based on the ICH E2A criteria. 
B.2.i.4 Date of start of reaction or event 
User Guidance:   See the companion document for format specifications. 
B.2.i.5 Date of end of reaction or event 
B.2.i.6 Duration of reaction or event 
User Guidance:   This section can usually be computed from start (or end) of reaction or event.  Both 
dates and duration may be useful (e.g., for a reaction or event of short duration such as anaphylaxis or 
arrhythmia). Imprecise dates can be used.   See the companion document for format specifications. 
B.2.i.7 Time intervals between suspect drug administration and start of reaction or event 
User Guidance:   The major uses of intervals are to cover circumstances where both the dates are 
known but the interval is very short (e.g., minutes, such as in anaphylaxis) and when only imprecise 
dates are known but more information concerning the interval is known. Dates, if available, should 
always be transmitted in the appropriate fields rather than intervals. B.2.i.7 captures the interval 
between each reaction or event and only the first iteration of the drug in B.4.k. 
15
  If there is more than one suspect drug, and it is deemed critical, more than one ICSR can be used to 
provide all the intervals between each reaction or event and all suspect drugs. In this circumstance it 
is advisable to indicate the reports are linked in A.1.12. The complexity of the intervals highlights the 
desirability of providing dates. See the companion document for format specifications. 
B.2.i.7.1 Time interval between beginning of suspect drug administration and start of reaction or event 
B.2.i.7.2 Time interval between last dose and start of reaction or event 
B.2.i.8 Outcome of reaction or event at the time of last observation 
   Recovered/resolved 
   Recovering/resolving 
   Not recovered/not resolved 
   Recovered/resolved with sequelae 
   Fatal 
   Unknown 
User Guidance:   In case of irreversible congenital anomalies the choice, not recovered/not resolved 
should be used. Fatal should be used when death is possibly related to the reaction or event. 
Considering the difficulty of deciding between "reaction/event caused death" and "reaction or event 
contributed significantly to death," both were grouped in a single category. Where the death is 
unrelated, according to both the reporter and the sender, to the reaction or event, death should not be 
selected here, but should be reported only under section B.1.9. 
B.3 Results of tests and procedures relevant to the investigation of the patient 
User Guidance:   This section should capture the tests and procedures performed to diagnose or 
confirm the reaction or event, including those tests done to investigate (exclude) a nondrug cause, 
(e.g., serologic tests for infectious hepatitis in suspected drug-induced hepatitis). Both positive and 
negative results should be reported. Although structured information is preferable, provisions have 
been made to transmit the information as free text in B.3.2. 
B.3.1 Structured information (repeat as necessary) 
Date  Test  Result  Unit  Normal low range  Normal high range  More information 
available (Y/N) 
User Guidance:  Imprecise dates can be used, units and normal ranges should be in free text unless 
covered by a controlled vocabulary.  The column entitled "more information available" accepts only 
yes or no (see the companion document for the appropriate format).  If results and units cannot be 
split, use B.3.2.  More than one test can be included in B.3.2. 
16
  B.3.2 Results of tests and procedures relevant to the investigation 
B.4 Drug information 
User Guidance: This section covers both suspect drugs and concomitant medications, including 
biologicals. In addition, the section can be used to identify drugs thought to have an interaction. For 
each drug, the characterization of the drug role (B.4.k.1) is that indicated by the primary reporter (i.e., 
the original source of the information). The designation k in this section indicates that each item is 
repeatable and that it carries an appropriate correspondence to the same k in all subsections. A 
separate block (k) should be used for each drug. The drug specified in the first iteration should be the 
one used in assessing the intervals in item B.2.i.7. Drugs used to treat the reaction or event should not 
be included here. 
B.4.k.1 Characterization of drug role 
   Suspect 
   Concomitant 
   Interacting 
User Guidance:   Characterization of the drug as provided by primary reporter.  All spontaneous 
reports should have at least one suspect drug (see Section 1.5). If the reporter indicates a suspected 
interaction, interacting  should be selected. All interacting drugs are considered to be suspect drugs. 
B.4.k.2 Drug identification 
User Guidance:   Drug substance name and/or proprietary medicinal product name should be provided 
as it was reported. In the case of investigational drugs, only a code may be known and provided. If 
more than one active substance is specified, each should be included as a separate drug in item 
B.4.k.2.2. and the entire drug block (reiteration of k) should be repeated rather than as a repeating 
item B.4.k.2.2. An exception can be made when a proprietary medicinal product is provided in 
B.4.k.2.1, in which case the active substances can be specified as a repeating item in B.4.k.2.2. 
B.4.k.2.1 Proprietary medicinal product name 
User Guidance:   The name should be that used by the reporter. It is recognized that a single product 
may have different proprietary names in different countries, even when produced by a single 
manufacturer. 
B.4.k.2.2 Active substance names 
User Guidance:   The International Nonproprietary Names (INN) for Pharmaceutical Substances or 
drug substance name or drug identification code should be provided if no name exists. For 
combination products, each active ingredient should be specified. This information, as well as that 
requested for proprietary medicinal product name (B.4.k.2.1) may not be known for concomitant or 
interacting drugs when the sender is a pharmaceutical company. In the case of blinded trials, in the 
exceptional circumstance when the blind has not been broken, the word blinded  should precede the 
17
  names of the drugs included in the study. Placebo can be included as a drug. 
B.4.k.2.3 Identification of the country where the drug was obtained.
 
User Guidance:   See the companion document for the appropriate codes and format.
 
B.4.k.3 Batch or lot number 
User Guidance:   This information is particularly important for vaccines and biologicals.  The section 
allows for multiple batch or lot numbers, each separated by a delimiter defined by the transmission 
standard chosen. The most specific information available should be provided. For expiration date 
and other related information, see additional information on drug (B.4.k.19). 
B.4.k.4 Holder and authorization or application number of drug 
User Guidance:   If relevant and known, the name of the holder should be provided with the 
authorization number in the country where the drug was obtained when the case report is sent to that 
country. These items apply to both applications and authorizations. Pharmaceutical companies provide 
this information for their own suspect drugs. 
B.4.k.4.1 Authorization or Application Number 
B.4.k.4.2 Country of authorization or application 

User Guidance:   See the companion document for the appropriate codes and format. 

B.4.k.4.3 Name of holder or applicant 
B.4.k.5 Structured Dosage Information 
(e.g., 2 mg three times a day for five days) 
B.4.k.5.1 dose (number)  2 
B.4.k.5.2 dose (unit)  mg 
B.4.k.5.3 number of separate dosages  3 
B.4.k.5.4 number of units in the interval  1 
B.4.k.5.5 definition of the interval unit  day 
B.4.k.5.6 cumulative dose to first reaction (number)  30 
B.4.k.5.7 cumulative dose to first reaction (unit)  mg 
User Guidance:   Please note the above side-by-side illustration of how the structured dosage is 
provided. For the more complex example of 5 mg (in one dose) every other day for 30 days, 
subsections B.4.k.5.1 through B.4.k.5.7 would be 5, mg, 1, 2, day, 75, mg, respectively. In the same 
way, 50 mg daily for 2 days would be 50, mg, 1, 1, day, 100, mg. For prolonged chronic therapy, the 
sender should consider the need to complete the cumulative dose sections. The cumulative dose 
provided is the total dose administered until the first sign, symptom, or reaction. 
18
  In the case of a parent-child or parent-fetus report, the dosage section applies to the parental dose. 
For dosage regimens that involve more than one dosage form and/or changes in dosage, the 
information should be provided in section B.4.k.6 as text. Alternatively, the sender can provide more 
than one iteration (k) for the same drug. Categories for "dose unit" and for "definition of the interval" 
are described in Attachment 1. 
B.4.k.6 Dosage text 
User Guidance:   This item should be used in cases where provision of structured dosage information 
is impossible. 
B.4.k.7 Pharmaceutical form (Dosage form) 

User Guidance:   e.g., tablets, capsules, syrup.  Free text until a controlled vocabulary is available. 

B.4.k.8 Route of administration 
User Guidance:   See suggested vocabulary in the route of administration list in Attachment 2. For a 
parent-child or parent-fetus report, this indicates the route of administration of a drug given to the 
child or fetus. This is usually an indirect exposure, such as transmammary, but can include more usual 
routes of administration for other drugs given to the child. The parents route of administration should 
be provided in B.4.k.9. 
B.4.k.9 Parent route of administration (in case of a parent child or fetus report) 
User Guidance:   This section should be used in a parent-child or fetus report and linked to parent 
reports to indicate the route of administration to the parent. 
B.4.k.10 Gestation period at time of exposure 
User Guidance:   Use the gestational age at the time of the earliest exposure.  Gestation period at time 
of exposure should be expressed by providing both a number and designation of units of days, weeks, 
months, or trimester.   See the companion document for format specifications. 
B.4.k.11 Indication for use in the case 
User Guidance: The indication as reported. For multiple indications for the same drug, repeat the 
entire B.4.k block specifying the same drug for each indication. MedDRA terms should be provided as 
either text or code, according to regional preferences, until January 2003 when codes should be used 
in all regions. B.4.k.19 can be used to provide indications in other terminologies. 
B.4.k.12 Date of start of drug 
B.4.k.13 Time intervals between drug administration and start of reaction or event 
User Guidance:   The major uses of intervals are to cover circumstances where both the dates are 
19
  known but the interval is very short (e.g., minutes, such as in anaphylaxis) and when only imprecise 
dates are known but more information concerning the interval is known. Dates, if available, should 
always be transmitted in the appropriate items, rather than intervals. B.4.k.13 captures the interval 
between each drug and only the reaction or event in the first iteration of B.2.i. If there is more than 
one reaction or event and it is deemed necessary, more than one ICSR  can be used to provide all the 
intervals between each suspect drug and all reactions or events.   In this circumstance, it is advisable 
to indicate the reports are linked in A.1.12. The complexity of the intervals highlights the desirability 
of providing dates. See the companion document for format specifications. 
B.4.k.13.1 Time interval between beginning of drug administration and start of reaction or event 
B.4.k.13.2 Time interval between last dose of drug and start of reaction or event 
B.4.k.14 Date of last administration 
User Guidance:   For ongoing drug administration after the onset of the reaction or event, this item 
should be blank and Actions taken with drug (B.4.k.16) should be used. 
B.4.k.15 Duration of drug administration 
User Guidance:   This item should be used if exact dates of drug administration are unavailable at the 
time of the report, but there is information concerning the duration of drug administration. The 
information requested is the overall duration of drug administration and covers intermittent 
administration. See the companion document for the appropriate format. 
B.4.k.16 Actions taken with drug 
   Drug withdrawn 
   Dose reduced 
   Dose increased 
   Dose not changed 
   Unknown 
   Not applicable 
User Guidance:   These data, taken together with the outcome of the reaction (B.2.i.8), provide the 
information concerning dechallenge. Not applicable should be used in circumstances such as if the 
patient died or the treatment had been completed prior to the reaction or event. 
B.4.k.17 Effect of rechallenge (or re-exposure), for suspect drugs only 
B.4.k.17.1 Did reaction recur on readministration? 
   Yes 
   No 
   Unknown 
20
  User Guidance:   Unknown indicates that a rechallenge was done, but it is unknown if the event 
recurred. This segment should not be completed if it is unknown whether a rechallenge was done. 
B.4.k.17.2 If yes to item B.4.k.17.1, which reactions or events recurred 
User Guidance:   Use MedDRA terms 
B.4.k.18 Relatedness of drug to reactions or events (repeat B.4.k.18.1 through B.4.k.18.4 as 
necessary) 
User Guidance:   This section provides the means to transmit the degree of suspected relatedness of 
each drug to the reaction or event. The repeating items could also be used to provide the assessment 
of relatedness by different sources or methods of assessment. For the purpose of reporting, there is an 
implied suspicion of causality for spontaneous reports. It is recognized that information concerning 
the relatedness, especially for spontaneous reports, is often subjective and may not be available. 
 	  The following example illustrates the extensive functionality contained in this section. 
 	  Assume a patient being treated with two medications: Drug A and Drug B. 
 	  Assume the patient has had three adverse events: Event 1, Event 2, and Event 3 
 	  The reporter provided assessment of causality for events 1 and 2 for both Drug A and Drug B, 
but not for either drug concerning event 3.  The reporters assessment of causality is based on 
overall impression, which the sender codes as global introspection. 
 	  The sender applies two methods of causality assessment, one with an algorithm (coded 
algorithm), and the other a Bayesian analysis, which provides a decimal probability (coded 
Bardi), but it does so only for the drug it manufactures (in this case Drug A). 
  	 From the above, there are 4 sets of data for the reporter (2drugsX2eventsX1method of 
assessment) and 6 sets for the sender (1drugX3eventsX2methods of assessment) for a total 10 
sets of data. 
 	  The appropriate item with the information is B.4.k.18 (and its four subfields 1-4). In this 
example k is replaced by Drug A and Drug B respectively. Please note the subfields 1-4 are 
repeatable. Thus: 
B.4.k.18.1  B.4.k.18.2  B.4.k.18.3  B.4.k.18.4 
k(1) = DRUG A 
Event1  Reporter  global introspection  related 
Event1  Company  algorithm  possibly related 
Event1  Company  Bardi  0.76 
Event2  Reporter  global introspection  not related 
Event2  Company  algorithm  possibly related 
Event2  Company  Bardi  0.48 
Event3  Company  algorithm  unlikely related 
Event3  Company  Bardi  0.22 
k(2) = DRUG B 
Event1  Reporter  global introspection  not related 
Event2  Reporter  global introspection  not related 
21
  The order of the rows is not important since each one represents a complete set, however the E2B 
message and M2 specifications state that all assessments for Drug A (k=1) appear before Drug B 
(k=2). 
For subsection B.4.k.18.1 MedDRA terms should be used. Subsections B.4.k.18.2 through B.4.k.18.4 
do not require a controlled vocabulary. 
B.4.k.18.1 Reaction assessed 
User Guidance:   Generally the reactions assessed are ordered from the most important or the most 
serious to the least important. 
B.4.k.18.2 Source of assessment (e.g., initial reporter, investigator, regulatory agency, company). 
B.4.k.18.3 Method of assessment (e.g., global introspection, algorithm, Bayesian calculation). 
B.4.k.18.4 Result 
B.4.k.19 Additional information on drug 
User Guidance:   This should be used to specify any additional information pertinent to the case that is 
not covered by above sections (e.g., beyond expiration date, batch and lot tested and found to be 
within specifications). This item can also be used to provide additional information concerning the 
indication for the drug. Regional requirements may involve the use of a controlled vocabulary to 
provide the additional information concerning indication. 
B.5 Narrative case summary and further information 
B.5.1 Case narrative including clinical course, therapeutic measures, outcome, and additional relevant 
information. 
User Guidance:  Focused, factual, and clear description of the case should be given, including the 
words or short phrases used by the reporter. 
B.5.2 Reporter's comments 
User Guidance:   This item should be used to include the reporter's comments on the diagnosis, 
causality assessment, or other issues considered relevant. 
B.5.3 Sender's diagnosis or syndrome and/or reclassification of reaction or event 
User Guidance:   This section provides the sender with an opportunity to combine signs and symptoms 
that were reported into a succinct diagnosis and the reasoning would be included in section B.5.4. 
MedDRA terminology. 
22
  B.5.4 Sender's comments 
User Guidance:   This section provides information concerning the sender's assessment of the case and 
can be used to describe disagreement with, and/or alternatives to the diagnoses given by the initial 
reporter. 
23
  GLOSSARY 

Parent-child or parent-fetus report: Report in which the administration of medicines to a parent 
results in a suspected reaction or event in a child or fetus. 
Receiver:  The intended recipient of the transmission. 
Reporter:  Reporter is the primary source of the information, (i.e., a person who initially reports the 
facts). This should be distinguished from the sender of the message, though the reporter could also be 
a sender. 
Sender:  The person or entity creating the message for transmission. Although the reporter and sender 
may be the same person, the function of the sender should not be confused with that of the reporter. 
24
  ATTACHMENT 1 

Unit List 
Mass 
kg  kilogram(s) 
g  gram(s) 
mg  milligram(s) 
m g  microgram(s) 
ng  nanogram(s) 
pg  picogram(s) 
mg/kg  milligram(s)/kilogram 
m g/kg  microgram(s)/kilogram 
mg/m2  milligram(s)/sq. meter 
m g/ m2  microgram(s)/ sq. meter 
Radioactivity 
Bq  becquerel(s) 
GBq  gigabecquerel(s) 
MBq  megabecquerel(s) 
Kbq  kilobecquerel(s) 
Ci  curie(s) 
mCi  millicurie(s) 
m Ci  microcurie(s) 
nCi  nanocurie(s) 
Volume 
l  litre(s) 
ml  millilitre(s) 
m l  microlitre(s) 
Other 
mol  mole(s) 
mmol  millimole(s) 
m mol  micromole(s) 
iu  international unit(s) 
kiu  iu(1000s) 
Miu  iu(1,000,000s) 
iu/kg  iu/kilogram 
mEq  milliequivalent(s) 
%  percent 
gtt  drop(s) 
DF  dosage form 
25
  User  Guidance:  This  is  the  suggested  list  of  units.  When  using  other  units,  transformation  is 
recommended if possible. Otherwise the free text field should be used. 
Definition of Interval List 
Minutes 
Hours 
Days 
Weeks 
Months 
Years 
Cyclical 
As necessary 
Total 
26
  ATTACHMENT 2: 
Route of Administration List 
Intravenous (not otherwise specified) 
Auricular (otic)  Intravesical 
Iontophoresis 
Buccal 
Cutaneous  Nasal 
Dental  Occlusive dressing technique 
Endocervical  Ophthalmic 
Endosinusial  Oral 
Endotracheal  Oropharingeal 
Epidural  Other 
Extra-amniotic  Parenteral 
Hemodialysis  Periarticular 
Intra corpus cavernosum  Perineural 
Intra-amniotic  Rectal 
Intra-arterial  Respiratory (inhalation) 
Intra-articular  Retrobulbar 
Intra-uterine  Subconjunctival 
Intracardiac  Subcutaneous 
Intracavernous  Subdermal 
Intracerebral  Sublingual 
Intracervical  Topical 
Intracisternal  Transdermal 
Intracorneal  Transmammary 
Intracoronary  Transplacental 
Intradermal  Unknown 
Intradiscal (intraspinal)  Urethral 
Intrahepatic  Vaginal 
Intralesional 
Intralymphatic 
Intramedullar (bone marrow) 
Intrameningeal 
Intramuscular 
Intraocular 
Intrapericardial 
Intraperitoneal 
Intrapleural 
Intrasynovial 
Intratumor 
Intrathecal 
Intrathoracic 
Intratracheal 
Intravenous bolus 
Intravenous drip 
27
  ATTACHMENT 3 

Examples of how to populate fields relevant to identifying cases and their reports 
The figure provides an example of how one would populate the fields relevant to identifying cases and 
their reports. Patient XX suffers three separate adverse events (AE1, AE2, AE3) spaced over a time 
period. 
Example of a simple single report from a company to a regulator: 
Hospital X reports AE1 to Company K who then in turn sends ICSR1 to Regulator. Population of 
relevant fields for this case is illustrated in the first row of the table. Company K populates A.1.0.1 with 
Company Ks (case) safety report unique identifier JP-K-001. Company K populates A.1.10.2 with JP
K-001 because company K is the initial sender of the report. Because there has not been a previous 
E2B/M2 electronic report, the identifiers in A.1.0.1 and A.1.10.2 are the same. 
Example of company to company to company to regulator transmission 
Hospital X reports AE1 to Company B who then in turn sends ICSR2 to Company C. Population of 
relevant fields for this case is illustrated in the second row of the table. Company B populates A.1.0.1 
with Company Bs (case) safety report unique identifier JP-B-001. Company B populates A.1.10.2 
with JP-B-001 because company B considers itself the initial sender of the report because it is unaware 
that Company K also sent an ICSR for this case. 
Company C sends ICSR3 to Company D. The third row of the table indicates how Company C populates 
the relevant fields. Company C populates A.1.0.1 with JP-C-001. Company C populates A.1.10.2 with 
JP-B-001, leaving the field unchanged from the way Company B populated it. In addition, Company C 
populates A.1.11.1 (Source of the case identifier) with the name of company B, B. A.1.11.2 is populated 
with Case Identifier in the Previous Transmission by Company B JP-B-001. 
Company D sends ICSR4 to regulator. The fourth row of the table indicates how Company D populates 
the relevant fields. Company D populates A.1.0.1 with JP-D-001. Company D retains in fields 
A.1.10.2, A.1.11.1, and A.1.11.2 the information populated by Company C, and Company D adds to the 
retained information in repeatable field A.1.11.1 C to represent that Company C is another source of the 
case identifier, and Company D adds in field A.1.11.2 JP-C-001 to represent Company Cs case 
identifier from the previous transmission. 
Example of a simple single report with follow-up from a company to a regulator 
Hospital X reports AE1 to Company E who then in turn sends ICSR5 to Regulator. Population of 
relevant fields for this case is illustrated in the fifth row of the table. Company E populates A.1.0.1 with 
Company Es (case) safety report unique identifier JP-E-001. Company E populates A.1.10.2 with JP
E-001 because company E is the initial sender of the report. Because to Company Es knowledge, there 
has not been a previous E2B/M2 electronic report, the identifiers in A.1.0.1 and A.1.10.2 are the same. 
28
  ICH E2BM Data elements for transmission of individual case safety reports  29 
ICSR6 represents Hospital Xs follow-up information about AE1 to Company E. Company E submits 
follow-up to ICSR5 to the regulator.  The relevant fields, A.1.0.1 and A.1.10.2, are populated the same 
as for ICSR5. ICSR6, a follow-up report, is differentiated from ICSR5 by A.1.7, Date of Receipt of the 
Most Recent Information for this Report. 
Example of linking two separate adverse events affecting the same patient 
Patient XX later suffers a separate adverse event, AE2. Hospital X reports AE2 to Company K who then 
in turn sends ICSR7 to Regulator. Population of relevant fields for this new case is illustrated in the 
seventh row of the table. Company K populates A.1.0.1 with Company Ks (case) safety report unique 
identifier JP-K-002. Company K assigns a new (case) safety report unique identifier JP-K-002 because 
JP-K-001, as described above, represent a separate adverse event. Company K populates A.1.10.2 with 
JP-K-002 because company K is the initial sender of the report. Because there has not been a previous 
E2B/M2 electronic report, the identifiers in A.1.0.1 and A.1.10.2 are the same. The previous report 
from Company K, JP-K-001, for patient XX should be represented in A.1.12, Identification Number of 
the Report which is Linked to this Report. 
In a contrasting example, Hospital X also reports AE2 to Company F. Company F had not previously 
received an AE concerning Patient XX, and therefore there is no linked report and A.1.12 is not 
populated. As in the first example concerning ICSR1, ICSR8 is a simple single report from a company 
to a regulator. 
Example of linking three separate adverse events affecting the same patient 
Patient XX later suffers a third, separate,and distinct adverse event, AE3. Hospital Y reports AE3 to 
Company K who then in turn sends ICSR9 to Regulator. Population of relevant fields for this new case 
is illustrated in the ninth row of the table. Company K populates A.1.0.1 with Company Ks (case) 
safety report unique identifier JP-K-003. Company K assigns a new (case) safety report unique 
identifier JP-K-003 because JP-K-001 and JP-K-002, as described above, represent separate, adverse 
events. Company K populates A.1.10.2 with JP-K-003 because company K is the initial sender of the 
report. The previous reports from Company K, JP-K-001 and JP-K-002, for patient XX should be 
represented in the repeatable field A.1.12, Identification Number of the Report, which is Linked to this 
Report. 
29
  ICH E2BM Data elements for transmission of individual case safety reports  30 
Patient  HP  Company 
XX  ICSR1 
K 
ICSR2  ICSR3  ICSR4 
AE1  X  B  C  D R 
ICSR5(initial)
FU  E
T 
ICSR6(follow-up)
i 
m 
ICSR7 
e  AE2  X  K 
ICSR8 
F 
ICSR9 
AE3  Y  K
AE: Adverse Event report(case) 
HP: Hospital observing the event
 Report of AE
 ICSR report 
FU : Follow up 
30
  ICH E2BM Data elements for transmission of individual case safety reports  31 
Tabular representation of fields contents for the above examples 
A.1.0.1.  A.1.10.2  A.1.11.1  A.1.11.2  A.1.12 
ICSR1(K)  JP-K-001  JP-K-001 
ICSR2(B)  JP-B-001  JP-B-001 
ICSR3(C)  JP-C-001  JP-B-001  B  JP-B-001 
ICSR4(D)  JP-D-001  JP-B-001  B  JP-B-001 
C  JP-C-001 
ICSR5(E)  JP-E-001  JP-E-001  *
 
ICSR6(E)  JP-E-001  JP-E-001  *
 
ICSR7(K)  JP-K-002  JP-K-002  JP-K-001 
ICSR8(F)  JP-F-001  JP-F-001 
ICSR9(K)  JP-K-003  JP-K-003  JP-K-001 
JP-K-002 
*These cases have different dates of most recent information (A.1.7) 
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