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3.2Code Sets, Terminologies and Vocabularies for E2B(R3)
There are several terminologies and controlled vocabularies that are used to describe or code
information within an ICSR. Some of these terminologies or code sets are general and are used
by many applications, such as units for mass or time, or country codes. Others are specific to the
medical section, such as MedDRA (Medical Dictionary for Regulatory Activities).Still others
are specific code lists created for the ICH. This section will address the code sets, terminologies
and vocabularies used in this IG. Specific guidance is provided in Section 3.4 for each
individual element.
Although the technical specifications for the code sets (e.g. Data Types) are provided in Section
3.4, these are current as of printing this IG. Specifications may evolve over time to adapt to new
technologies and new business needs. Ultimately, the validation specifications of code sets (e.g.
technical format and values allowed) are defined by the organisation that maintains the
terminology, and those organisations should be consulted to obtain the most current
specifications for their code sets.
Code set specifications (e.g. technical format and values allowed) are defined by the
organisation that maintains the terminology. As they may evolve at a different pace
than the publication of this IG, those organisations should be consulted to obtain
their most current specifications.
An Object Identifier (OID) is a sequence of numbers to uniquely identify an object. The
numbers represent a hierarchically-assigned namespace, formally defined using the
International Telecommunications Union ASN.1 standard. These numbers are written either as a
string of digits separated by dots or as a list of named ‘branches.’ For example, the MedDRA
dictionary of terms is identified by the OID 2.16.840.1.113883.6.163 which also represents the
branch ‘joint-iso-itu-t.country.us.organisation.hl7.external-code-system.MedDRA’.
Organizations can obtain an OID by requesting an identifier from a registrar, and, if it desires,
an organisation can in turn become a registrar and subsequently generate child OIDs to its
internal objects. The ICH is implementing OIDs to identify code systems used in ICSR message
exchange.
Tables 1 through 7 in this section of the IG list all the OIDs used to code the data elements of
the ICH ICSR. A list of OIDs registered by ICH is available on the ICH website. In addition to
OIDs in the tables 1 to 7, some OIDs registered by HL7 are used in ICSR messages to
differentiate the intended use of some elements (e.g. in data elements F.r.4 and F.r.5 for normal
values of test results, different OIDs are used to differentiate between ‘low’ and ‘high’,
respectively).Although those HL7 registered OIDs are not described in the tables below, the
reference instance in Appendix I (D) provides all OIDs in the context they are used.
ICH ICSR Implementation Guide 12 April 2013
-23-
3.2Code Sets, Terminologies and Vocabularies for E2B(R3)
There are several terminologies and controlled vocabularies that are used to describe or code
information within an ICSR. Some of these terminologies or code sets are general and are used
by many applications, such as units for mass or time, or country codes. Others are specific to the
medical section, such as MedDRA (Medical Dictionary for Regulatory Activities).Still others
are specific code lists created for the ICH. This section will address the code sets, terminologies
and vocabularies used in this IG. Specific guidance is provided in Section 3.4 for each
individual element.
Although the technical specifications for the code sets (e.g. Data Types) are provided in Section
3.4, these are current as of printing this IG. Specifications may evolve over time to adapt to new
technologies and new business needs. Ultimately, the validation specifications of code sets (e.g.
technical format and values allowed) are defined by the organisation that maintains the
terminology, and those organisations should be consulted to obtain the most current
specifications for their code sets.
Code set specifications (e.g. technical format and values allowed) are defined by the
organisation that maintains the terminology. As they may evolve at a different pace
than the publication of this IG, those organisations should be consulted to obtain
their most current specifications.
An Object Identifier (OID) is a sequence of numbers to uniquely identify an object. The
numbers represent a hierarchically-assigned namespace, formally defined using the
International Telecommunications Union ASN.1 standard. These numbers are written either as a
string of digits separated by dots or as a list of named ‘branches.’ For example, the MedDRA
dictionary of terms is identified by the OID 2.16.840.1.113883.6.163 which also represents the
branch ‘joint-iso-itu-t.country.us.organisation.hl7.external-code-system.MedDRA’.
Organizations can obtain an OID by requesting an identifier from a registrar, and, if it desires,
an organisation can in turn become a registrar and subsequently generate child OIDs to its
internal objects. The ICH is implementing OIDs to identify code systems used in ICSR message
exchange.
Tables 1 through 7 in this section of the IG list all the OIDs used to code the data elements of
the ICH ICSR. A list of OIDs registered by ICH is available on the ICH website. In addition to
OIDs in the tables 1 to 7, some OIDs registered by HL7 are used in ICSR messages to
differentiate the intended use of some elements (e.g. in data elements F.r.4 and F.r.5 for normal
values of test results, different OIDs are used to differentiate between ‘low’ and ‘high’,
respectively).Although those HL7 registered OIDs are not described in the tables below, the
reference instance in Appendix I (D) provides all OIDs in the context they are used.