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C.1.3 Type of Report
User Guidance This data element captures the type of report independently of its source a
separate element for the designation of the source is covered in item C.4
and is not duplicated in this section.
For example, if a case in the literature arises from spontaneous
observations, ‘type of report’ should be Spontaneous report.
If a case in the literature arises from a study, ‘type of report’ should be
Report from study and the differentiation between types of studies (e.g.
clinical trials or others) should be given in Section C.5.4 (See the user
guidance for C.5.4).
If it is unclear from the literature report whether or not the case(s) cited
are spontaneous observations or whether they arise from a study, then this
item should be Other.
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 that the sender knows the type of report but cannot fit it
into the categories provided.
Conformance Required
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.2
Value Allowed 1=Spontaneous report
2=Report from study
3=Other
4=Not available to sender (unknown)
Business Rule(s)
C.1.4 Date Report Was First Received from Source
User Guidance For organisations transmitting an initial case, this data element should be
the date when the information was received from the primary source and
fulfilling the 4 minimum criteria, as described in the Section 3.3.1.
When retransmitting information received from another regulatory agency
or another company or any other secondary source, C.1.4 should be the
date the retransmitter first received the information.
Conformance Required
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
Business Rule(s)
Minimum precision required is the day (i.e. ‘CCYYMMDD’).
The date specified cannot refer to a future date.
ICH ICSR Implementation Guide 12 April 2013
-48-
C.1.3 Type of Report
User Guidance This data element captures the type of report independently of its source a
separate element for the designation of the source is covered in item C.4
and is not duplicated in this section.
For example, if a case in the literature arises from spontaneous
observations, ‘type of report’ should be Spontaneous report.
If a case in the literature arises from a study, ‘type of report’ should be
Report from study and the differentiation between types of studies (e.g.
clinical trials or others) should be given in Section C.5.4 (See the user
guidance for C.5.4).
If it is unclear from the literature report whether or not the case(s) cited
are spontaneous observations or whether they arise from a study, then this
item should be Other.
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 that the sender knows the type of report but cannot fit it
into the categories provided.
Conformance Required
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.2
Value Allowed 1=Spontaneous report
2=Report from study
3=Other
4=Not available to sender (unknown)
Business Rule(s)
C.1.4 Date Report Was First Received from Source
User Guidance For organisations transmitting an initial case, this data element should be
the date when the information was received from the primary source and
fulfilling the 4 minimum criteria, as described in the Section 3.3.1.
When retransmitting information received from another regulatory agency
or another company or any other secondary source, C.1.4 should be the
date the retransmitter first received the information.
Conformance Required
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
Business Rule(s)
Minimum precision required is the day (i.e. ‘CCYYMMDD’).
The date specified cannot refer to a future date.