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ICH ICSR Implementation Guide 12 April 2013
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o F -Results of Tests and Procedures Relevant to the Investigation of the Patient
o G -Drug(s) Information and
o H -Narrative Case Summary and Further Information.
In addition to the letters ‘i’ and ‘k’ indicating iterations of the event (E.i) or the drug (G.k), the
letter ‘r’ is used to indicate that the data element or the section is repeatable.
It is recognised that the numbering scheme for the data elements in this IG is
different than the one used in the E2B (R2).
3.3.6 General rules for Data Entry
Date /Time Format
HL7 uses a single format to represent dates and times:
CCYYMMDDHHMMSS.UUUU[+|-ZZzz]. Complete date time information down to
seconds can be reported using this format. This date format makes it possible to provide
data to the appropriate degree of precision.
‘Future dates’ cannot be transmitted in an ICH ICSR message.When transmissions occur
across different time zones, senders and receivers should configure their systems (e.g.
attach the ZZzz offset to Coordinated Universal Time) to prevent dates and times to be
interpreted as ‘future dates’.
Please refer to Appendix II in this IG for more detail.
For E2B(R3), minimum level of date precision for each date data element is specified in
Section 3.4.
A single format (CCYYMMDDHHMMSS.UUUU[+|-ZZzz]) is used to represent
dates and times throughout this IG. This format allows for varying degrees of
precision to be exchanged for date and time information, from only the year, down
to the second.
The minimum level of precision for the date data elements is specified in Section
3.4, however, as much information as available (e.g. known) should be provided.
All free text data elements (with the exception of the ‘Reaction/Event as Reported by the
Primary Source in Native Language’ (E.i.1.1a)and the ‘Case Summary and Reporter’s
Comments in Native Language’(H.5.r)) are to be provided in English for international
transmission. However, the message control act wrapper supports language codes for
regional message exchanges. Please refer to regional implementation guides.
ICH ICSR Implementation Guide 12 April 2013
-35-
o F -Results of Tests and Procedures Relevant to the Investigation of the Patient
o G -Drug(s) Information and
o H -Narrative Case Summary and Further Information.
In addition to the letters ‘i’ and ‘k’ indicating iterations of the event (E.i) or the drug (G.k), the
letter ‘r’ is used to indicate that the data element or the section is repeatable.
It is recognised that the numbering scheme for the data elements in this IG is
different than the one used in the E2B (R2).
3.3.6 General rules for Data Entry
Date /Time Format
HL7 uses a single format to represent dates and times:
CCYYMMDDHHMMSS.UUUU[+|-ZZzz]. Complete date time information down to
seconds can be reported using this format. This date format makes it possible to provide
data to the appropriate degree of precision.
‘Future dates’ cannot be transmitted in an ICH ICSR message.When transmissions occur
across different time zones, senders and receivers should configure their systems (e.g.
attach the ZZzz offset to Coordinated Universal Time) to prevent dates and times to be
interpreted as ‘future dates’.
Please refer to Appendix II in this IG for more detail.
For E2B(R3), minimum level of date precision for each date data element is specified in
Section 3.4.
A single format (CCYYMMDDHHMMSS.UUUU[+|-ZZzz]) is used to represent
dates and times throughout this IG. This format allows for varying degrees of
precision to be exchanged for date and time information, from only the year, down
to the second.
The minimum level of precision for the date data elements is specified in Section
3.4, however, as much information as available (e.g. known) should be provided.
All free text data elements (with the exception of the ‘Reaction/Event as Reported by the
Primary Source in Native Language’ (E.i.1.1a)and the ‘Case Summary and Reporter’s
Comments in Native Language’(H.5.r)) are to be provided in English for international
transmission. However, the message control act wrapper supports language codes for
regional message exchanges. Please refer to regional implementation guides.