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ICH ICSR Implementation Guide 12 April 2013
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APPENDIX II DATE /TIME
ICH has elected to utilise the HL7 Standard for datatypes to specify numeric representations of
date and time. The time notation is the de facto standard in almost all countries while the date
notation is increasingly popular.HL7 Standard for datatypes notation is the commonly
recommended format for representing date and time as human-readable strings in
communication protocols and file formats.
This notation has several important advantages when used in electronic files or messages as
compared to traditional date and time notations. Since it orders the units from most significant
to least significant, there are benefits with regard to flexibility, sorting, and for comparison after
truncation.
Appendix II (A) Date /Time
The international standard date /time notation is CCYYMMDDhhmmsswhere
i) CCYY is the century and year in the usual Gregorian calendar,
ii) MM is the month of the year between 01 (January) and 12 (December),
iii) DD is the day of the month between 01 and 31,
iv) hh is the number of complete hours that have passed since midnight (00-24),
v) mm is the number of complete minutes that have passed since the start of the hour (00-
59), and
vi) ss is the number of complete seconds since the start of the minute (00-59).
For example, the fourth day of February, 1995 is written as 19950204.
If only the month is of interest, then CCYYMM can be used.
Example: 199502
If only the year is of interest, then just CCYY is acceptable.
Example: 1995
The time (hhmmss) one second before midnight is written as 235959.
The precision can be reduced by omitting the seconds or both the seconds and minutes.
Example: 2359, or just 23
It is also possible to add fractions of a second after a decimal dot (.).
Example: 235959.9942 is 5.8ms before midnight.
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