Posting: # 4612
writing a protocol for a multi-center multiple dose PK study reminded me on the issue of summer time (en-UK) / daylight saving time (en-US).
Especially the autumn switch might be confusing, since there are two [sic] local time intervals from 02:00–03:00; in local time these hours are denoted by suffixes A and B.*
The best way to handle the issue is to use the universal time (UTC). Actual sampling times should be coded according to
Once you have got sampling times in ISO 8601, you may set up your PK database taking the offset into account – I would suggest to set the base to your local time without DST (not to UTC).
Caution: You have to improvise, since I’m not aware of any PK software handling the ISO-format with offset. Pharsight’s Phoenix (like Excel) supports the ISO-format, but only without offset. The R packages
The latter is quite useful, containing rule sets for more than 400 locations worldwide.
The ISO-date/time gives the switch in UTC, the difference in seconds to UTC, a flag (DST on/off), and the ISO timezone code.
Nice for our Indian friends because they would have faced the problem only once back in 1942;
Another option would be to set up a local timebase (essentially ignoring the switch). Some EDC systems might allow for that. Great, if you still use paper CRFs. But: It would need clear communication between staff and volunteers about the consequences. If in spring (before the switch) sampling starts at 08:00, in the second period the corresponding time point should be sampled at 09:00. Again no big deal in single dose studies, but may be tricky in a MD study, where subjects come to the clinical site for dosing in the saturation-/switch-over phase…
PS: A short personal story. In the CRO I was working for, we had a fancy LIMS (running on a UNIX-machine acting as a local timeserver for all connected equipment; so time-format was not an issue – as we believed). Administration, sampling, and centrifugation were registered by barcode readers. Of course we were hit during an MD study in spring. At the end of the study I clicked the button to get the list of deviations of actual from scheduled sampling times – expecting 10–20 lines fitting on a single sheet of paper as usual. But the printer wouldn’t stop…
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