SD1011 does not take into account ISO 8601 uncertainty formatting

Pinnacle 21 Support Troubleshooting and Problems
1

Hi Carol,

Could you provide a reference to CDISC documents about your example?

In SDTM IG 3.1.2 intervals with uncertainty are represented only as a reference to a particular date/time point. E.g., in 4.1.4.3.2 (on page 40)

YYYY-MM-DDThh:mm:ss/PnYnMnDTnHnMnS

PnYnMnDTnHnMnS/YYYY-MM-DDThh:mm:ss

Thank you,

Sergiy

2

Rule violation SD1011 is triggered when durations are formatted according to ISO 8601 uncertainty rules. The SDTMIG instructes to follow ISO 8601 uncertainty formatting when representing a durations such as “between 24 weeks and 26 weeks”. This example duration would be formatted as " P24W/P26W" according to ISO 8601, but OpenCDISC does not recognize this as a valid duration.