Currently we notice that in EC domain when ECMOOD=SCHEDULED the timing variables ECSTDTC and ECENDTC are blank. As per SDTM IG when ECMOOD is scheduled both ECPRESP and ECOCCUR variables are null. As per recent pinnacle report this below rule triggered when ECOCCUR is null records. How are we going to handle in this case?
One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != '').
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Hi,
Currently we notice that in EC domain when ECMOOD=SCHEDULED the timing variables ECSTDTC and ECENDTC are blank. As per SDTM IG when ECMOOD is scheduled both ECPRESP and ECOCCUR variables are null. As per recent pinnacle report this below rule triggered when ECOCCUR is null records. How are we going to handle in this case?
One Start Time-Point variable is expected to be populated when an event or intervention occurred. (E.g., Start Date/Time of Event or Intervention (--STDTC), or Start Relative to Reference Period (--STRF), or Start Relative to Reference Period (--STRTPT) should not be missing, or Occurrence (--OCCUR) = 'N' or Completion Status (--STAT) != '').
Thanks in advance.
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