EPOCH Derivation

p Priyanka

on April 25, 2019

Hi,

In case if VSDTC (15Jan2019) is exactly equal to SEENDTC of TREATMENT EPOCH. Should the EPOCH in VS domain be derived as TREATMENT or should it be NULL.

Please note that subject is LOST TO FOLLOW-UP (Withdrawn) , last contact date on 15Jan2019. Hence Treatment EPOCH record is last record of that subject .

EPOCH SESTDTC SEENDTC

Screening 10-Jan-19 10-Jan-19

Treatment 10-Jan-19 15-Jan-19

Forums: SDTM

r Ruiting

on August 5, 2019

Hi Priyanka, I would…

Hi Priyanka,

I would populate "Treatment" instead of NULL. Thanks!

Regards,

Ruiting

j Jozef

on August 11, 2019

As Ruiting already suggested, use "TREATMENT". As long as a subject is in the study (also during follow up), the EPOCH can essentially never be "null". A subject can also never be "between" two epochs.
It is always a good idea to define exactly where an epoch (thus also a "study element") exactly starts and ends in advance. The use of datetimestamps instead of just dates in data collection will also make life much easier.