一般我们在sdtm中做epoch的时候,通常分为"SCREENING", "TREATMENT", "FOLLOW-UP"三个阶段,这里提到一种更为精细的分类,在treatment中根据study schedule再在细分,这样让reviewer更为清楚的了解某个event或intervention发生的具体时间点。
In-order to make the data more useful, the agency has asked industry to identify the Epoch that collected General-Observation-Class data starts in or is collected in. Doing this at a more granular level than a single Treatment Epoch should help the reviewer/consumer understand when things happened relative to discrete study activities more easily, which should facilitate review.
The EPOCHvariable’s values defined in TA are expected to be assigned to collected datain the General-Observation-Class domains to identify which Epoch the collecteddata began in, or was collected in.
Let’sassume each of the administrations is once-a-day for two weeks, and the Run-in,Rests and Wash-out are somehow different from each other.
Manywould map Run-in and Wash-out to separate Epochs, but many would map theDosing1-Rest-Dosing2-Rest-Dosing3 to a single Treatment Epoch. Let’s thinkabout this is relationship to the AE Treatment Emergent flag.
If theentire Dosing1-Dosing3 period of time is one Epoch, then
how is this different from Treatment Emergent?
How to knowthat data records started or were collected somewhere in the Treatment periodof time?
Mappingthis more granularly would likely aid the review, and in this example we shouldprobably have an Epoch for each of the Elements. Generally the Elements should be moregranular, but in this example since we assumed the treatments were allonce-a-day for two weeks the granularity of the Elements and Epochs should bethe same.
TheEpochs are defined in TA, then used to identify the boundaries and values forassigning EPOCH in the General-Observation-Class domains. Thegranularity beyond “Treatment” provides value to reviewers to identify thestudy-period at a more granular level.
TAExample for the first two Arms: