Disposition Event

Pinnacle 21 Support SDTM
1

Hi Andreu,

Your term “Disposition Event Treatment” is quite confusing.

In general, Disposition Event and Treatment are two separate concepts.

Subject are expected to have one disposition record per study or different treatment period which are usually defined based on additional Randomization. In your example, it looks like it’s enough to have one Completion record for the whole study.

Info about non-compliance with study Protocol is usually captured in DV (Protocol Deviations) domain. Of course, there is also EX (Exposure) domain to store details about subject treatment.

Kind Regards,

Sergiy

According to SDTM IG: “The Disposition dataset provides an accounting for all subjects who entered the study and may include protocol milestones, such as randomization, as well as the subject’s completion status or reason for discontinuation for the entire study or each phase or segment of the study, including screening and post-treatment follow-up. Sponsors may choose which disposition events and milestones to submit for a study. See ICH E3: Section 10.1 for information about disposition events.“

2

Hi!

I have a question regarding the Disposition Event Treatment. For example, if the total treatment duration is 6 weeks, but the treatment administration is each week. The Disposition event should be one per week or the whole treatment? In SDTMIG seems that should be only ones dispositio event for all duration of treatment, If so, how I can define the DSTERM and DSCODE if subjects can skip the treatment one week for any reason, continue with the treatment the next week and withdraw of the treatment the other one week? Or do you think would be correct define a Disposition Event per week?

Thanks for your help in advance