Populating PLANSUB value in Trial Summary when the study is Phase1/2

s Srigowri

on November 5, 2015

Hi,

While creating Trial summary domain where Study design involves phase 1 and phase 2, not sure how to populate the values for PLANSUB because for phase1 Planned Sample size is :Approximately 4 to 15 eligible subjects will be enrolled and for the Phase 2 portion of the study, a total of 100 subjects will be randomized.I am thinking of only way is to use null flavor ,however no detailed info for reviewer if we use null flavor.

Let me know if anyone has idea how to tackle this situation.

Thanks in advance.

Forums: SDTM

n Nitin

on November 12, 2015

You can use TSSEQ/TSGRPID

You can use TSSEQ/TSGRPID variable to separate data for Phase 1 and Phase 2 portions. Then use 2 PLANSUB tests for each phase: PLANSUB=15 and PLANSUB=100.

s Srigowri

on November 13, 2015

Multiple PLANSUB records

Hi Nithin,

Thanks!

Rule is " Trial Summary (TS) domain must contain only one record for 'PLANSUB' Parameter"

Using TSSEQ/TSGRPID will result in ERROR in Severity Column.

SRGM

j Jozef

on November 14, 2015

Multiple PLANSUB records

Personally, I think this is a flaw in the FDA rules. For the trial design parameter there is CDISC controlled terminology allowing the value "PHASE I/II TRIAL" (code C15693).
There are two FDA rules on PLANSUB, one stating that there may only be one record with TSPARMCD=PLANSUB (rule FDAC247), the other one saying that the value of PLANSUB must be numeric (FDAC246).
Essentially, this means that Phase 1/2 cannot be described in TS without breaking one of these 2 rules!
Sometimes, I have the impression that the FDA rules have been developed starting from a "complaints box" in their offices. In a number of cases, they just don't make sense, in other cases they are completely wrong (e.g. rule FDAC084), and in other cases they are an expectation rather than a rule. See e.g. http://cdiscguru.blogspot.com/2015/02/rule-fdac084-is-just-damned-wrong.html.

I think the best you can do is to violate one of the two rules, and explain in the reviewers guide why you violated the rule. It is more important to provide correct information than trying not to violate (badly developed) rules.