SEND requirement for dermal tolerability study

Pinnacle 21 Support SEND
1

Dear Umang,
This question has nothing to do with Pinnacle21, so I would not be surprised when you never receive an answer from them.
A much better place to post this question is on LinkedIn, where there is a “CDISC” discussion group (over 27,000 members - LinkedIn Login, Sign in | LinkedIn) or the “CDISC - SDTM Experts” discussion group (over 3,300 members, LinkedIn Login, Sign in | LinkedIn). I do not know whether there is a specific “SEND” group there, but I do regularly see discussion on SEND topics coming by.
Best, Jozef

2

Thanks Jozef

3

Dear Team,

We have conducted 4 cycle repeated dermal local tolerability study in minipigs. As per study design, one animal receives six types of treatment at once i.e. untreated, control, saline and placebo control and three type of different strength of compound. Do we required SEND for this type of typical study design or not?. If you guys any idea please suggest.