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SEND requirement for dermal tolerability study
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Jozef
on September 9, 2024
SEND requirement
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 - https://www.linkedin.com/groups/56393/) or the "CDISC - SDTM Experts" discussion group (over 3,300 members, https://www.linkedin.com/groups/2758697/). 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
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.