Country Level EDLs

[Anupama Tewari]

Hello,

Is there a standard set of core EDLs per country within EU? We have had conversations with couple of CROs we are working with in EU, and they have different standards when it come to some documents. One main document that is in question is Medical License for PI/SubI; there seems to be a difference between EU countries.

First of all, is there a difference?
Can anyone on this Forum share their EU country core/recommended essential document list or point me in a direction where I can find it? If it also includes APAC and LATAM countries, that will be wonderful! 🙂

I’m just looking for industry standards when it comes to core required EDLs for countries outside US.

Thank you very much!

Anu

[Author]

Posts