Reply To: Supply for Inv Initiated Studies (IIS’s) or Inv Sponsored Trials (IST's)

[Ed Groleau]

Reply To: Supply for Inv Initiated Studies (IIS’s) or Inv Sponsored Trials (IST's)

For IMP, I’ve done a) and c) but I’ve also done a variant of b) where the bottles were imprinted with an identifier (lot number) or had a tear-off label applied. I’d say a) is probably the most common method that I’ve used.

I’ve never supplied commercial products for an IIS. I’ve always had them obtain it on their own.