put pilot2 files into eCTD structure

Question

put pilot2 files into eCTD structure

Closed this issue 2 years ago · 3 comments

https://github.com/RConsortium/submissions-pilot2-to-fda

Answer 1 · 2022-09-16T18:05:17.000Z

As I finalized the ectd files for Pilot 2, I want to make sure I'm aligned with the scope. Should we include the previous ectd files from pilot 1 within the pilot 2 version, or should we include only what is necessary to install and execute the Shiny application in the pilot 2 ectd files?

Answer 2 · 2022-09-16T18:17:08.000Z

I would prefer the latter (only files needed for pilot 2), otherwise it may be too overwhelming? I know in adrg we also included the static TLF info, perhaps in adrg we can make it clear that those files are included in the pilot 1 esub pkg (and link to our pilot1-to-fda repo?)

Answer 3 · 2022-09-16T18:27:27.000Z

Thanks @lengning , I've been working under that assumption as well. I'll make sure the ADRG for pilot 2 is clear about the included files.