New N2 SOPs are now available that reflect changes to ICH E6 (V7, effective date May 15)

Good Morning N2 members (yes, all C17 sites are members):

N2 happy to announce that V.7 N2 SOPs are now available through the N2 website; the SOPs include adjustments due to the changes to ICH E6. The effective date is May 15th 2017. Should the site roll them out after this date, all that is required is a note to file to explain the different effective date. For all SOPs, changes are documented in the revision section at the back of the SOP.

Also, available for download:

  • two quiz versions (one with answers and justifications and one student copy)
  • the compliance letter
  • the French translation is underway and will be available in the coming weeks