Home Forums General Discussion Forum Protocol Synopsis Amendments

Viewing 2 reply threads
  • Author
    • #5001
      Shah Ashraf

      My question is Where do we file Protocol Synopsis Amendment Documents ?
      Should we file them in :-02.01.03 Protocol Synopsis (and capture the Amendment # in Metadata)
      Should we file them with Protocol Amendment in :- 02.01.04 Protocol Amendment

      My recommendation we should file all Synopsis (original Synopsis or Amendment Synopsis) in :- 02.01.03 Protocol Synopsis
      and we should file only Protocol Amendments in :- 02.01.04 Protocol Amendment

      Thanks in advance for any advice.

    • #5002
      Eldin Rammell

      I agree with you Shah. The notes that accompany the Model explain that each artifact also includes revisions.

    • #5003
      Shah Ashraf

      I really appreciate that. Thanks for confirming that Eldin.

Viewing 2 reply threads
  • You must be logged in to reply to this topic.