Hi all,
Our procedure has the following definitions:
I have a protocol this is mastered and issued for use (Doc-001). The client requests that an additional time point be added. Currently we would revise the master and issue a new executable protocol (Doc-002). Shouldn't we just use an amendment, add the time point with a justification and issue the amendment to the executable protocol or is the right think to do, revise the original protocol and reissue?
We mainly only use either amendments or addendums for reports.
Any advice appreciated
Our procedure has the following definitions:
Addendum: additional pages or sections that are added to an existing document
Amendment: minor changes to pages of an existing document, correcting an error in the original document, or supplying supplementary information to clarify the original document.
Now here's my situation,I have a protocol this is mastered and issued for use (Doc-001). The client requests that an additional time point be added. Currently we would revise the master and issue a new executable protocol (Doc-002). Shouldn't we just use an amendment, add the time point with a justification and issue the amendment to the executable protocol or is the right think to do, revise the original protocol and reissue?
We mainly only use either amendments or addendums for reports.
Any advice appreciated