Documentation - Use of Addendum vs Amendment

#1
Hi all,

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 :)
 
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Ronen E

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#2
Sounds way overcomplicated.
First, your definitions are ambiguous at this point:
Addendum: additional pages or sections that are added to an existing document
Amendment: ...supplying supplementary information to clarify the original document.
I can't see how these two don't relate to the exact same thing in some situations.

Second, why create a brand new document for a fix/change (Doc-001 to Doc-002)? I would just uprev (e.g. Doc-001 R1 to Doc-001 R2).

IMO,
the right thin[g] to do, revise the original protocol and reissue
Cheers,
Ronen.
 
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