
Version control fundamentals: naming conventions, superseded documents, and effective dates
Implement a version control system built on consistent naming conventions, disciplined handling of superseded documents, and clear effective dates.
Three versions, one crisis
The site is conducting a Phase III trial. Protocol Version 4.0 has been in effect since the IRB approved Amendment 3 six weeks ago. The informed consent form references Version 3.0 dosing -- because the consent was never updated after the amendment. And the IRB approval letter on file? It references Protocol Version 4.0 and an informed consent form that aligns with it. Three different versions of reality coexist in the same regulatory binder, and none of them agree.