Key Messages and Best Practices for Documentation Flashcards
1
Q
What are some key benefits of Key Messages?
A
Alignment, Clarity, Quality, Consistency, Focus.
2
Q
Should key messages be repeated in each section after the data becomes available?
A
No. You should avoid repetition of Key Messages; instead, the aim is to build a cohesive story from bottom up.
3
Q
What are the two key phases of filings?
A
Pre & post database lock
4
Q
What occurs during pre-database lock phase?
A
Frontloading activities that are data independent (Briefing packages/HA feedback)
5
Q
What are content maps?
A
Content maps provide the framework for the results section for each clinical document.
