Week 7 Flashcards
1
Q
What does DOA stand for?
A
Delegation of Authority
2
Q
Where do the eCRFs live?
A
the EDC
3
Q
Who transcribes source data into eCRFs in EDC?
A
The site (coordinator) So CRO and sponsor can view info in real time
4
Q
Why are PSVs done?
A
Record what it looks like and get and idea if they are qualified to host clinical trial
5
Q
SIV
A
The visit performed in order to activate the site
Perform training
Perform site tour
Complete regulatory
6
Q
IMV
A
Review the Clinical Monitoring Plan in order to identify the frequency of IMVs and also action at the IMV
