CT Flashcards
1
Q
report LT/death due to CT in..
and the remaining extra info…
A
7 days
8 days after first report
2
Q
report non LR usadr in ___ days
A
15 days
3
Q
report defect posing srs threat in…
if non srs threat in…
A
48h
15d
4
Q
recall CRM must tell hsa how early
A
24h before start of recall
5
Q
notify authorities on conclusion of trial in how many days
A
30 days
6
Q
sponsor must notify authority of early termination of ct within _ days?
A
15