Investigator Responsibilities

Question 1

The investigator Must retain records involving the drug case histories of subjects receiving the drug For how long after completion of this study

Answer 1

Two years

Question 2

The investigator must report Serious adverse events to the sponsor

Answer 2

Immediately

Question 3

Financial disclosures are to be made by the investigator to the sponsor when

Answer 3

At the initial start of the study updated when necessary and for at least 1 year after the closure of the study

Question 4

Under an IDE, Investigators to report UADE and study approval WD to whom and when?

Answer 4

UADE to sponsor with in 10 working days
IRB approval withdraw to sponsor within 5 working days

Question 5

Reporting device use without informed consent must occur

Answer 5

With in 5 working days to the IRB and sponsor.

Question 6

Investigator to submit final report to whom and when?

Answer 6

Sponsor and irb within 3 months of investigation termination or completion