Question

When the sponsor-investigator holds the ind for an investigational drug he or she is responsible for annual reporting of which one of the following to fda?

Answer 1

Answer: IND report

Explanation:

A sponsor investigator has numerous roles to perform which includes

Control of the investigational drug

Record retention

Reporting

Assurance of IRB review

Inspection.

So, under the reporting role he or she will be saddled with the responsibility of giving an annual report of the IND investigation.