Conducting Investigator-Initiated Studies According to FDA Regulations and GCP

Sponsor-Investigator

An individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject. The term does not include any other person other than an individual, e.g. corporation or agency. (21 CFR, sec. 50.3)

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

IND report

Drug Supplier/Manufacturer

In addition to producing the drug the company also provides the investigator with the drug for use in the study

Sponsor

The entity who takes responsibility for the initiates a clinical investigation the sponsor can be any legal entity including a company, an academic organization, or an individual

Who is responsible for making the initial rest a termination for a device being used in a study?

The sponsor - investigator

Which of the following is an acceptable criterion for determining that a study of an approved drug does not require an IND?

The study is not intended to be reported to FTA to support a new indication or support a legal and change