Conducting Investigator-Initiated Studies According to FDA Regulations and GCP | Latest Update | 100% Correct

Conducting Investigator-Initiated Studies According to FDA Regulations and GCP | Latest Update | 100% Correct **Drug Supplier/Manufacturer** Apart from manufacturing the drug, the company also supplies it to the investigator for use in the study. **Sponsor** The entity that assumes responsibility for initiating a clinical investigation. The sponsor can be any legal entity, such as a company, academic organization, or individual. **Sponsor-Investigator** An individual who both initiates and conducts, alone or with others, a clinical investigation. This person directly administers the test article to subjects or is involved in its use, excluding entities like corporations or agencies (21 CFR, sec. 50.3). Which of the following is a valid criterion for determining that a study involving an approved drug does not require submission of an Investigational New Drug (IND) application? a. The study does not intend to report to the FDA to support a new indication or legal claim b. The study has no intention to alter the composition of the drug c. The study is conducted outside the U.S. d. The study is limited to pharmacokinetic assessments a. The study is not intended to be reported to the FDA to support a new indication or legal claim When a sponsor-investigator holds the IND for an investigational drug, what must they annually report to the FDA? a. Study protocol updates b. Adverse events from clinical trials c. Investigational New Drug (IND) report d. Manufacturing changes c. IND report Who bears the responsibility for initiating