Can a sponsor be an investigator?

Sponsor means a person who takes responsibility for and initiates a clinical investigation. Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed.

Who is the sponsor in investigator initiated trials?

Sponsor. Similar to an investigator, the sponsor’s role is the same on an IIT as it would be on an industry-sponsored trial. The sponsor is the entity initiating the clinical trial and acting as the coordinating center. They select qualified investigators at other sites they believe are a good fit for the trial.

Which section of the CFR requires investigators to file safety reports to the sponsor if the adverse event is believed to be caused by the drug?

21 CFR 312.64
Under 21 CFR 312.64, investigators are required to provide a causality assessment for each serious adverse event reported to the sponsor.

Which adverse event feature is not used to determine whether expedited reporting to FDA by sponsor is required?

Expectedness (option B) is the correct response because it does not need the sponsor to report to FDA in a timely manner.

What is difference between sponsor and investigator?

Investigator: An individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). Sponsor: A person who takes responsibility for and initiates a clinical investigation.

What is an investigator sponsored study?

Investigator Sponsored Studies are defined as unsolicited research originating from an external sponsor entity, institution or organization and include studies also known as investigator sponsored trials (IST), expert initiated research (EIR) or any other term which may reference investigator-sponsored or investigator- …

What is investigator initiated study?

Investigator initiated studies (IIS) are clinical studies initiated and managed by a non-pharmaceutical company researchers, like individual investigators, institutions, collaborative study groups or cooperative groups.

What is the investigators commitment to the sponsor?

Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols …

When must a serious adverse event be reported by an investigator to the sponsor?

An investigator (if he/she is not a sponsor-investigator) must report to the sponsor any serious adverse event within 24 hours of investigator learning about the event, whether or not considered drug related, including those listed in the protocol or investigator brochure and must include an assessment of whether there …

When FDA conducts an inspection the inspectors will?

When the FDA conducts an inspection, the inspectors will: Review regulatory records. The overall goal of monitoring, audits, and inspection activities is to: Ensure the protection of human research subjects and data integrity.

What is an FDA investigator?

The FDA defines an “investigator” to be the “individual who actually conducts a clinical investigation (ie, under whose immediate direction the drug is administered or dispensed to a subject).”2Investigators may conduct clinical studies for a sponsor.

What are the ongoing obligations of the sponsor-investigator under FDA form 1571?

There are ongoing obligations that the sponsor-investigator agrees to with the signature of the FDA Form 1571. In brief, the sponsor-investigator agrees to keep the IND current, to notify the FDA about any safety issues, to file annual reports, and to notify the FDA when the study ends for any reason.

What is a sponsor-investigator in a drug investigation?

The sponsor-investigator is defined as “an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term, as defined in FDA regulations, does not include any entity other than an individual.

What is MedWatch and how does it work?

MedWatch, the FDA’s medical product safety reporting program for health professionals, patients and consumers. MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products such as: