__________means an individual who both initiates and conducts the clinical investigation and under whose immediate direction the investigational drug is being administered, used, or dispensed. The sponsor-investigator assumes all of the responsibilities of the sponsor as well as all the responsibilities of an investigator as outlined in the Form FDA 1572 (see the module, Investigator Obligations in FDA-Regulated Research). Usually, the intent of the sponsor-investigator trial is to gain scientific knowledge without seeking market approval for the drug. These are considered investigator-initiated or sponsor-investigator trials.

The term that describes an individual who both initiates and conducts the clinical investigation, and under whose immediate direction the investigational drug is being administered, used, or dispensed is "sponsor-investigator." The sponsor-investigator assumes all of the responsibilities of the sponsor as well as all the responsibilities of an investigator.

In the context of clinical trials, the sponsor-investigator takes on a dual role, being responsible for both the initiation and conduct of the study. They oversee the entire process, from designing the trial protocol to recruiting participants, administering the investigational drug, collecting and analyzing data, and ensuring compliance with regulatory requirements.

The sponsor-investigator is required to adhere to the guidelines outlined in Form FDA 1572, which details the obligations of investigators in FDA-regulated research. They are responsible for ensuring the safety and well-being of the study participants, maintaining accurate and complete records, and reporting any adverse events or deviations from the protocol.

It's important to note that sponsor-investigator trials typically aim to gain scientific knowledge without seeking market approval for the drug. These trials are often referred to as investigator-initiated or sponsor-investigator trials.

In summary, the sponsor-investigator is an individual who takes on both the responsibilities of a sponsor and an investigator in a clinical investigation. They play a crucial role in the design, implementation, and oversight of the trial, ensuring the safety of participants and the integrity of the study data.

aditigarg62399 aditigarg62399 · Answer 2 · 2024-02-01T13:07:28+01:00

Final answer:

A sponsor-investigator is an individual who initiates, conducts, and is responsible for a clinical investigation, managing both sponsor and investigator duties. They must comply with FDA regulations to ensure participant safety and the integrity of clinical trial data. Violations can lead to disqualification and prevention from contributing data to product submissions.

Explanation:

A sponsor-investigator is an individual who both initiates and conducts a clinical investigation, and under whose immediate direction the investigational drug is being administered, used, or dispensed. In addition to all the responsibilities of the sponsor, the sponsor-investigator also bears the responsibilities of an investigator as outlined in Form FDA 1572. Clinical investigations are crucial for Investigational New Drug Applications (INDs), which are submitted to the FDA for approval to test a drug on human subjects. Compliance with regulations such as "Protections of Human Subjects" (21 CFR 50) and Institutional Review Board (IRB) review is mandated to ensure the safety and welfare of participants in clinical studies.

It is important to note that these regulations are in place to maintain the integrity of the data collected during the clinical trials and to ensure the protection of human subjects involved. Should a clinical investigator fail to comply with these regulations, the FDA has the authority to disqualify them, which prevents them from providing clinical data for any product submissions. Moreover, the FDA's "Guideline for the Monitoring of Clinical Investigations" provides further insight into the necessary monitoring and documentation required throughout the research process.

Ultimately, the sponsor-investigator plays a dual role in both managing the trial and being accountable for the ethical, methodological, and regulatory oversight of the research. This dual role emphasizes the importance of thorough knowledge of FDA regulations and an unwavering commitment to participant safety and the generation of reliable data.