What central roles are involved in the conduct of a research study: Sponsor (Sponsor) or Principal Investigator (Principal Investigator)?

From the Guidelines

The correct answer is D. B and C. In the conduct of a research study, both the Sponsor and the Principal Investigator play central roles. The Sponsor is the entity (individual, company, institution, or organization) that takes responsibility for initiating, managing, and often financing the research, as noted in a study published in the Journal of Clinical Oncology 1. They ensure the study has adequate resources and oversight. The Principal Investigator is the qualified person responsible for the conduct of the clinical trial at the research site, overseeing the scientific integrity of the study, protecting subjects' rights and welfare, and ensuring compliance with protocols and regulations. While interns may assist in research, they do not hold a central role with primary responsibilities as defined in Good Clinical Practice (GCP) guidelines.

Key responsibilities of the Sponsor and Principal Investigator include:

• Ensuring the study has adequate resources and oversight
• Overseeing the scientific integrity of the study
• Protecting subjects' rights and welfare
• Ensuring compliance with protocols and regulations Understanding these roles is essential for anyone involved in clinical research to ensure proper accountability, oversight, and adherence to ethical and regulatory standards, as highlighted in a study published in the American Journal of Respiratory and Critical Care Medicine 1. The importance of clear roles and responsibilities in clinical research is also emphasized in a study published in Stroke 1, which discusses the relationship between sponsors and investigators in the design and conduct of clinical trials.

From the Research

Central Roles in Research Study Conduct

The following are central roles in the conduct of a research study:

• Principal Investigator: The principal investigator is responsible for the overall conduct of the study, including ensuring compliance with regulations and guidelines 2.
• Sponsor: The sponsor is the organization or individual that initiates and funds the research study.

Relevant Roles

Based on the provided options, the correct answer is:

• D. B and C: Both the Sponsor and the Principal Investigator play central roles in the conduct of a research study 2.

Irrelevant Options

The following option is not a central role in the conduct of a research study:

• A. Intern: There is no evidence to suggest that an intern plays a central role in the conduct of a research study 2, 3, 4, 5, 6.