For those wondering about the responsibilities of a principal investigator, here is the result of my research on this topic.

The Principal Investigator receives no direct supervision and has complete authority and responsibility for the clinical trials they perform. Personal initiative is imperative. He or she must have a firm understanding of the principles of planning, organizing and management. The Principal Investigator must promote Good Clinical Practices thought the clinical research process by ensuring strict adherence to the protocol, protection of the patient’s health and welfare, integrity of the data generated, and compliance with all federal and state regulations The person who holds this position must have a current physician’s licensure to practice with five to eight years of experience in clinical research. They must have an above average ability to interface with patients, staff, sponsor, and IRB. The Principal Investigator is responsible for maintaining a cohesive team that consistently completes clinical trials on time and at budget.

Provides investigator qualifications and agreements to sponsors by maintaining current curriculum vitae, demonstrates the proper education, training and experience to conduct the clinical investigations Principal Investigator is responsible for signing Form FDA 1572, the protocol, and all sponsor contract(s), and complete disclose of any conflicts of interest

Ensures protocol compliance by possesses a thorough understanding of the protocol, determines if the inclusion/exclusion criteria are compatible with the intended study population, establishes recruitment goals and gains approval of both the IRB and the sponsor prior to any amendments or protocol deviations

Ensures continuous oversight of the clinical trial by the IRB, by providing the protocol, investigator’s brochure, informed consent, recruitment materials, protocol amendments or deviations, adverse events and any other materials regarding the study to the IRB for review

Ensures adequate facility and number of staff to conduct the study and makes adequate time to supervise and conduct the study.

Manages medical care and ensures that all medical decisions related to the clinical trial are made by a qualified physician. The Principal Investigator evaluates subject compliance and response to therapy, is responsible for adverse events, proper medical attention in the occurrence of an adverse event, and notification of primary care physician

Protects the rights and welfare of subjects ensuring the informed consent is in accordance with CFG 56 and 45 and that the subjects are aware of all aspects of the clinical trial

Oversees the quality of the trial by ensuring all case report forms are legible, complete, and accurately reflect the source documents. Reviews, understands, and approves corrections made to case report forms and ensures the proper quarantine and use of the investigational materials

Communicates effectively with subjects, the research team, the sponsor, and the IRB and is responsible for the clarity of the protocol and purpose of therapies by the research staff. The Principal Investigator will participate in study monitoring conducted by the sponsor and regulatory administrations

The Principal Investigator maintains professional knowledge and technical expertise by reviewing medical research publications and participating in professional organizations

John Dyba, Senior Account Executive

 

 

 

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