Every clinical trial conducted at a research site is led by a physician called the principal investigator (PI). The PI plays a central role in participant safety, scientific integrity, and the overall quality of the trial’s execution.
Who Is the Principal Investigator?
The principal investigator is a licensed physician with relevant specialty expertise who takes on legal and ethical responsibility for conducting the clinical trial at their site. At NuLine Clinical Trial Center, PIs are board-certified physicians with expertise in the therapeutic area being studied, dermatology, nephrology, or hematology depending on the trial.
What the PI Is Responsible For
Participant safety. The PI is the physician responsible for all medical decisions related to participants during the study. They evaluate adverse events, make dose modification decisions, and determine when a participant should be discontinued from the study for safety reasons.
Protocol adherence. The PI certifies that the trial is being conducted exactly as specified in the approved protocol, FDA regulations, and ICH Good Clinical Practice guidelines.
Informed consent oversight. The PI is responsible for ensuring that the informed consent process is conducted properly, that participants genuinely understand what they are agreeing to before they sign.
Staff supervision. The PI supervises the study coordinator, sub-investigators, and all other site staff involved in the trial.
Regulatory documentation. The PI signs all required regulatory documents, including FDA Form 1572, which is a legally binding statement of investigator obligations.
Sub-Investigators
Many trials also designate sub-investigators, additional physicians at the site who share clinical responsibilities with the PI. Sub-investigators are listed on regulatory documents and take on defined portions of the PI’s responsibilities.
What This Means for Participants
You are never just a patient of a coordinator or research assistant. A qualified, accountable physician is responsible for your safety throughout your participation. You have the right to speak with the PI or a sub-investigator at any time during the study.