A Principal Investigator (PI) is the physician who leads the conduct of a clinical trial at a study site. The leadership role of the PI helps create the foundation of a successful clinical trial. The doctor who chooses to be a PI can provide his/her patients the possibility of participating in the study, while assisting drug companies in evaluating the efficacy and safety of these investigational treatments.
The PI is responsible for all clinical research activities at the site. These responsibilities include ensuring the study is run in accordance with national regulatory agency requirements and "Good Clinical Practice" (GCP). GCP is a set of internationally recognized ethical and scientific quality standards for the design, conduct, recording and reporting of clinical trials that involve humans. Compliance with GCP provides assurance that the rights, safety and well-being of trial participants are protected, and that the results of the clinical trials are credible and accurate.
To successfully run a clinical trial, certain ancillary staff are typically needed to support the PI. Most study sites have a study coordinator, a clinically-oriented individual who is involved in the daily operations of a study under the supervision of the PI. This person will often schedule subjects, perform minor assessments and laboratory work (depending on level of clinical skills), and organize the data for transfer into Case Report Forms (CRF). CRFs are the official records that sponsor companies use to house the data collected by the Investigator. It is critical that the information contained in a CRF be accurate, as it is the final information used by statisticians to analyze the safety and efficacy of an investigational drug. As a PI, your responsibilities are two-fold: to assure that your subjects receive appropriate study-related medical care, and to assure that all study-related activities follow the principles of GCP.
Conducting clinical trials requires a number of resources. Here are some of the most commonly used resources:
The PI and ancillary study staff should be available to the sponsor company to review study issues and answer pertinent study related questions.
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