A Principal Investigator (PI) is the physician who leads the conduct of a clinical trial. Being involved in clinical trials enables physicians to learn and become exposed to new medical therapies. The PI is responsible for all clinical research activities at the investigative site. However, certain ancillary staff, such as research coordinators and regulatory specialists, typically support the PI in order to successfully run a clinical trial.
According to the Code of Federal Regulations, a PI must be adequately qualified by education, training, and experience to assume responsibility for the proper conduct of a clinical trial. The FDA mandates the PI to sign form 1572 that outlines the specific responsibilities a doctor must accept as leader of a clinical investigation. These responsibilities are defined as "Good Clinical Practice" (GCP). An investigator's qualifications must also meet any applicable local requirements. At The Reading Hospital and Medical Center, investigators are required to provide a current signed and dated Curriculum Vitae and medical license. Additionally, they must complete the NIH GCP training course available at http://crt.nihtraining.com/login.php.
Responsibilities of the PI include (but are not limited to):
Professionals who are interested in conducting industry sponsored clinical research should contact the Clinical Trials Office Director at ClinicalTrialsOffice@readinghospital.org or 610-988-8318 for further details.