How to Become a Principal Investigator

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):

• Performs all job responsibilities in accordance with standards of Good Clinical Practice.
• Delegates study responsibilities as appropriate to trained study staff.
• Has a working knowledge of GCP/ICH guidelines, Clinic SOPs and QA/QC procedures and Investigator 1572 Form.
• Reviews all protocols prior to acceptance at the site for feasibility.
• Reviews Investigator’s Brochure prior to performing any study procedures.
• Reviews all documentation in order to approve subject for admission to study and randomization.
• Participates in safety discussions with the Medical Monitor.
• Performs all study responsibilities in compliance with the IRB approved protocol.
• Reviews and evaluates all site study data and comments to the clinical significance of any out of range results.
• Provides ongoing assessment of the study subject/patient to identify and manage Adverse Events.

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.