The Pi in a clinical research trial is the doctor that is
conducting the drug study.He is the one
who is ultimately responsible for everything that occurs at his site
(office).There are sometimes assistant
Pi's and they are referred to as Sub-I's or Sub-Investigators.
It is the responsibility of the Pi to conduct the trial
properly.That is, attention to both the
needs of the Sponsor (drug Company that is sponsoring the trial) and the
research subject volunteer (patient) that was good enough to consider
volunteering for an experimental medical research drug study are needed to
simultaneously provide the patient with a beneficial experience and the Sponsor
with data that will help support their goal of getting this new drug FDA
approved with an NDA (New Drug Application) thru the Pi leaded IND
(Investigational New Drug) process.
Qualifications of the Pi
GCP requires the Pi
(Principle Investigator) to be adequately qualified to assume responsibility
for the proper conduct of a clinical trial. GCP measures these qualifications
by: Education; Training; and, Experience. An investigator's qualifications must
also meet any applicable local requirements. The Pi is required to provide
evidence of their qualifications (through an up-to-date curriculum vitae or
other relevant document) upon request by the sponsor, IRB, IEC and regulatory
authorities. GCP also requires sponsors to select only those investigators who
are appropriately qualified to conduct a clinical investigation. GCP requires investigators to have adequate
resources available to conduct a clinical trial, including: Facilities; Time;
Staff; and, abundant Research Subject Volunteers. The Pi's signature on the FDA
Form 1572 obligates the investigator to comply with these commitments. This
also makes the PI responsible for teaching the staff about meeting all
regulatory obligations.