How Physicians Become Principal Investigators
Greg Van Horn
Growth
6
min read
Many physicians who have never run a trial are already well qualified to lead one. They treat the conditions being studied, perform the procedures protocols require, and have patients who trust them. Here is what it takes to become a principal investigator.
What a principal investigator does
The principal investigator, or PI, is the physician responsible for conducting a clinical trial at a site. The PI makes sure the study follows the protocol, protects the rights and safety of participants, and produces accurate data. The PI can delegate tasks to qualified staff, but remains responsible for the study.
Who can be a PI
Sponsors select investigators who are qualified by training and experience to conduct the study. For most industry trials, that means a licensed physician with specialty expertise in the condition being studied. Prior research experience helps but is not always required, especially when the PI is supported by an experienced research team.
Key requirements and documents
Form FDA 1572: for drug and biologic studies under an IND, the investigator signs this statement committing to conduct the study according to the protocol and federal regulations.
Current CV and medical license: kept on file in the regulatory binder.
Good Clinical Practice training: most sponsors require current GCP training, which is widely available online.
Financial disclosure: investigators disclose certain financial interests in the sponsor or product, as required by FDA rules.
Protocol training: study-specific training before the first patient is enrolled.
Core responsibilities
Ensure informed consent is obtained properly before any study procedure.
Confirm each patient's eligibility.
Provide medical oversight during study visits.
Assess adverse events and report them as required.
Supervise delegated staff and maintain a delegation log.
Keep accurate records and make them available to monitors and regulators.
How much time it takes
This is the question physicians ask most. The honest answer is that oversight must be real, and it typically comes to a few hours a week per study: seeing study patients, reviewing eligibility and lab results, assessing safety events, and signing documents. The administrative work around those tasks is what an experienced coordinator team takes off your plate.
Sub-investigators
Larger practices often name additional physicians or advanced practice providers as sub-investigators. They share clinical duties under the PI's supervision, which makes it easier to cover schedules and enroll more patients.
Your first study
Identify the conditions you treat most and check for open trials in those areas.
Complete GCP training and update your CV.
Partner with a team that can handle feasibility, contracts, regulatory work, and coordinators.
Start with one well-matched study rather than several at once.
Why it matters
Serving as a PI lets physicians offer patients access to new treatments without referring them away, contribute to the evidence that shapes their field, and add a new, professionally rewarding part of their practice.
Whizz Health supports physicians as investigators with trained coordinators and full regulatory, contract, and billing support. Talk to us about your first study.
Many physicians who have never run a trial are already well qualified to lead one. They treat the conditions being studied, perform the procedures protocols require, and have patients who trust them. Here is what it takes to become a principal investigator.
What a principal investigator does
The principal investigator, or PI, is the physician responsible for conducting a clinical trial at a site. The PI makes sure the study follows the protocol, protects the rights and safety of participants, and produces accurate data. The PI can delegate tasks to qualified staff, but remains responsible for the study.
Who can be a PI
Sponsors select investigators who are qualified by training and experience to conduct the study. For most industry trials, that means a licensed physician with specialty expertise in the condition being studied. Prior research experience helps but is not always required, especially when the PI is supported by an experienced research team.
Key requirements and documents
Form FDA 1572: for drug and biologic studies under an IND, the investigator signs this statement committing to conduct the study according to the protocol and federal regulations.
Current CV and medical license: kept on file in the regulatory binder.
Good Clinical Practice training: most sponsors require current GCP training, which is widely available online.
Financial disclosure: investigators disclose certain financial interests in the sponsor or product, as required by FDA rules.
Protocol training: study-specific training before the first patient is enrolled.
Core responsibilities
Ensure informed consent is obtained properly before any study procedure.
Confirm each patient's eligibility.
Provide medical oversight during study visits.
Assess adverse events and report them as required.
Supervise delegated staff and maintain a delegation log.
Keep accurate records and make them available to monitors and regulators.
How much time it takes
This is the question physicians ask most. The honest answer is that oversight must be real, and it typically comes to a few hours a week per study: seeing study patients, reviewing eligibility and lab results, assessing safety events, and signing documents. The administrative work around those tasks is what an experienced coordinator team takes off your plate.
Sub-investigators
Larger practices often name additional physicians or advanced practice providers as sub-investigators. They share clinical duties under the PI's supervision, which makes it easier to cover schedules and enroll more patients.
Your first study
Identify the conditions you treat most and check for open trials in those areas.
Complete GCP training and update your CV.
Partner with a team that can handle feasibility, contracts, regulatory work, and coordinators.
Start with one well-matched study rather than several at once.
Why it matters
Serving as a PI lets physicians offer patients access to new treatments without referring them away, contribute to the evidence that shapes their field, and add a new, professionally rewarding part of their practice.
Whizz Health supports physicians as investigators with trained coordinators and full regulatory, contract, and billing support. Talk to us about your first study.
