Clinical research plays a crucial role in the medical advancement, and a large part of this role is due to the efforts of investigators. For this reason, sponsors and CROs are encouraged to offer fair compensation to the PIs responsible for conducting their studies.
A PI or a Principal Investigator is the lead researcher in a clinical trial who takes direct responsibility for conducting and leading the trial, taking care of the safety and efficacy of the investigational product (IP), and caring about the subjects’ well-being.
Being such an important part of clinical research, a PI has to be well compensated. Finding the best compensation method and amount that will be fair for both the research site and the PI can be pretty challenging, especially for new and inexperienced sites. It’s because of this that we’ve decided to give you an idea of the ways in which you can compensate your PI, as well as the fair percentage or amount as compensation.
2. Introduction
Clinical research plays a crucial role in the medical advancement, and a large
part of this role is due to the efforts of investigators. For this reason, sponsors
and CROs are encouraged to offer fair compensation to the PIs responsible for
conducting their studies.
A PI or a Principal Investigator is the lead researcher in a clinical trial
who takes direct responsibility for conducting and leading the trial,
taking care of the safety and efficacy of the investigational product
(IP), and caring about the subjects’ well-being.
Being such an important part of clinical research, a PI has to be well
compensated. Finding the best compensation method and amount that will be
fair for both the research site and the PI can be pretty challenging, especially
for new and inexperienced sites. It’s because of this that we’ve decided to give
you an idea of the ways in which you can compensate your PI, as well as the
fair percentage or amount as compensation.
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3. Principles of PI Compensation
When deciding on how and how much to compensate your PI, take into
consideration the following principles and characteristics:
Fairness
Ethics & Legality
Reasonable
Stimulation & Incentive
The compensation for your PI has to be
proportionate to his/her contribution to your study.
The ratio between compensation and contribution
has to be balanced.
The way in which you decide to compensate your
PI has to be legal and documented, as well as
compliant with the codes of ethics.
When compensating your PI, you have to take
affordability into account. All study budgets have
their limits, so always take this into consideration
when deciding PI compensation.
Your PI has to receive enough compensation to
motivate him and give him the incentive to perform
his job well.
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PI compensation: PERCENTAGE OR FIXED SALARY?
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From a site owner’s point of view, this questions
depends on multiple conditions.
The most important thing that you have to consider
in order to determine what’s best for your site is
the number of subjects that your PI is
enrolling.
With this consideration in mind, there can be 3
different scenarios:
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PERCENTAGE SALARY
MIXED
2nd Scenario: PI enrolls a lot of
subjects - SALARY
Working with a PI who manages
to enroll a big number of patients
or maybe patients for multiple
studies at your site will be the
first sign that it’s better to put this
PI on a fixed salary. Paying a
percentage for so many patients
enrolled will turn out to be a
huge amount of money!
1st Scenario: PI doesn’t enroll a lot
of subjects - PERCENTAGE
If your study doesn’t require a
large number of patients, or your
PI does not manage to enroll a
large number of patients, then it’s
best that the compensation is
based on a percentage. In this
case, paying a fixed salary to the PI
would not be proportionate with
his contribution to your study!
3rd Scenario: MIXED COMPENSATION
A mixed compensation can mean a lot of different
things. For example, start compensating your PI
with a percentage up to a certain point, and once
they start enrolling more patients to switch them
to a regular and fixed salary. Another possible
option would be to pay your PI a percentage based
on procedures, plus a compensation based on the
success of the study. Remember that it is not
correct to pay PIs only for referring patients.
PI compensation: PERCENTAGE OR FIXED SALARY?
6. How to pay PIs a percentage compensation?
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If you’ve decided to pay your PI based on percentage, you’re probably wondering how exactly this is done.
First of all, you should know that the percentage is calculated from your gross revenue, not from your
profits. The expenses that the site is paying are not something that concerns the PIs.
1. Calculate a % of your gross revenue,
not your profits.
7. How to pay PIs a percentage compensation?
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Next, you should learn what’s the best way to calculate this percentage. In order to avoid any confusion and conflicts, the
best way to calculate the percentage that is supposed to go as a compensation to your PI is to pay him/her each time the
site receives a check from the sponsor or CRO.
So, once the site receives the check from the sponsor, you should make a copy of it, calculate the established percentage
from that amount, and then write a check with the calculated percentage amount for the PI. Next, give the PI his own
check with his calculated compensation together with the copy of the check from the sponsor. In this way, the PI will
receive compensation each time that the site receives a payment from the sponsor. Normally, the check from your
sponsor will contain detailed items which will explain which visits they are paying for. In this way, the PI can also see what
he’s compensated for.
2. Pay the PI each time the site gets
paid by the sponsor/CRO.
8. How to pay PIs a percentage compensation?
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And finally, you should determine how big of a percentage to give to your PI as a compensation. Although this mostly
depends on the study itself, the complexity, the study budget, the PI’s contribution, etc., a commonly accepted number is
10%. Depending on the role of the PI in your study, how much he’s involved, whether you’re using his physical space and
facilities or you have your own, whether he’s your business partner or just an employee...this number can go as high as
35%.
However, in normal conditions (when you’re using your own space, and the PI is only your employee and doesn’t have
shares), 10% is a reasonable number. In most cases, the PI will try to negotiate, so starting with 10% gives you enough
space to settle on 12% or 13% and find some common ground.
3. Anywhere from 10% to 35%, depending
on many factors.
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How to pay PIs a percentage compensation?
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So, first, you calculate a
percentage of your study gross
revenue, not of your profits. This is
because the PI has nothing to do
with the rest of the site’s expenses.
In order to avoid confusion, pay
the PI each time that the site
receives a check from the
sponsor.
Finally, decide how much you
want to pay the PI, based on their
involvement in the study (their
responsibilities, whether or not
you’re using their space, etc).
10. Medical professionals
available 24/7
More expensive than
others
Additional staff
employed for when the
PI isn’t there
Bigger budgets
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PI compensation for Phase I studies
Phase I Study
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CONCLUSION
To sum up, in order to determine the best compensation method and amount for your PI, many things have to be taken into
consideration such as the PI’s contribution, expertise, study budget, study protocol and complexity, PI tasks at the site, fair
market value for other similar sites and studies, good or bad PI performance, etc. All of these factors determine the
compensation that’s appropriate for your PI. Whether you choose to pay your PI a fixed salary, or a percentage based on
subject visits, performed services, or time spent, it’s important that this compensation remains fair for both the site and the
PI. However, since we know that there are many factors to be considered, you shouldn’t be surprised if you don’t get it right
at the beginning of the study. Many conditions can shift and change as the study begins, so it’s important that you and your
PI make the effort to understand each other’s points and re-open the compensation topic when the time comes. By openly
discussing on this subject, both sides will be satisfied!
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