How to address pi concerns

1. How to Address PI
Concerns

2. It’s important to keep
a PI interested...
2
first
Initially when selling
them on conducting
research
In the interim before the
site gets its first study
second
During the study, once
the site has gotten them
up and running
third

3. Getting a PI interested in
Research
When presenting the proposition of
conducting clinical research to a new PI,
emphasize the main selling points:
● PI will be required to do limited work
● It is an easy source of revenue
● Excellent pay
3

4. Keeping the PI interested
until your site gets a study
Once your PI has agreed to come onboard, it is important to keep
them engaged.
Initially the PI will be very excited to get started, but may lose
interest as time goes on.
Until your site gets a study, there is no work required from the PI
aside from signing a CDA
4

5. Keeping the PI interested
until your site gets a study
Explain
Explain to your PI that
there will be no work until
your site finds a study,
and that you will be in the
process of getting a
sponsor interested in
working with you
Lower Expectations
Lower expectations of
how quickly it will take to
get started. Explain that
the industry can move
slowly in the beginning
and that it will take time to
get the ball rolling
Set a Timeline
Let them know that it will
usually take around
3 months to get a site
selection visit. Follow up
at the 3 month mark if
there is still no study.
5

6. Keeping the PI interested
until your site gets a study
In the meantime, ask your PI to:
● Provide you with an updated CV
● Include any/all research experience they may have
● Participate as Sub-I on another study to add research
experience to their CV
6

7. Continuously Follow Up
Whether or not a study has been secured, make sure to follow up
with your PI once every other week or so with an update
Let them know what studies you have been applying for, and ask for
their input when completing feasibility questionnaires
This will show your PI that there has been some activity and will
keep them in the loop
7

8. Keeping the PI interested after
your site has gotten studies
Once your site has gotten studies and has started screening
patients, it is still important to communicate with your PI because it
often takes up to 3 months after your site has started screening for
you to get paid.
If this point has not been properly communicated to your PI, it could
cause them to lose interest or be upset.
8

9. Keeping the PI interested after
your site has gotten studies
In some cases, CRAs can cause the PI to feel uneasy by mentioning
that the PI is ultimately responsible for the conduct of the study and
that an FDA audit can happen at any time
In these situations, it can be helpful to address the worst case
scenario with the PI: even in the event that the FDA blacklists the PI
from conducting research, their medical license will likely be
unaffected by this.
9

10. As always…
Communication is key.
The more that you communicate with your PI and keep them in the
loop, the more at ease they should feel about the progression of the
study.
10