How to fill out a clinical trial feasibility survey for PI with little experience

In this video, I answered the question below in regards to filling out feasibility surveys for clinical research sites who may have PI’s with very little to no research experience. Here is the question in it’s entirety:

Dear Dan,
My PI does not have any clinical trial experience, he has been i n practice for 20 years and has a great patient population. Obviously if i fill a site selection form i would have to say he has no experience and have not done any studies in the past 5 years. This would automatically disqualify him in 99% of trials, although most of the sponsors say no they always look for new PI’s.

As we know, majority of the work is done by the CRA’s and if it’s an SMO like us it’s a team effort. Our CRA has over 10 years of clinical trial experience. Can we include her experience and make the PI marketable? The site selection form has one line item for the CRA and most of them look for an experienced PI. The study is done at the PI’s office but can we include the SMO’s experience as PI’s office experience?

Leave a Reply

Your email address will not be published.