Principal investigator

They are, in addition to screening, pre-screening, randomizing, scheduling, doing study startup, doing ongoing maintenance, doing IRB approvals, doing vendor trainings for new studies, doing archiving, vetting a new system for one particular study.

Like there's so much going on responding to queries, responding to monitor questions, responding to PI questions, making sure PIs signing labs, making sure sub-I signing lab.

There's so much pulling their attention even on a minute by minute basis.

Now you might say, well, the good thing we have PIs and good thing we have sub eyes.

Yes.

Good thing.

And you can work with all of those 80 and the majority of our industry runs on those 80.

The stories, the highlight reels are made from those top 10 and the fear porn stories of the FDA is going to get you and 483s and all that comes from that bottom 10%.

Welcome to the NIH Pragmatic Trials Collaboratory podcast, where we discuss the latest knowledge and best practices in pragmatic clinical trials.

I'm Adrian Hernandez, co-PI for the NIH Collaboratory and one of the moderators for this series.

You can find a full list of episodes at RethinkingClinicalTrials.org slash podcasts.

Thanks for joining.

Hi, I'm Leslie Curtis, co-PI for the NIH Pragmatic Trials Collaboratory, and today I'm joined by Sebastian Tong and Greg Simon for part two of our podcast series, Laying the Foundation for Successful Pragmatic Trials.

In these four episodes, we're covering aspects of pragmatic trial design that are essential to the success of embedded research.

Today, we'll be discussing piloting and assessing feasibility.

I think we doubled the numbers after we actually heard the protocol being explained and broken down into every little nuance imaginable.

And we got the PI's feedback, which we did get some prior, but nothing's the same as just your unfocused, undivided attention.

Everyone's focused for at least a half an hour.

The PI stayed a half an hour.

The sub-I stayed an hour.

And then me and the site director and the other coordinator stayed another hour.

So if you're a small site, you're kind of left out.

Now, luckily for you, we have a free tool called coordinator c-o-o-r d-i-n-a-r-e dot c-o where in addition to getting free study leads and tracking where your leads are going are you in the feasibility process did you have a site selection visit scheduled is it just a warm lead is it a cold lead you can upload documents and all those things so you can keep track we have a feasibility helper on there so we have a tool where you can actually go and it will help you answer your feasibilities in case you need help and so you just go to the ctms which is free and within the ctms you have feasibility You have a lead pipeline, which is what I was using today, study startup, budget, where it will kind of generate based on the study, the budget.