Quote from Guest on May 4, 2022, 1:40 am

We have run into a problem with sponsors requesting items to be scanned to them after they did an audit of their TMF post COV.  For some it has been as much as 12 to 15 months after COV! We use an offsite storage for our files and even have to request them from offsite to be able to get the items to them. I am going to start adding a fee up front for anything requested post COV. Anyone else see this going on and am I being petty?

 

Quote from brad on May 4, 2022, 1:46 am

Quote from Guest on May 4, 2022, 1:40 am

We have run into a problem with sponsors requesting items to be scanned to them after they did an audit of their TMF post COV.  For some it has been as much as 12 to 15 months after COV! We use an offsite storage for our files and even have to request them from offsite to be able to get the items to them. I am going to start adding a fee up front for anything requested post COV. Anyone else see this going on and am I being petty?

 

This is a great idea. We know so much happens at the site that we aren't paid for so I say get everything that you can.

Quote from Guest on May 4, 2022, 4:11 pm

FYI by comparison a CRO is typically paid $3500-$4500 per 1 day monitoring visit onsite, a little less for remote.

Quote from brad on May 4, 2022, 5:05 pm

Quote from Guest on May 4, 2022, 4:11 pm

FYI by comparison a CRO is typically paid $3500-$4500 per 1 day monitoring visit onsite, a little less for remote.

This is the kind of info I'm here for. Thanks for that.

Quote from Guest on May 5, 2022, 5:08 pm

Guest #14 coming in hot.  let's hear some more from him about what CROs are paid

Quote from brad on May 5, 2022, 5:31 pm

Quote from Guest on May 5, 2022, 5:08 pm

Guest #14 coming in hot.  let's hear some more from him about what CROs are paid

Haha. I'm with you. This is the reason I started this. Transparency will really change the game.

Quote from Guest on May 6, 2022, 3:22 pm

Ask and ye shall receive!

Quote from MLowery on May 8, 2022, 5:24 pm

Quote from Guest on May 3, 2022, 10:08 pm

Quote from Guest on May 3, 2022, 8:58 pm

We ask for remote monitoring and on site monitoring fee, not the same amount, as well as a standard fee for eReg + eSource remote access.

We also ask for audit (remote or onsite) fee and inspection fee, if not for cause.

I also add to all of my budgets an audit prep free and a per-day audit fee.  I don't add not-for-cause language.  Most sponsors/CROs will add the not-for-cause language but I then add "or for-cause with no major findings". 

Why shouldn't we be paid for the massive amount of time spent prepping and participating in an audit if the result is that the sponsor sees that we did a great job? 

Quote from MLowery on May 8, 2022, 5:28 pm

Quote from Guest on May 4, 2022, 1:40 am

We have run into a problem with sponsors requesting items to be scanned to them after they did an audit of their TMF post COV.  For some it has been as much as 12 to 15 months after COV! We use an offsite storage for our files and even have to request them from offsite to be able to get the items to them. I am going to start adding a fee up front for anything requested post COV. Anyone else see this going on and am I being petty?

 

I have been adding this to my budgets for years...a post-close-out visit request fee.  It's almost always removed.  I add it again along with a description of what it is.  It's usually removed again and at that point I tell the sponsor/CRO that we will not honor any post-COV requests until we have something in place that governs site compensation in case we receive requests after we are closed by the sponsor/CRO and tell them that in many cases these requests are due to missing documents after they have audited their TMF or there is an upcoming submission to FDA.

The funny thing is that when I tell sponsors and CROs about this in person (at conferences, other meetings, etc), they think it's a great idea and wonder why it isn't automatically approved.