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Quote from brad on May 8, 2022, 7:09 pmQuote from MLowery on May 8, 2022, 5:28 pmQuote from Guest on May 4, 2022, 1:40 amWe 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.
Honestly, unless there is some compensation involved, I'll pretty much ignore requests that are more than a year after COV. I like your strategy of addressing it directly as I've never even considered that.
Way too much site work goes uncompensated as it is.
Quote from MLowery on May 8, 2022, 5:28 pmQuote from Guest on May 4, 2022, 1:40 amWe 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.
Honestly, unless there is some compensation involved, I'll pretty much ignore requests that are more than a year after COV. I like your strategy of addressing it directly as I've never even considered that.
Way too much site work goes uncompensated as it is.
Quote from CJO on May 12, 2022, 12:52 amQuote from Guest on May 4, 2022, 1:40 amWe 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?
ALL our efforts need to be paid for. We are not there yet. You are not petty - you are right. Copying costs can be addressed in the invoicables.
Quote from Guest on May 4, 2022, 1:40 amWe 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?
ALL our efforts need to be paid for. We are not there yet. You are not petty - you are right. Copying costs can be addressed in the invoicables.
Quote from Guest on June 7, 2022, 11:48 pmI pretty consistently get monitor visits covered although it's definitely one of the hardest fees (and usually one of the last agreed to) to negotiate. I work for a public institution, so we can generally win the argument that tax payer dollars cannot be spent on site staff effort for an industry sponsored clinical trial regardless of whether it's "the cost of doing business". But if a Sponsor is really refusing to pay for a monitoring visit, my backup is to assume monitoring visits of 1-2 days every 4-6 weeks and add that cost into the cost per patient or regulatory maintenance fee and add a contract clause stating that monitoring visits in excess of 12 occurrences per calendar year will be invoiced at a rate of X per day. And I always make sure I define a monitoring occurrence and a per day monitoring visit as a max of 8 hours. Generally, I find if you give Sponsor's a few reasonable options for how to cover the effort that you expect and provide reasonable justification, they will come around. It does always make me nervous when I start gambling with negotiation tactics for a few line items but I think it is important to set the expectation that sites will be paid reasonable for our work especially since we are so often the one's taking the financial risk with unexpected effort or costs.
I love this forum BTW. These are the conversations sites desperately need to be having with each other.
I pretty consistently get monitor visits covered although it's definitely one of the hardest fees (and usually one of the last agreed to) to negotiate. I work for a public institution, so we can generally win the argument that tax payer dollars cannot be spent on site staff effort for an industry sponsored clinical trial regardless of whether it's "the cost of doing business". But if a Sponsor is really refusing to pay for a monitoring visit, my backup is to assume monitoring visits of 1-2 days every 4-6 weeks and add that cost into the cost per patient or regulatory maintenance fee and add a contract clause stating that monitoring visits in excess of 12 occurrences per calendar year will be invoiced at a rate of X per day. And I always make sure I define a monitoring occurrence and a per day monitoring visit as a max of 8 hours. Generally, I find if you give Sponsor's a few reasonable options for how to cover the effort that you expect and provide reasonable justification, they will come around. It does always make me nervous when I start gambling with negotiation tactics for a few line items but I think it is important to set the expectation that sites will be paid reasonable for our work especially since we are so often the one's taking the financial risk with unexpected effort or costs.
I love this forum BTW. These are the conversations sites desperately need to be having with each other.
Quote from Guest on November 19, 2022, 4:01 amThis revenue item has been a lifeline for our site. We had to lease an additional little office suite in our building to accommodate an acute increase in monitoring visits due to high enrollment. The old space couldn't accommodate more than two at once because of all of their paraphernalia and roller backpacks. Since we had to lease an additional suite I was able to exponentially increase our fee and was able to justify the increase in cost because of the newly leased space. It took a lot of back and forth and had to be escalated into oblivion at the CRO lol, but I was able to get approval for $1,200 per monitor per visit. I remember Brad saying to not be afraid to have the CRO escalate things and he was right!! Thank you so much!!! At this rate, I think we will be able to have monitoring visits pay for 1/2 of our rent for the entire office in a few months! Thanks again Brad!
This revenue item has been a lifeline for our site. We had to lease an additional little office suite in our building to accommodate an acute increase in monitoring visits due to high enrollment. The old space couldn't accommodate more than two at once because of all of their paraphernalia and roller backpacks. Since we had to lease an additional suite I was able to exponentially increase our fee and was able to justify the increase in cost because of the newly leased space. It took a lot of back and forth and had to be escalated into oblivion at the CRO lol, but I was able to get approval for $1,200 per monitor per visit. I remember Brad saying to not be afraid to have the CRO escalate things and he was right!! Thank you so much!!! At this rate, I think we will be able to have monitoring visits pay for 1/2 of our rent for the entire office in a few months! Thanks again Brad!
Quote from Guest on January 30, 2023, 11:15 pmWe were told by a large, well known sponsor that they will not pay for onsite monitoring visits. However, it is required for the study. I received an e-mail when I asked about this and the sponsor stated "onsite monitor visits are a part of running a clinical trial". How unfortunate for the site who is collecting data for the sponsor so they can market their drug and make billions of dollars.
We were told by a large, well known sponsor that they will not pay for onsite monitoring visits. However, it is required for the study. I received an e-mail when I asked about this and the sponsor stated "onsite monitor visits are a part of running a clinical trial". How unfortunate for the site who is collecting data for the sponsor so they can market their drug and make billions of dollars.
Quote from brad on January 30, 2023, 11:22 pmQuote from Guest on January 30, 2023, 11:15 pmWe were told by a large, well known sponsor that they will not pay for onsite monitoring visits. However, it is required for the study. I received an e-mail when I asked about this and the sponsor stated "onsite monitor visits are a part of running a clinical trial". How unfortunate for the site who is collecting data for the sponsor so they can market their drug and make billions of dollars.
I absolutely hate this justification. No shit. It's all part of running a clinical trial. That doesn't mean that you don't have to pay for the time and effort that goes in to it.
Keep pressing. You'd be surprised what they'll do when you start asking to escalate these things.
Quote from Guest on January 30, 2023, 11:15 pmWe were told by a large, well known sponsor that they will not pay for onsite monitoring visits. However, it is required for the study. I received an e-mail when I asked about this and the sponsor stated "onsite monitor visits are a part of running a clinical trial". How unfortunate for the site who is collecting data for the sponsor so they can market their drug and make billions of dollars.
I absolutely hate this justification. No shit. It's all part of running a clinical trial. That doesn't mean that you don't have to pay for the time and effort that goes in to it.
Keep pressing. You'd be surprised what they'll do when you start asking to escalate these things.
