David Vulcano, Vice President of Research Compliance at HCA Healthcare and Honorary President of SCRS, discusses the challenges clinical research sites face in document storage and record retention amid evolving regulations. Hear considerations for sponsors pushing record storage obligations onto sites, advising them to listen to sites' concerns and avoid binding contracts. David also provides insights for sites as well as solutions for sponsors, CROs and sites to move forward with record retention needs.
David Vulcano, Vice President of Research Compliance at HCA Healthcare and Honorary President of SCRS, discusses the challenges clinical research sites face in document storage and record retention amid evolving regulations. Hear considerations for sponsors pushing record storage obligations onto sites, advising them to listen to sites' concerns and avoid binding contracts. David also provides insights for sites as well as solutions for sponsors, CROs and sites to move forward with record retention needs.
Welcome and thank you for joining the Society for Clinical Research Sites for SCRS Talks. I'm Jimmy Bechtel, the Vice President of Site Engagement for the Society. SCRS Talks allows our partners and those that we work closely with to take a few minutes to address issues of industry concern, share exciting achievements, and learn more about our extensive community. Today, we have David Vulcano, the Vice President of Research Compliance and Integrity with HCA Healthcare and SCRS's current Honorary President here to share and talk with us a little bit more about document storage and record retention challenges that the sites are facing in today's modern clinical trial times.
David Vulcano:Yeah, Jimmy. Thanks a lot. It's great to be back and talking about this topic. It's a very timely topic. We're hearing more and more from sites about this especially with the whirligig of, of countries starting to change their regulations and GCP starting to think about changing their expectations of this topic. So it's definitely discussion worthy and something that should be on all of our agenda in 24.
Jimmy Bechtel:Well, and you know, with the shift that we've seen recently from paper to electronic records, it's really important for sites to understand what that landscape is and what they're signing up for with long term record storage. So could you start us off maybe talking a little bit of how the industry evolved since the era of. So if you're doing a lot of paper records and throwing them all into boxes and shipping them off somewhere to some long term document storage place, then you know, as part of that, what some of the challenges sites face with electronic record storage.
David Vulcano:Yeah, absolutely. A lot of these regulations, like when you look at the FDA regulations on it, were written back in those days and in the late nineties was when they were written and we did it all paper, threw it in a box and stuck it somewhere, forgot about it. You know, that, that seemed to be it, but nowadays it's just not the case. Unfortunately, a lot of these regulations and expectations are, are renewing and not seemingly thinking of electronic records, which is a bigger issue. But, a site's got to think about if they are no longer just throwing stuff in a box, if the records are electronic. The throwing hard drive or thumb drives in a box or whatnot may not be enough anymore. When you had paper and you were able to recreate the study, you can read that. But when you have thumb drives, hard drives, things along those lines, it introduces a lot of new issues with with being able to recreate that study. So, fundamental difference of saying, Oh, look, here's a thumb drive versus being able to recreate the study. So a number of things that we've talked about is regarding the storage media itself. So you have media degradation, these things don't last forever. If you're going to Store them. If you know what you're doing, there are NIST and ISO standards for storing things like hard drives or optical media, like discs, thumb drives and things along those lines. Humidity logs, temperature logs, things along those lines if we're going to store them to those particular standards. The other thing is that they do degrade if you have moving parts like on a hard disk drive, we say, oh, we'll just you know, store on a hard drive. What bother is that? Well, your manufacturer only warrants them for about 3 to 5 years. They say after 3 to 5 years, they're going to start the degrade. So if you have to store something on a hard drive for 25 years, you better make plans to Replace that hard drive eight to nine times and do a validated transfer to that hard drive. People talk about, oh, well, I don't have to worry about the hard drive. I'll just store it on the cloud. Well, you got to make sure your cloud provider is doing that, number one. Number two, now you're into the world of cyber security and what's the cost of cloud storage. Cost of cloud storage is going up, up, up, cyber security, up, up, up, insurance for cyber issues, up, up, up. So vast increase in cost in the, the storage media. Then we have hardware obsolescence. There's the old famous story about the U. S. census was done on some computers back in the 1960s and less than a decade later, they says, Oh, let's read that tape. And there are only two machines left in the world that can read that tape. One was in Japan and the other was in the Smithsonian. So we have this today, you know, people are talking about, oh, 25 years record storage. Well, if we had to recreate a study from 25 years ago, 1998, one of the standards of large storage was called an orb drive. Well, orb went out of business in, I think, 2001. So if we were to recreate that study from an orb tape, we'd have to go on eBay to find an orb drive, doesn't run on modern computers. The plug doesn't plug in. So we'd have to find a Windows 98 computer to be able to plug in this, install the software to recreate that study. People say, well, yeah, well, we've evolved since orb drives. Well, yeah, we went from floppy disks to CD ROMs. They've come and gone. USB has come and gone. Now we're on the, like the third generation of USB. I just bought a new laptop. It doesn't have any regular USBs, it's all on USB C now. So what's that going to be 10, 15, 20 years from now? Then we have software obsolescence. While things like PDF and JPEG still seem to be around and relatively stable, some of these systems are proprietary systems. So it's a vendor that's providing the data. But I have to contract with the vendor to read that data. So what happens if that cost goes up year over year? What happens if that vendor goes out of business? And then, for God's sake, the password management. Jeez, I can't remember my password in 25 days, maybe even 25 hours sometimes. How are we going to remember in 15, 20, 25 years and manage that with cloud media? Or local storage media when employees are coming and going, retiring and whatnot. And then how are we going to inventory this? So a whole different world when we're talking about electronic archiving versus paper.
Jimmy Bechtel:Yeah, I think there's a lot obviously David to tease out of there and what we generally hear from the sites is that fact of that a lot of it's just so unknown. There's so many unknowns that are associated with record storage. We don't know what it's going to be. We don't know what the sponsors and CROs are going to ask us and we don't ultimately receive the financial compensation for that in the end. So thank you for bringing up a lot of those points and I know you were able to help us present some of this data. At the global site solution summit in the site landscape survey where we saw 68 percent of sites said that they don't want to be in the record storage business. They're not here to be storing records. They don't want to, I guess, quote unquote, make money doing this, but they're unfortunately not always willing to walk away from studies as a result of that, right? We see them kind of grit and bare their teeth on and they may accept those terms despite the risk and despite some of those unknowns. So I guess let's start by talking about what should sponsors take into account when deciding whether to push these obligations related to record storage onto sites.
David Vulcano:Well, I think they need to understand and listen to the sites on this. I mean, 68 percent of them said that they have no interest in being in this business as a record archivist for the sponsor. And when we're saying that to be clear, we're not saying that they don't want to meet their regulatory obligations, which are much shorter. We're talking about situations when the site has met their regulatory obligations, and they have no business needs for those records as a site, and they're only holding them to be a record storage vendor for the sponsor or the CRO, because the sponsor or CRO has business needs for them. And for some reason, they don't want to put it with their tried, trued, and trusted storage vendor. We talked to sites. We know our regulatory obligations in our individual countries. The survey on the sites on the landscape survey was, you know, if there were no rules or contracts, how long would you keep the records for? And,, 44 percent said less than two years, 23 percent said, more than two, probably, but less than five, only 9 percent say they would keep them like 15 years or, or, or more in those scenarios. So, so we see, we don't really want to be in this business on a voluntary basis. And, and many sites use the word, I was bullied into this by the sponsor or, you know, gee, I, I didn't know what to do. I wasn't willing to walk away. I got a patient here that this is the last negotiating thing. And I can't sit here and tell a patient. Gee, I know you want to be in this trial. We've got everything done. But, sponsor wants us to keep these records 15 years and we're just not set up to do that. That's an uncomfortable conversation to have with the patient. Patient will say, Hey, Help put me on the study. I'll keep the records, but sites need to understand why the sponsors and CRO thinks we're going to be great at this. We don't really know. And we would love to have that information. I mean, if sponsors want the information, we don't believe the site is the place to do this. We think that there are existing mechanisms to do it. We have a lot of sponsors that say, Oh, my gosh, no, we can't hold the investigator site file. There would have to be separate. We can't have access to that. And then Later in the study, when the study is over, that very same sponsor will go and send us a thumb drive and say, look, here's your data. Go ahead and store it. It's like, well, if you can't have access to it, why are you sending us the data from the EDC or the whatnot that we have filled out or completed?
Jimmy Bechtel:That's right, David. I think that's an important point to emphasize as well is that sites aren't saying we don't need to do what we need to do. We just don't want to be in the business of doing this. We don't want to have to do it beyond what our legal obligations are to store some of these things. And I think that's a really important distinction because it obviously has a tremendous effect to some of the points that you made and goes to underpin some of those challenges that you had brought up. But what about then the sites? What should sites know or ask before agreeing then to be someone who's an organization rather that stores those records for the sponsor?
David Vulcano:I mean, the first thing a site's got to understand is their regulatory obligations and their business desires for these records as a site and make no bones about it. Once their regulatory and their business as a site are over, they're now entering into being in the record archiving business. If you don't want to be in this business, then you need to push back and it's not pushing back to be annoying. It's really in the best interest of those records. You're telling the sponsor, I don't know how to do this. I'm not in this business. It's really, if you want those records after my obligations are over, I need to send them to you. So knowing your regulations and knowing to push back. When you're pushing back with a sponsor or negotiating. That you are going to keep them even with regulatory stuff. Watch out for danger language such as, oh, the site will not destroy the records without permission from the sponsor. You know, you may never get that permission and they've kind of enslaved you into keeping those records in perpetuity. Don't get bullied into. Oh, but we'll pay you. You have to recognize that accepting this is not a prize. It's a job and you have to be prepared to meet this job. As far as money, you have no idea what your costs are going to be in the future on this. So you need to have the intelligence on this. And just simply because they offer to pay doesn't make you magically capable of keeping the records. We always joke that a sponsor offers to pay and we say well, hey, come cut my lawn and they say, well, I'm not in a lawn cutting business. And they say, No, now you have to because i'm going to offer to pay you. So just because they offer to pay Doesn't necessarily make you magically capable and willing to enter into it. I mean, in fact, it's kind of bizarre. We get that counter argument a lot of oh, we'll pay you so now we have to do it. No other place in a protocol Would we tell a sponsor we can't do this or we don't know how to do this. And they say, Oh, well, we'll just pay you money. And then it magically happens. In fact, we have the opposite. We say, Hey, we know how to recruit patients. And he says, Oh, no, no, no, no. We're not going to give you a recruitment budget. We're going to contract with a third party because they're professional patient recruiters. So, why is record retention any different on that? And then always have the option to confirm the regulatory period is over. Some countries it's a set of years, 15 years or two years or something like that. FDA and some other countries have this little floating years of, well, it's, it's two years after the product is approved or withdrawn and you may never know that information. So you should always have in your trial agreements something along the lines of identifying clear communication line to ask is our can you tell us if you have withdrawn the drug or whatnot so that we can destroy the records? So,, is that the address of the correspondence in the CTA? Is it a designated email address that the sponsors have set up? And many sponsors are setting up designated emails for this. Generally give about 30 to 60 days prior to destruction of saying, let us know. But if we don't hear from you in 30 to 60 days, whatever you want to pick, then, we're going to go ahead and destroy the records. If you want to be in this business, then understand your obligations and take them seriously. Don't just sign a contract just to take the money and hope nobody ever comes for the records. You need to learn record archiving, especially in electronic age. And there's organizations out there that offer education and even certification in, in record archiving. So don't just blindly sign it and think that, oh, this is great. I'm going to take a bunch of money and nobody will ever come for the records because it's a job, not, not a prize.
Jimmy Bechtel:Very interesting, David, and, and super, super valuable. I think a lot of Really important tips and things for sites to keep in consideration, and I think it really does again, it starts with you need to determine what you want to do as a site. You need to understand the path you want to go. You need to understand what your regulatory requirement is as an organization in your given state and or country. And then go from there and really determine whether or not you you want to be in that business, or if you don't want to be in that business, and if you've met your obligations, then make sure then that the conversations and the agreements that you put in place with your sponsor and CRO partners reflect that appropriately based on what you've determined from that perspective. So begin to wrap our conversation up here, David, how can the industry then strike a balance, between the sponsor's goal of maintaining records and what they need to do as the owner of that IP and the site's operational capabilities and preferences. I know you alluded to some of the ways we can do this, but maybe, let's talk a little bit more about striking that balance most appropriately and then how the two sides can come together on this.
David Vulcano:Yeah, I think we need to have an honest conversation among the stakeholders, both at a macro and a micro level. So, at large initiatives with SCRS and our global impact partners and other folks, as well as have that discussion locally at the site negotiations level as to their capabilities. It needs to be an honest conversation with the shared goal of these records want to be available for the sponsors business reasons. That is our goal. How can we make this happen? And certainly ask that the sponsors be flexible. Our operating hypothesis, at least my operating hypothesis, not speaking for SCRS, HCA or anybody, is that if I wanted to have records reproduced. Say a decade from now, I, I would like them under my control and I know where they are and how I can get them, not sprayed across a wide variety of research sites of varying capacities and inconsistent practices. And most say they have no interest or capabilities in doing this. And most of them won't even be in business for, you know, 15, 20, 25 years from now, that, that seems more risk averse if I know where they are, I'm controlling the inventory, and I have those assurances for technology obsolescence and software obsolescence and all that kind of stuff. So, I think it starts with that honest conversation, both at a macro level to find some solutions. And at a micro level, if sites want to diversify and sponsors feel that that's the better place, great. But sites that can't do this, we need some alternate solutions. So, greater than two thirds of the sites said that they don't want to be in this business, as you, as you quoted earlier. That means about a little less than a third said that they are interested in being in this business. So, have that dialogue. If it's important for the sponsors to get those records. See how the site's going to do it, test their capabilities on doing that and and sites in that equation Shouldn't just go. Oh my god. Yeah, i'll take it and i'll keep the money and hope nobody ever comes for them. And further with that as as we mentioned, you know majority of the sites Do not want to be in this business. So,, what are some solutions? Can we get together either at the micro level in that individual site negotiation or at the macro level. So we had a session on this at the last global conference of bringing this to many sponsors attentions true to form sponsors at the higher level haven't heard of this issue. They haven't heard of the site's pushback on this issue and they hadn't heard our voice as to reasons why we don't feel that this is appropriate and records are better kept somewhere. So, one solution that came out was, well, why, why are we asking the site to do this? Anyway, why, why don't we get the sites out of the middle of this and just contract directly with the storage vendor? I mean, the site doesn't want it. They don't know how to do it. They're telling us they don't know how to do it. We're the ones the sponsor CROs that are going to be needing those records. So, we contract directly with IRBs. We contract directly with E source, we contract directly with EDC, we contract directly now. We're doing that more and more. Why can't this be the next thing that we contract directly and get the sites out of the middle of it? And if there's some theory that you need to have even though it's stored at a sponsor's location that you need a PI or the site to authorize that release, that's fine. You can set up the storage parameters so that the site's not responsible for the inventory or paying for it, but can control their release. But in all fairness, make sure that there's backup plans, because if they're needing them for 15, 20, 25 years, sites and PIs aren't going to be around that long. So, so again, back to let's have an honest conversation about this with a shared goal of making sure that those records are available for the sponsors for their business needs in the future, and come up with some creative solutions on this. Especially for the sites that are not capable of doing this.
Jimmy Bechtel:That's a great point, David, and I think that's where the power of organizations like SCRS come into play here is hopefully we can continue to facilitate and emphasize the need of those conversations and bring to the attention our sponsors and CROs to ask these questions of the sites. And make it more of a negotiation and a discussion and less of a requirement at that level. So you know, David, thank you again for being here with us. Thank you for sharing some insights into this really important issue as we continue our shift into electronics for storing a lot of our patient records. And again, thanks for being with us today.
David Vulcano:Always a pleasure and always a privilege to be the voice of the sites in situations like this. Thanks again.
Jimmy Bechtel:For those listening, make sure that you register for upcoming summits being held throughout the year where we have conversations around topics like this for several days by visiting our summit page on our website, myscrs. org. While you're on our website, be sure to also check out the other SCRS publications and resources for the community in the publications and membership portion of that same website. We appreciate everyone's participation and listening to today's program and look forward to having you join us for more great content coming out soon. Thanks for listening.