Archiving Clinical Site Documents: The Hidden Gold Mine for Virtual Workspaces?
Archiving study documents is a pain point for research clinics and principal investigators, but there are ways to manage costs and simplify the process.
6 October 2015
For those of you who follow me regularly, you may recall a few weeks ago when I made a blog and video comparing virtual workspaces with electronic data capture (EDC), and the revolution it brought about during the early and mid-2000s. That was the time when the industry moved pretty much all of the studies from paper-based case report forms (CRFs) to electronic CRFs; that paradigm shift had a lot of initial resistance.
Towards the end of that video, I started talking about study archiving. Archiving study documents may be considered one of the biggest pain points for research clinics and principal investigators, and have been since the beginning of clinical research (or at least since the late-1990s when I’ve been involved).
When a sponsor closes out a study at a research site, you have the Close Out Visit. The Close Out Visit is a final monitoring visit of sorts where the CRA comes to the site and ensures that all queries made concerning collected data have been answered and everything else is wrapped up. But this isn’t truly the end for you, as a site is required by contract to keep all documents associated with the study including: all source data, regulatory documents and all CRFs (usually a CD-ROM from the sponsor of eCRF EDC data).
Study Archiving: Spanning Five to Thirty Years
Essentially research sites are retaining hundreds of boxes, potentially thousands of documents. At just one of my medium-sized clinics, we have managed to accumulate 186 boxes from the roughly 40 protocols we’ve participated in over the previous 10 years.
To add more pain to all of this, different sponsors have varying requirements for how long a research site needs to keep these study archives. These can range from five to 30 years, although I have even seen requests for longer. This determined range of time depends on whether the investigational product makes it successfully through the clinical gauntlet, coupled with different sponsors have varying internal processes and regulatory requirements (depending on where they’re located and sell their drugs). For instance, European and Japanese sponsors are usually required to keep their records available for inspection over 30 years while in the U.S. it is usually 5 years for adult studies (longer for pediatric).
The Cost of Archiving
When it’s all said and done, a research site needs to count on study archiving and storage costs for anywhere from five to 30 years — and in an inspection-ready state.
This can be quite a problem for most sites. For starters, we often forget about this little caveat when we are negotiating our budget so this generally gets paid for out of our own pockets. And while it is true that we can get some of this cost reimbursed, what we usually get reimbursed is only a fraction of the cost of storing and maintaining these documents. Furthermore, this does not factor in extra costs such as retrieving documents from a study; should a sponsor or regulatory agency make that request.
Putting the monetary paint points for study archiving aside, the archiving process today is also very inefficient. It’s 2015 yet the way it ‘works’ right now is that some sites still store their records onsite, wherever they have enough space — whether that be in an attic, a garage or a warehouse attached to their clinic. In terms of managing costs, these are the lucky ones, but the merits of this approach are debatable. How secure is this? Is it disaster proof? What if a fire happens? Or a flood? Or someone breaks in? I mean, in 30 years anything can happen! Will the building even still be there 30 years from now? Will the clinic still exist when everyone working there today has retired? Most research sites simply do not have this kind of space or they just have so many different studies that it would be very difficult to archive them properly onsite.
Also these documents can clearly get lost and since they don’t have electronic backups other than the CD-ROM from the sponsor which is, by the way, not backed up on any server anywhere and are not designed to stand the test of time — especially when they’re aren’t being stored with suitable archive environmental conditionals — speaking of which, let me share my stories on this. When I initially started out at my first research clinic, I rented out a public self-storage space for storing our study archives and there was only one person in charge of maintaining these records — me! One hot summer day, I was there looking through boxes of files instead of being in the clinic screening a waiting room full of anxious patients. One of my monitors had requested me to go and find files from seven years ago (a study that a previous employee was working on). And there was one piece of paper I just couldn’t find. I remember thinking how inefficient this was and that I needed to be back in my clinic conducting my study visits where I had patients waiting for me.
Today needless to say, I like many others outsource document storage and retrieval demands to a provider of document storage and retrieval. For those of you who aren’t familiar with this process, it essentially works like this: You are provided with a bunch of boxes and barcodes to affix to those boxes. Your research site still gets to organize each box with a corresponding barcode and keep internal logs of these barcodes, box numbers and what’s in each box. It's key that you never lose those barcodes because when you want something back, the storage provider will need that exact label to locate your boxes and deliver them to your site — which can be an additional cost on top of a monthly storage fee.
It's easy to imagine, that in the 30 years a research site is required to keep these archives, that one or more of these barcodes or logs might get lost. Especially if a site has 10 to 20 different individuals that are tasked with keeping these archive file logs.
When the FDA comes knocking unannounced to a research site, requesting access to your archives from a particular study, presuming you’re organized, it may take your storage provider at least three or five business days to have them delivered to you. For those sites that keep these documents onsite, you will be opening up all of your archives for a possible audit if there are problems finding/making the documents available to the inspectors in timely manner.
How to have Greater Efficiency in Study Archiving
So here we are with many inefficiencies in the study archiving and storage ‘best practices.’ On the other hand, we are using virtual workspaces to store our study documents online. Why don’t we just upload all of this onto Intralinks VIA® and just not control? This was exactly the lightbulb moment that occurred for me this past week as I was actually in the process of archiving a whole bunch of studies for one of my sites .
Intralinks is perfect as it is HIPAA-compliant and meets the FDA’s 21 CFR Part 11 Guidelines. Why don’t we just upload our records there and then ship the originals — or better yet, just the wet ink signature pages — back to the sponsor? Or send the originals to the storage provider which can destroy the documents once the five to 30 years archiving period is over?
Uploading these study archives to the virtual workspace would also make the retrieval process so much simpler. Sponsors and sites will have the peace of mind that the documents are not going to disappear, get lost or damaged.
Even if the PI retires or a study coordinator leaves the organization, another authorized member of the virtual workspace can be there to assist whomever it is that will need to retrieve these documents and get access to the record instantaneously (rather than waiting three to five days). No more going to your attic, basement, garage or a hot, dark and scary warehouse to search for study documents.
If I would have had something like a virtual workspace back then when I had my first clinic, I would have been able to retrieve this file from the comfort of my own desk, my laptop, even from my iPhone or iPad. I could have even gone a step further and simply given my CRA temporary access to that particular protocol file so she could retrieve it herself! Ultimately this is an application that has not been thought out yet by most Sponsors, CROs or research clinics. I think it would just add yet another element to why virtual workspaces are so mutually beneficial for both CROs and sponsors, as well as, participating research clinics.
Let me know your thoughts on this and your current archiving pains are. How much are you paying for document storage? How do you retrieve your study archives? What is your retrieval process? What are your thoughts on the viability of the virtual workspace for this purpose, and whether or not you think it could actually solve the archiving problem?
Join the discussion in my LinkedIn group. And get talking!
Dan Sfera is the CEO and President of The Clinical Trials Guru, LLC and DSCS Sweat Equity & Investments, LLC. Through these two companies Dan assists Sponsors and CRO's with Site Selection, Research Staff Training, Recruitment, Contract and Budget Negotiations and Business Development. Dan is also owner, partner and advisor for dozens of clinical research sites across the United States as well as Internationally. With a focus on marketing, finance and operations, he and his team have helped successfully launch many research organizations in the past 10 years.