Finding room for closed studies
Finding room for closed studies
Charging sponsors can help offset costs
Want a concrete reminder of all the work your institution does? Go take a long look at your documents room. Source documents, case report forms (CRFs) — they’re the paper history of the research conducted at a site. And all that history is starting to pile up.
Some sites are beginning to feel the squeeze of years of documents crowding their filing cabinets and storage rooms. Theoretically, most of these documents have a shelf life, a time by which they’re no longer needed and can be destroyed.
In the real world, however, that may be a long time coming.
Rosemarie Jacob, BS, MT, CCRC, a coordinator at the Clinical Research Center of Connecticut/New York in Danbury, CT, began looking into the center’s storage issues at the request of her doctors, who were concerned about the growing number of closed studies they were continuing to store.
The research center, which is associated with a private practice and focuses mostly on treatments for arthritis and osteoporosis, has been conducting studies for the past nine years. Jacob estimates the center currently stores about 70 studies and is usually enrolling patients in two to four new studies at any given time.
When she began looking at the contract language for guidance on when documents for older, closed studies could be destroyed, she ran into the same problem over and over.
"I’ve not been able to figure out any one that I can look at and determine yes, we’ve met our obligation as stated in the contracts," Jacob says. "According to the wording, basically, we’re never going to meet that requirement until the sponsor says we have. And whenever I call a sponsor, they say, Oh no, no, no, you have to hold on to that.’"
Newer contracts are calling for even longer storage times, as more studies go global. With the cost of storage beginning to become a problem, Jacob’s center is considering changing its contracts to negotiate storage fees to be paid by sponsors.
It’s a step that other research institutions already have taken.
"The way we present it to the sponsor is it’s a contractual agreement," says Lynda Lane, MS, RN, senior associate in medicine and administrative director of Vanderbilt University’s General Clinical Research Center in Nashville, TN. "We’re storing their documents; it’s just reasonable that their business pay for that cost."
Special handling needed
Part of the growing expense of storing documents is that they now require greater care, particularly to protect patient privacy. Just making sure you have enough filing cabinets and some spare space under the stairs to keep them in won’t suffice.
Facilities now keep their records under double locks — locked cabinets in a locked storage area. Jacob’s institution has purchased special plastic cabinets to resist water damage.
Documents related to human subjects research must be maintained for at least three years following the completion of the research, according to Patricia El-Hinnawy, spokeswoman for OHRP.
Curtis Meinert, PhD, director of the Johns Hopkins Center for Clinical Trials at Johns Hopkins University in Baltimore, says that in conducting multicenter trials, his center recommends that individual clinics keep files longer than that.
"Questions that arise with regard to a trial can come up long after the trial is done, long after the study is published," he notes. "So in general, it seems to me it’s not wise to get rid of records, because you never quite know when something will come up.
"I’ll tell you my own rule, and that is I’m going to store them a lot longer than I’m legally obliged to store them because I don’t want to be caught with my pants down, so to speak."
Meinert says his institution has had various discussions in the last five years regarding a study that began in 1988, and contains many records. "We’ve discussed, Well, shouldn’t we get rid of some of these?’ and every time, we’ve said, Let’s revisit this down the road.’"
In fact, he says that when Hurricane Isabel flooded a storage facility with 20 inches of water in 2003, Johns Hopkins actually paid to have the files freeze-dried and preserved.
"We still thought enough about those records that rather than deep-sixing them, we paid a fair amount of money so that the records could be retained," he said. "Some studies associated with that were at least a decade old."
Other factors can extend the life of old files. Jacob says one of the first studies the Clinical Research Center of Connecticut/New York was involved in was a Lyme vaccine trial back in 1995. Now, she says, the vaccine is embroiled in a lawsuit, and the sponsor has told her not to destroy any files because of the litigation.
And as more studies are conducted across international borders, sponsors routinely ask that documents be retained for 10-15 years, Jacob says. Even in those cases, "because of the wording, you have to rely on the sponsor to say, Yes, it’s OK to destroy things,’ and as I’ve said, nobody’s told me that so far."
Michael Spiegel, MD, a rheumatologist with Jacob’s center, says the center could scan the records to store them digitally, but the cost would be prohibitive.
Spiegel says it’s only natural for sponsors to demand that sites keep studies as long as possible.
"From their point of view, why would they want to destroy a document if it can be stored for free? What’s the downside of them holding on to it if they don’t have any costs?"
He says the center "absolutely" plans to negotiate storage costs in future contracts.
One-time fees preferred
At Vanderbilt, Lane has been charging research sponsors for document storage for about five years, after she began to have difficulty finding storage for documents. The university has a medical archives facility in the basement of the medical library, but charges her department for the storage.
"They charge us for the use of it on an annual basis," she says. "And since we are required to store documents from seven to 15 years, then we have to pay that fee every year. We just felt it was very reasonable and appropriate to pass that along to the sponsors, since they’re the ones asking us to store their documents."
Lane calculated the average cost of storing documents for a single study, and then began charging a $100 yearly storage fee in new contracts. The entire storage cost is charged as a one-time fee at the beginning of the contract. Lane recommends that approach, rather than adding it to the per-patient costs or attempting to go back to the sponsor every year for a new storage charge.
"For some reason, it just seems like there’s some different bucket that those [one-time charges] come from that don’t give the sponsors as much heartburn as the per-patient fees," she says. "There seems to be some magic number that the sponsor comes up with for the per-patient enrollment and they just can’t go beyond that. But they are able to pay for these one-time fees."
At the end of the contracted time, Lane says she asks permission before destroying documents. If the sponsor doesn’t respond, they destroy the records. If the sponsor asks Vanderbilt to keep the records longer, she asks for an additional fee.
Storage fees gaining ground
Although she says charging sponsors for storage was considered unusual when she started doing it, Lane says she hasn’t encountered any complaints. She says no one has ever refused to do research with the university because of the charges.
Washington University School of Medicine in St. Louis recently began charging $250 per study for long-term storage of documents, says Phyllis Klein, RN, CCRC, BSN, operations administrator for the school’s Center for Clinical Studies.
"The materials that are currently stored did not pay this fee," she says. "However, the newer studies, within the last one to two years, have been accumulating fees. We hope that the total of all of these fees will offset the expense. It’s better than nothing."
Charging for storage is not a panacea, however. Meinert notes that when the sponsor is the National Institutes of Health (NIH), there’s no mechanism for building in document storage costs.
"There’s no way I know of with regards to NIH funding, and certainly for grant funding, to, in a sense, sequester money," he says. "You can’t do it."
Going electronic
Some of this problem may resolve itself as more studies are electronically based, says Alan Goldhammer, PhD, associate vice president for Pharmaceutical Research and Manufacturers of America.
"From the perspective of the pharmaceutical industry, they’re very much interested in moving towards electronic data and data storage," he says. "Our long-term goal is to move toward paperless clinical trials and paperless submissions to the regulatory agencies."
He says that in some cases, pharmaceutical companies have provided computers for individual investigators to assist in record keeping.
Jacob agrees that electronic data are a lot easier to keep than paper.
"That’s the reason electronic CRFs are so nice; because when it’s done, you get a CD-ROM and everything’s right in there," she says. "I can just put that in my regulatory binder and I’ve got the whole study right there."
While the trend has definitely been more toward electronic data collection, there still are many new studies that are entirely paper-based, she says.
"Somewhere, somehow, somebody has got to get a hold of how long do these records really need to be kept at the investigator level," Jacob says. "If every study has 20 or 30 or 40 investigators all holding on to all these things for 10 to 15 years, I can’t see how this isn’t going to become a really big problem."
Want a concrete reminder of all the work your institution does? Go take a long look at your documents room. Source documents, case report forms (CRFs) theyre the paper history of the research conducted at a site. And all that history is starting to pile up.Subscribe Now for Access
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