Improve project management by following best practices
Improve project management by following best practices
Key: smart budgeting that captures all
Clinical trial sites can develop solid relationships with sponsors and improve their accuracy with study budgets if they put in the up-front work and time, an expert says.
When a pharmaceutical company contacts you, it's important to obtain as much background about the study as possible and then do the research necessary to make certain you have the necessary patient population, says Joanne M. Chilton, BS, CCRP, clinical research associate with SUNY Upstate Medical University, bone marrow transplant program, in Syracuse, NY.
"If it's a study we're not going to accrue patients for, then we say, 'We don't have a patient population, so there's no sense in our participating in this and wasting everyone's time,'" Chilton says.
If the study will work and the clinical trial agreement is signed, then the sponsor will send a feasibility questionnaire to the site, and this will be completed by Chilton and investigators, she says.
"No agreement is fully signed off until the budget and everything is agreed upon," Chilton notes. "If the budget is a lot of work then there's no sense in doing the study."
With about 18 years of experience, Chilton has a pretty good idea about what items should be captured in a budget and how to make sure nothing is forgotten.
"We look at the clinical research forms (CRFs) that will need to be filled out to see how time-consuming they'll be and what the reimbursement is," Chilton says. "If they're detailed and time-consuming, then we make sure appropriate budget is there for each visit."
Chilton's other budgeting tips include these:
- Add in the cost of storing records in a secure area for the required time;
- Check with other departments to determine which procedures are standard of care and which are not, and then make certain an accurate price is in the budget for the procedures that will be billed to the study;
- Put in a facility fee for study participant visits;
- Use current, standard prices when possible, and have these mapped out in advance by having each department keep a fee list;
- Include pharmacy storage and drug preparation fees;
- Add in an upfront fee for the physician investigator's and clinical research associate's time;
"I try to be as complete as possible in the budget," Chilton says. "Then if the sponsor does balk at some items, we have to go back and renegotiate."
Most sponsors don't have a problem dealing with a thorough and accurate budget, she notes.
Once a site's budget is complete, it should be reviewed by the institution's legal department, and then it's sent to the sponsor, Chilton says.
Some sites will save time by working on the budget at the same time other steps are being taken, such as submitting a protocol for IRB approval, she says.
While the IRB process can take a couple of months, Chilton typically works with a contact person in the IRB office to make certain all of the documents are in place and all questions are answered.
Next, after the clinical trial agreement is signed, the sponsor might want to perform a site initiation visit to see the answers to these questions:
- Where will samples be stored?
- Is this a good facility to work with?
- Is this a secure facility?
"Then once you come back with an IRB approval, and you do a study start-up visit, the next step is to meet with staff and train them on the pertinent details of the protocol," Chilton says.
It's also important to develop a good relationship with the site monitor, and this is why it's important to have a consistent monitor, Chilton says.
"It's really tough when monitors keep changing," she adds. "So if you can continue to talk with the same people, it makes the work flow much easier."
Chilton often will comment to the monitor at the first visit, "We hope we'll see you again."
Sometimes the monitors don't know whether they'll be the person returning to the site, but often they'll try to be consistent, she adds.
Another tip for dealing with monitors is to maintain contact with them and call them back in a reasonable amount of time, Chilton suggests.
"If I have any questions, I'll go to the monitor first before going to the company because they're the person you're supposed to go to," she adds.
"Monitors would much rather have the phone calls than to have something go drastically wrong," Chilton says. "So you need to keep that line of communication open."
When something unplanned happens in a study, it's important to document it and let the site monitor and sponsor know what has happened, Chilton says.
"If you have a deviation, contact the company right away and say, 'We're sorry this happened,'" she says.
For example, the weather might be bad and a participant could not make it to the site for a scheduled visit, Chilton says.
"It's not a big deal, but you should document why this little deviation happened," she adds.
It's essential to keep up on the documentation to avoid the appearance of problems or violations, she notes.
"The monitor will come in and go through charts, making sure that what's on case report forms matches what's documented, and if there are any deviations, the monitor will look at the notes about these," Chilton explains.
If a site has missed an item, then the monitor will ask about it and the sponsor will send the site a data clarification form.
"So you will go back through the chart and see how to clarify what they're asking for and see if there's documentation for clarifying it," Chilton says. "We have a doctor/investigator review all data clarification forms and sign off on them before they're sent back to the company."
Once a study closes to new patients and there are no more follow-ups to be done, then the monitor will return, collect all data, and do a study close-out visit to make certain the site's regulatory binder and the sponsor's regulatory binder match with updates on all IRB correspondence and serious adverse event (SAE) reports, she explains.
"If the study is permanently closed and there will be no more follow-up, then that's the last visit with the monitor," Chilton says. "You've looked at all the patient case report forms and all data questions are answered."
Then the sponsor will tell the site how long to store the information, and that is the end of it.
Except, this also is a good time to look for more studies, Chilton suggests.
"At this point you might say, 'If you have another study you think we'd be interested in, we'd be very happy to take a look at it and see if we have the patient population for it,'" she says. "Or you might say, 'Keep us in mind if something comes up with regard to this disease area."
The best way to develop a good, long-term relationship with a sponsor is to produce good studies with minimal violations and deviations, Chilton says.
But it's also important to stay in contact with the company. When a site is approached about a study that won't work with its patient population, it's important for clinical trial administrators to let the sponsor know the site is still interested in working with the sponsor, even if the site is unable to do a certain study at that moment, she says.
Clinical trial sites can develop solid relationships with sponsors and improve their accuracy with study budgets if they put in the up-front work and time, an expert says.Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.