Compliance Corner: More efficient systems improve site compliance
More efficient systems improve site compliance
Make sure change of scope is understood
Research sites need to document their contract negotiating positions in policies and then give staff the authority to act on their own within those guidelines, states Kris Rhodes, MS, CRA, director of grants administration for Wake Forest University Health Sciences of Winston-Salem, NC.
"Ensure you have clear internal documentation on what you preferred position is and what secondary and tertiary positions are and clearly state what the deal breakers are," advises Rhodes. Rhodes was scheduled to speak about the legal fundamentals of sponsored research at the Society of Research Administrators (SRA), North Carolina Chapter, conference held March 5-7, 2007, in Cary, NC.
"Make sure your staff is aware and trained on those positions," Rhodes adds. "When employees move beyond those guidelines, that's when they need to seek input from management."
Sponsored research units should stay in close coordination with the legal department, Rhodes says.
"Legal can be an asset and can push sponsors on intractable issues," Rhodes says.
"For example, if they feel very strong about indemnification language in relation to a particular study, or if the funds are flowing from one organization to the other, I think legal can help push the need to get all the parties together," she explains. "For most of the work I've done, I haven't had to have a lot of legal input, but occasionally it helps."
Rhodes also offers these tips:
• Understand different challenges of individual studies.
"If it's a phase 1 or phase 2 study, the intellectual property is different than if it's a phase 3 study," Rhodes says.
Also, the challenges with billing to Medicare versus the research sponsor are critical to many institutions, she says.
"Unfortunately, it's somewhat subjective still," Rhodes says. "Is it medically necessary? Is it part of the study? It's the billing issues that place institutions at significant risk when those costs are billed to Medicare."
• Improve staff training.
Institutions should provide good training to study coordinators as a best practice in compliance, Rhodes says.
"We spend a lot of time focusing on compliance at study start-up, but the real challenge for compliance is balancing it with study administration and all of the other obligations study coordinators have," she adds.
"Organizations that have good study coordinator training are going to be in the best position for compliance," Rhodes says.
• Use best available billing system.
"I also think organizations that have solid systems in place that can help with billing decisions are going to be in a better place than those that have weaker systems," Rhodes says.
"Unfortunately, I haven't seen much in the way of commercially available billing systems that take a lot of subjectiveness out of the decision-making process," she adds. "It's something we need, but I haven't seen a really solid system that helps with this."
While there are systems that help to ensure clinical trial billing is taken care of and that costs are allocated to the correct study, most of these systems are focused on billing, she notes.
So it's up to research sites to make certain the budget is well-developed and that staff understand how to distribute budgets appropriately, Rhodes says.
At Wake Forest University, there is a study Excel spreadsheet for budgets that outlines items, she notes.
"But the challenge still remains," Rhodes says. "Would this be provided under standard of care or would it benefit the study? What if it falls under standard of care but still benefits the study and should be a study cost?"
• Rely on systems to run reports.
"I'm a big systems person," Rhodes says. "I like to rely on systems to run reports, do tests, and check proposal commitments against actual contributions."
It's wise to enter as much data into the system from the front end as possible, Rhodes says.
"There is some risk to this strategy," she notes. "The more data you maintain, and if you are maintaining and not checking it, your risk is heightened."
• Check effort reporting.
"In terms of grant administration, we focus on effort deviation," Rhodes says. "We also have to work with our progress report certification, and we're submitting progress reports to the National Institutes of Health (NIH)."
For example, these questions must be answered:
- Has there been a change in effort for key personnel?
- Has the site extended funds as originally projected or is there a carryover greater than 25%?
- Is the site reporting on key personnel for the past reporting period?
- Does the reporting match what was said in the prior reporting period?
- Are there any deviations to address?
• Look for changes in scope.
Sites receiving grants should link grant proposals to the protocol, looking at end points, variation in charges, and changes in scope, Rhodes says.
All sponsors want the opportunity to approve any change in scope prior to it being implemented, Rhodes notes.
Changes in scope can be sticky issues.
For example, if a site would like to use a significant new piece of equipment that was not in the original projection, then these questions should be answered and documented:
- How will equipment acquisition not adversely impact data continuity?
- How will equipment not result in a change in the original scope of work or specific aims?
- How, based on the original scope of work, is the equipment necessary and reasonable for continuing the project?
"If the new equipment is a replacement piece, I assume it's not a change in technique, but it can impact continuity," Rhodes says.
If the equipment is a completely new technology that wasn't anticipated, but now is necessary, then Rhodes will ask even more questions, including this one: "Is this moving us outside what we originally proposed to capture and report on, and if it is, is that a change in scope?"
Other changes in scope may include rebudgets for subcontractors and investigator departures and additions.
"If we have an investigator who is moving to another institution, we have to get prior approval for that investigator's absence," Rhodes says. "We have to carry out the same work, but if we find someone who can take our data to another step, then that can be a change in scope."
Sometimes the best action is to change a study, and it's necessary to receive approval for the change from the program officer, she notes.
"Getting approval for a change in a study is directly related to an individual's relationship with the program officer," Rhodes says. "It's important to have a good working relationship."
The request is best handled by first calling the program officer and then following it up by having the program officer review the request prior to official submission to ensure clarity and consistency of the written request with the program officer's expectations based on the informal phone conversation, Rhodes says.
"There needs to be a one-on-one discussion, and it doesn't need to be in person," Rhodes says. "But the phone conversation does need to discuss how the study is changing, what direction the investigator would like to take, and whether this is appropriate."
If the conversation doesn't take place and the support is not there for the change at the program level, then the investigator is going to receive a response asking for more details, and this back-and-forth can go on several times, Rhodes explains.
"If the questions and answers are taken care of before the first official piece of documentation goes to the sponsor, then you're in a much better position of getting it approved," Rhodes says. "And the sponsor has some paper trail that it's a reasonable request."
Research sites need to document their contract negotiating positions in policies and then give staff the authority to act on their own within those guidelines, states Kris Rhodes, MS, CRA, director of grants administration for Wake Forest University Health Sciences of Winston-Salem, NC.Subscribe Now for Access
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