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QI monitoring forms, tools put compliance checking at fingertips
Check boxes, bullet points make it clear, concise
A good compliance program can be built around monitoring tools. At least that's what has worked well for one research institution.
"We started our compliance plan with our monitoring tools," says Julie Ozier, MHL, CIP, an associate director of the IRB at Vanderbilt University in Nashville, TN.
"It's really evolved over the past six years," Ozier says. "The forms and tools we used were interview-based where we'd go to a research site and with an interview gather data, check forms, look at the program, check source documents and regulatory documents, and put together a report."
Over time the tools have evolved into streamlined forms with "yes" and "no" check-boxes, making it visually easy to comprehend, she adds. (See sample regulatory documentation tool .)
"It's much easier now to give feedback to an investigator, saying, 'Yes, this is present,'or 'Yes this is correct or not,'" she says. "At the end we do an exit interview with our preliminary findings and then come back and compile them all and give them a report."
Also, the monitoring tools are fluid and Web-based with the ability to adapt based on a principal investigator's (PI's) answers
"That seems to work better when we give PIs feedback, rather than giving them narratives and lumping findings together," Ozier says.
For a post-monitoring report, PIs are given a paper document, although the next step is to make these Web-based, as well, Ozier says.
"We do manual data entry into a database, and we give them paper," she says. "The review could be up to eight or nine different sheets of information, depending on what type of review has been done."
Most reviews are specific to one particular area, Ozier notes.
"For instance, we might say we'll look at the consenting process," she explains. "And I'll pick some PIs and studies to do just that piece."
Monitors also will try to visit an informed consent process as it takes place, she adds.
"Most of the random compliance reviews we do are not of the entire program," Ozier says. "Although, certainly if the committee directed us to do an audit and look for specific problems, say an allegation or a finding, then we might do a more thorough review."
The compliance review reports also have evolved into a more readable format, Ozier notes.
"Before we might take a whole paragraph of text and tell them the findings in a paragraph format," she says. "Now we use bullet points and don't go through every detail, covering only the areas where there are concerns and saying that otherwise the program looks good."
The new format does include recommendations and suggestions for improvements, however, she adds.
The changes were made based on PI feedback, and they've resulted in PIs understanding more precisely what it is they need to do to improve their programs, Ozier says.
"There's been less back and forth between sites about what it is we wanted," she says. "We tell the PI: 'To correct this, you need to do this,'and then they implement the change, and that's it — so the process has been streamlined."
Previously, PIs would call for clarifications about findings, Ozier says.