Compliance Corner: Quality assurance is a necessary component
Quality assurance is a necessary component
Here are tips for a QA template
Everyone in the clinical trial industry wants to catch their own mistakes and omissions before a regulatory agency does, but the problem is finding the most efficient way to do this.
One model would be to have a research or clinical trial resource office provide quality assurance assistance and protocols, as well as education and training, suggests Pamela DeWeese, MAT, CCRP, administrative director of the clinical trials program at Indiana University Department of Medicine in Indianapolis.
"The important thing to remember is this is all for the good of human subjects research," DeWeese says. "The good of patients depends on us doing good work, so a logical place to start is to look at one's own vulnerabilities."
For instance, sites that rely on a number of industry-sponsored studies probably will not need to focus on these trials because they already are being monitored by sponsors, DeWeese notes.
"On the other hand, you have investigator-initiated protocols that are generated internally, and there’s no external body coming in to check for those errors and omissions, so that may be an area of vulnerability," DeWeese says.
DeWeese offers these tips for starting a quality assurance program:
1. Decide how thorough audits will be.
"It’s probably not realistic to check 100% of every patient on every study," DeWeese says.
Clinical trial sites will need a good representative sample that will let them know if they’re on the right track, DeWeese explains.
This sample might be a policy to review records from 10% of new enrollees on investigator-initiated studies each quarter, she says.
Other decisions to make include:
- Which records will be reviewed?
- At what frequency (i.e., monthly, quarterly, annually) will the records be reviewed?
- What tools will be needed for the review process?
- What key issues will be assessed during the review?
- If there are problems, how much more information will the auditor seek?
The audits likely will include a look at documentation, particularly with IRB forms, adverse events information, and informed consent, DeWeese says.
"The auditor will need to look at source documents and what was put in case report forms," she explains. "The auditor is looking at actual data."
But the bigger answers an auditor will seek involve whether the clinical trial staff are adhering to the protocol and doing what they said they’d do, DeWeese says.
This can be determined by using consistent audit points, including:
- Did the site use the right version of the informed consent document?
- Did subjects receive the consent before treatment began?
- What are the trends regarding informed consent?
"You may not have to look at all 50 patients," DeWeese explains. "But if you’ve audited five, and three of those were using the wrong version of the informed consent form, that may indicate that the trial needs more thorough auditing."
2. Provide education and training assistance.
At the Indiana University School of Medicine, each department is free to select their own education method and requirements, DeWeese says.
"Our research compliance education offers some research training, and we’ve tried to be a primary source of clinical research training on campus," DeWeese says. "Education and training are another form of quality assurance."
For example, there is a three-day training program for research coordinators, and it’s offered twice a year, DeWeese says.
"A couple of years ago the training program became mandatory for any new research coordinator with less than two years’ experience at our institution," DeWeese says.
Items covered in the program include:
- history of drug development;
- regulatory issues;
- good clinical practice, IRBs and IRB forms, serious adverse event reporting;
- budgets and contracts;
- how to talk with patients;
- consenting subjects; and
- surviving audits.
"We recently added a behavioral side for sites doing quality of life surveys," DeWeese says.
"It’s a pretty intense three days," DeWeese notes. "For some folks it may be the most thorough orientation and training they ever get."
The education also is structured in a way that might ensure better understanding, DeWeese adds. "We try to not just present the regulations, which can be pretty boring," DeWeese says. "We try to bring in people who help interpret regulations for our environment, looking at how to implement a study at Indiana University."
The idea is to make the information as concrete as possible so research coordinators will know how to apply the knowledge at their university trial site, she adds.
Aside from the three-day orientation, there is ad hoc training whenever important new regulations emerge, DeWeese says.
"Sometimes the education sessions are intense, and sometimes they include light topics, such as how to use the computer to manage documents," DeWeese explains.
The education and training are offered to each department, and the three-day sessions are limited to 35 people, she adds.
3. Focus on instruction, not punishment.
"I think of myself as an educator at heart, and we approach our internal quality improvement and assurance programs as an educational experience, rather than a punitive experience," DeWeese says.
When a study is audited, the study’s staff are provided with help with writing a corrective action plan, DeWeese notes.
"We always do it with a flavor of how this is an educational experience, and we’re here to help you understand what's going on," DeWeese says.
The idea is for trial staff to feel as though they can better take care of problems that arise and that if they have any questions or issues, they will know who to call for advice, she says.
"Stuff happens," DeWeese says. "You can make an error and omit something, and you just want to fix it and not have it happen again."
Often a quality assurance auditing program involves having people audit themselves or their peers, so it's important to do it within an atmosphere of professionalism and collegiality, she says.
"What we're trying to do is protect patients and provide self-improvement," DeWeese explains. "With that kind of philosophy, people are more willing to engage in activity that would otherwise seem more negative."
Everyone in the clinical trial industry wants to catch their own mistakes and omissions before a regulatory agency does, but the problem is finding the most efficient way to do this.Subscribe Now for Access
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