Program uses systems approach training
Trains trial monitors on FDA warnings, audits
When Jill Matzat was monitoring clinical studies, she approached it the way she had approached her work in the lab and as a nurse.
"One of the things I understood is that when you're running an experiment or you're treating a patient, there's a certain approach that you take and it's instituted in your training," Matzat says. "When I started to monitor, I would create a systems approach to it so I was applying the same standard across every patient that I monitored."
This approach, she says, allowed her to catch problems that other monitors missed.
"When I was monitoring, I noticed that everybody was kind of a cowboy out there — they kind of did their own thing with Post-it notes or whatever," she says. "Or they'd inventory and say, 'Oh, the consent's present,' without thinking about the compliance component."
So Matzat, RN, BSN, CRA, now president of Medical Research Management Inc. & CRA Solutions, Inc. in Coral Springs, FL, developed her own training program for clinical research associates (CRA) who monitor clinical studies.
That training program was selected as a 2011 winner of the Health Improvement Institute's Award for Excellence in Human Subjects Protection – Best Practice.
Using warnings, audits
Matzat says she's been fine-tuning the program since introducing a 140-hour CRA Certificate program in 1999. She says she used FDA warning letters and audit findings to help discover where monitors needed to focus their attention.
"I probably spent about three years going through a process of figuring out what worked and didn't work — looking at different issues, seeing the audit findings and then doing a gap analysis between the [findings and the] monitoring and trying to figure out why the monitors aren't picking up on these issues," she says.
She says too often, monitors simply inventory the items that are supposed to be present and go no further.
For example, in looking at consent, a monitor might check to make sure a consent document is present and signed.
But Matzat goes further, with an eight-point system, based on the regulations and guidance documents.
She would ask questions such as: Does the file contain the right version of the consent? Is it the right patient? Are the signatures from the right people? Are the dates correct? Are all the pages readable? Was the person who administered consent to the subject trained to do so? Was there someone available to answer medical questions?
"You might find that all the dates are off — why is the investigator signing this three weeks later? Or it's the incorrect version [of the consent] on 15 of 20 patients," she says.
Matzat says her program uses a similar approach to validate HIPAA compliance, protocol compliance, inclusion and exclusion procedures, and other aspects of the study.
Online and hands-on
Covering all of these points requires a rigorous training process — Matzat says students spend 70 hours doing an e-learning course and then do two weeks of hands-on training, practicing monitoring on mock studies.
Matzat says she would like to expand the course, adding more e-learning modules about such issues as dealing with electronic medical records. And because so many people are coming to the monitoring without a medical background, she says she would like to offer courses in anatomy and physiology.
But she says the hands-on component of the training is vital — too often, she says, monitors only complete an online course, but don't know how to apply the regulations to real-life studies.
"I'm not sure that just recommending e-learning is always adequate," she says. "I think that [IRBs] are best requiring some sort of way to validate their knowledge."
Matzat has trained CRAs for work in universities, private industry and at the National Institutes of Health.
She says that institutions that are concerned about ensuring quality monitoring — particularly those that have received warning letters for violations — should consider a more structured and hands-on training program.
"If these sites are having warning letters because of violations, you have to wonder how this is getting past an IRB," she says.
When Jill Matzat was monitoring clinical studies, she approached it the way she had approached her work in the lab and as a nurse.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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