By Melinda Young, Author

Using a quality assurance process and feedback loop, an IRB improved its good clinical practice (GCP), education, and overall research protection compliance.

Orlando Health in Orlando, FL, built a quality assurance program, including a research education series and GCP audits, around these goals. Research operations used a positive feedback loop to provide tailored education and risk reduction for research records. The feedback loop circles around from internal monitoring findings to education series content to more internal monitoring findings to more education, and an annual competency review.1

“We wanted the quality improvement program to link and leverage all strengths together,” says Valerie Danesh, PhD, RN, CCRP, assistant professor at the University of Texas at Austin. Danesh formerly was a corporate manger of research and clinical grants at Orlando Health.

“We were meeting benchmarks across all of our different areas, regardless of where their intrinsic natural strengths are,” Danesh adds. “With this centralization of research, we wanted to make sure everyone was meeting best practices, and we wanted to make sure it was consistent across all different areas.”

As a result of the quality assurance focus and feedback loop, the research program has improved engagement and enhanced enthusiasm among research protection professionals.1

Internal monitoring, called good clinical practice audits, and audit readiness regulatory reviews are conducted periodically. Peer volunteers conduct the audits.1

“It’s a highly sought-after role,” says Stephanie Brown, BSN, RN, CCRP, quality assurance manager of the corporate office of research operations at Orlando Health.

“They are the peer volunteers that act as regulatory reviewers for GCP meetings,” Brown says. “There are about six studies selected for each meeting, and they cover different regulatory aspects.”

Peer auditors and regulatory auditors can reference the binders, which list all needed information clearly and with an intuitive flow. The binders are designed to be easily referenced and viewed by research professionals and auditors, Brown says.

“The binder has been very well-received with monitors through audits we’ve had in the past,” Brown says. “It provides a nice flow for regulatory binders.”

There is a table of contents, so if auditors pull binders, they’ll know where to find what they want, she adds.

The QA initiative also includes the following actions:

• Train peer reviewers. “The idea in the beginning was to select documentation as if we went through a recognized FDA inspection or an inspection by any other outside authority,” says Tara Roberts, CIP, CIM, corporate director of research regulation and compliance at Orlando Health.

Research compliance leaders trained peer reviewers to check documentation, informed consent, delegation of authority logs, training logs, and other information.

Trainees are asked to consider these questions:

- What are GCPs?

- Where are GCPs going well?

- Where do GCPs need to improve?

• Share GCP across divisions. “We share best practices across the divisions, which has been very helpful,” says Marlene Miller, RN, BSN, audit and quality assurance supervisor at corporate office of research operations at Orlando Health.

For instance, common factors all research areas share are the need to advocate for patients and to follow protocols, Miller says.

“A lot of times we get caught up in the terminology of good clinical practice, but if you just advocate for the patient and follow protocol, it comes naturally,” she says.

• Use shared regulatory binders. “When we’ve used this shared binder experience, I’ve had auditors provide feedback that they love the setup,” Roberts says. “It’s easy for them to find the documents they are looking for, and when they see that kind of nice organization, they feel more confident about how things will flow at the organizational level.”

Roberts recalls how two investigators thumbed through the binders quickly, saying it was easy to find what they were looking for. “It helps them focus on what they need to focus on, and the binder gives it a nice flow,” she says.

“We are sharing this across all of our divisions because it’s been successful in our audits,” Roberts adds.

• Design a monthly education series. Orlando Health’s entire research enterprise may participate voluntarily for most of the monthly educational sessions. A few sessions are mandatory. Attendees include research staff across all research divisions, as well as fellows and others involved in human research.

“We cover hot topics, and sometimes we might see that there has been a deficiency in an area,” Roberts says.

Educational themes have included audit readiness, data management, GCP, regulatory issues, patient recruitment, research billing, research ethics, and privacy/confidentiality practices.1

“Sometimes topics are generated by a team that goes to an investigators’ meeting or to a conference,” Roberts says. “We try to support the sessions with credentials so staff can earn credits toward their credentials.”

Leadership led the educational sessions for the first 10 months, and then peer volunteers took over.

“I would say it really is wholly team member-led with leadership guidance,” Danesh says. “There are no prepackaged materials.”

• Develop GCP audit readiness. “Regulatory coordinators and others involved sit in on sessions and they provide documents for review, and we meet to discuss and review further,” Brown says. “That’s where feedback is developed.”

Study selection for audits is random for each division, Brown notes.

• Apply the feedback loop. The feedback loop that ties together education, internal monitoring, and annual competency reviews is applied to all quality assurance programs, Danesh says.

“They’ve built a beautiful culture where it’s an expectation that an external agency, like the FDA, will provide feedback, and the organization learns lessons,” Danesh explains.

Problems identified in reviews and internal monitoring are resolved through education and the quality assurance process, she adds.

“We route all quality assurance through the process and provide continued education hours,” she says. “We make it a continuous feedback loop from FDA inspection to QA program, and shared with everyone through continuing education.”

• Provide annual competency review. The annual review assesses each research team member’s content knowledge. It’s a closed-book exam with multiple choice questions. There also are two interactive skills stations.


1. Danesh V, Roberts T, Brown, S, et al. Quality assurance without carrots or sticks: using feedback loops for good clinical practice audits. Poster presented at the Public Responsibility in Medicine and Research (PRIM&R) Advancing Ethical Research Conference, held Nov. 5-8, 2017, in San Antonio. Abstract: 7.