Dogged dedication to reviewing documents and keeping training on the cutting edge at study sites are keys to an effective quality assurance (QA) program, says Katrina Quidley, regulatory manager with IACT Health in Columbus, Ga.
“We review every interim monitoring visit letter as it comes in,” Quidley says of her efficient shop. Letters are sorted by reviewer so that trends, such as dosing errors, can be caught early in the cycle, she adds. IACT takes a hard look at letters as a group each week, in order to catch patterns and trends that might spell trouble down the line.
Training and communication are equally important components of a strong site QA program, Quidley says. While IACT formally updates its training manual annually, managers review its components every six months, and have regular informal meetings and communications to consider new tools and tactics gathered at events such as the Association of Clinical Research Professionals’ annual Meeting & Expo.
IACT also conducts full-scale quarterly meetings, plus informal gatherings and e-mail communication on an ongoing basis, to best share new ideas and incorporate those into training sessions.
Among other benefits, such diligence helps give clinical research coordinators at sites better understanding of and more input on the reasons behind, and development of, standard operating procedures, Quidley says.
Learn more about effective quality assurance programs and site quality management:
- Site Quality Management Tools: SOPs, Metrics, and Training
- Building Quality Management Systems for Sites and Sponsors: Root Cause and CAPA
- Keys Skills for Ensuring Quality Control through Risk-Based Decision Making
- Quality Essentials: Monitoring Visit Report Review Plans
- Quality by Design: The Value of CRF Mapping
- CAPA Isn’t Just a Compliance Tool: Maximizing Site Performance Applying CAPA Principles
- Reverse Engineering 483s and Warning Letters to Improve Your QA Program