Quality Systems Boost Rigor, Reproducibility, Reliability of Data
The University of Rochester Clinical and Translational Science Institute can help researchers boost the rigor and reproducibility of their data by developing quality systems to standardize research procedures and track training of key personnel. Any research team can benefit from implementing a quality system, but they are especially useful if you plan to submit your data to the FDA in the future, such as for an investigational new drug (IND) application or if you are trying to license a technology.
Quality systems exist on a spectrum depending on the level of rigor needed for a project or lab. The UR Quality Systems team works with research groups to develop quality systems that meet each team’s unique needs. With the help of UR Quality Systems team leaders, Joan Adamo, Ph.D., and Sharyl Zaccaglino, each group can decide how much rigor they need to introduce into their work.
“We tailor to your needs,” said Zaccaglino, director of Research Quality and Compliance at University of Rochester Medical Center. “Each quality system we help develop is right-sized for your team.”
In order to get the right size, Adamo, director of Regulatory Support Services at the UR CTSI, recommends starting the process when you are writing a grant. Planning ahead is especially important if you see potential for an IND application or technology license on the horizon.
“In order to ensure maximum quality of your data, this needs to be a very forward-looking process,” said Adamo. “The quality system should be in place before you collect your data.”
To get started, researchers can consult UR CTSI Research Engagement Specialist, Carrie Dykes, Ph.D. Dykes can help researchers understand NIH rigor and reproducibility policies – especially a new policy requiring authentication of key biological and chemical resources – and develop language for grant applications indicating how you will meet the guidelines.
From there, researchers should meet with Adamo and Zaccaglino to outline their project(s), personnel, and end goals of their research. Adamo and Zaccaglino will help parse the important steps in your processes, categorize equipment, develop standard operating procedures (SOPs), and identify personnel who need specific training, such as Good Laboratory Practice or current Good Manufacturing Practice.
While quality systems can benefit anyone, they are not efficient for very early-stage “tinkering” phases of research, which require a freer, less standardized approach. Once that tinkering has led to a solid hypothesis and clear specific aims, it may be time to consider implementing a quality system.
Contact Research Help to learn more about setting up your own quality system. You may also request an informational session to learn about quality “from A to Z” with Adamo and Zaccaglino for your department or center.
Learn more about grant requirements for rigor and reproducibility.
Susanne Pritchard Pallo |