Quality Assurance: A Tool for Improving Research Quality and

Supporting a Quality Culture By

Catherine Bens, Colorado State University Ft. Collins, CO

Rebecca Davies, University of Minnesota, Minneapolis, MN

Melissa Eitzen, University of Texas Medical Branch, Galveston, TX

What is Quality?

• Fit for use

• Free from defects

• Meets a certain predetermined quality standard

What is Quality Assurance?

Maintaining a desired level of quality in a service or product, especially by means of attention to every stage of the process of delivery or production.

Series of activities designed to assure that the product is ‘fit for purpose’ and intended quality standards have been met.

Quality Assurance Professional (QAU)

• Born through regulation in a era of fraud

Quality Assurance Professional

• Provides assurance that the facilities, equipment, personnel, methods, practices, records, and reports meet the quality standard

• Independent of research conduct

Assures sound scientific principles through attention to

quality assurance and quality control principles and practices

Challenges to Bringing Regulatory Concepts to Academic Research

•Adds cost

•Adds time

•A Negative Mythology o Applies only to ‘tightly controlled

experimental designs’ o Restrictive with no added value o Rigidly applied

Challenges to Bringing Regulatory Concepts to Academic Research

• Lack of understanding, training and access to QA Professionals

•Unclear quality expectations and standards

Quality Assurance Professional?

Applicability of Bringing Regulatory Concepts to Academic Research

•Can be applied to any study

•Can be flexible and selectively adopted

•Adds veracity, trust, repeatability and relevance to data

• Avoids unnecessary duplication and costs

Research Life Cycle

Quality Assurance -assuring that research data and reports are accurate, complete, and transparent allowing for study reconstruction and reproduction throughout the life cycle

Planned

Conducted

Results Stored and Indexed

Results Accessed and Manipulated

Results Used or Reported

Results Retained and

Destroyed

Audit Trail

Some QA Practices Research Planning

• Study Plan Review • Study Design • Control of Bias – randomization, blinding, blocking

• Training and Education • Good Documentation Practices (ALCOA Plus)

Conduct • SOP Development • Method Validation • Monitoring and Inspection

Data Review • Complete, consistent and accurate throughout the data lifecycle

Reporting • Does the report/publication reflect the data, all the data, the correct data

Quality Assurance Professional

Value added resource providing: • Advice and training on best practices

• Independent monitoring and auditing

• Subject Matter Expertise (regulations, standards and guidances)

• Culture of quality and integrity

• Increased efficiencies, effectiveness, real time quality

• Increased funding opportunities

QA Thinking What is your source data?

What are the quality expectations of your source data?

What system do you have to communicate and ensure data quality and integrity throughout the data cycle?

How do you measure and trend your data integrity? How do you know?

QA Thinking Do we have all the data?

Has the data been properly collected, controlled and managed?

Is the audit trail assured from the source data

Are we reviewing all the data?

Are we reporting all the data?

Are we preserving all the data?

Leads to: Increased trust in the state of your data Increased transparency

Trust in Publications

“reviewers have no time and no resources to reproduce data and to dig deeply into the presented work.” https://lifescivc.com/2011/03/academic-bias-biotech-failures/

Quality Assurance Professionals in Academic Research Today The Society of Quality Assurance University Specialty Section 2017 Membership = 79

Publication Endorsement Cutler CG and Scott-Dupree CD. 2016. Bee Ecotoxicology and Data Veracity: Appreciating the GLP Process. BioScience, Vol. 66 No. 12, pp1066-1069

“For us, the role of the independent QA was perhaps the most eye-opening aspect of the GLP process.”

Quality Assurance

Assures the absence of ‘errors that matter’

Creates quality expectations that reinforces a culture of quality

QA Professionals are a resource for improved research integrity

But QA principles and practices are available to anyone and can be selectively applied to fit the quality needs of the research

Quality Research = Ethical Research = Reproducible Research = Responsible Research

Acknowledgements