Authors and Advisors

Authors

Rebecca L. Davies, Ph.D.

Rebecca L. Davies received her Ph.D. in comparative animal physiology from the University of Minnesota and is an Associate Professor in the Veterinary Population Medicine department at the College of Veterinary Medicine. She is the Director of Quality Central at the University Of Minnesota College Of Veterinary Medicine. Quality Central provides scientists with tools and support for integrating quality assurance (QA) best practices into academic research, service and training programs. Rebecca is developing training programs for research trainees and other scientists to help them use quality management systems and QA best practices to provide assurance that research data and records are accurate, complete, and can be readily reconstructed. This assurance stems from the use of good documentation practices, the integration of quality checkpoints throughout the research life cycle, and the adoption of research monitoring strategies to ensure continuous improvement.

Rebecca's interests include the adoption of voluntary QA practices within non-regulated research programs, sustainable models for incorporating research QA into basic research environments, research on research to improve research rigor and reproducibility, and the use of laboratory error data and QA metrics to drive continuous improvement in laboratory and research settings.


Melissa Eitzen, M.T. (A.S.C.P.), M.S., R.Q.A.P.-G.L.P.

Melissa Eitzen has over 30 years of laboratory development, management, equipment validation, regulatory compliance, and course development experience. Her experience in the development of quality systems to meet regulatory requirements began in 1985, when she developed a quality system infrastructure for a new environmental testing laboratory that resulted in dual accreditation by the National Voluntary Laboratory Accreditation Program and American Industrial Hygiene Association. In 2004, she initiated efforts at the University of Texas Medical Branch in Galveston, Texas to build the infrastructure necessary to support regulated studies conducted under a quality system based on the U.S. Department of Health and Human Services Food and Drug Administration (FDA) Good Laboratory Practices for Nonclinical Laboratory Studies (GLP) as codified in the Federal Register (21 CFR Part 58).

Melissa holds a Master of Science degree in Instructional Technology from the University of Houston Clear Lake and a Bachelor of Science in Medical Technology from the Indiana University School of Medicine. She is a Registered Quality Assurance Professional in the GLP regulations and holds graduate certificates in Performance Technology and Distance Education. She served as the 2017 President of the Society of Quality Assurance, serves as faculty for a Rigor and Reproducibility workshop that won the 2017 Innovations in Research and Research Education Award from the Association of American Medical Colleges and serves as co-Principal Investigator and faculty for a collaborative educational project with the FDA to assure data quality and integrity in maximum containment laboratories.


Lead advisors

Rebecca L. Davies, Ph.D.

Rebecca L. Davies received her Ph.D. in comparative animal physiology from the University of Minnesota and is an Associate Professor in the Veterinary Population Medicine department at the College of Veterinary Medicine. She is the Director of Quality Central at the University Of Minnesota College Of Veterinary Medicine. Quality Central provides scientists with tools and support for integrating quality assurance (QA) best practices into academic research, service and training programs. Rebecca is developing training programs for research trainees and other scientists to help them use quality management systems and QA best practices to provide assurance that research data and records are accurate, complete, and can be readily reconstructed. This assurance stems from the use of good documentation practices, the integration of quality checkpoints throughout the research life cycle, and the adoption of research monitoring strategies to ensure continuous improvement.

Rebecca's interests include the adoption of voluntary QA practices within non-regulated research programs, sustainable models for incorporating research QA into basic research environments, research on research to improve research rigor and reproducibility, and the use of laboratory error data and QA metrics to drive continuous improvement in laboratory and research settings.


Richard Coico, Ph.D.

Richard Coico is Professor of Cell Biology and Medicine and Director of the Clinical and Translational Science Center at SUNY Downstate College of Medicine. As an immunologist, his research focuses on the investigation of lymphocyte regulation of immune responses. His translational research activities include the study of peptide immunization strategies to develop effective vaccines. His laboratory uses computational and bioinformatics approaches to identify candidate peptide vaccines for hemorrhagic viruses such as Ebola and Lassa. His group was the first to identify immunogenic Lassa virus peptides capable of stimulating protective cytotoxic T cell responses. Richard has been a leader in medical education, specifically as it relates to the biomedical disciplines of microbiology and immunology. He has served on the National Board of Medical Examiners and has chaired several national meetings including those sponsored by the Association of Medical School Microbiology and Immunology Chairs organization of which he is past-President.


Reviewers

E. Andrew Balas, M.D., Ph.D.

E. Andrew Balas leads academic, local, and national initiatives facilitating innovative life sciences research responsive to societal needs and developing global competitiveness in the production of new scientific knowledge. Andrew serves as Professor at Augusta University, Director of the Biomedical Research Innovation Laboratory, Vice President of the Friends of the NIH National Library of Medicine, member of the American College of Medical Informatics, and is an elected member of the European Academy of Sciences and Arts. His studies about delay and waste in the transfer of research results to health care are often mentioned reference points in translational research initiatives. The results have been cited by numerous research studies and policy-makers. His academic credentials include over 100 publications, externally funded research in excess of 10 million dollars and publications that cumulatively attracted thousands of citations. He obtained degrees in medicine (M.D.), medical informatics (Ph.D.), and applied mathematics (MS).


Claudia von Vacano, Ph.D.

Dr. Claudia von Vacano is the Executive Director of the Social Sciences D-Lab and the Digital Humanities (DH) at University of California (UC), Berkeley. She is the lead online course developer of the SAGE Campus "Introduction to Applied Data Science Methods for Social Scientists." She received a master's degree from Stanford University in Learning, Design, and Technology. Her doctorate is in Policy, Organizations, Measurement, and Evaluation from UC Berkeley. Her expertise is in organizational theory and behavior and in educational and language policy implementation. The Phi Beta Kappa Society, the Andrew W. Mellon Foundation, the Rockefeller Brothers Foundation, and the Thomas J. Watson Foundation, among others, have recognized her scholarly work and service contributions.


Accessibility advisor

Wilma Alexander

Wilma Alexander is a Fellow of the Higher Education Academy with Masters in Human-Computer Interaction, Linguistics, and Information Science. She has over 15 years of experience as a manager with the online learning team at the University of Edinburgh, where she specialized in usable and accessible digital practice, tutored on the groundbreaking Masters in Digital Education, and developed online staff training on accessible e-learning and online tutoring skills. Since retiring from the University at the end of 2015, Wilma has provided consultancy services on all aspects of online learning, with a special focus on accessibility and usability issues.

Module structure

Welcome

Orientation

  • Introduction
  • Learning outcomes

Module files

    Module 1: Execution, management, and documentation of experiments

    • Fostering research reproducibility
    • Managing research to support research quality and reproducibility
    • Identifying risk to research quality and reproducibility
    • Managing threats to research quality and reproducibility
    • The importance of research records
    • Documenting research records and procedures
    • Using research notebooks or journals
    • Research Quality Management Systems
    • Application (1)
    • Application (2)

Closing

  • Module summary
  • Resource bank
  • References

Course features

  • Video interviews with scientists in which they discuss the strategies they implement to maintain and sustain quality and reproducibility in their work.
  • Interactive scenarios to guide you through appropriate steps to take when keeping research records.
  • A range of useful articles and resources relating to quality and reproducibility.

Supporting institutions

  • Boston University, Boston MA
  • Duke University, Durham NC
  • Ohio State University, Columbus OH
  • Oxford University, Oxford UK
  • University of Minnesota, Minneapolis MN
  • University of Southern Maine, Portland ME