Quality assurance mechanisms for the unregulated research environment.
Discussions on research quality and reproducibility are appearing in the pages of scientific journals with heightened significance and gaining media attention. Many institutions have developed guidelines to address the topic of quality in basic research, but questions remain about how best to implement and monitor compliance. Herein we present quality assurance (QA) mechanisms developed specifically for the unregulated discovery research environment to preempt growing concerns arising in both academia and industry for data-driven applications of biotechnology.
Ferring Research Institute, 4245 Sorrento Valley Blvd., San Diego, CA 92121, USA.
Denise Hanway
DH
Riedl
Michael K
MK
Dunn
D035843:Biomedical Research / Q000331:legislation & jurisprudence / Q000592:standards*; D001709:Biotechnology / Q000592:standards*; D004345:Drug Industry / Q000592:standards*; D011786:Quality Control; D015203:Reproducibility of Results
data audit; discovery research; electronic laboratory notebook; integrity; quality; traceability