CLARA: an integrated clinical research administration system.
Administration of human subject research is complex, involving not only the institutional review board but also many other regulatory and compliance entities within a research enterprise. Its efficiency has a direct and substantial impact on the conduct and management of clinical research. In this paper, we report on the Clinical Research Administration (CLARA) platform developed at the University of Arkansas for Medical Sciences. CLARA is a comprehensive web-based system that can streamline research administrative tasks such as submissions, reviews, and approval processes for both investigators and different review committees on a single integrated platform. CLARA not only helps investigators to meet regulatory requirements but also provides tools for managing other clinical research activities including budgeting, contracting, and participant schedule planning.
Division of Biomedical Informatics, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA Research Systems, Information Technology, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.
Jiang
J
Bian
Department of Computer Science, University of Arkansas at Little Rock, Little Rock, Arkansas, USA.
Mengjun
M
Xie
Division of Biomedical Informatics, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.
William
W
Hogan
Department of Hematology and Oncology, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.
Laura
L
Hutchins
Division of Biomedical Informatics, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA Research Systems, Information Technology, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.
Umit
U
Topaloglu
Research Systems, Information Technology, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.
Cheryl
C
Lane
Office of Institutional Review Board, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.
Jennifer
J
Holland
Research Support Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.
Thomas
T
Wells
D035843:Biomedical Research / Q000458:organization & administration*; D028744:Ethics Committees, Research; D006801:Humans; D020407:Internet; D012984:Software
Clinical and Translational Science Award; clinical research administration; clinical research workflow; electronic IRB