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CLARA: an integrated clinical research administration system.

ABSTRACT: 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.

SUBMITTER: Bian J

PROVIDER: S-EPMC4173184 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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CLARA: an integrated clinical research administration system.

Bian Jiang J Xie Mengjun M Hogan William W Hutchins Laura L Topaloglu Umit U Lane Cheryl C Holland Jennifer J Wells Thomas T

Journal of the American Medical Informatics Association : JAMIA 20140428 e2

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 res ...[more]

PMID: 24778201

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Project description:BACKGROUND:The majority of obese subjects are treated by primary care physicians (PCPs) who often feel uncomfortable with the management of obesity. In a previous study, we successfully developed, implemented and evaluated an obesity management system based on training and coaching of health professionals of family medicine groups (FMGs) by a team of experts in obesity management. Using a pre/post design, this study suggested a positive impact on health professionals' perceptions and reported obesity care. The current research project is aimed at evaluating the impact on obesity screening and care of this integrated obesity management system. We hypothesize that our program combining preceptorships with a virtual community and on-site coaching will improve: (1) management and weight loss of obese/overweight subjects treated by PCPs for hypertension, type 2 diabetes or impaired glucose tolerance; and (2) screening and initial management of obesity among a regular follow-up group of patients of PCPs who practice in FMGs. METHODS/DESIGN:Ten FMGs will be approached for a practice monitoring project and will be randomised to receive the intervention developed in our previous project or will only be provided clinical practice guidelines. In the participating FMGs, we will enrol 22 patients per FMG with weight related targeted disease and 24 patients with regular follow-up. These patients will be evaluated for the care they received regarding screening and/or management of obesity using medical chart reviews, and will fill out a questionnaire on their lifestyle and satisfaction. They will also be examined for anthropometric measures, vital signs, blood markers for chronic diseases and physical fitness. The same patients will be assessed again after 18 months. The impact of the program on health professionals will be evaluated at baseline, and at 1 year. Qualitative data will also be collected from both professional and patient participants. Direct and indirect costs and QALYs will be evaluated as indicators of cost-effectiveness. DISCUSSION:In the context of the dramatic increase in obesity prevalence and the low perception of PCPs' self-efficacy, providing efficient strategies to PCPs and interdisciplinary health care teams for management of obesity is crucial. TRIAL REGISTRATION:Clinicaltrials.gov Identifier: NCT00991640.

Project description:BACKGROUND:Clinical trials pose potential risks in both communications and management due to the various stakeholders involved when performing clinical trials. The academic medical center has a responsibility and obligation to conduct and manage clinical trials while maintaining a sufficiently high level of quality, therefore it is necessary to build an information technology system to support standardized clinical trial processes and comply with relevant regulations. OBJECTIVE:The objective of the study was to address the challenges identified while performing clinical trials at an academic medical center, Asan Medical Center (AMC) in Korea, by developing and utilizing a clinical trial management system (CTMS) that complies with standardized processes from multiple departments or units, controlled vocabularies, security, and privacy regulations. METHODS:This study describes the methods, considerations, and recommendations for the development and utilization of the CTMS as a consolidated research database in an academic medical center. A task force was formed to define and standardize the clinical trial performance process at the site level. On the basis of the agreed standardized process, the CTMS was designed and developed as an all-in-one system complying with privacy and security regulations. RESULTS:In this study, the processes and standard mapped vocabularies of a clinical trial were established at the academic medical center. On the basis of these processes and vocabularies, a CTMS was built which interfaces with the existing trial systems such as the electronic institutional review board health information system, enterprise resource planning, and the barcode system. To protect patient data, the CTMS implements data governance and access rules, and excludes 21 personal health identifiers according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rule and Korean privacy laws. Since December 2014, the CTMS has been successfully implemented and used by 881 internal and external users for managing 11,645 studies and 146,943 subjects. CONCLUSIONS:The CTMS was introduced in the Asan Medical Center to manage the large amounts of data involved with clinical trial operations. Inter- and intraunit control of data and resources can be easily conducted through the CTMS system. To our knowledge, this is the first CTMS developed in-house at an academic medical center side which can enhance the efficiency of clinical trial management in compliance with privacy and security laws.

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CLARA: an integrated clinical research administration system.

Publications

CLARA: an integrated clinical research administration system.

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