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A1.0100 OVERVIEW OF UK RESEARCH ENVIRONMENT - page 18 / 23

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A1.0050

ensure advertising meets human subject and institutional graphic requirements prior to IRB review. All clinical trials are subject to institutional policy requiring IRB approval of promotional/ recruitment materials as well as research protocols.

The UK IRB reviews and approves all research conducted in the CR-DOC to ensure protection of the rights and welfare of research subjects. The CR-DOC Research Development unit closely coordinates the process of obtaining IRB approval with the investigator. A Scientific Review Committee reviews protocols for sound study design and is supported by the CCTS Biostatistics, Epidemiology, and Research Design unit. The CR-DOC maintains documentation of IRB approval of protocols, as well as copies of currently approved consent forms. The ORI Director serves an ex officio member of the CR-DOC Scientific Advisory Committee to ensure coordination of IRB and CR-DOC operations.

A1.2000 Biostatistics, Epidemiology, and Research Design

The infrastructure to ensure sound and ethical study design is a key priority of the CCTS. Faculty from core academic disciplines in biostatistics, epidemiology, clinical bioethics, patient’s rights, and statistics serve the study design and data analysis needs of CCTS investigators through consultation, protocol review, and data management and analysis. Individualized consultation during the protocol development process allows investigators early access to expertise with study design. The Biostatistics, Epidemiology, and Research Design unit within the CCTS also provides ad hoc reviewers to the Scientific Review Committee in the CR-DOC to support high quality scientific review outcomes. This unit provides a cost-effective support for study-specific data collection, management, and dissemination as well as assistance in developing research data management plans to meet the needs of each project, from instrument design, data capture, and database design to analysis of the dataset. Collectively, these services contribute to quality study design and enhanced investigator expertise.

A1.2025 Regulatory Support and Research Ethics

The Regulatory Support and Research Ethics unit within the CCTS was designed to provide enhanced levels of “researcher-focused” support for regulatory compliance, management, and oversight. Program faculty assist investigators and study personnel in maintaining high levels of regulatory knowledge. Through this unit, the CCTS offers an integrated program of training on regulatory and research integrity topics, investigator mentoring, regulatory support to CCTS community partners, research subject advocacy, data safety and monitoring, and quality assurance and quality improvement services. The Regulatory Unit within the CR-DOC functions under the oversight of the Regulatory Support and Research Ethics component of the CCTS.

A Quality Assurance Plan is under development to assure subject safety and regulatory and fiscal compliance. QA/QI facilitators will provide structured assessment activities: on-site review, investigator self-assessment tools, and unit and program review. Review results will be used to develop comprehensive QI initiatives to be implemented within the CR-DOC and at community sites.

With assistance from both the Regulatory Support and Research Ethics unit and the ORI, a Regional IRB Consortium has been established to focus on the challenges and opportunities inherent in off-site and multi-site research. The consortium has been tasked with sharing IRB resources and expertise, assessing the feasibility of developing regional IRB application

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