All successful clinical or healthcare research endeavors in the current era depend on a carefully designed oversight process. One integral part of the same is the Research Compliance Program. This paper skims trough some of the most basic parts of the Research Compliance Department as part of studies related to understanding the relationship between the Department itself and the program. I hope it accurately reveals new insight into the subject matter.
Inhaltsverzeichnis (Table of Contents)
- HOW THE RESEARCH COMPLIANCE DEPARTMENT WILL FIT INTO THE ORGANIZATIONAL STRUCTURE
- THE PRIMARY ETHICAL CONCERNS AFFECTING THE PROCESS
- HOW THE COMPLIANCE DEPARTMENT WOULD MAINTAIN OVERSIGHT OF RESEARCH OPERATIONS
- TOOLS AND APPROACHES USABLE IN THE ORGANIZATION AND THEIR EFFECTIVENESS
- HOW TO INDUCT THE PERSONNEL INVOLVED INTO THE NOTION OF ADDITIONAL LAYERS OF OVERSIGHT
- CONCLUSION
Zielsetzung und Themenschwerpunkte (Objectives and Key Themes)
This paper explores the process of creating a Research Compliance Program by examining the considerations involved in designing and implementing a Research Compliance Department. The paper analyzes key aspects of the program, such as the department's organizational structure, the primary ethical concerns, oversight mechanisms, applicable tools and approaches, and the process of integrating personnel into the new oversight framework.
- Organizational Structure of the Research Compliance Department
- Ethical Considerations in Research
- Oversight Mechanisms for Research Operations
- Tools and Approaches for Research Compliance
- Personnel Induction into a Research Compliance Framework
Zusammenfassung der Kapitel (Chapter Summaries)
- HOW THE RESEARCH COMPLIANCE DEPARTMENT WILL FIT INTO THE ORGANIZATIONAL STRUCTURE: This chapter examines the integration of a Research Compliance Department into different organizational structures, considering factors such as the presence of a Chief Operations Officer (COO) and the reporting lines of the Chief Compliance Officer (CCO).
- THE PRIMARY ETHICAL CONCERNS AFFECTING THE PROCESS: This chapter identifies key ethical concerns that must be addressed during the formation of a Research Compliance Department. These concerns include issues related to personnel integrity, training and education, performance incentives, financial integrity, and disciplinary measures.
- HOW THE COMPLIANCE DEPARTMENT WOULD MAINTAIN OVERSIGHT OF RESEARCH OPERATIONS: This chapter explores the role of the Research Compliance Department in maintaining oversight of research operations. The chapter discusses the importance of a compliance strategy, the strategic use of manpower, and the role of quality indicators in maintaining oversight.
Schlüsselwörter (Keywords)
The main keywords and focus topics of this text include research compliance, organizational structure, ethical considerations, oversight mechanisms, personnel induction, compliance strategy, quality indicators, and healthcare research.
- Quote paper
- Ernestoh Khomu (Author), 2017, Designing a Research Compliance Program, Munich, GRIN Verlag, https://www.grin.com/document/366636
