Designing Regulatory - Compliant Clinical Research Data Management Systems

Electronic data capture and management systems for clinical research must support many kinds of research, including clinical trials, prospective observational studies, and retrospective "chart mining".Regulatory requirements for new drug and device trials are the most stringent and complex, but even the smallest investigator-initiated study in an academic health center or community hospital or clinic must comply with human subject protection regulations and professional ethical guidelines, and meet information security requirements such as the HIPAA Privacy and Security Rules. This presentation covers the fundamental principles underlying the various compliance regulations and discusses their implications for system designers and integrators.

Areas Covered in the seminar:

• Types of clinical research
• A brief history of clinical research regulation
• The 21st Century clinical research regulatory landscape
• The World Medical Association Declaration of Helsinki
• The EU Directive on Data Protection
• The Safe Harbor principles
• The Common Rule
• Investigator-initiated research: what’s different, what’s the same
• GxP: implications for software design, development, and testing
• FDA clinical trial phases: implications for software design, development, and testing
• The FDA Guidance: implications for software design, development, and testing
• The Safe Harbor principles: implications for software design, development, and testing
• The Common Rule: implications for software design, development, and testing

Who Will Benefit:

This webinar will help engineering managers and staff developing systems for clinical trial data capture and management to grasp the scope and complexity of the various regulations applicable to clinical research, and their implications for design, development, and testing.

• Engineering managers
• Requirements analysts
• Software designers
• Software engineers
• Testing and QA engineers

Instructor Profile:

Dale Hunscher, MSI, is a senior systems analyst at the Michigan Institute for Clinical and Health Research at the University of Michigan, where he specifies and oversees the design and development of clinical research data management systems and conducts technology strategy analyses for Health System leadership. He has 24 years experience in commercial and enterprise software development, including two years in pharmaceutical publishing and four years in clinical research.

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