Dispelling the Myths About Clinical Standardization

Why Should You Attend:

Within the next 4 to 8 years, all CROs and sponsors will have to adopt clinical data standards for all studies being submitted to the FDA. While some companies have implemented standards already, many more have not. Designing and implementing the right standards the right way is a significant challenge, and to make matters worse, there are many beliefs about standards that make the task seem even more daunting than it is.

This webinar will help to dispel the myths and common misconceptions surrounding the adoption of clinical data standards and show how the broader the standards implementation across functional areas is, the greater the benefits to both FDA and sponsors.

Areas Covered in the Seminar:

• The definition of clinical data standards.
• What standards will have to be implemented?
• Myths about standards that get in the way of adoption.
• “Standards stifle scientific creativity”.
• “Standards prevent us from meeting (changing) business and scientific needs”.
• CRFs should be the center of the standards.
• Standards only apply to CRFs and databases, i.e., the techies.
• Each functional area can standardize by itself.
• Everyone must use exactly the same standards.
• Sites will benefit if the sponsor standardizes.
• Having standards means having quality.
• Efficacy data cannot be standardized.
• Once standards are developed, the work is done.
• Standardization is expensive and time-consuming.
• Standards are a product.
• Standards must be driven from the top down.
• Standards require enforcement.
• The goal of standards is to reduce costs and increase efficiency.
• There is no good time to implement standards.
• Some real challenges in adopting standards.
• The broader picture of why standards are beneficial to FDA and sponsors.

Who Will Benefit:

• Clinical data standards specialists
• Biostatistics
• Medical writing
• Clinical data management
• Database programming
• Statistical programming
• Case report form design
• EDC systems
• Clinical Operations
• Data warehouse design and development
• Regulatory submissions design and development

Instructor Profile:

Kit Howard, the founder and owner of Kestrel Consultants, has almost 30 years of experience in the biopharmaceutical industry and is a recognized expert in clinical data standardization, data quality and data management. She provides consulting and training services in these topics for pharma, biotech, medical device, academic research and regulatory organizations. She has published extensively, presented at more than 50 conferences, and has recorded more than three dozen webinars.

Kit co-leads the CDISC Medical Devices Standards team, is a member of the CDISC CDASH (data capture) management team, a CDISC Registered Solutions Provider and an official CDISC trainer. She is a certified clinical data manager and serves on the Society for Clinical Data Management’s Editorial Board. Kit an instructor in the School of Medicine’s Program in Public Health at Michigan State University and holds a graduate degree in Clinical Research Design and Statistical Analysis from the University of Michigan.

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