ICH Quality Guidelines: An Implementation Guide, Teasdale

In the first edition of this book published in 2008, the EFC Working Parties WP13 and WP15 engaged together to provide guidelines on managing CUI with contributions from a number of European refining, petrochemical and offshore companies. The guidelines are intended for use on all plants and installation that contain insulated vessels, piping and equipment. The guidelines cover a risk-based inspection methodology for CUI, inspection techniques and recommended best practice for mitigating CUI, including design of plant and equipment, coatings and the use of thermal spray techniques, types of insulation, cladding/jacketing materials and protection guards. The guidelines also include case studies.

The original document first published in 2008 was very successful and provided an important resource in the continuing battle to mitigate CUI. Many members of the EFC corrosion community requested an update and this has taken between 18-24 months to do so. Hopefully this revised document will continue to serve the community providing a practical source of information on how to monitor and manage insulated systems.

Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research explains how to determine sample size for studies with correlated outcomes, which are widely implemented in medical, epidemiological, and behavioral studies.

The book focuses on issues specific to the two types of correlated outcomes: longitudinal and clustered. For clustered studies, the authors provide sample size formulas that accommodate variable cluster sizes and within-cluster correlation. For longitudinal studies, they present sample size formulas to account for within-subject correlation among repeated measurements and various missing data patterns. For multiple levels of clustering, the level at which to perform randomization actually becomes a design parameter. The authors show how this can greatly impact trial administration, analysis, and sample size requirement.

Addressing the overarching theme of sample size determination for correlated outcomes, this book provides a useful resource for biostatisticians, clinical investigators, epidemiologists, and social scientists whose research involves trials with correlated outcomes. Each chapter is self-contained so readers can explore topics relevant to their research projects without having to refer to other chapters.