Handbook of SOPs for Good Clinical Practice, Second Edition Review

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(More customer reviews)The need for writing and implementing effective SOPs in a whole spectrum of fields is on an exponential rise. Unfortuntely, there aren't many SOP books available in the market. This book by Celine Clive is one of a very few fine books on SOPs. It provides quite a few ready to go SOP templates in the clinical field. The templates seem to be consistent with the International standards. The List of SOPs covered include Spnosor/monitor/CRO SOPs, Investigational site SOPs, and Institutional Rebiew Board SOPs. The book also includes some useful forms in the clinical industy. One thing that may concern the reader is that the book is priced very high.
Again, the book is focussed on the clinical industry. If you want a book to learn the basics of writing and implementing effective SOPs that could be applied to any field, begin with the following book:
SOP Workshop: Workshop in a Book on Standard Operating Procedures for Biotechnology, Health Science, and Other Industries
If you are a beginner in the field of SOPs, this book by Dr. Paul Sanghera is your book. It explains the basic SOP concepts from scratch and offers simple examples, exercises, and templates. It's a general book on SOPs that can be used by any reader in any field. It's a good starting point for any professional in any field who wants to start with writing and implementing effective SOPs. Topics covered include: Introduction to SOPs *Effective SOPs *Producing Effective SOPs *Living with Approved SOPs: following, monitoring, and controlling SOPs *Process Based Approach to SOPs *Solutions to Self Test Exercises * Example SOP Templates *Glossary of terms. I specifically like the process based approach to SOPs: very innovative and useful approach. The price is right.
After this book, you can use the book by Celine Clive reviewed above if you are in the clinical field. There is also another good book on SOPs reviewed below:
SOP Guidelines
This book by D.H. Shah covers SOPs in quite a few areas including Production, Quality Control, Quality Assurance, Stores, Engineering, Maintenance and Housekeeping. It also contains SOP templates in these fields. A good collection of SOPs on Tablets & Capsules, Ointments, Quality Control, Liquid Orals, and Sterile Preparations. The book is highly priced, but useful.




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Completely revised and updated, this second edition of a classic handbook provides templates of SOPs ready for immediate adaptation to readers' requirements, allowing them to benchmark their existing SOPs against an internationally accepted set of SOPs. It includes a CD-ROM containing an electronic copy of each of the SOPs and forms in the handbook so that readers can easily modify the text to reflect their organization's processes. The language ranges from the specific to the very general, depending on the activity described and the number of the existing regulations governing it. The handbook gives readers a starting point for the development of their company or institution's SOPs.

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Handbook of Statistics, Volume 27: Epidemiology and Medical Statistics Review

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(More customer reviews)This series is a long and successful collection of volumes on the most important topics in statistics. Professor Krishnaiah from the University of Pittsburgh was one of the first editors. When the famous Professor C. R. Rao moved from India to the US he joined his colleague Krishnaiah at Pittsburgh and helped coedit some of these handbooks. After Krishnaiah's death Professor Rao continued to edit these volumes and brought in some of his colleagues as co-editors.
This is volume 27 and it contains 27 chapters on the topic of medical statistics and epidemiology. This is very important to me as I work in the medical research area.
The editors have assembly the leading experts in statistical methodology and applied biostatistical reserach to produce these 27 chapters.
Ross Prentice (coauthor of 2 edition of a book on survival analysis and the Cox model) wrote an overview chapter on the topics to be covered. He has had a long career at the Fred Hutchinson Cancer Research Center in Seattle Washington. Fred Hutchinson was a famous manager for the Cincinnati Reds in the early 1960s and brought them to the World Series in 1961. He died of cancer and his estate started an endowment to form this research center.
Don Rubin covers causal analysis in Chapter 2. Rubin is an expert on causal inference, Bayesian methods and missing data. He presents the randomized trial approaches of Fisher and Neyman introduces propensity scores. A Bayesian approach is also covered.
Other chapters cover epidemiologic study designs, assessments for biomarkers, linear and nonlinear regression models, logistic regression, regression models for count data, mixed linear and nonlinear models, survival analysis, competing risk models, cluster analysis, factor analysis, structural equation models, crossover trials, group sequential methods, early phase trials (I and II), late phase (III and IV), missing data, Meta-Analysis, multiple comparisons, sample size determination
statistical learning using splines, evidence based medicine, marginal regression models, use of difference equations in modeling and the Bayesian approach to medical inference.
This volume is over 800 pages and each chapter is fairly long and includes large bibliographies.

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