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Vous voulez être sûr que vos cadeaux seront sous le sapin de Noël à temps? Nos magasins vous accueillent à bras ouverts. La plupart de nos magasins sont ouverts également les dimanches, vous pouvez vérifier les heures d'ouvertures sur notre site.
- Retrait gratuit dans votre magasin Club
- 7.000.0000 titres dans notre catalogue
- Payer en toute sécurité
- Toujours un magasin près de chez vous
Description
This newly updated edition of the benchmark guide to computer-assisted clinical trials provides a comprehensive primer for prospective managers. It covers every critical issue of the design and conduct of clinical trials, including study design, organization, regulatory agency liaison, data collection and analysis, as well as recruitment, software, monitoring, and reporting.
Keeping the same user-friendly format as the original, this Second Edition features new examples and the latest developments in regulatory guidelines, such as e-submission procedures and computerized direct data acquisition. The new edition also reflects the increasing globalization of clinical trial activities, and includes new information about international standards and procedures, including the Common Technical Document and CDISC standards.
This step-by-step guide is supported by handy checklists and extracts from submitted protocols. Experienced author and consultant Phillip Good incorporateshumorous yet instructive anecdotes to illustrate common pitfalls. Based on the proven industrial formula of planning, implementing, and finally performing essential checks, the book's three sections-"Plan," "Do," and "Check"-includethe following material:
* Should the trials be conducted?
* Put it in the computer and keep it there
* Staffing for success
* Designing trials and determining sample size
* Budgeting
* Recruiting and retaining patients and physicians
* Data management
* Monitoring the trials
* Data analysis
* After action review
* Exception handling
Executive and managerial professionals involved in the design and analysis of clinical experiments, along with clinical research associates, biostatisticians, and students in public health will find A Manager's Guide an indispensable resource.
Praise for the First Edition:
". . . readable, informative and at times witty . . . never stops being concise and well written . . . a book worth a read . . ."
-Statistics in Medicine
"The book is very prescriptive and full of lists and tables with which to guide managers in making effective decisions in using computer-assisted clinical trials in pharmaceutical studies." -Technometrics
"This book is must-have reading for anyone in the business . . ."
-Clinical Chemistry
Keeping the same user-friendly format as the original, this Second Edition features new examples and the latest developments in regulatory guidelines, such as e-submission procedures and computerized direct data acquisition. The new edition also reflects the increasing globalization of clinical trial activities, and includes new information about international standards and procedures, including the Common Technical Document and CDISC standards.
This step-by-step guide is supported by handy checklists and extracts from submitted protocols. Experienced author and consultant Phillip Good incorporateshumorous yet instructive anecdotes to illustrate common pitfalls. Based on the proven industrial formula of planning, implementing, and finally performing essential checks, the book's three sections-"Plan," "Do," and "Check"-includethe following material:
* Should the trials be conducted?
* Put it in the computer and keep it there
* Staffing for success
* Designing trials and determining sample size
* Budgeting
* Recruiting and retaining patients and physicians
* Data management
* Monitoring the trials
* Data analysis
* After action review
* Exception handling
Executive and managerial professionals involved in the design and analysis of clinical experiments, along with clinical research associates, biostatisticians, and students in public health will find A Manager's Guide an indispensable resource.
Praise for the First Edition:
". . . readable, informative and at times witty . . . never stops being concise and well written . . . a book worth a read . . ."
-Statistics in Medicine
"The book is very prescriptive and full of lists and tables with which to guide managers in making effective decisions in using computer-assisted clinical trials in pharmaceutical studies." -Technometrics
"This book is must-have reading for anyone in the business . . ."
-Clinical Chemistry
Spécifications
Parties prenantes
- Auteur(s) :
- Editeur:
Contenu
- Nombre de pages :
- 272
- Langue:
- Anglais
- Collection :
Caractéristiques
- EAN:
- 9780471788706
- Date de parution :
- 01-04-06
- Format:
- Livre relié
- Format numérique:
- Genaaid
- Dimensions :
- 164 mm x 240 mm
- Poids :
- 585 g
