Tom Clancy's Splinter Cell 3: Chaos Theory
Author: Prima Temp Authors
• Complete Walkthrough for Every Mission
• All Secret Bonus Objectives Revealed
• Discover Hidden Alternate Paths to Victory
• Killer Co-op Strategies
• Full Coverage of Every Version
• Learn Scores of Deadly Techniques in our Detailed Training Section
Book review: Comunicação Crítica Contínua:Planejamento, Direção, e Resposta
Practical Guide to Clinical Data Management
Author: Susanne Prokscha
Introducing professionals to the role of data management in clinical trials, Practical Guide to Clinical Data Management highlights current thinking about data management, focusing on responsibilities that typical data managers have today. This second edition includes detailed requirements of 21CFR11, the standard for electronic records and signatures. It features new chapters on training of data collection staff as well as controlling access and security. It explores software applications for CDM and explains how to use computerized data collection software. It addresses clinical data for drug and medical device trials. It also presents overviews of various documents for use as templates.
Table of Contents:
| Ch. 1 | The data management plan | 3 |
| Ch. 2 | CRF design considerations | 9 |
| Ch. 3 | Database design considerations | 19 |
| Ch. 4 | Study setup | 35 |
| Ch. 5 | Entering data | 43 |
| Ch. 6 | Tracking CRF pages and corrections | 53 |
| Ch. 7 | Cleaning data | 61 |
| Ch. 8 | Managing laboratory data | 75 |
| Ch. 9 | Collecting adverse event data | 89 |
| Ch. 10 | Creating reports and transferring data | 99 |
| Ch. 11 | Locking studies | 107 |
| Ch. 12 | Standard operating procedures and guidelines | 117 |
| Ch. 13 | Training | 127 |
| Ch. 14 | Controlling access and security | 133 |
| Ch. 15 | Working with CROs | 139 |
| Ch. 16 | Clinical data management systems | 149 |
| Ch. 17 | Electronic data capture systems | 153 |
| Ch. 18 | Choosing vendor products | 163 |
| Ch. 19 | Implementing new systems | 171 |
| Ch. 20 | System validation | 179 |
| Ch. 21 | Test procedures | 187 |
| Ch. 22 | Change control | 193 |
| Ch. 23 | Coding dictionaries | 199 |
| Ch. 24 | Migrating and archiving data | 209 |
| App. A | Data management plan outline | 215 |
| App. B | Typical data management standard operating procedures | 219 |
| App. C | CRO-sponsor responsibility matrix | 221 |
| App. D | Implementation plan outline | 223 |
| App. E | Validation plan outline | 225 |
| App. F | CDISC and HIPAA | 227 |
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