| Stark NJ, Investigator's Guide to Clinical Research, Clinical Device Group Inc, Chicago, IL. (2002) Three-ring bound, illustrated, 182 pages. $100 US |
Let's face it, device studies are a little different, and no matter how knowledgeable you are about pharmaceuticals, the device rules don't always make sense. To confound the issue, many sponsor's want to use the data on the other side of the Atlantic, meaning you have to have a passing knowledge of what the other continent expects, in order to give the sponsor the study they need. The Investigator's Guide is the resource for you: An easy and entertaining read, it applies the familiar principles of clinical research methodology to the unique world of medical device evaluations; illustrating the concepts with practical case studies and friendly artwork.
Contents
Good Clinical Practices
Clinical Trials in the United States
Clinical Trials in the European Union
Organizing Your Study Site Efficiently
Seven FDA Guidances
Example Warning Letters
Seven Model SOPs
Certification Exam