| Description |
1 online resource (xvii, 250 pages) |
| Contents |
Front Matter -- Challenges to the Design of Clinical Study -- Challenges to Managing the Study -- Selection of Historic Controls -- Fraud and Misconduct in Clinical Trials -- Challenges to the Regulation of Medical Device -- Challenges of Global Clinical Studies and the CE Mark Process -- Challenging FDA PMA Cases -- Bioethics in Clinical Research -- Glossary of Clinical, CE Mark, and Statistical Terms -- References -- Index |
|
Challenges to the design of clinical study -- Challenges to managing the study -- Selection of historic controls -- Fraud and misconduct in clinical trials -- Challenges to the regulation of medical device -- Challenges of global clinical studies and the CE mark process -- Challenging FDA PMA cases -- Bioethics in clinincal research |
| Summary |
Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It discusses key obstacles such as challenges to patient recruitment, investigator and study site selection, and dealing with compliance issues. Through practical examples, professionals working with medical device clinical trials will discover the appropriate s |
| Bibliography |
Includes bibliographical references and index |
| Notes |
English |
|
Print version record |
| Subject |
Medical instruments and apparatus -- Research
|
|
Clinical trials.
|
|
Clinical Trials as Topic -- methods
|
|
Equipment and Supplies
|
|
Device Approval
|
|
MEDICAL -- Instruments & Supplies.
|
|
Clinical trials
|
|
Medical instruments and apparatus -- Research
|
| Form |
Electronic book
|
| LC no. |
2009045887 |
| ISBN |
9781118164617 |
|
111816461X |
|
9780470602256 |
|
0470602252 |
|
9781118164624 |
|
1118164628 |
|
1283273969 |
|
9781283273961 |
|
9786613273963 |
|
6613273961 |
|
1118125452 |
|
9781118125458 |
|
