Customer Reviews

eClinical Trials: Planning and Implementation

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"eClinical Trials: Planning & Implementation" is an excellent guide for clinical researchers interested in taking advantage of the electronic techology that is becoming increasingly available. In such a highly-regulated industry, there are a lot of questions before someone moves from the comfortable environment of paper-based clinical trials to the less-familiar ground of electronic records. This book addresses such topics as data quality and data integrity, safety surveillance and IRBs, and the regulatory environment's intent and impact on clinical trials. The material in this book is presented in a way that can help a researcher understand the implications using the new technologies and processes in planning and implementing a clinical trial.

Given the relative dearth of clear, accessible, relevant literature on applying electronic technologies to clinical trials, this book is a rare find. It begins with a comprehensive and easy-to-understand overview of the clinical trial process and then methodically moves through the process of applying electronic data capture and other electronic technologies to existing workflows. It paints a realistic picture, giving credence to the advantages of using EDC and CTMS while including frequent reality checks, acknowledging the relative infancy of these technologies. I used this book as a part of my study curriculum for preparing for the Certified Clinical Data Manager (CCDM) examination, and I believe it helped immensely. I especially recommend the book if you're preparing for that exam.